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The purpose of this study is to assess the efficacy and safety of repeating dTpa booster in adults 10 years after previous booster vaccination with dTpa in a previous clinical study (NCT01267058). Only subjects who received the booster vaccination in a previous clinical study are eligible for participation in this study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
No new recruitment will be performed in this booster phase (see inclusion criteria).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Boostrix I Group | Experimental | Subjects who had received the Boostrixâ„¢ vaccine in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the same vaccine, intramuscularly in the deltoid region of the non-dominant arm. |
|
| Boostrix II Group | Active Comparator | Subjects who had received the Td vaccines in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the Boostrixâ„¢ vaccine intramuscularly in the deltoid region of the non-dominant arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Boostrixâ„¢ | Biological | Intramuscular injection, 1 dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations Equal to or Above (≥) 0.1 International Units Per Milliliter (IU/mL) | Cut-off values defining seroprotected subjects against anti-DT/anti-TT were greater than or equal to (≥) 0.1 IU/mL as assessed by the Enzyme-Linked Immunosorbent Assay (ELISA). The analysis was performed and presents results only for subjects who in the previous study NCT01267058, had received the Boostrix™ vaccine as first booster. | One month after the booster vaccination [PI(M1)] |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Equal to or Above Cut-off Values | Cut-off values, as assessed by ELISA, were greater than or equal to (≥) 0.1 IU/mL and (≥) 1 IU/mL. | Prior to (PRE) and one month after [PI(M1)] the booster vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Westmead | New South Wales | 2145 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20974302 | Background | Booy R, Van der Meeren O, Ng SP, Celzo F, Ramakrishnan G, Jacquet JM. A decennial booster dose of reduced antigen content diphtheria, tetanus, acellular pertussis vaccine (Boostrix) is immunogenic and well tolerated in adults. Vaccine. 2010 Dec 10;29(1):45-50. doi: 10.1016/j.vaccine.2010.10.025. Epub 2010 Oct 23. | |
| Background | Booy R et al. The decennial administration of a reduced antigen content diphtheria, tetanus, acellular pertussis vaccine (dTpa; BoostrixTM) in adults. Abstract presented at IDSA. Philadelphia, USA, 29 October- 1 November 2009. | ||
| Background | Mertsola J et al. The immunogenicity of repeated administration of reduced-antigen-content dTpa booster in adults. Abstract presented at WSPID. Buenos Aires, Argentina, 19-22 November 2009. | ||
| Background |
| 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 |
|---|---|---|---|
| 110804 | Informed Consent Form | View IPD |
IPD is available via the Clinical Study Data Request site (click on the link provided below)
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
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| ID | Title | Description |
|---|---|---|
| FG000 | Boostrix I Group | Subjects who had received the Boostrixâ„¢ vaccine in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the same vaccine, intramuscularly in the deltoid region of the non-dominant arm. |
| FG001 | Boostrix II Group | Subjects who had received the Td vaccines in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the Boostrixâ„¢ vaccine intramuscularly in the deltoid region of the non-dominant arm. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Boostrix I Group | Subjects who had received the Boostrixâ„¢ vaccine in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the same vaccine, intramuscularly in the deltoid region of the non-dominant arm. |
| BG001 | Boostrix II Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations Equal to or Above (≥) 0.1 International Units Per Milliliter (IU/mL) | Cut-off values defining seroprotected subjects against anti-DT/anti-TT were greater than or equal to (≥) 0.1 IU/mL as assessed by the Enzyme-Linked Immunosorbent Assay (ELISA). The analysis was performed and presents results only for subjects who in the previous study NCT01267058, had received the Boostrix™ vaccine as first booster. | The ATP cohort for immunogenicity included all evaluable subjects who had received the booster dose of Boostrix™ vaccine and for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination blood-sampling time point. | Posted | Count of Participants | Participants | One month after the booster vaccination [PI(M1)] |
|
Solicited symptoms: during the 4-day (Days 0-3) follow-up period post booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) follow-up period post booster vaccination; SAEs: during the entire study period (following booster vaccination).
For safety assessment Boostrix I Group and Boostrix II Group were pooled into Booster Pooled Group.
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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 Pooled Group | Subjects who had received the Boostrixâ„¢ and the Td vaccines in the primary study 263855/002 (NCT01267058) administrated intramuscularly in the deltoid region of the non-dominant arm were boosted in the current study with one dose of Boostrixâ„¢ vaccine, intramuscularly in the deltoid region of the non-dominant arm. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA 9.0 | Systematic Assessment |
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| 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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| Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations |
Concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL). |
| Prior to (PRE) and one month after [PI(M1)] the booster vaccination |
| Number of Subjects With Anti-DT and Anti-TT Antibody Concentrations Equal to or Above Cut-off Values | Cut-off values, as assessed by ELISA, were greater than or equal to (≥) 0.1 IU/mL and ≥ 1 IU/mL. This endpoint presents results for subjects included in the ATP cohort for antibody persistence. | Prior (PRE) to booster vaccination |
| Anti-DT and Anti-TT Antibody Concentrations | Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL). | Prior to the booster vaccination |
| Number of Seronegative Subjects for Anti-DT Antibodies - ELISA | Seronegative subjects were defined as subjects with anti-DT antibody concentrations < 0.1 IU/mL prior to vaccination, as assessed by ELISA. | Prior the booster vaccination |
| Number of Seronegative Subjects for Anti-DT Antibodies - Neutralisation Test | Sera with ELISA concentrations <0.1 IU/mL before vaccination were tested for neutralising antibodies using a Vero-cell neutralisation assay. Concentrations ≥0.016 IU/mL by Vero-cell indicated detectable anti-diphteria neutralising antibodies. | Prior the booster vaccination |
| Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies | Cut-off values, as assessed by ELISA, were greater than or equal to ≥ 5 ELISA Units per millilitre (EL.U/mL) defining seropositive subjects post-vaccination. | Prior the booster vaccination |
| Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EL.U/mL) | Prior the booster vaccination |
| Number of Seronegative Subjects for Anti-DT Antibodies - ELISA. | Seronegative subjects were defined as subjects with anti-DT antibody concentrations < 0.1 IU/mL prior to vaccination, as assessed by ELISA. | Prior to the booster vaccination |
| Number of Seronegative Subjects for Anti-DT Antibodies - Neutralisation Test. | Sera with ELISA concentrations <0.1 IU/mL before vaccination were tested for neutralising antibodies using a Vero-cell neutralisation assay. Concentrations ≥0.016 IU/mL by Vero-cell indicated detectable anti-diphteria neutralising antibodies. | Prior to the booster vaccination |
| Number of Seronegative Subjects for Anti-DT Antibodies - ELISA | Seronegative subjects were defined as subjects with anti-DT antibody concentrations < 0.1 IU/mL prior to vaccination, as assessed by ELISA. | One month after the booster vaccination |
| Number of Seronegative Subjects for Anti-DT Antibodies - Neutralisation Test | Sera with ELISA concentrations <0.1 IU/mL before vaccination were tested for neutralising antibodies using a Vero-cell neutralisation assay. Concentrations ≥ 0.016 IU/mL by Vero-cell indicated detectable anti-diphteria neutralising antibodies. | One month after the booster vaccination |
| Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies | Cut-off values, as assessed by ELISA, were greater than or equal to ≥ 5 ELISA Units per millilitre (EL.U/mL) defining seropositive subjects post-vaccination. | Prior to (PRE) and one month after [PI(M1)] the booster vaccination |
| Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EL.U/mL). | Prior to (PRE) and one month after [PI(M1)] the booster vaccination |
| Number of Subjects With Booster Response to Anti-PT, Anti-FHA and Anti-PRN | Booster response was defined as appearance of antibodies in subjects who were seronegative at the pre-vaccination time point (i.e. with concentrations < 5 El.U/mL) or at least 2-fold increase of pre-vaccination antibody concentrations in subjects who were seropositive at the pre-vaccination time point (i.e. with concentrations ≥5 El.U/mL). | One month after the booster vaccination |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. Relationship analysis was not performed. For safety assessment Boostrix I Group and Boostrix II Group were pooled into Booster Pooled Group. | During the 4-day (Day 0-3) follow-up period after booster vaccination |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Assessed solicited general symptoms were fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], headache, gastrointestinal symptoms [nausea, vomiting, diarrhoea and/or abdominal pain]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. For safety assessment Boostrix I Group and Boostrix II Group were pooled into Booster Pooled Group. | During the 4-day (Day 0-3) follow-up period after booster vaccination |
| Number of Subjects With Any 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. For safety assessment Boostrix I Group and Boostrix II Group were pooled into Booster Pooled Group. | During the 31-day (Day 0-30) follow-up period after booster vaccination |
| 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. For safety assessment Boostrix I Group and Boostrix II Group were pooled into Booster Pooled Group. | Following the booster vaccination |
| Mertsola J et al. The safety of repeated administration of Boostrixâ„¢, a reduced-antigen-content dTpa booster. Abstract presented at Excellence In Paediatrics (EIP). Florence, Italy, 3-6 December 2009. |
| Background | Mertsola J et al. The safety of repeated administration of reduced-antigen-content dTpa boosters. Abstract presented at WSPID. Buenos Aires, Argentina, 19-22 November 2009. |
For additional information about this study please refer to the GSK Clinical Study Register |
| 110804 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110804 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110804 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110804 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110804 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110804 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
Subjects who had received the Td vaccines in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the Boostrixâ„¢ vaccine intramuscularly in the deltoid region of the non-dominant arm. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
Subjects who had received the Boostrixâ„¢ vaccine in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the same vaccine, intramuscularly in the deltoid region of the non-dominant arm. |
| OG001 | Boostrix II Group | Subjects who had received the Td vaccines in the primary study 263855/002 (NCT01267058), were boosted in the current study with one dose of the Boostrixâ„¢ vaccine intramuscularly in the deltoid region of the non-dominant arm. |
|
|
| Secondary | Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Equal to or Above Cut-off Values | Cut-off values, as assessed by ELISA, were greater than or equal to (≥) 0.1 IU/mL and (≥) 1 IU/mL. | The ATP cohort for immunogenicity included all evaluable subjects who had received the booster dose of Boostrix™ vaccine and for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination blood-sampling time point. | Posted | Count of Participants | Participants | Prior to (PRE) and one month after [PI(M1)] the booster vaccination |
|
|
|
| Secondary | Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations | Concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL). | The ATP cohort for immunogenicity included all evaluable subjects who had received the booster dose of Boostrixâ„¢ vaccine and for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination blood-sampling time point. | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | Prior to (PRE) and one month after [PI(M1)] the booster vaccination |
|
|
|
| Secondary | Number of Subjects With Anti-DT and Anti-TT Antibody Concentrations Equal to or Above Cut-off Values | Cut-off values, as assessed by ELISA, were greater than or equal to (≥) 0.1 IU/mL and ≥ 1 IU/mL. This endpoint presents results for subjects included in the ATP cohort for antibody persistence. | The ATP cohort for antibody persistence included all subjects who had not received any additional dose of DTP vaccine after the booster dose received in study 263855/002 (dTpa-002), with no evidence of diphtheria, tetanus, or pertussis infection or disease, and for whom serological results were available at the pre-booster blood sampling time point | Posted | Count of Participants | Participants | Prior (PRE) to booster vaccination |
|
|
|
| Secondary | Anti-DT and Anti-TT Antibody Concentrations | Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL). | The ATP cohort for antibody persistence included all subjects who had not received any additional dose of DTP vaccine after the booster dose received in study 263855/002 (dTpa-002), with no evidence of diphtheria, tetanus, or pertussis infection or disease, and for whom serological results were available at the pre-booster blood sampling time point | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | Prior to the booster vaccination |
|
|
|
| Secondary | Number of Seronegative Subjects for Anti-DT Antibodies - ELISA | Seronegative subjects were defined as subjects with anti-DT antibody concentrations < 0.1 IU/mL prior to vaccination, as assessed by ELISA. | The ATP cohort for antibody persistence included all subjects who had not received any additional dose of DTP vaccine after the booster dose received in study 263855/002 (dTpa-002), with no evidence of diphtheria, tetanus, or pertussis infection or disease, and for whom serological results were available at the pre-booster blood sampling time point | Posted | Count of Participants | Participants | Prior the booster vaccination |
|
|
|
| Secondary | Number of Seronegative Subjects for Anti-DT Antibodies - Neutralisation Test | Sera with ELISA concentrations <0.1 IU/mL before vaccination were tested for neutralising antibodies using a Vero-cell neutralisation assay. Concentrations ≥0.016 IU/mL by Vero-cell indicated detectable anti-diphteria neutralising antibodies. | This analysis was performed on those participants from the According to Protocol (ATP) cohort for antibody persistence who were found to be seronegative for anti-diphtheria antibodies as tested by ELISA. | Posted | Count of Participants | Participants | Prior the booster vaccination |
|
|
|
| Secondary | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies | Cut-off values, as assessed by ELISA, were greater than or equal to ≥ 5 ELISA Units per millilitre (EL.U/mL) defining seropositive subjects post-vaccination. | The ATP cohort for antibody persistence included all subjects who had not received any additional dose of DTP vaccine after the booster dose received in study 263855/002 (dTpa-002), with no evidence of diphtheria, tetanus, or pertussis infection or disease, and for whom serological results were available at the pre-booster blood sampling time point | Posted | Count of Participants | Participants | Prior the booster vaccination |
|
|
|
| Secondary | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EL.U/mL) | The ATP cohort for antibody persistence included all subjects who had not received any additional dose of DTP vaccine after the booster dose received in study 263855/002 (dTpa-002), with no evidence of diphtheria, tetanus, or pertussis infection or disease, and for whom serological results were available at the pre-booster blood sampling time point | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | Prior the booster vaccination |
|
|
|
| Secondary | Number of Seronegative Subjects for Anti-DT Antibodies - ELISA. | Seronegative subjects were defined as subjects with anti-DT antibody concentrations < 0.1 IU/mL prior to vaccination, as assessed by ELISA. | The ATP cohort for immunogenicity included all evaluable subjects who had received the booster dose of Boostrixâ„¢ vaccine and for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination blood-sampling time point. | Posted | Count of Participants | Participants | Prior to the booster vaccination |
|
|
|
| Secondary | Number of Seronegative Subjects for Anti-DT Antibodies - Neutralisation Test. | Sera with ELISA concentrations <0.1 IU/mL before vaccination were tested for neutralising antibodies using a Vero-cell neutralisation assay. Concentrations ≥0.016 IU/mL by Vero-cell indicated detectable anti-diphteria neutralising antibodies. | This analysis was performed on those participants from the According to Protocol (ATP) cohort for immunogenicity who were found to be seronegative for anti-diphtheria antibodies as assessed by ELISA. | Posted | Count of Participants | Participants | Prior to the booster vaccination |
|
|
|
| Secondary | Number of Seronegative Subjects for Anti-DT Antibodies - ELISA | Seronegative subjects were defined as subjects with anti-DT antibody concentrations < 0.1 IU/mL prior to vaccination, as assessed by ELISA. | The ATP cohort for immunogenicity included all evaluable subjects who had received the booster dose of Boostrixâ„¢ vaccine and for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination blood-sampling time point. | Posted | Count of Participants | Participants | One month after the booster vaccination |
|
|
|
| Secondary | Number of Seronegative Subjects for Anti-DT Antibodies - Neutralisation Test | Sera with ELISA concentrations <0.1 IU/mL before vaccination were tested for neutralising antibodies using a Vero-cell neutralisation assay. Concentrations ≥ 0.016 IU/mL by Vero-cell indicated detectable anti-diphteria neutralising antibodies. | This analysis was performed on those participants from the According to Protocol (ATP) cohort for immunogenicity who were found to be seronegative for anti-diphtheria antibodies as assessed by ELISA. | Posted | Count of Participants | Participants | One month after the booster vaccination |
|
|
|
| Secondary | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies | Cut-off values, as assessed by ELISA, were greater than or equal to ≥ 5 ELISA Units per millilitre (EL.U/mL) defining seropositive subjects post-vaccination. | The ATP cohort for immunogenicity included all evaluable subjects who had received the booster dose of Boostrix™ vaccine and for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination blood-sampling time point. | Posted | Count of Participants | Participants | Prior to (PRE) and one month after [PI(M1)] the booster vaccination |
|
|
|
| Secondary | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EL.U/mL). | The ATP cohort for immunogenicity included all evaluable subjects who had received the booster dose of Boostrixâ„¢ vaccine and for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination blood-sampling time point. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | Prior to (PRE) and one month after [PI(M1)] the booster vaccination |
|
|
|
| Secondary | Number of Subjects With Booster Response to Anti-PT, Anti-FHA and Anti-PRN | Booster response was defined as appearance of antibodies in subjects who were seronegative at the pre-vaccination time point (i.e. with concentrations < 5 El.U/mL) or at least 2-fold increase of pre-vaccination antibody concentrations in subjects who were seropositive at the pre-vaccination time point (i.e. with concentrations ≥5 El.U/mL). | The ATP cohort for immunogenicity included all evaluable subjects who had received the booster dose of Boostrix™ vaccine and for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination blood-sampling time point. | Posted | Count of Participants | Participants | One month after the booster vaccination |
|
|
|
| Secondary | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. Relationship analysis was not performed. For safety assessment Boostrix I Group and Boostrix II Group were pooled into Booster Pooled Group. | The Total Vaccinated Cohort (TVC) included all vaccinated subjects for whom data were available. | Posted | Count of Participants | Participants | During the 4-day (Day 0-3) follow-up period after booster vaccination |
|
|
|
| Secondary | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Assessed solicited general symptoms were fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], headache, gastrointestinal symptoms [nausea, vomiting, diarrhoea and/or abdominal pain]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. For safety assessment Boostrix I Group and Boostrix II Group were pooled into Booster Pooled Group. | The Total Vaccinated Cohort (TVC) included all vaccinated subjects for whom data were available. | Posted | Count of Participants | Participants | During the 4-day (Day 0-3) follow-up period after booster vaccination |
|
|
|
| Secondary | Number of Subjects With Any 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. For safety assessment Boostrix I Group and Boostrix II Group were pooled into Booster Pooled Group. | The Total Vaccinated Cohort (TVC) included all vaccinated subjects for whom data were available. | Posted | Count of Participants | Participants | During the 31-day (Day 0-30) follow-up period after booster vaccination |
|
|
|
| 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. For safety assessment Boostrix I Group and Boostrix II Group were pooled into Booster Pooled Group. | The Total Vaccinated Cohort (TVC) included all vaccinated subjects for whom data were available. | Posted | Count of Participants | Participants | Following the booster vaccination |
|
|
|
| 0 |
| 203 |
| 0 |
| 203 |
| 163 |
| 203 |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Swelling | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 9.0 | Systematic Assessment |
|
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 |
| Anti-DT ≥ 0.1 IU/mL, PI(M1) |
|
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| Anti-DT ≥ 1 IU/mL, PRE |
|
|
| Anti-DT ≥ 1 IU/mL, PI(M1) |
|
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| Anti-TT ≥ 0.1 IU/mL, PRE |
|
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| Anti-TT ≥ 0.1 IU/mL, PI(M1) |
|
|
| Anti-TT ≥ 1 IU/mL, PRE |
|
|
| Anti-TT ≥ 1 IU/mL, PI(M1) |
|
|
| Anti-DT, PI(M1) |
|
|
| Anti-TT, PRE |
|
|
| Anti-TT, PI(M1) |
|
|
| Anti-DT ≥ 1 IU/mL, PRE |
|
|
| Anti-TT ≥ 0.1 IU/mL, PRE |
|
|
| Anti-TT ≥ 1 IU/mL, PRE |
|
|
| Anti-TT, PRE |
|
|
| Anti-FHA |
|
|
| Anti-PRN |
|
|
| Anti-FHA |
|
|
| Anti-PRN |
|
|
| Anti-PT, PI(M1) |
|
|
| Anti-FHA, PRE |
|
|
| Anti-FHA, PI(M1) |
|
|
| Anti-PRN, PRE |
|
|
| Anti-PRN, PI(M1) |
|
|
| Anti-PT, PI(M1) |
|
|
| Anti-FHA, PRE |
|
|
| Anti-FHA, PI(M1) |
|
|
| Anti-PRN, PRE |
|
|
| Anti-PRN, PI(M1) |
|
|
| Anti-FHA |
|
|
| Anti-PRN |
|
|
| Title | Measurements |
|---|---|
|
| Grade 3 Redness |
|
| Any Swelling |
|
| Grade 3 Swelling |
|
| Title | Measurements |
|---|---|
|
| Any Fever |
|
| Grade 3 Fever |
|
| Related Fever |
|
| Any Gastrointestinal symptom |
|
| Grade 3 Gastrointestinal symptom |
|
| Related Gastrointestinal symptom |
|
| Any Headache |
|
| Grade 3 Headache |
|
| Related Headache |
|