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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BOOSTRIX NEW GROUP | Experimental | Subjects, aged 10 to 15 years, received one dose of Boostrixâ„¢ vaccine administered using a new syringe presentation (prefilled syringes from a different manufacturer) in the deltoid of the non-dominant arm, at Day 0. |
|
| BOOSTRIX PREV GROUP | Active Comparator | Subjects, aged 10 to 15 years, received one dose of Boostrixâ„¢ 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Boostrix TM (new syringe presentation) | Biological | Single dose, intramuscular administration in a new syringe presentation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | At Month 1 |
| 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) | At Month 1 |
| 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). | At Day 0 |
| 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). | At Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | At Day 0 (PRE) and at Month 1 (POST) |
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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:
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 :
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.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Santiago | Chile | ||||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26075317 | Derived | Pavia-Ruz N, Abarca K, Lepetic A, Cervantes-Apolinar MY, Hardt K, Jayadeva G, Kuriyakose S, Han HH, de la O M. Evaluation of a new syringe presentation of reduced-antigen content diphtheria, tetanus, and acellular pertussis vaccine in healthy adolescents--A single blind randomized trial. Hum Vaccin Immunother. 2015;11(7):1770-4. doi: 10.1080/21645515.2015.1041697. |
| 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 |
|---|---|---|---|
| 114778 | Statistical Analysis Plan | 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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During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
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| ID | Title | Description |
|---|---|---|
| FG000 | Boostrix New Group | Subjects, aged 10 to 15 years, received one dose of Boostrixâ„¢ vaccine administered using a new syringe presentation (prefilled syringes from a different manufacturer) in the deltoid of the non-dominant arm, at Day 0. |
| FG001 | Boostrix Prev Group | Subjects, aged 10 to 15 years, received one dose of Boostrixâ„¢ 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Boostrix New Group | Subjects, aged 10 to 15 years, received one dose of Boostrixâ„¢ vaccine administered using a new syringe presentation (prefilled syringes from a different manufacturer) in the deltoid of the non-dominant arm, at Day 0. |
| BG001 | Boostrix Prev 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 | 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). | 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. | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | At Month 1 |
|
Solicited symptoms during the 4-day post-vaccination period (Day 0 - Day 3), Unsolicited AEs during the 31-day post-vaccination period (Day 0 - Day 30), SAEs during the entire period (Day 0 - Month 1).
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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 New Group | Subjects, aged 10 to 15 years, received one dose of Boostrixâ„¢ vaccine administered using a new syringe presentation (prefilled syringes from a different manufacturer) in the deltoid of the non-dominant arm, at Day 0. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injury | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D004165 | Diphtheria |
| D013742 | Tetanus |
| ID | Term |
|---|---|
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| Boostrix TM (previous syringe presentation) | Biological | Single dose, intramuscular administration in previous syringe presentation |
|
| 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). |
| At Day 0 (PRE) vaccine and at Month 1 (POST) |
| 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). | At Day 0 (PRE) vaccine and at Month 1 (POST) |
| 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. | At Month 1 |
| 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. | At Month 1 |
| 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. | Within 4 days (Days 0-3) post vaccination period |
| 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. | Within 31 days (Days 0-30) post |
| 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. | Within 4 days (Days 0-3) post vaccination period |
| 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. | During the entire study period (Day 0 - Month 1) |
| Monterrey |
| Nuevo León |
| 64460 |
| Mexico |
| GSK Investigational Site | Estado de México | 55075 | Mexico |
For additional information about this study please refer to the GSK Clinical Study Register |
| 114778 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114778 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114778 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114778 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114778 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
Subjects, aged 10 to 15 years, received one dose of Boostrixâ„¢ 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. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Subjects, aged 10 to 15 years, received one dose of Boostrixâ„¢ 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. |
|
|
|
| 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) | 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. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | At Month 1 |
|
|
|
|
| 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). | 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. | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | At Day 0 |
|
|
|
| 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). | 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. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | At Day 0 |
|
|
|
| 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). | 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. | Posted | Count of Participants | Participants | At Day 0 (PRE) and at Month 1 (POST) |
|
|
|
| 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). | 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. | Posted | Count of Participants | Participants | At Day 0 (PRE) vaccine and at Month 1 (POST) |
|
|
|
| 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). | 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. | Posted | Count of Participants | Participants | At Day 0 (PRE) vaccine and at Month 1 (POST) |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | At Month 1 |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | At Month 1 |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Within 4 days (Days 0-3) post vaccination period |
|
|
|
| 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. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of the study vaccine. | Posted | Count of Participants | Participants | Within 31 days (Days 0-30) post |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Within 4 days (Days 0-3) post vaccination period |
|
|
|
| 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. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of the study vaccine. | Posted | Count of Participants | Participants | During the entire study period (Day 0 - Month 1) |
|
|
|
| 1 |
| 335 |
| 263 |
| 335 |
| EG001 | Boostrix Prev Group | Subjects, aged 10 to 15 years, received one dose of Boostrixâ„¢ 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. | 0 | 336 | 279 | 336 |
| Fatigue | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Swelling | General disorders | MedDRA 16.1 | 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.
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D003015 | Clostridium Infections |
| Anti-FHA |
|
|
| Anti-PRN |
|
|
| 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. | Adjusted Ratio | 0.92 | 2-Sided | 95 | 0.83 | 1.03 | Non-Inferiority or Equivalence | Non-inferiority was demonstrated if the upper limit (UL) of the 95% confidence interval (CI) on the geometric mean concentration (GMC) ratios [Boostrix-Prev Group over Boostrix-New Group] for anti-filamentous haemagglutinin (anti-FHA) antibodies was ≤ 1.5 (clinical limit for non-inferiority). |
| 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. | Adjusted ratio | 0.98 | 2-Sided | 95 | 0.85 | 1.13 | Non-Inferiority or Equivalence | Non-inferiority was demonstrated if the upper limit (UL) of the 95% confidence interval (CI) on the geometric mean concentration (GMC) ratios [Boostrix-Prev Group over Boostrix-New Group] for anti-pertactin (anti-PRN) antibodies was ≤ 1.5 (clinical limit for non-inferiority). |
| Anti-FHA PRE |
|
|
| Anti-PRN PRE |
|
|
| Anti-T PRE |
|
| Anti-T POST |
|
| Anti-T PRE |
|
| Anti-T POST |
|
| Anti-PT POST |
|
|
| Anti-FHA PRE |
|
|
| Anti-FHA POST |
|
|
| Anti-PRN PRE |
|
|
| Anti-PRN POST |
|
|
| Anti-FHA |
|
|
| Anti-PRN |
|
|
| Any Swelling |
|
| Any Headache |
|
| Any Temperature |
|