Diphtheria-Tetanus-acellular Pertussis Vaccines
Conditions
Keywords
Diphtheria, Pertussis, Tetanus, Immunogenicity
Brief summary
Diphtheria, tetanus and pertussis are common causes of diseases worldwide, with significant morbidity and mortality. The purpose of this study is to assess the immunogenicity, safety and reactogenicity of a single dose of GlaxoSmithKline (GSK) Biologicals' Boostrix vaccine, administered as a booster dose in healthy Russian subjects. An equal number of subjects are expected to be recruited in the following age categories: 4-9 years (children), 10-17 years (adolescents), 18-64 years (adults) and ≥65 years (elderly population). By receiving the Boostrix vaccine, the subjects could be protected against diphtheria, tetanus and pertussis diseases.
Detailed description
The study is a phase III, open-label, self-contained, multi-centre, uncontrolled, single-country study with a single group. Treatment will be allocated in a non-randomised process and stratified by age as 4-9 years (children), 10-17 years (adolescents), 18-64 years (adults) and ≥65 years (elderly population). The study will consist of a single primary epoch (001) starting at Visit 1 (Day 1) with the administration of a single dose of Boostrix vaccine and ending at Visit 2 (Day 31). Blood samples will be collected at Visits 1 and 2. Protocol Amendment 1 was developed to implement the following changes: * Wording parents/Legally Acceptable Representative(s) (LAR\[s\]) was replaced by the wording parent(s)/adoptive parent(s). As per Russian legislation, only parents or adoptive parents can give consent for the enrolment of their child in a clinical trial. No other person is allowed to give consent on behalf of a minor to participate in a clinical trial. * The age groups at inclusion to study were amended according to the approved Boostrix EU label and physiological particularities i.e., from 3-9 to 4-9 years (children), 10-19 to 10-17 years (adolescents), 20-64 to 18-64 years (adults) and ≥65 years (elderly population). * The inclusion criteria have been amended in order to clarify the following, * Children from four to seven years of age who have received diphtheria, tetanus and pertussis vaccination prior to study enrolment as per local recommendations will be enrolled * Subjects eight years of age and older who have received diphtheria, tetanus and pertussis vaccination to the best of their/subjects' parent(s)/subjects' adoptive parent(s) knowledge and did not receive an additional diphtheria, tetanus or pertussis vaccination within five years prior to enrolment in the study will be enrolled. Protocol amendment 2 was developed after the comments from the Russian regulatory authorities \[Ministry of Health (MoH)\]. Adjustments to the text were made to clarify the inclusion and exclusion criteria for enrolment of subjects and the conduct of the study. In addition, adjustments for the reporting period and assessment of adverse events in the safety sections were made for consistency. The newly re-developed and re-validated GSK's DTPa ELISA cut-offs were updated as per the most recent CBER recommendation (2017). Protocol amendment 3 is developed to accommodate older adults (approximately 58 years old and older) who were born before national recommendations in Russia for infant DTP vaccination. Adjustments to the text are made in the inclusion criteria to clarify the enrolment of subjects for age group eight years and above.
Interventions
BIOLOGICALBoostrix
One dose administered intramuscularly in the deltoid muscle of the non-dominant arm in dTap group.
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Masking description
The treatment allocation would be non-randomised and stratified by age into four strata \[4-9 years (children), 10-17 years (adolescents), 18-64 (adults) years and ≥65 years (elderly population)\].
Eligibility
Sex/Gender
ALL
Age
4 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects or subjects' parent(s)/adoptive parent(s) who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * A male or female four years of age and older. * Written informed consent obtained from the subject/from the parent(s)/adoptive parent(s) of the subject prior to performing any study specific procedure. * Written informed assent obtained from subjects aged 14 years to \<18 years. * Healthy subjects as established by medical history and physical examination before entering into the study. * Children 4-7 years of age with documented previous diphtheria, tetanus and pertussis vaccination (primary series and first booster) as per local recommendation prior to study enrolment, but should have not received any further diphtheria-tetanus containing booster planned at 6-7 years of age as per local recommendations or any other diphtheria, tetanus and pertussis containing vaccine. * Subjects eight years of age and older who can report previous diphtheria, tetanus with or without pertussis vaccination - documented or to the best of their/subjects' parent(s)/subjects' adoptive parent(s) knowledge - and did not receive an additional diphtheria, tetanus with or without pertussis vaccination within five years prior to enrolment in the study will be enrolled. * Female subjects of non-childbearing potential may be enrolled in the study. * Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause. * Female subjects of childbearing potential may be enrolled in the study, if the subject: * has practiced adequate contraception within 30 days prior to vaccination, and * has a negative pregnancy test on the day of vaccination, and * has agreed to continue adequate contraception during the entire treatment period and for 1 month after completion of the vaccination.
Exclusion criteria
* Child in care * Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period. * History of previous or intercurrent diphtheria, tetanus or pertussis diseases since birth in subjects four to seven years of age. * History of previous or intercurrent diphtheria, tetanus or pertussis diseases within 5 years prior to enrolment in subjects aged eight years and above. * Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose. For corticosteroids, this will mean prednisone ≥ 20 mg/day (for adult subjects, ≥18 years of age) or ≥ 0.5 mg/kg/day (for paediatric subjects, aged 4-17 years), or equivalent. Inhaled and topical steroids are allowed * Administration of long-acting immune-modifying drugs at any time during the study period. * Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting 30 days before and ending 30 days after the dose of vaccine with the exception of inactivated influenza vaccine which can be given at any time during the study conduct as per the Summary of Product Characteristics (SPC) and according to the local governmental recommendations. * Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device). * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * Family history of congenital or hereditary immunodeficiency. * History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine. * Hypersensitivity to latex. * History of encephalopathy after administration of a previous dose of pertussis vaccine that could not be attributed to another identifiable cause, progressive neurologic disorder, uncontrolled epilepsy or progressive encephalopathy: pertussis vaccine should not be administered to individuals with these conditions until a treatment regimen has been established and the condition has stabilised. * Acute disease and/or fever at the time of enrolment. * Fever is defined as temperature ≥38.0°C. The preferred location for measuring temperature in this study will be the axilla. * Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator. * Acute or chronic, clinically significant uncontrolled pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination and/or laboratory screening tests. * Administration of immunoglobulins and/or any blood products within the 3 months preceding the dose of study vaccine or planned administration during the study period. * Pregnant or lactating female. * Female planning to become pregnant or planning to discontinue contraceptive precautions during the study conduct. * Any medical condition that, in the opinion of the investigator, might interfere with the evaluations required by the study. * Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Seroprotected Subjects for Anti-diphtheria (Anti-D). | At Day 31 | A seroprotected subject was a subject whose anti-D concentrations were greater than or equal to (≥) 0.1 International units per milliliter (IU/ml). Seroprotection was assessed by enzyme-linked immunosorbent assay (ELISA) method. In addition, sera with ELISA concentrations \<0.1 IU/ml were tested for neutralising antibodies using a Vero-cell neutralisation assay. Both the ELISA test (antibody concentrations ≥ 0.1 IU/ml) and Vero-cell test (antibody concentration ≥ 0.01 IU/ml) defined the seroprotection status for the primary endpoint. |
| Number of Seroprotected Subjects for Anti-tetanus (Anti-T). | At Day 31 | A seroprotected subject was a subject whose anti-T concentrations were ≥ 0.1 IU/ml. Seroprotection was assessed by ELISA method. |
| Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN). | At Day 31 | A seropositive subject was a subject whose antibody concentration was greater than or equal to the assay cut-off value. Assay cut-off was 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA and 2.187 IU/mL for anti-PRN respectively. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Solicited Local Symptoms. | During the 4-day (Day 1-4) follow-up period after vaccination. | Assessed solicited local symptoms were pain, redness, swelling. Any = Occurrence of any local symptom regardless of its intensity grade. Any redness and swelling were defined as \> 0 millimeters (mm) diameter for all subjects. |
| Number of Subjects Aged Below 6 Years With Solicited General Symptoms. | During the 4-day (Day 1-4) follow-up period after vaccination. | Assessed solicited general symptoms were Drowsiness, Irritability/Fussiness, Loss of appetite and Fever. Any = Occurrence of any general symptom regardless of its intensity grade and relationship to the study vaccination. Fever was defined as temperature ≥ 38.0 degrees Celsius (°C). The location for measuring temperature was the axilla. |
| Number of Subjects Aged 6 Years and Above With Solicited General Symptoms. | During the 4-day (Day 1-4) follow-up period after vaccination. | Assessed solicited general symptoms were Fatigue, Gastrointestinal symptoms (included nausea, vomiting, diarrhoea and/or abdominal pain), Headache and Fever. Any = Occurence of any general symptom regardless of its intensity grade and relationship to the study vaccination. Fever was defined as axilla temperature ≥ 38 °C. |
| Number of Subjects With a Booster Response to the Diphtheria and Tetanus Antigens | At Day 31 | Booster response to diphtheria (D) and tetanus (T) antigens was defined according to pre-vaccination antibody concentration: 1. for subjects with values \<0.1 IU/ml (i.e. below the seroprotection cut-off), antibody concentrations of at least ≥0.4 IU/ml, one month after vaccination; and 2. for subjects with values ≥0.1 IU/ml (i.e. equal to or above the seroprotection cut-off), an increase in antibody concentrations of at least four times the pre-vaccination concentration, one month after vaccination. Seronegative (S-) subjects are those who have antibody concentration less than (\<) 0.1 IU/mL and seropositive (S+) subjects are those who have antibody concentration ≥ 0.1 IU/mL prior to vaccination. |
| Number of Subjects With Unsolicited Adverse Events (AEs) | During the 31-day (Day 1-31) follow-up period after vaccination | Any unsolicited AE was defined as any AE reported in addition to those solicited during the clinical study. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event. |
| Number of Subjects With Serious Adverse Events (SAEs) | From Day 1 to Day 31 | A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject. |
| Number of Subjects With Large Swelling Reactions. | During the 4-day (Day 1-4) follow-up period after vaccination. | Large injection site reaction for subjects \< 6 years of age defined as a swelling with a diameter of \> 50 mm and for subjects ≥ 6 years of age swelling with a diameter of \> 100 mm, noticeable diffuse swelling or noticeable increase in limb circumference. Any = Occurence of any large swelling regardless of its intensity grade and relationship to the study vaccination. |
| Number of Subjects With a Booster Response to the PT, FHA and PRN Antigens. | At Day 31 | Booster response to PT, FHA and PRN antigens was defined according to pre-vaccination antibody concentrations: 1. for subjects with pre-vaccination values below (\<) the assay cut-off, post-vaccination antibody concentration ≥ 4 times the assay cut-off; and 2. for subjects with pre-vaccination values between the assay cut-off and \<4 times the assay cut-off, post-vaccination antibody concentration ≥ 4 times the pre-vaccination antibody concentration; and for subjects with pre-vaccination antibody concentration ≥ 4 times the assay cut-off, post-vaccination antibody concentration ≥ 2 times the pre-vaccination antibody concentration. Seronegative (S-) subjects are those who have antibody concentration less than (\<) assay cut-off and seropositive (S+) subjects are those who have antibody concentration ≥ assay cut-off prior to vaccination. Assay cut-off was 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti- FHA and 2.187 IU/mL for anti-PRN respectively. |
| Anti-D, Anti-T, Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations , One Month After Vaccination. | At Day 31 | Antibody concentrations are presented as Geometric Mean Concentrations (GMCs) and expressed in IU/mL. The cut-off for the assays were: 0.057 IU/mL for anti-D, 0.043 IU/mL for anti-T, 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA and 2.187 IU/mL for anti-PRN, respectively. |
Countries
Russia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| dTpa Group Healthy female and male subjects aged 4 years and above, who received a single dose of Boostrix vaccine at Day 1. | 447 |
| Total | 447 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 1 |
Baseline characteristics
| Characteristic | dTpa Group |
|---|---|
| Age, Continuous | 32.7 Years STANDARD_DEVIATION 27.29 |
| Race/Ethnicity, Customized White - Caucasian / European Heritage | 447 Participants |
| Sex: Female, Male Female | 241 Participants |
| Sex: Female, Male Male | 206 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 447 |
| other Total, other adverse events | 52 / 447 |
| serious Total, serious adverse events | 1 / 447 |
Outcome results
Primary
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN).
A seropositive subject was a subject whose antibody concentration was greater than or equal to the assay cut-off value. Assay cut-off was 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA and 2.187 IU/mL for anti-PRN respectively.
Time frame: At Day 31
Population: The Per Protocol (PP) Cohort for immunogenicity included all evaluable subjects who had received the dose of study vaccine, met all eligibility criteria, complied with the procedures and intervals defined in the protocol, for whom assay results were available for antibodies against at least one study vaccine antigen component.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| dTpa Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN). | Anti-PT antibody | 430 Participants |
| dTpa Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN). | Anti-FHA antibody | 442 Participants |
| dTpa Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN). | Anti-PRN antibody | 431 Participants |
Primary
Number of Seroprotected Subjects for Anti-diphtheria (Anti-D).
A seroprotected subject was a subject whose anti-D concentrations were greater than or equal to (≥) 0.1 International units per milliliter (IU/ml). Seroprotection was assessed by enzyme-linked immunosorbent assay (ELISA) method. In addition, sera with ELISA concentrations \<0.1 IU/ml were tested for neutralising antibodies using a Vero-cell neutralisation assay. Both the ELISA test (antibody concentrations ≥ 0.1 IU/ml) and Vero-cell test (antibody concentration ≥ 0.01 IU/ml) defined the seroprotection status for the primary endpoint.
Time frame: At Day 31
Population: The Per Protocol (PP) Cohort for immunogenicity included all evaluable subjects who had received the dose of study vaccine, met all eligibility criteria, complied with the procedures and intervals defined in the protocol, for whom assay results were available for antibodies against at least one study vaccine antigen component.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| dTpa Group | Number of Seroprotected Subjects for Anti-diphtheria (Anti-D). | Anti-D antibody ≥ 0.1 IU/ml | 437 Participants |
| dTpa Group | Number of Seroprotected Subjects for Anti-diphtheria (Anti-D). | Neutralizing anti-D antibody ≥ 0.01 IU/ml | 1 Participants |
Primary
Number of Seroprotected Subjects for Anti-tetanus (Anti-T).
A seroprotected subject was a subject whose anti-T concentrations were ≥ 0.1 IU/ml. Seroprotection was assessed by ELISA method.
Time frame: At Day 31
Population: The Per Protocol (PP) Cohort for immunogenicity included all evaluable subjects who had received the dose of study vaccine, met all eligibility criteria, complied with the procedures and intervals defined in the protocol, for whom assay results were available for antibodies against at least one study vaccine antigen component.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| dTpa Group | Number of Seroprotected Subjects for Anti-tetanus (Anti-T). | 439 Participants |
Secondary
Anti-D, Anti-T, Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations , One Month After Vaccination.
Antibody concentrations are presented as Geometric Mean Concentrations (GMCs) and expressed in IU/mL. The cut-off for the assays were: 0.057 IU/mL for anti-D, 0.043 IU/mL for anti-T, 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA and 2.187 IU/mL for anti-PRN, respectively.
Time frame: At Day 31
Population: The Per Protocol (PP) Cohort for immunogenicity included all evaluable subjects who had received the dose of study vaccine, met all eligibility criteria, complied with the procedures and intervals defined in the protocol, for whom assay results were available for antibodies against at least one study vaccine antigen component.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| dTpa Group | Anti-D, Anti-T, Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations , One Month After Vaccination. | Anti-D antibody | 6.287 IU/mL |
| dTpa Group | Anti-D, Anti-T, Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations , One Month After Vaccination. | Anti-T antibody | 13.507 IU/mL |
| dTpa Group | Anti-D, Anti-T, Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations , One Month After Vaccination. | Anti-PT antibody | 59.279 IU/mL |
| dTpa Group | Anti-D, Anti-T, Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations , One Month After Vaccination. | Anti-FHA antibody | 396.938 IU/mL |
| dTpa Group | Anti-D, Anti-T, Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations , One Month After Vaccination. | Anti-PRN antibody | 249.638 IU/mL |
Secondary
Number of Subjects Aged 6 Years and Above With Solicited General Symptoms.
Assessed solicited general symptoms were Fatigue, Gastrointestinal symptoms (included nausea, vomiting, diarrhoea and/or abdominal pain), Headache and Fever. Any = Occurence of any general symptom regardless of its intensity grade and relationship to the study vaccination. Fever was defined as axilla temperature ≥ 38 °C.
Time frame: During the 4-day (Day 1-4) follow-up period after vaccination.
Population: Analysis was performed on subset of TVC which included subjects aged above and equal to 6 years, with the study vaccine administration documented and had solicited symptoms documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| dTpa Group | Number of Subjects Aged 6 Years and Above With Solicited General Symptoms. | Fatigue | 126 Participants |
| dTpa Group | Number of Subjects Aged 6 Years and Above With Solicited General Symptoms. | Gastrointestinal symptoms | 34 Participants |
| dTpa Group | Number of Subjects Aged 6 Years and Above With Solicited General Symptoms. | Headache | 107 Participants |
| dTpa Group | Number of Subjects Aged 6 Years and Above With Solicited General Symptoms. | Fever ( ≥ 38°C), Overall | 10 Participants |
Secondary
Number of Subjects Aged Below 6 Years With Solicited General Symptoms.
Assessed solicited general symptoms were Drowsiness, Irritability/Fussiness, Loss of appetite and Fever. Any = Occurrence of any general symptom regardless of its intensity grade and relationship to the study vaccination. Fever was defined as temperature ≥ 38.0 degrees Celsius (°C). The location for measuring temperature was the axilla.
Time frame: During the 4-day (Day 1-4) follow-up period after vaccination.
Population: Analysis was performed on subset of TVC which included subjects aged below 6 years, with the study vaccine administration documented and had solicited symptoms documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| dTpa Group | Number of Subjects Aged Below 6 Years With Solicited General Symptoms. | Drowsiness | 1 Participants |
| dTpa Group | Number of Subjects Aged Below 6 Years With Solicited General Symptoms. | Irritability/Fussiness | 5 Participants |
| dTpa Group | Number of Subjects Aged Below 6 Years With Solicited General Symptoms. | Loss of appetite | 3 Participants |
| dTpa Group | Number of Subjects Aged Below 6 Years With Solicited General Symptoms. | Fever ( ≥ 38°C) | 0 Participants |
Secondary
Number of Subjects With a Booster Response to the Diphtheria and Tetanus Antigens
Booster response to diphtheria (D) and tetanus (T) antigens was defined according to pre-vaccination antibody concentration: 1. for subjects with values \<0.1 IU/ml (i.e. below the seroprotection cut-off), antibody concentrations of at least ≥0.4 IU/ml, one month after vaccination; and 2. for subjects with values ≥0.1 IU/ml (i.e. equal to or above the seroprotection cut-off), an increase in antibody concentrations of at least four times the pre-vaccination concentration, one month after vaccination. Seronegative (S-) subjects are those who have antibody concentration less than (\<) 0.1 IU/mL and seropositive (S+) subjects are those who have antibody concentration ≥ 0.1 IU/mL prior to vaccination.
Time frame: At Day 31
Population: The Per Protocol (PP) Cohort for immunogenicity included all evaluable subjects who had received the dose of study vaccine, met all eligibility criteria, complied with the procedures and intervals defined in the protocol, for whom assay results were available for antibodies against at least one study vaccine antigen component.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| dTpa Group | Number of Subjects With a Booster Response to the Diphtheria and Tetanus Antigens | Anti-D antibody, S- | 26 Participants |
| dTpa Group | Number of Subjects With a Booster Response to the Diphtheria and Tetanus Antigens | Anti-D antibody, S+ | 282 Participants |
| dTpa Group | Number of Subjects With a Booster Response to the Diphtheria and Tetanus Antigens | Anti-D antibody, Overall | 308 Participants |
| dTpa Group | Number of Subjects With a Booster Response to the Diphtheria and Tetanus Antigens | Anti-T antibody, S- | 38 Participants |
| dTpa Group | Number of Subjects With a Booster Response to the Diphtheria and Tetanus Antigens | Anti-T antibody, S+ | 338 Participants |
| dTpa Group | Number of Subjects With a Booster Response to the Diphtheria and Tetanus Antigens | Anti-T antibody, Overall | 376 Participants |
Secondary
Number of Subjects With a Booster Response to the PT, FHA and PRN Antigens.
Booster response to PT, FHA and PRN antigens was defined according to pre-vaccination antibody concentrations: 1. for subjects with pre-vaccination values below (\<) the assay cut-off, post-vaccination antibody concentration ≥ 4 times the assay cut-off; and 2. for subjects with pre-vaccination values between the assay cut-off and \<4 times the assay cut-off, post-vaccination antibody concentration ≥ 4 times the pre-vaccination antibody concentration; and for subjects with pre-vaccination antibody concentration ≥ 4 times the assay cut-off, post-vaccination antibody concentration ≥ 2 times the pre-vaccination antibody concentration. Seronegative (S-) subjects are those who have antibody concentration less than (\<) assay cut-off and seropositive (S+) subjects are those who have antibody concentration ≥ assay cut-off prior to vaccination. Assay cut-off was 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti- FHA and 2.187 IU/mL for anti-PRN respectively.
Time frame: At Day 31
Population: The Per Protocol (PP) Cohort for immunogenicity included all evaluable subjects who had received the dose of study vaccine, met all eligibility criteria, complied with the procedures and intervals defined in the protocol, for whom assay results were available for antibodies against at least one study vaccine antigen component.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| dTpa Group | Number of Subjects With a Booster Response to the PT, FHA and PRN Antigens. | Anti-PT antibody, S- | 138 Participants |
| dTpa Group | Number of Subjects With a Booster Response to the PT, FHA and PRN Antigens. | Anti-PT antibody, S+ (< 4*assay cut-off) | 140 Participants |
| dTpa Group | Number of Subjects With a Booster Response to the PT, FHA and PRN Antigens. | Anti-PT antibody, S+ (≥ 4*assay cut-off) | 97 Participants |
| dTpa Group | Number of Subjects With a Booster Response to the PT, FHA and PRN Antigens. | Anti-PT antibody, Overall | 375 Participants |
| dTpa Group | Number of Subjects With a Booster Response to the PT, FHA and PRN Antigens. | Anti-FHA antibody, S- | 8 Participants |
| dTpa Group | Number of Subjects With a Booster Response to the PT, FHA and PRN Antigens. | Anti-FHA antibody, S+ (< 4*assay cut-off) | 57 Participants |
| dTpa Group | Number of Subjects With a Booster Response to the PT, FHA and PRN Antigens. | Anti-FHA antibody, S+ (≥ 4*assay cut-off) | 345 Participants |
| dTpa Group | Number of Subjects With a Booster Response to the PT, FHA and PRN Antigens. | Anti-FHA antibody, Overall | 410 Participants |
| dTpa Group | Number of Subjects With a Booster Response to the PT, FHA and PRN Antigens. | Anti-PRN antibody, S- | 57 Participants |
| dTpa Group | Number of Subjects With a Booster Response to the PT, FHA and PRN Antigens. | Anti-PRN antibody, S+ (< 4*assay cut-off) | 114 Participants |
| dTpa Group | Number of Subjects With a Booster Response to the PT, FHA and PRN Antigens. | Anti-PRN antibody, S+ (≥ 4*assay cut-off) | 225 Participants |
| dTpa Group | Number of Subjects With a Booster Response to the PT, FHA and PRN Antigens. | Anti-PRN, Overall | 396 Participants |
Secondary
Number of Subjects With Large Swelling Reactions.
Large injection site reaction for subjects \< 6 years of age defined as a swelling with a diameter of \> 50 mm and for subjects ≥ 6 years of age swelling with a diameter of \> 100 mm, noticeable diffuse swelling or noticeable increase in limb circumference. Any = Occurence of any large swelling regardless of its intensity grade and relationship to the study vaccination.
Time frame: During the 4-day (Day 1-4) follow-up period after vaccination.
Population: Analysis was performed on TVC which included all subjects with the study vaccine administration and solicited symptoms documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| dTpa Group | Number of Subjects With Large Swelling Reactions. | 1 Participants |
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject.
Time frame: From Day 1 to Day 31
Population: Analysis was performed on TVC which included all subjects with the study vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| dTpa Group | Number of Subjects With Serious Adverse Events (SAEs) | 1 Participants |
Secondary
Number of Subjects With Solicited Local Symptoms.
Assessed solicited local symptoms were pain, redness, swelling. Any = Occurrence of any local symptom regardless of its intensity grade. Any redness and swelling were defined as \> 0 millimeters (mm) diameter for all subjects.
Time frame: During the 4-day (Day 1-4) follow-up period after vaccination.
Population: Analysis was performed on Total Vaccinated Cohort (TVC) which included all subjects with the study vaccine administration and solicited symptoms documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| dTpa Group | Number of Subjects With Solicited Local Symptoms. | Pain | 284 Participants |
| dTpa Group | Number of Subjects With Solicited Local Symptoms. | Redness | 207 Participants |
| dTpa Group | Number of Subjects With Solicited Local Symptoms. | Swelling | 174 Participants |
Secondary
Number of Subjects With Unsolicited Adverse Events (AEs)
Any unsolicited AE was defined as any AE reported in addition to those solicited during the clinical study. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
Time frame: During the 31-day (Day 1-31) follow-up period after vaccination
Population: Analysis was performed on TVC which included all subjects with the study vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| dTpa Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 52 Participants |