Acellular Pertussis, Diphtheria, Tetanus
Conditions
Keywords
dTpa vaccine, pertussis, Tdap, Boostrix, booster, tetanus, diphtheria
Brief summary
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 prior clinical study. Only subjects who received booster vaccination in the previous clinical study are eligible for participation in this study.
Detailed description
This Protocol Posting has been updated in order to comply with FDA AA, Sep 2007.
Interventions
BIOLOGICALBoostrix TM
Single booster dose of vaccine
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 24 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study. * Subjects who have received dTpa vaccine or Td and pa vaccines in study 263855/004. * A male or female subject, recruited 10 years after booster vaccination in study 263855/004. * Healthy subjects as established by medical history and clinical examination before entering into the study. * If the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must use adequate contraception for 30 days prior to vaccination and continue for 2 months after completion of the vaccination series. * Written informed consent obtained from the subject.
Exclusion criteria
* 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. * Administration of a vaccine not foreseen by the study protocol within 30 days prior to booster vaccination or planned administration during the active study period. * Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product. * Previous booster vaccination against tetanus, diphtheria or pertussis since the last dose received in study 263855/004. * History of documented diphtheria, tetanus, or pertussis diseases. * Any confirmed or suspected immunosuppressive or immunodeficiency condition, based on medical history and physical examination. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period. * Occurrence of transient thrombocytopenia or neurological complications following an earlier immunisation against diphtheria and/or tetanus. * Occurrence of any of the following adverse event after a previous administration of a DTP vaccine : * hypersensitivity reaction to any component of the vaccine, * encephalopathy of unknown aetiology occurring within 7 days following previous vaccination with pertussis-containing vaccine, * fever \>= 40°C within 48 hours of vaccination not due to another identifiable cause, * collapse or shock-like state (hypotonic-hyporesponsiveness episode) within 48 hours of vaccination, * convulsions with or without fever, occurring within 3 days of vaccination. * Acute disease at the time of enrolment. * Pregnant or lactating female. * Female planning to become pregnant or planning to discontinue contraceptive precautions within 2 months after completion of the vaccination series.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Above the Cut-offs | At Month 0 | The antibody concentrations cut-offs assessed were: equal to or above (≥) 0.1 international units per milliliter (IU/mL) and ≥ 1 IU/mL. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | At Month 0 (PRE) and Month 1 (POST) | A seropositive subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 ELISA unit per milli-liter (EL.U/ml) |
| Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | At Month 0 (PRE) and Month 1 (POST) | Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EL.U/mL). |
| Number of Subjects With Booster Response to Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | At Month 1 | 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 prevaccination antibody concentrations in subjects who were seropositive at the pre-vaccination time point (i.e. with concentrations ≥5 El.U/mL. |
| Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations | At Month 0 (PRE) and Month 1 (POST) | Concentrations are presented as international units per millilitre (IU/mL). |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | During the 4-day (Day 0-3) follow-up period after booster vaccination | Assessed solicited general symptoms were fatigue, fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\], headache and gastrointestinal symptoms. 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. |
| Number of Subjects With Unsolicited Adverse Events (AEs) | During the 31-day (Day 0-30) follow-up period after booster vaccination | 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. |
| Number of Subjects With Serious Adverse Events (SAEs) | For safety assessment Boostrix I Group and Boostrix II Group were pooled (Pooled Group) | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | During the 4-day (Day 0-3) follow-up period after booster vaccination | 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. |
Countries
Finland
Participant flow
Pre-assignment details
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
Participants by arm
| Arm | Count |
|---|---|
| Boostrix I Group Subjects, who had received Boostrix vaccine in the primary study (263855/004), received one additional booster dose of Boostrix vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm. | 75 |
| Boostrix II Group Subjects, who had received Wyeth's (formerly Lederle) combined adult diphtheria and tetanus vaccine and GSK Biologicals' acellular pertussis vaccine in the primary study (263855/004), received one booster dose of Boostrix vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm. | 7 |
| Total | 82 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Boostrix I Group | Boostrix II Group | Total |
|---|---|---|---|
| Age, Continuous | 21.1 Years STANDARD_DEVIATION 0.31 | 21.1 Years STANDARD_DEVIATION 0.38 | 21.1 Years STANDARD_DEVIATION 0.33 |
| Sex: Female, Male Female | 66 Participants | 6 Participants | 72 Participants |
| Sex: Female, Male Male | 9 Participants | 1 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 78 / 82 |
| serious Total, serious adverse events | 1 / 82 |
Outcome results
Primary
Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Above the Cut-offs
The antibody concentrations cut-offs assessed were: equal to or above (≥) 0.1 international units per milliliter (IU/mL) and ≥ 1 IU/mL.
Time frame: At Month 1
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine and for whom immunogenicity data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Boostrix I Group | Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Above the Cut-offs | Anti-diphtheria ≥ 0.1 IU/mL | 73 Subjects |
| Boostrix I Group | Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Above the Cut-offs | Anti-tetanus ≥ 0.1 IU/mL | 73 Subjects |
| Boostrix I Group | Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Above the Cut-offs | Anti-diphtheria ≥ 1 IU/mL | 68 Subjects |
| Boostrix I Group | Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Above the Cut-offs | Anti-tetanus ≥ 1 IU/mL | 71 Subjects |
| Boostrix II Group | Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Above the Cut-offs | Anti-diphtheria ≥ 1 IU/mL | 7 Subjects |
| Boostrix II Group | Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Above the Cut-offs | Anti-diphtheria ≥ 0.1 IU/mL | 7 Subjects |
| Boostrix II Group | Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Above the Cut-offs | Anti-tetanus ≥ 1 IU/mL | 7 Subjects |
| Boostrix II Group | Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Above the Cut-offs | Anti-tetanus ≥ 0.1 IU/mL | 7 Subjects |
Primary
Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Above the Cut-offs
The antibody concentrations cut-offs assessed were: equal to or above (≥) 0.1 international units per milliliter (IU/mL) and ≥ 1 IU/mL.
Time frame: At Month 0
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine and for whom immunogenicity data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Boostrix I Group | Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Above the Cut-offs | Anti-tetanus ≥ 0.1 IU/mL | 72 Subjects |
| Boostrix I Group | Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Above the Cut-offs | Anti-diphtheria ≥ 1 IU/mL | 17 Subjects |
| Boostrix I Group | Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Above the Cut-offs | Anti-tetanus ≥ 1 IU/mL | 44 Subjects |
| Boostrix I Group | Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Above the Cut-offs | Anti-diphtheria ≥ 0.1 IU/mL | 61 Subjects |
| Boostrix II Group | Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Above the Cut-offs | Anti-tetanus ≥ 1 IU/mL | 4 Subjects |
| Boostrix II Group | Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Above the Cut-offs | Anti-diphtheria ≥ 1 IU/mL | 0 Subjects |
| Boostrix II Group | Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Above the Cut-offs | Anti-tetanus ≥ 0.1 IU/mL | 7 Subjects |
| Boostrix II Group | Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Above the Cut-offs | Anti-diphtheria ≥ 0.1 IU/mL | 5 Subjects |
Secondary
Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations
Concentrations are presented as international units per millilitre (IU/mL).
Time frame: At Month 0 (PRE) and Month 1 (POST)
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine and for whom immunogenicity data were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Boostrix I Group | Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations | Anti-diphtheria Pre [N=74;7] | 0.318 IU/mL |
| Boostrix I Group | Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations | Anti-diphtheria Post [N=73;7] | 5.994 IU/mL |
| Boostrix I Group | Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations | Anti-tetanus Pre [N=74;7] | 1.246 IU/mL |
| Boostrix I Group | Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations | Anti-tetanus Post [N=73;7] | 9.596 IU/mL |
| Boostrix II Group | Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations | Anti-tetanus Post [N=73;7] | 8.975 IU/mL |
| Boostrix II Group | Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations | Anti-diphtheria Pre [N=74;7] | 0.196 IU/mL |
| Boostrix II Group | Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations | Anti-tetanus Pre [N=74;7] | 0.989 IU/mL |
| Boostrix II Group | Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations | Anti-diphtheria Post [N=73;7] | 3.226 IU/mL |
Secondary
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations
Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EL.U/mL).
Time frame: At Month 0 (PRE) and Month 1 (POST)
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine and for whom immunogenicity data were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Boostrix I Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-PT Pre [N=75;7] | 9.1 EL.U/mL |
| Boostrix I Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-PT Post [N=73;7] | 90.3 EL.U/mL |
| Boostrix I Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-FHA Pre [N=75;7] | 63.8 EL.U/mL |
| Boostrix I Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-FHA Post [N=73;7] | 793.4 EL.U/mL |
| Boostrix I Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-PRN Pre [N=75;7] | 36.9 EL.U/mL |
| Boostrix I Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-PRN Post [N=73;7] | 548.1 EL.U/mL |
| Boostrix II Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-PRN Pre [N=75;7] | 41.8 EL.U/mL |
| Boostrix II Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-PT Pre [N=75;7] | 12.5 EL.U/mL |
| Boostrix II Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-FHA Post [N=73;7] | 584.3 EL.U/mL |
| Boostrix II Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-PT Post [N=73;7] | 116.5 EL.U/mL |
| Boostrix II Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-PRN Post [N=73;7] | 685.3 EL.U/mL |
| Boostrix II Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-FHA Pre [N=75;7] | 118.8 EL.U/mL |
Secondary
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)
A seropositive subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 ELISA unit per milli-liter (EL.U/ml)
Time frame: At Month 0 (PRE) and Month 1 (POST)
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine and for whom immunogenicity data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Boostrix I Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PT Pre [N=75;7] | 46 Subjects |
| Boostrix I Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PT Post [N=73;7] | 73 Subjects |
| Boostrix I Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-FHA Pre [N=75;7] | 75 Subjects |
| Boostrix I Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-FHA Post [N=73;7] | 73 Subjects |
| Boostrix I Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PRN Pre [N=75;7] | 72 Subjects |
| Boostrix I Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PRN Post [N=73;7] | 73 Subjects |
| Boostrix II Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PRN Pre [N=75;7] | 7 Subjects |
| Boostrix II Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PT Pre [N=75;7] | 7 Subjects |
| Boostrix II Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-FHA Post [N=73;7] | 7 Subjects |
| Boostrix II Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PT Post [N=73;7] | 7 Subjects |
| Boostrix II Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PRN Post [N=73;7] | 7 Subjects |
| Boostrix II Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-FHA Pre [N=75;7] | 7 Subjects |
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.
Time frame: During the 4-day (Day 0-3) follow-up period after booster vaccination
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available and with the symptom sheet filled in.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Boostrix I Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any pain | 76 Subjects |
| Boostrix I Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 pain | 8 Subjects |
| Boostrix I Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any redness | 48 Subjects |
| Boostrix I Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 redness | 14 Subjects |
| Boostrix I Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any swelling | 46 Subjects |
| Boostrix I Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 swelling | 15 Subjects |
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 and gastrointestinal symptoms. 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.
Time frame: During the 4-day (Day 0-3) follow-up period after booster vaccination
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available and with the symptom sheet filled in.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Boostrix I Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue | 44 Subjects |
| Boostrix I Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue | 2 Subjects |
| Boostrix I Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue | 36 Subjects |
| Boostrix I Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever | 7 Subjects |
| Boostrix I Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever | 0 Subjects |
| Boostrix I Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever | 7 Subjects |
| Boostrix I Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal symptoms | 14 Subjects |
| Boostrix I Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal symptoms | 1 Subjects |
| Boostrix I Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal symptoms | 8 Subjects |
| Boostrix I Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache | 27 Subjects |
| Boostrix I Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache | 0 Subjects |
| Boostrix I Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache | 22 Subjects |
Secondary
Number of Subjects With Booster Response to Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (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 prevaccination antibody concentrations in subjects who were seropositive at the pre-vaccination time point (i.e. with concentrations ≥5 El.U/mL.
Time frame: At Month 1
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine and for whom immunogenicity data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Boostrix I Group | Number of Subjects With Booster Response to Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PT [N=73;7] | 72 Subjects |
| Boostrix I Group | Number of Subjects With Booster Response to Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-FHA [N=73;7] | 71 Subjects |
| Boostrix I Group | Number of Subjects With Booster Response to Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PRN [N=73;7] | 68 Subjects |
| Boostrix II Group | Number of Subjects With Booster Response to Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PT [N=73;7] | 7 Subjects |
| Boostrix II Group | Number of Subjects With Booster Response to Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-FHA [N=73;7] | 6 Subjects |
| Boostrix II Group | Number of Subjects With Booster Response to Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PRN [N=73;7] | 7 Subjects |
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: For safety assessment Boostrix I Group and Boostrix II Group were pooled (Pooled Group)
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Boostrix I Group | Number of Subjects With Serious Adverse Events (SAEs) | 1 Subjects |
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.
Time frame: During the 31-day (Day 0-30) follow-up period after booster vaccination
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Boostrix I Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 26 Subjects |