Acellular Pertussis, Diphtheria, Poliomyelitis, Tetanus
Conditions
Keywords
BoostrixTM Polio, dTpa-IPV, booster
Brief summary
This study will evaluate the persistence of immune response against diphtheria, tetanus, pertussis and poliomyelitis in healthy adults, 10 years after a booster dose, and also assess the immunogenicity and safety of another booster dose of BoostrixTM Polio.
Detailed description
This protocol posting has been updated following protocol amendment 1, dated 03 June 2011. The impacted section is: Eligibility Criteria (Exclusion criteria).
Interventions
BIOLOGICALBoostrixTM Polio
Single dose, intramuscular administration.
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes can and will comply with the requirements of the protocol. * Male or female subjects who have received vaccine in study NCT01277705. * Written informed consent obtained from the subject. * Healthy subjects as established by medical history and clinical examination before entering into the study. * Female subjects of non-childbearing potential may be enrolled in the study. * Female subjects of childbearing potential may be enrolled in the study and receive the booster vaccine, if the subject: * practices/has practiced adequate contraception for 30 days prior to vaccination, and * has a negative pregnancy test on the day of vaccination, and * agrees to continue adequate contraception during the entire booster epoch.
Exclusion criteria
* Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the booster dose of the 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. * History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine. * Previous booster vaccination against diphtheria, tetanus, pertussis or poliovirus since the dose received in study NCT01277705. In Germany, previous dose of a monovalent vaccine against pertussis is allowed for subjects in the Group C. * History of diphtheria, tetanus, pertussis or poliomyelitis diseases following the receipt of booster dose in study NCT01277705. * Any confirmed or suspected immunosuppressive or immunodeficiency condition based on medical history and physical examination. * 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 seven 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 within 48 hours of vaccination, * convulsions with or without fever, occurring within 3 days of vaccination. * Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period. * Acute disease and/or fever at the time of enrolment. * Pregnant or lactating female. * Female planning to become pregnant or planning to discontinue contraceptive precautions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens | At Month 1 | A seroprotected subject is defined as a vaccinated subject with anti-D and anti-T antibody concentration greater than or equal to (≥) 0.1 international units per millilitre (IU/mL). |
| Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 | At Month 1 | A seroprotected subject is defined as a vaccinated subject with anti-poliovirus types 1, 2 and 3 antibody concentration greater than or equal to (≥) 8 Effective Dose 50 (ED50) |
| Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies | At Day 0 | Cut-off values assessed were greater than or equal to ≥ 5 Enzyme Linked Immunosorbent Assay (ELISA) units per millilitre (EL.U/ml) |
| Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations | At Day 0 | Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per millilitre (IU/mL) |
| Anti-polio 1, Anti-polio 2 and Anti-polio 3 Antibody Titers | At Day 0 | Titers are presented as geometric mean titers (GMTs). |
| Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Antibody Concentrations | At Day 0 | Concentrations are presented as geometric mean concentrations (GMCs), expressed in expressed in ELISA units per millilitre (EL.U/mL) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | During the 4-day (Day 0-Day 3) follow-up period after 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 Booster Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), Pertactin (PRN) | At Month 1 | Booster response was defined as: for initially seronegative subjects: antibody concentration ≥ 20 EL.U/mL at post booster vaccination; for initially seropositive subjects with pre-vaccination antibody concentration \< 20 EL.U/mL: antibody concentration at post booster ≥ 4 fold the pre-vaccination antibody concentration; and for initially seropositive subjects with pre-vaccination antibody concentration ≥ 20 EL.U/mL: antibody concentration at post booster ≥ 2 fold the pre-vaccination antibody concentration. |
| Number of Subjects With Serious Adverse Events (SAEs). | Month 0 - Month 1 | 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 Unsolicited Adverse Events (AEs). | During the 31-day (Day 0-Day 30) follow-up period after 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. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. |
| Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Above the Cut-off | At Month 1 | Cut-off values assessed were greater than or equal to ≥ 5 Enzyme Linked Immunosorbent Assay (ELISA) units per millilitre (EL.U/ml) |
| Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations | At Month 1 | Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per millilitre (IU/mL) |
| Anti-polio 1, Anti-polio 2 and Anti-polio 3 Antibody Titers | At Month 1 | Titers are presented as geometric mean titers (GMTs). |
| Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Antibody Concentrations | At Month 1 | Concentrations are presented as geometric mean concentrations (GMCs), expressed in expressed in ELISA units per millilitre (EL.U/mL) |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | During the 4-day (Day 0-Day 3) follow-up period after 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
France, Germany
Participant flow
Pre-assignment details
Out of the 212 subjects enrolled, 1 subject number was allocated without the study vaccine being administered to that subject, therefore the total number of subjects was 211.
Participants by arm
| Arm | Count |
|---|---|
| Boostrix Polio Group Healthy subjects who had received one booster dose Boostrix™ Polio vaccine in the NCT01277705 study received one additional booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm. | 67 |
| Boostrix+Poliorix Group Healthy subjects who had received one booster dose of the co-administered Boostrix™ and Poliorix™ vaccines in the NCT01277705 study received one booster dose Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm. | 72 |
| Revaxis Group Healthy subjects who had received one booster dose of Revaxis® vaccine in the NCT01277705 study received one booster dose of Boostrix™ Polio vaccine in this study, administered as an intramuscular injection into the deltoid region of the left arm. | 72 |
| Total | 211 |
Baseline characteristics
| Characteristic | Boostrix Polio Group | Boostrix+Poliorix Group | Revaxis Group | Total |
|---|---|---|---|---|
| Age, Continuous | 50.4 Years STANDARD_DEVIATION 12.82 | 49.2 Years STANDARD_DEVIATION 12.53 | 51.4 Years STANDARD_DEVIATION 13.06 | 50.33 Years STANDARD_DEVIATION 12.78 |
| Sex: Female, Male Female | 35 Participants | 47 Participants | 39 Participants | 121 Participants |
| Sex: Female, Male Male | 32 Participants | 25 Participants | 33 Participants | 90 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 52 / 67 | 54 / 72 | 54 / 72 |
| serious Total, serious adverse events | 0 / 67 | 0 / 72 | 0 / 72 |
Outcome results
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 millilitre (IU/mL)
Time frame: At Day 0
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Boostrix Polio Group | Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations | Anti-D | 0.416 IU/mL |
| Boostrix Polio Group | Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations | Anti-T | 1.371 IU/mL |
| Boostrix+Poliorix Group | Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations | Anti-D | 0.360 IU/mL |
| Boostrix+Poliorix Group | Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations | Anti-T | 1.578 IU/mL |
| Revaxis Group | Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations | Anti-D | 0.501 IU/mL |
| Revaxis Group | Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations | Anti-T | 1.491 IU/mL |
Primary
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Antibody Concentrations
Concentrations are presented as geometric mean concentrations (GMCs), expressed in expressed in ELISA units per millilitre (EL.U/mL)
Time frame: At Day 0
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Boostrix Polio Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Antibody Concentrations | Anti-FHA | 93.7 EL.U/mL |
| Boostrix Polio Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Antibody Concentrations | Anti-PT | 10.3 EL.U/mL |
| Boostrix Polio Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Antibody Concentrations | Anti-PRN | 66.1 EL.U/mL |
| Boostrix+Poliorix Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Antibody Concentrations | Anti-FHA | 124.0 EL.U/mL |
| Boostrix+Poliorix Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Antibody Concentrations | Anti-PT | 13.4 EL.U/mL |
| Boostrix+Poliorix Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Antibody Concentrations | Anti-PRN | 93.9 EL.U/mL |
| Revaxis Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Antibody Concentrations | Anti-PT | 14.7 EL.U/mL |
| Revaxis Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Antibody Concentrations | Anti-PRN | 19.4 EL.U/mL |
| Revaxis Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Antibody Concentrations | Anti-FHA | 68.6 EL.U/mL |
Primary
Anti-polio 1, Anti-polio 2 and Anti-polio 3 Antibody Titers
Titers are presented as geometric mean titers (GMTs).
Time frame: At Day 0
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Boostrix Polio Group | Anti-polio 1, Anti-polio 2 and Anti-polio 3 Antibody Titers | Anti-polio 2 | 308.3 Titers |
| Boostrix Polio Group | Anti-polio 1, Anti-polio 2 and Anti-polio 3 Antibody Titers | Anti-polio 1 | 341.0 Titers |
| Boostrix Polio Group | Anti-polio 1, Anti-polio 2 and Anti-polio 3 Antibody Titers | Anti-polio 3 | 388.9 Titers |
| Boostrix+Poliorix Group | Anti-polio 1, Anti-polio 2 and Anti-polio 3 Antibody Titers | Anti-polio 2 | 322.6 Titers |
| Boostrix+Poliorix Group | Anti-polio 1, Anti-polio 2 and Anti-polio 3 Antibody Titers | Anti-polio 1 | 567.0 Titers |
| Boostrix+Poliorix Group | Anti-polio 1, Anti-polio 2 and Anti-polio 3 Antibody Titers | Anti-polio 3 | 648.5 Titers |
| Revaxis Group | Anti-polio 1, Anti-polio 2 and Anti-polio 3 Antibody Titers | Anti-polio 1 | 332.0 Titers |
| Revaxis Group | Anti-polio 1, Anti-polio 2 and Anti-polio 3 Antibody Titers | Anti-polio 3 | 542.1 Titers |
| Revaxis Group | Anti-polio 1, Anti-polio 2 and Anti-polio 3 Antibody Titers | Anti-polio 2 | 331.5 Titers |
Primary
Number of Seroprotected Subjects Against Diphteria (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 (≥) 0.1 international units per millilitre (IU/mL)
Time frame: At Day 0
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Boostrix Polio Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens | Anti-D | 51 Subjects |
| Boostrix Polio Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens | Anti-T | 62 Subjects |
| Boostrix+Poliorix Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens | Anti-D | 50 Subjects |
| Boostrix+Poliorix Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens | Anti-T | 68 Subjects |
| Revaxis Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens | Anti-D | 55 Subjects |
| Revaxis Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens | Anti-T | 65 Subjects |
Comparison: The objective of the analysis was to dose in study NCT01277705. Samples were analysed both with ELISA (enzyme-linked immunosorbent assay), and VERO-cell (African green monkey kidney cell) neutralisation testing.95% CI: [82.4, 97.4]
Comparison: The objective of the analysis was to demonstrate that a booster dose of Boostrix™ Polio vaccine, administered to adults 10 years after a dose of Boostrix™ Polio vaccine or co-administered Boostrix™ + Poliorix™ vaccines, elicited seroprotective antibody concentrations, one month after the booster dose, in at least 80% of the subjects against diphtheria.95% CI: [67.9, 88.3]
Comparison: The objective of the analysis was to demonstrate that a booster dose of Boostrix™ Polio vaccine, administered to adults 10 years after a dose of Boostrix™ Polio vaccine or co-administered Boostrix™ + Poliorix™ vaccines, elicited seroprotective antibody concentrations, one month after the booster dose, in at least 80% of the subjects against diphtheria.95% CI: [73.3, 91.8]
Primary
Number of Seroprotected Subjects Against Diphteria (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 (≥) 0.1 international units per millilitre (IU/mL).
Time frame: At Month 1
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Boostrix Polio Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens | Anti-D | 61 Subjects |
| Boostrix Polio Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens | Anti-T | 63 Subjects |
| Boostrix+Poliorix Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens | Anti-D | 66 Subjects |
| Boostrix+Poliorix Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens | Anti-T | 69 Subjects |
| Revaxis Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens | Anti-D | 68 Subjects |
| Revaxis Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens | Anti-T | 69 Subjects |
Comparison: The objective of the analysis was to demonstrate that a booster dose of Boostrix™ Polio vaccine, administered to adults 10 years after a dose of Boostrix™ Polio vaccine or co-administered Boostrix™ + Poliorix™ vaccines, elicited seroprotective antibody concentrations, 1 month after the booster dose, in at least 80% of the subjects against diphtheria.~Samples were analysed both with ELISA (enzyme-linked immunosorbent assay), and VERO-cell (African green monkey kidney cell) neutralisation testing.95% CI: [89, 99.6]
Comparison: The objective of the analysis was to demonstrate that a booster dose of Boostrix™ Polio vaccine, administered to adults 10 years after a dose of Boostrix™ Polio vaccine or co-administered Boostrix™ + Poliorix™ vaccines, elicited seroprotective antibody concentrations, one month after the booster dose, in at least 80% of the subjects against diphtheria.95% CI: [87.8, 99.1]
Comparison: The objective of the analysis was to demonstrate that a booster dose of Boostrix™ Polio vaccine, administered to adults 10 years after a dose of Boostrix™ Polio vaccine or co-administered Boostrix™ + Poliorix™ vaccines, elicited seroprotective antibody concentrations, one month after the booster dose, in at least 80% of the subjects against diphtheria.95% CI: [94.8, 100]
Primary
Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3
A seroprotected subject is defined as a vaccinated subject with anti-poliovirus types 1, 2 and 3 antibody concentration greater than or equal to (≥) 8 Effective Dose 50 (ED50)
Time frame: At Day 0
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Boostrix Polio Group | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 | Anti-polio 2 | 56 Subjects |
| Boostrix Polio Group | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 | Anti-polio 1 | 52 Subjects |
| Boostrix Polio Group | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 | Anti-polio 3 | 57 Subjects |
| Boostrix+Poliorix Group | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 | Anti-polio 2 | 60 Subjects |
| Boostrix+Poliorix Group | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 | Anti-polio 1 | 58 Subjects |
| Boostrix+Poliorix Group | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 | Anti-polio 3 | 65 Subjects |
| Revaxis Group | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 | Anti-polio 1 | 59 Subjects |
| Revaxis Group | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 | Anti-polio 3 | 67 Subjects |
| Revaxis Group | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 | Anti-polio 2 | 62 Subjects |
Primary
Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3
A seroprotected subject is defined as a vaccinated subject with anti-poliovirus types 1, 2 and 3 antibody concentration greater than or equal to (≥) 8 Effective Dose 50 (ED50)
Time frame: At Month 1
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Boostrix Polio Group | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 | Anti-polio 2 | 46 Subjects |
| Boostrix Polio Group | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 | Anti-polio 1 | 58 Subjects |
| Boostrix Polio Group | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 | Anti-polio 3 | 58 Subjects |
| Boostrix+Poliorix Group | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 | Anti-polio 2 | 58 Subjects |
| Boostrix+Poliorix Group | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 | Anti-polio 1 | 62 Subjects |
| Boostrix+Poliorix Group | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 | Anti-polio 3 | 60 Subjects |
| Revaxis Group | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 | Anti-polio 1 | 58 Subjects |
| Revaxis Group | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 | Anti-polio 3 | 60 Subjects |
| Revaxis Group | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 | Anti-polio 2 | 56 Subjects |
Primary
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies
Cut-off values assessed were greater than or equal to ≥ 5 Enzyme Linked Immunosorbent Assay (ELISA) units per millilitre (EL.U/ml)
Time frame: At Day 0
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Boostrix Polio Group | Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies | Anti-FHA | 62 Subjects |
| Boostrix Polio Group | Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies | Anti-PT | 48 Subjects |
| Boostrix Polio Group | Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies | Anti-PRN | 55 Subjects |
| Boostrix+Poliorix Group | Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies | Anti-FHA | 69 Subjects |
| Boostrix+Poliorix Group | Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies | Anti-PT | 58 Subjects |
| Boostrix+Poliorix Group | Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies | Anti-PRN | 64 Subjects |
| Revaxis Group | Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies | Anti-PT | 49 Subjects |
| Revaxis Group | Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies | Anti-PRN | 59 Subjects |
| Revaxis Group | Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies | Anti-FHA | 66 Subjects |
Secondary
Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations
Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per millilitre (IU/mL)
Time frame: At Month 1
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Boostrix Polio Group | Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations | Anti-D | 2.159 IU/mL |
| Boostrix Polio Group | Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations | Anti-T | 8.568 IU/mL |
| Boostrix+Poliorix Group | Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations | Anti-D | 1.821 IU/mL |
| Boostrix+Poliorix Group | Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations | Anti-T | 9.692 IU/mL |
| Revaxis Group | Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations | Anti-D | 2.649 IU/mL |
| Revaxis Group | Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations | Anti-T | 9.390 IU/mL |
Secondary
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Antibody Concentrations
Concentrations are presented as geometric mean concentrations (GMCs), expressed in expressed in ELISA units per millilitre (EL.U/mL)
Time frame: At Month 1
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Boostrix Polio Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Antibody Concentrations | Anti-FHA | 485.8 EL.U/mL |
| Boostrix Polio Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Antibody Concentrations | Anti-PT | 97.5 EL.U/mL |
| Boostrix Polio Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Antibody Concentrations | Anti-PRN | 365.9 EL.U/mL |
| Boostrix+Poliorix Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Antibody Concentrations | Anti-FHA | 553.5 EL.U/mL |
| Boostrix+Poliorix Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Antibody Concentrations | Anti-PT | 100.1 EL.U/mL |
| Boostrix+Poliorix Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Antibody Concentrations | Anti-PRN | 404.2 EL.U/mL |
| Revaxis Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Antibody Concentrations | Anti-PT | 92.9 EL.U/mL |
| Revaxis Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Antibody Concentrations | Anti-PRN | 581.0 EL.U/mL |
| Revaxis Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Antibody Concentrations | Anti-FHA | 854.9 EL.U/mL |
Secondary
Anti-polio 1, Anti-polio 2 and Anti-polio 3 Antibody Titers
Titers are presented as geometric mean titers (GMTs).
Time frame: At Month 1
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Boostrix Polio Group | Anti-polio 1, Anti-polio 2 and Anti-polio 3 Antibody Titers | Anti-polio 2 | 1071.3 Titers |
| Boostrix Polio Group | Anti-polio 1, Anti-polio 2 and Anti-polio 3 Antibody Titers | Anti-polio 1 | 1519.0 Titers |
| Boostrix Polio Group | Anti-polio 1, Anti-polio 2 and Anti-polio 3 Antibody Titers | Anti-polio 3 | 2035.7 Titers |
| Boostrix+Poliorix Group | Anti-polio 1, Anti-polio 2 and Anti-polio 3 Antibody Titers | Anti-polio 2 | 1269.8 Titers |
| Boostrix+Poliorix Group | Anti-polio 1, Anti-polio 2 and Anti-polio 3 Antibody Titers | Anti-polio 1 | 1665.4 Titers |
| Boostrix+Poliorix Group | Anti-polio 1, Anti-polio 2 and Anti-polio 3 Antibody Titers | Anti-polio 3 | 2047.9 Titers |
| Revaxis Group | Anti-polio 1, Anti-polio 2 and Anti-polio 3 Antibody Titers | Anti-polio 1 | 1526.7 Titers |
| Revaxis Group | Anti-polio 1, Anti-polio 2 and Anti-polio 3 Antibody Titers | Anti-polio 3 | 2024.6 Titers |
| Revaxis Group | Anti-polio 1, Anti-polio 2 and Anti-polio 3 Antibody Titers | Anti-polio 2 | 1550.1 Titers |
Secondary
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Above the Cut-off
Cut-off values assessed were greater than or equal to ≥ 5 Enzyme Linked Immunosorbent Assay (ELISA) units per millilitre (EL.U/ml)
Time frame: At Month 1
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Boostrix Polio Group | Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Above the Cut-off | Anti-FHA | 63 Subjects |
| Boostrix Polio Group | Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Above the Cut-off | Anti-PT | 63 Subjects |
| Boostrix Polio Group | Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Above the Cut-off | Anti-PRN | 63 Subjects |
| Boostrix+Poliorix Group | Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Above the Cut-off | Anti-FHA | 69 Subjects |
| Boostrix+Poliorix Group | Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Above the Cut-off | Anti-PT | 69 Subjects |
| Boostrix+Poliorix Group | Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Above the Cut-off | Anti-PRN | 69 Subjects |
| Revaxis Group | Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Above the Cut-off | Anti-PT | 67 Subjects |
| Revaxis Group | Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Above the Cut-off | Anti-PRN | 69 Subjects |
| Revaxis Group | Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Above the Cut-off | Anti-FHA | 69 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-Day 3) follow-up period after vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of the study booster vaccine, for whom data was available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Boostrix Polio Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Pain, Any | 42 Subjects |
| Boostrix Polio Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Pain, Grade 3 | 0 Subjects |
| Boostrix Polio Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Rednes, Any | 22 Subjects |
| Boostrix Polio Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Redness, >50 mm | 1 Subjects |
| Boostrix Polio Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Swelling, Any | 18 Subjects |
| Boostrix Polio Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Swelling, >50 mm | 0 Subjects |
| Boostrix+Poliorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Swelling, >50 mm | 3 Subjects |
| Boostrix+Poliorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Pain, Any | 49 Subjects |
| Boostrix+Poliorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Redness, >50 mm | 4 Subjects |
| Boostrix+Poliorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Swelling, Any | 21 Subjects |
| Boostrix+Poliorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Pain, Grade 3 | 0 Subjects |
| Boostrix+Poliorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Rednes, Any | 26 Subjects |
| Revaxis Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Pain, Grade 3 | 0 Subjects |
| Revaxis Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Rednes, Any | 32 Subjects |
| Revaxis Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Swelling, >50 mm | 1 Subjects |
| Revaxis Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Redness, >50 mm | 3 Subjects |
| Revaxis Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Pain, Any | 46 Subjects |
| Revaxis Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Swelling, Any | 19 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-Day 3) follow-up period after vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of the study booster vaccine, for whom data was available and the symptom sheet filled in.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Boostrix Polio Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fatigue, Any | 12 Subjects |
| Boostrix Polio Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fatigue, Grade 3 | 1 Subjects |
| Boostrix Polio Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fatigue, Related | 9 Subjects |
| Boostrix Polio Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Gastrointestinal symptoms, Any | 7 Subjects |
| Boostrix Polio Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Gastrointestinal symptoms, Grade 3 | 0 Subjects |
| Boostrix Polio Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Gastrointestinal symptoms, Related | 3 Subjects |
| Boostrix Polio Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Headache, Any | 7 Subjects |
| Boostrix Polio Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Headache, Grade 3 | 0 Subjects |
| Boostrix Polio Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Headache, Related | 6 Subjects |
| Boostrix Polio Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fever (axillary), ≥ 37.5 °C | 3 Subjects |
| Boostrix Polio Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fever (axillary), > 39 °C | 0 Subjects |
| Boostrix Polio Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fever (axillary), Related | 1 Subjects |
| Boostrix+Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fever (axillary), Related | 2 Subjects |
| Boostrix+Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fatigue, Any | 16 Subjects |
| Boostrix+Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Headache, Any | 11 Subjects |
| Boostrix+Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Headache, Related | 6 Subjects |
| Boostrix+Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fatigue, Grade 3 | 1 Subjects |
| Boostrix+Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Gastrointestinal symptoms, Related | 4 Subjects |
| Boostrix+Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fever (axillary), > 39 °C | 0 Subjects |
| Boostrix+Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fatigue, Related | 11 Subjects |
| Boostrix+Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Headache, Grade 3 | 0 Subjects |
| Boostrix+Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Gastrointestinal symptoms, Grade 3 | 0 Subjects |
| Boostrix+Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Gastrointestinal symptoms, Any | 9 Subjects |
| Boostrix+Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fever (axillary), ≥ 37.5 °C | 2 Subjects |
| Revaxis Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Gastrointestinal symptoms, Any | 4 Subjects |
| Revaxis Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Gastrointestinal symptoms, Grade 3 | 0 Subjects |
| Revaxis Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fever (axillary), ≥ 37.5 °C | 1 Subjects |
| Revaxis Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Gastrointestinal symptoms, Related | 3 Subjects |
| Revaxis Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Headache, Any | 11 Subjects |
| Revaxis Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Headache, Grade 3 | 0 Subjects |
| Revaxis Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fever (axillary), > 39 °C | 0 Subjects |
| Revaxis Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fatigue, Any | 15 Subjects |
| Revaxis Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fatigue, Grade 3 | 0 Subjects |
| Revaxis Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Headache, Related | 9 Subjects |
| Revaxis Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fatigue, Related | 9 Subjects |
| Revaxis Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Fever (axillary), Related | 1 Subjects |
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.
Time frame: During the 31-day (Day 0-Day 30) follow-up period after vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of the study booster vaccine, for whom data was available and the symptom sheet filled in.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Boostrix Polio Group | Number of Subjects With Any Unsolicited Adverse Events (AEs). | 6 Subjects |
| Boostrix+Poliorix Group | Number of Subjects With Any Unsolicited Adverse Events (AEs). | 5 Subjects |
| Revaxis Group | Number of Subjects With Any Unsolicited Adverse Events (AEs). | 6 Subjects |
Secondary
Number of Subjects With Booster Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), Pertactin (PRN)
Booster response was defined as: for initially seronegative subjects: antibody concentration ≥ 20 EL.U/mL at post booster vaccination; for initially seropositive subjects with pre-vaccination antibody concentration \< 20 EL.U/mL: antibody concentration at post booster ≥ 4 fold the pre-vaccination antibody concentration; and for initially seropositive subjects with pre-vaccination antibody concentration ≥ 20 EL.U/mL: antibody concentration at post booster ≥ 2 fold the pre-vaccination antibody concentration.
Time frame: At Month 1
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Boostrix Polio Group | Number of Subjects With Booster Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), Pertactin (PRN) | Anti-FHA | 53 Subjects |
| Boostrix Polio Group | Number of Subjects With Booster Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), Pertactin (PRN) | Anti-PT | 60 Subjects |
| Boostrix Polio Group | Number of Subjects With Booster Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), Pertactin (PRN) | Anti-PRN | 46 Subjects |
| Boostrix+Poliorix Group | Number of Subjects With Booster Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), Pertactin (PRN) | Anti-FHA | 62 Subjects |
| Boostrix+Poliorix Group | Number of Subjects With Booster Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), Pertactin (PRN) | Anti-PT | 60 Subjects |
| Boostrix+Poliorix Group | Number of Subjects With Booster Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), Pertactin (PRN) | Anti-PRN | 43 Subjects |
| Revaxis Group | Number of Subjects With Booster Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), Pertactin (PRN) | Anti-PT | 52 Subjects |
| Revaxis Group | Number of Subjects With Booster Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), Pertactin (PRN) | Anti-PRN | 63 Subjects |
| Revaxis Group | Number of Subjects With Booster Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), Pertactin (PRN) | Anti-FHA | 57 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: Month 0 - Month 1
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of the study booster vaccine, for whom data was available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Boostrix Polio Group | Number of Subjects With Serious Adverse Events (SAEs). | 0 Subjects |
| Boostrix+Poliorix Group | Number of Subjects With Serious Adverse Events (SAEs). | 0 Subjects |
| Revaxis Group | Number of Subjects With Serious Adverse Events (SAEs). | 0 Subjects |