Acellular Pertussis, Diphtheria, Poliomyelitis, Tetanus
Conditions
Keywords
Diphtheria, vaccine, DTP, Poliomyelitis, Pertussis, Booster, Tetanus
Brief summary
Subjects aged 9 to 13 years who participated in the 711866/001 study 5 years ago will be evaluated for immune persistence and will receive a combined dTpa-IPV booster dose that will be evaluated in terms of immunogenicity, safety and reactogenicity.
Interventions
BIOLOGICALBoostrix-Polio
A single booster dose of dTpa-IPV vaccine will be administered to all subjects. IM administration in the deltoid muscle of the non-dominant arm.
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
9 Years to 13 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes that they or their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study. * A male or female subject who received a booster vaccination with dTpa-IPV or dTpa + IPV in study 711866/001. * Healthy subjects as established by medical history and clinical examination before entering into the study. * Females of childbearing potential at the time of study entry must have a negative pregnancy test prior to administration of the dose of vaccine and are required to be abstinent or to use adequate contraceptive precautions for one month prior to vaccination. Subjects are required to agree to continue such precautions for two months after vaccination. * Written informed consent obtained from both parents/ guardians of the subject; assent from the subject himself/herself should also be requested whenever possible.
Exclusion criteria
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the booster dose of study vaccine, or planned use during the study period. * Chronic administration (defined as more than 14 days) of immunosuppressant 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 vaccination, or planned administration during 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, pertussis, or poliomyelitis since the booster dose received in study 711866/001. * History of diphtheria, tetanus, pertussis, or poliomyelitis 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 immunoglobulin 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 events (AEs) 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 within 48 hours of vaccination * Persistent, severe, inconsolable screaming or crying lasting \>3 hours occurring within 48 hours of receipt of a previous dose of DTP vaccine convulsions with or without fever, occurring within 3 days of vaccination. * Acute disease at the time of enrolment. * Pregnant or lactating female.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Any Grade 3 Solicited Local Symptoms | During the 4-day (Days 0-3) follow-up period after booster vaccination | Assessed solicited local symptoms were pain, redness and swelling. Grade 3 Pain: Pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Any Solicited Local Symptoms | During the 4-day (Days 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. |
| Number of Subjects With Any Solicited General Symptoms | During the 4-day (Days 0-3) follow-up period after booster vaccination | Assessed solicited general symptoms were fatigue, gastrointestinal, headache and temperature \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade and relationship to vaccination. |
| Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Toxoids | Prior to (Month 0) and one month after (Month 1) booster vaccination | Anti-D and anti-T antibody concnetration greater than or equal to (≥) 0.1 international units per milliliter (IU/mL) and ≥ 1 IU/mL have been assessed by enzyme-linked immunosorbent assay (ELISA). Pre-vaccination sera with ELISA concentrations \< 0.1 IU/mL were tested for neutralising antibodies using a Vero-cell neutralisation assay with a 0.016 IU/mL cut-off. |
| Anti-D and Anti-T Antibody Concentrations | Prior to (Month 0) and one month after (Month 1) booster vaccination | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL). |
| Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Prior to (Month 0) and one month after (Month 1) booster vaccination | A seropositive subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 ELISA unit per milliliter (EL.U/ml). |
| Anti-Polio 1, 2 and 3 Antibody Titers | Prior to (Month 0) and one month after (Month 1) booster vaccination | Antibody titers were presented as geometric mean titers (GMTs). |
| Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Antigens | Prior to (Month 0) and one month after (Month 1) booster vaccination | A seroprotected subject was defined as a subject with anti-Polio type 1, 2 and 3 antibody titers ≥ the value of 8. |
| Number of Subjects With Booster Response to Anti-PT, Anti-FHA and Anti-PRN | One month after booster vaccination (At Month 1) | Booster vaccine response was defined as appearance of antibodies in subjects who were seronegative at the pre-vaccination time point (i.e. with concentrations \< 5 EL.U/mL) or at least 2-fold increase of pre-vaccination antibody concentrations in subjects who were seropositive at the pre-vaccination time point (i.e. with concentrations \< 5 EL.U/mL). |
| Number of Subjects With Unsolicited Adverse Events (AEs) | During the 31-day (Days 0-30) follow-up period after booster vaccination | AEs results are presented for all subjects. 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 Serious Adverse Events (SAEs) | During the entire booster period (Month 0 to Month 1) | Assessed SAEs include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
| Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Prior to (Month 0) and one month after (Month 1) booster vaccination | Antibodies concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL. |
Countries
Germany
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-Polio Group Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm. | 351 |
| Boostrix + IPV Mérieux Group Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm. | 64 |
| Total | 415 |
Baseline characteristics
| Characteristic | Boostrix-Polio Group | Boostrix + IPV Mérieux Group | Total |
|---|---|---|---|
| Age, Continuous | 11.4 Years STANDARD_DEVIATION 0.97 | 11.3 Years STANDARD_DEVIATION 0.72 | 11.38 Years STANDARD_DEVIATION 0.94 |
| Race/Ethnicity, Customized Not specified | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White-Arabic/North African heritage | 4 Participants | 0 Participants | 4 Participants |
| Race/Ethnicity, Customized White-Caucasian/European heritage | 347 Participants | 63 Participants | 410 Participants |
| Sex: Female, Male Female | 169 Participants | 32 Participants | 201 Participants |
| Sex: Female, Male Male | 182 Participants | 32 Participants | 214 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 351 | 0 / 64 |
| other Total, other adverse events | 281 / 351 | 51 / 64 |
| serious Total, serious adverse events | 0 / 351 | 0 / 64 |
Outcome results
Primary
Number of Subjects With Any Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. 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 (Days 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Boostrix-Polio Group | Number of Subjects With Any Grade 3 Solicited Local Symptoms | Grade 3 Pain | 14 Participants |
| Boostrix-Polio Group | Number of Subjects With Any Grade 3 Solicited Local Symptoms | Grade 3 Redness (mm) | 14 Participants |
| Boostrix-Polio Group | Number of Subjects With Any Grade 3 Solicited Local Symptoms | Grade 3 Swelling (mm) | 10 Participants |
| Boostrix + IPV Mérieux Group | Number of Subjects With Any Grade 3 Solicited Local Symptoms | Grade 3 Pain | 3 Participants |
| Boostrix + IPV Mérieux Group | Number of Subjects With Any Grade 3 Solicited Local Symptoms | Grade 3 Redness (mm) | 5 Participants |
| Boostrix + IPV Mérieux Group | Number of Subjects With Any Grade 3 Solicited Local Symptoms | Grade 3 Swelling (mm) | 5 Participants |
Secondary
Anti-D and Anti-T Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).
Time frame: Prior to (Month 0) and one month after (Month 1) booster vaccination
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects vaccinated with a booster dose of Boostrix™-Polio vaccine in this current study (110947), for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Boostrix-Polio Group | Anti-D and Anti-T Antibody Concentrations | Anti-D, M0 | 0.51 IU/mL |
| Boostrix-Polio Group | Anti-D and Anti-T Antibody Concentrations | Anti-D, M1 | 4.784 IU/mL |
| Boostrix-Polio Group | Anti-D and Anti-T Antibody Concentrations | Anti-T, M0 | 1.197 IU/mL |
| Boostrix-Polio Group | Anti-D and Anti-T Antibody Concentrations | Anti-T, M1 | 11.81 IU/mL |
| Boostrix + IPV Mérieux Group | Anti-D and Anti-T Antibody Concentrations | Anti-T, M1 | 9.518 IU/mL |
| Boostrix + IPV Mérieux Group | Anti-D and Anti-T Antibody Concentrations | Anti-D, M0 | 0.446 IU/mL |
| Boostrix + IPV Mérieux Group | Anti-D and Anti-T Antibody Concentrations | Anti-T, M0 | 1.067 IU/mL |
| Boostrix + IPV Mérieux Group | Anti-D and Anti-T Antibody Concentrations | Anti-D, M1 | 4.153 IU/mL |
Secondary
Anti-Polio 1, 2 and 3 Antibody Titers
Antibody titers were presented as geometric mean titers (GMTs).
Time frame: Prior to (Month 0) and one month after (Month 1) booster vaccination
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects vaccinated with a booster dose of Boostrix™-Polio vaccine in this current study (110947), for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Boostrix-Polio Group | Anti-Polio 1, 2 and 3 Antibody Titers | Anti-polio 1, M0 | 138.7 Titers |
| Boostrix-Polio Group | Anti-Polio 1, 2 and 3 Antibody Titers | Anti-polio 1, M1 | 1359.6 Titers |
| Boostrix-Polio Group | Anti-Polio 1, 2 and 3 Antibody Titers | Anti-polio 2, M0 | 166.3 Titers |
| Boostrix-Polio Group | Anti-Polio 1, 2 and 3 Antibody Titers | Anti-polio 2, M1 | 1629.4 Titers |
| Boostrix-Polio Group | Anti-Polio 1, 2 and 3 Antibody Titers | Anti-polio 3, M0 | 117.2 Titers |
| Boostrix-Polio Group | Anti-Polio 1, 2 and 3 Antibody Titers | Anti-polio 3, M1 | 1882.4 Titers |
| Boostrix + IPV Mérieux Group | Anti-Polio 1, 2 and 3 Antibody Titers | Anti-polio 3, M0 | 118.4 Titers |
| Boostrix + IPV Mérieux Group | Anti-Polio 1, 2 and 3 Antibody Titers | Anti-polio 1, M0 | 128.9 Titers |
| Boostrix + IPV Mérieux Group | Anti-Polio 1, 2 and 3 Antibody Titers | Anti-polio 2, M1 | 1309.5 Titers |
| Boostrix + IPV Mérieux Group | Anti-Polio 1, 2 and 3 Antibody Titers | Anti-polio 1, M1 | 1088.9 Titers |
| Boostrix + IPV Mérieux Group | Anti-Polio 1, 2 and 3 Antibody Titers | Anti-polio 3, M1 | 1712.5 Titers |
| Boostrix + IPV Mérieux Group | Anti-Polio 1, 2 and 3 Antibody Titers | Anti-polio 2, M0 | 179.2 Titers |
Secondary
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Antibodies concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.
Time frame: Prior to (Month 0) and one month after (Month 1) booster vaccination
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects vaccinated with a booster dose of Boostrix™-Polio vaccine in this current study (110947), for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Boostrix-Polio Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PT, M0 | 5.2 EL.U/mL |
| Boostrix-Polio Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PT, M1 | 41.6 EL.U/mL |
| Boostrix-Polio Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-FHA, M0 | 69.8 EL.U/mL |
| Boostrix-Polio Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-FHA, M1 | 662.7 EL.U/mL |
| Boostrix-Polio Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PRN, M0 | 46.8 EL.U/mL |
| Boostrix-Polio Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PRN, M1 | 570.8 EL.U/mL |
| Boostrix + IPV Mérieux Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PRN, M0 | 41.1 EL.U/mL |
| Boostrix + IPV Mérieux Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PT, M0 | 4.5 EL.U/mL |
| Boostrix + IPV Mérieux Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-FHA, M1 | 733.9 EL.U/mL |
| Boostrix + IPV Mérieux Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PT, M1 | 32 EL.U/mL |
| Boostrix + IPV Mérieux Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PRN, M1 | 460.4 EL.U/mL |
| Boostrix + IPV Mérieux Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-FHA, M0 | 70.1 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 milliliter (EL.U/ml).
Time frame: Prior to (Month 0) and one month after (Month 1) booster vaccination
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects vaccinated with a booster dose of Boostrix™-Polio vaccine in this current study (110947), for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Boostrix-Polio Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PT, M0 | 134 Participants |
| Boostrix-Polio Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PT, M1 | 334 Participants |
| Boostrix-Polio Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-FHA, M0 | 332 Participants |
| Boostrix-Polio Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-FHA, M1 | 336 Participants |
| Boostrix-Polio Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PRN, M0 | 325 Participants |
| Boostrix-Polio Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PRN, M1 | 336 Participants |
| Boostrix + IPV Mérieux Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PRN, M0 | 57 Participants |
| Boostrix + IPV Mérieux Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PT, M0 | 21 Participants |
| Boostrix + IPV Mérieux Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-FHA, M1 | 61 Participants |
| Boostrix + IPV Mérieux Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PT, M1 | 59 Participants |
| Boostrix + IPV Mérieux Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-PRN, M1 | 62 Participants |
| Boostrix + IPV Mérieux Group | Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) | Anti-FHA, M0 | 60 Participants |
Secondary
Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Antigens
A seroprotected subject was defined as a subject with anti-Polio type 1, 2 and 3 antibody titers ≥ the value of 8.
Time frame: Prior to (Month 0) and one month after (Month 1) booster vaccination
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects vaccinated with a booster dose of Boostrix™-Polio vaccine in this current study (110947), for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Boostrix-Polio Group | Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Antigens | Anti-polio 1, M0 | 329 Participants |
| Boostrix-Polio Group | Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Antigens | Anti-polio 1, M1 | 335 Participants |
| Boostrix-Polio Group | Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Antigens | Anti-polio 2, M0 | 333 Participants |
| Boostrix-Polio Group | Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Antigens | Anti-polio 2, M1 | 335 Participants |
| Boostrix-Polio Group | Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Antigens | Anti-polio 3, M0 | 324 Participants |
| Boostrix-Polio Group | Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Antigens | Anti-polio 3, M1 | 333 Participants |
| Boostrix + IPV Mérieux Group | Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Antigens | Anti-polio 3, M0 | 60 Participants |
| Boostrix + IPV Mérieux Group | Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Antigens | Anti-polio 1, M0 | 60 Participants |
| Boostrix + IPV Mérieux Group | Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Antigens | Anti-polio 2, M1 | 62 Participants |
| Boostrix + IPV Mérieux Group | Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Antigens | Anti-polio 1, M1 | 62 Participants |
| Boostrix + IPV Mérieux Group | Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Antigens | Anti-polio 3, M1 | 62 Participants |
| Boostrix + IPV Mérieux Group | Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Antigens | Anti-polio 2, M0 | 62 Participants |
Secondary
Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Toxoids
Anti-D and anti-T antibody concnetration greater than or equal to (≥) 0.1 international units per milliliter (IU/mL) and ≥ 1 IU/mL have been assessed by enzyme-linked immunosorbent assay (ELISA). Pre-vaccination sera with ELISA concentrations \< 0.1 IU/mL were tested for neutralising antibodies using a Vero-cell neutralisation assay with a 0.016 IU/mL cut-off.
Time frame: Prior to (Month 0) and one month after (Month 1) booster vaccination
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects vaccinated with a booster dose of Boostrix™-Polio vaccine in this current study (110947), for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Boostrix-Polio Group | Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Toxoids | Anti-D ≥ 0.1 IU/mL, M0 | 298 Participants |
| Boostrix-Polio Group | Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Toxoids | Anti-D ≥ 0.1 IU/mL, M1 | 336 Participants |
| Boostrix-Polio Group | Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Toxoids | Anti-D ≥ 1 IU/mL, M0 | 91 Participants |
| Boostrix-Polio Group | Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Toxoids | Anti-D ≥ 1 IU/mL, M1 | 308 Participants |
| Boostrix-Polio Group | Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Toxoids | Anti-T ≥ 0.1 IU/mL, M0 | 330 Participants |
| Boostrix-Polio Group | Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Toxoids | Anti-T ≥ 0.1 IU/mL, M1 | 336 Participants |
| Boostrix-Polio Group | Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Toxoids | Anti-T ≥ 1 IU/mL, M0 | 181 Participants |
| Boostrix-Polio Group | Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Toxoids | Anti-T ≥ 1 IU/mL, M1 | 335 Participants |
| Boostrix + IPV Mérieux Group | Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Toxoids | Anti-T ≥ 1 IU/mL, M1 | 61 Participants |
| Boostrix + IPV Mérieux Group | Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Toxoids | Anti-D ≥ 0.1 IU/mL, M0 | 53 Participants |
| Boostrix + IPV Mérieux Group | Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Toxoids | Anti-T ≥ 0.1 IU/mL, M0 | 61 Participants |
| Boostrix + IPV Mérieux Group | Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Toxoids | Anti-D ≥ 0.1 IU/mL, M1 | 62 Participants |
| Boostrix + IPV Mérieux Group | Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Toxoids | Anti-T ≥ 1 IU/mL, M0 | 35 Participants |
| Boostrix + IPV Mérieux Group | Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Toxoids | Anti-D ≥ 1 IU/mL, M0 | 13 Participants |
| Boostrix + IPV Mérieux Group | Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Toxoids | Anti-T ≥ 0.1 IU/mL, M1 | 62 Participants |
| Boostrix + IPV Mérieux Group | Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Toxoids | Anti-D ≥ 1 IU/mL, M1 | 55 Participants |
Secondary
Number of Subjects With Any Solicited General Symptoms
Assessed solicited general symptoms were fatigue, gastrointestinal, headache and temperature \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade and relationship to vaccination.
Time frame: During the 4-day (Days 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 who had the symptoms sheet filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Boostrix-Polio Group | Number of Subjects With Any Solicited General Symptoms | Any Gastrointestinal | 41 Participants |
| Boostrix-Polio Group | Number of Subjects With Any Solicited General Symptoms | Any Fatigue | 87 Participants |
| Boostrix-Polio Group | Number of Subjects With Any Solicited General Symptoms | Any Temperature | 14 Participants |
| Boostrix-Polio Group | Number of Subjects With Any Solicited General Symptoms | Any Headache | 76 Participants |
| Boostrix + IPV Mérieux Group | Number of Subjects With Any Solicited General Symptoms | Any Temperature | 0 Participants |
| Boostrix + IPV Mérieux Group | Number of Subjects With Any Solicited General Symptoms | Any Gastrointestinal | 4 Participants |
| Boostrix + IPV Mérieux Group | Number of Subjects With Any Solicited General Symptoms | Any Fatigue | 14 Participants |
| Boostrix + IPV Mérieux Group | Number of Subjects With Any Solicited General Symptoms | Any Headache | 12 Participants |
Secondary
Number of Subjects With Any Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Time frame: During the 4-day (Days 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Boostrix-Polio Group | Number of Subjects With Any Solicited Local Symptoms | Any Pain | 257 Participants |
| Boostrix-Polio Group | Number of Subjects With Any Solicited Local Symptoms | Any Redness | 169 Participants |
| Boostrix-Polio Group | Number of Subjects With Any Solicited Local Symptoms | Any Swelling | 141 Participants |
| Boostrix + IPV Mérieux Group | Number of Subjects With Any Solicited Local Symptoms | Any Pain | 45 Participants |
| Boostrix + IPV Mérieux Group | Number of Subjects With Any Solicited Local Symptoms | Any Redness | 26 Participants |
| Boostrix + IPV Mérieux Group | Number of Subjects With Any Solicited Local Symptoms | Any Swelling | 22 Participants |
Secondary
Number of Subjects With Booster Response to Anti-PT, Anti-FHA and Anti-PRN
Booster vaccine response was defined as appearance of antibodies in subjects who were seronegative at the pre-vaccination time point (i.e. with concentrations \< 5 EL.U/mL) or at least 2-fold increase of pre-vaccination antibody concentrations in subjects who were seropositive at the pre-vaccination time point (i.e. with concentrations \< 5 EL.U/mL).
Time frame: One month after booster vaccination (At Month 1)
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects vaccinated with a booster dose of Boostrix™-Polio vaccine in this current study (110947), for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Boostrix-Polio Group | Number of Subjects With Booster Response to Anti-PT, Anti-FHA and Anti-PRN | Anti-PT | 308 Participants |
| Boostrix-Polio Group | Number of Subjects With Booster Response to Anti-PT, Anti-FHA and Anti-PRN | Anti-FHA | 311 Participants |
| Boostrix-Polio Group | Number of Subjects With Booster Response to Anti-PT, Anti-FHA and Anti-PRN | Anti-PRN | 319 Participants |
| Boostrix + IPV Mérieux Group | Number of Subjects With Booster Response to Anti-PT, Anti-FHA and Anti-PRN | Anti-PT | 56 Participants |
| Boostrix + IPV Mérieux Group | Number of Subjects With Booster Response to Anti-PT, Anti-FHA and Anti-PRN | Anti-FHA | 56 Participants |
| Boostrix + IPV Mérieux Group | Number of Subjects With Booster Response to Anti-PT, Anti-FHA and Anti-PRN | Anti-PRN | 61 Participants |
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
Assessed SAEs include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: During the entire booster period (Month 0 to Month 1)
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Boostrix-Polio Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
| Boostrix + IPV Mérieux Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
Secondary
Number of Subjects With Unsolicited Adverse Events (AEs)
AEs results are presented for all subjects. 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 (Days 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 (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Boostrix-Polio Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 47 Participants |
| Boostrix + IPV Mérieux Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 17 Participants |