Acellular Pertussis, Diphtheria, Poliomyelitis, Tetanus
Conditions
Keywords
MMR, dTpa-IPV, Boostrix Polio, Repevax, Priorix
Brief summary
The purpose of the study is to compare the immunogenicity and safety of a booster dose of BoostrixTM Polio to that of Sanofi Pasteur MSD's RepevaxTM, when co-administered with a second dose of PriorixTM, in healthy 3 and 4-year-old children.
Interventions
BIOLOGICALBoostrix PolioTM
Single dose, intramuscular administration.
BIOLOGICALRepevaxTM
Single dose, intramuscular administration.
BIOLOGICALPriorixTM
Single dose, intramuscular or subcutaneous administration.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 4 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol should be enrolled in the study. * A male or female child of 3 or 4 years of age at the time of booster vaccination (up to, but excluding 5 years of age). * Subjects who have received a complete three-dose primary vaccination with diphtheria-tetanus-acellular pertussis (DTPa) vaccine and inactivated poliovirus (IPV) vaccine in the first six months of life, in line with recommendations in the United Kingdom (UK). * Subjects who received a first dose of a live attenuated measles-mumps-rubella vaccine within the second year of life, in line with recommendations in the UK. * Written informed consent obtained from the parent(s)/LAR(s) of the subject at the time of enrolment. * Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion criteria
* Child in care. * Use of any investigational or non-registered product 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 of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccine dose. * Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period, with the exception of inactivated influenza vaccine. * 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 diphtheria, tetanus, pertussis, poliomyelitis since primary vaccination in the first year of life. * Previous measles, mumps and/or rubella second dose vaccination. * Evidence of previous or intercurrent diphtheria, tetanus, pertussis, poliomyelitis, measles, mumps and/or rubella disease. * Known exposure to measles, mumps and/or rubella within 30 days prior to study start. * Any confirmed or suspected immunosuppressive or immunodeficiency condition, based on medical history and physical examination. * History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine. * Administration of 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. * Occurrence of any of the following adverse events 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; * Convulsions with or without fever, occurring within 3 days of vaccination. * Acute disease and/or fever at the time of enrolment or within 24 hours of study vaccine administration.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With a Booster Response to Diphtheria (D) and Tetanus (T) Antigens | At Month 1, one month after the booster vaccination | Booster response was defined as: For initially seronegative subjects \[i.e. pre-vaccination concentration below (\<) cut-off value of 0.1 international units per milliliter (IU/mL)\] antibody concentrations at least four times the assay cut-off \[post vaccination concentration greater than or equal to (≥) 0.4 IU/ml\]. For initially seropositive subjects (pre-vaccination concentration ≥ 0.1 IU/ml), an increase in antibody concentrations of at least four times the Pre booster vaccination concentration. |
| Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | At Month 1, one month after the booster vaccination | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). |
| Anti-Polio Virus Type 1, 2 and 3 Antibody Titers | At Month 1, one month after the booster vaccination | Antibody titers were presented as geometric mean titers (GMTs). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN | Before (Month 0) and one month after (Month 1) the booster vaccination | A seropositive subject for anti-PT, anti-FHA and anti-PRN was a subject whose antibody concentration was ≥ 5 EL.U/mL. |
| Number of Seropositive Subjects for Anti-mumps Antibody | Before (Month 0) and one month after (Month 1) the booster vaccination | A seropositive subject was defined as a subject with anti-mumps antibody titers ≥ 231 U/mL. |
| Number of Seropositive Subjects for Anti-rubella Antibody | Before (Month 0) and one month after (Month 1) the booster vaccination | A seropositive subject was defined as a subject with anti-rubella antibody titers ≥ 4 IU/mL. |
| Anti-D and Anti-T Antibody Concentrations | Before (Month 0) and one month after (Month 1) the booster vaccination | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL. |
| Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | At Month 0, before the booster vaccination | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL. |
| Anti-mumps Antibody Concentrations | Before (Month 0) and one month after (Month 1) the booster vaccination | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in U/mL. |
| Anti-measles Antibody Concentrations | Before (Month 0) and one month after (Month 1) the booster vaccination | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL. |
| Anti-rubella Antibody Concentrations | Before (Month 0) and one month after (Month 1) the booster vaccination | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL. |
| Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 | Before (Month 0) and one month after (Month 1) the booster vaccination | A seroprotected subject was defined as a subject with anti-polio type 1, 2 and 3 antibody titres ≥ the value of 8. |
| Number of Subjects With a Booster Response to PT, FHA and PRN Antigens | At Month 1, one month after the booster vaccination | Booster response was defined as: For initially seronegative subjects (pre-vaccination concentration \< 5 EL.U/mL), antibody concentrations at least four times the assay cut-off (post vaccination concentration ≥ 20 EL.U/mL). For initially seropositive subjects (with pre-vaccination concentration ≥ 5 EL.U/mL and \< 20 EL.U/mL), an increase in antibody concentrations of at least four times the Pre booster vaccination concentration. For initially seropositive subjects (with pre-vaccination concentration ≥ 20 EL.U/mL), an increase in antibody concentrations of at least two times the Pre booster vaccination concentration. |
| Number of Subjects With Booster Response for Polio Type 1, 2 and 3 Antigens | At Month 1, one month after the booster vaccination | Booster response defined as: For initially seronegative subjects, antibody titers at least four times the cut-off (post-vaccination titer ≥ 32); For initially seropositive subjects, an increase in antibody titers of at least four times the Pre booster vaccination titer. |
| Number of Seroconverted Subjects for Anti-measles | Before (Month 0) and one month after (Month 1) the booster vaccination | Seroconversion for anti-measles was defined as the appearance of antibodies after vaccination in subjects who were initially seronegative \[with antibody concentrations ≥ 150 milli-international units per millilitre (mIU/mL)\]. |
| Number of Seroconverted Subjects for Anti-mumps | Before (Month 0) and one month after (Month 1) the booster vaccination | Seroconversion for anti-mumps was defined as the appearance of antibodies after vaccination in subjects who were initially seronegative \[with antibody concentrations ≥ 231 units per millilitre (U/mL)\]. |
| 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 drowsiness, irritability, loss of appetite and temperature \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. |
| Number of Subjects With Any Unsolicited Adverse Events (AEs) | During the 31-day (Days 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. 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 study period (From Day 0 to 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. |
| Anti-Polio Type 1, 2 and 3 Antibody Titers | At Month 0, before the booster vaccination | Antibody titers were presented as geometric mean titers (GMTs). |
| Number of Seropositive Subjects for Anti-measles Antibody | Before (Month 0) and one month after (Month 1) the booster vaccination | A seropositive subject was defined as a subject with anti-measles antibody titers ≥ 150 mIU/mL. |
| Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) | Before (Month 0) and one month after (Month 1) the booster vaccination | A seroprotected subject was defined a subject with anti-D and anti-T antibody concentrations ≥ 0.1 international units per millilitre (IU/mL). |
Countries
United Kingdom
Participant flow
Recruitment details
2 subjects did not receive vaccination.
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 children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix and Polio vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix Polio vaccine co-administered with Priorix vaccine at Day 0. Boostrix Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm. | 255 |
| Repevax Group Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix and Polio vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax vaccine co-administered with Priorix vaccine at Day 0. Repevax vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm. | 130 |
| Total | 385 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 2 |
| Overall Study | Migrated/moved from study area | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Repevax Group | Total | Boostrix Polio Group |
|---|---|---|---|
| Age, Continuous | 3.1 Years STANDARD_DEVIATION 0.2 | 3.1 Years STANDARD_DEVIATION 0.2 | 3.1 Years STANDARD_DEVIATION 0.2 |
| Race/Ethnicity, Customized African heritage/African American | 4 Participants | 6 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian-Central/South Asian heritage | 4 Participants | 8 Participants | 4 Participants |
| Race/Ethnicity, Customized Asian-South East Asian heritage | 1 Participants | 4 Participants | 3 Participants |
| Race/Ethnicity, Customized Not specified | 9 Participants | 27 Participants | 18 Participants |
| Race/Ethnicity, Customized White-Arabic/North African heritage | 1 Participants | 3 Participants | 2 Participants |
| Race/Ethnicity, Customized White-Caucasian/European heritage | 111 Participants | 337 Participants | 226 Participants |
| Sex: Female, Male Female | 65 Participants | 188 Participants | 123 Participants |
| Sex: Female, Male Male | 65 Participants | 197 Participants | 132 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 255 | 0 / 130 |
| other Total, other adverse events | 215 / 255 | 108 / 130 |
| serious Total, serious adverse events | 1 / 255 | 0 / 130 |
Outcome results
Primary
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Time frame: At Month 1, one month after the booster vaccination
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects 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) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-PRN | 151.4 EL.U/mL |
| Boostrix Polio Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-PT | 70.1 EL.U/mL |
| Boostrix Polio Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-FHA | 358.3 EL.U/mL |
| Repevax Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-FHA | 164.8 EL.U/mL |
| Repevax Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-PRN | 209.8 EL.U/mL |
| Repevax Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-PT | 47.8 EL.U/mL |
Primary
Anti-Polio Virus Type 1, 2 and 3 Antibody Titers
Antibody titers were presented as geometric mean titers (GMTs).
Time frame: At Month 1, one month after the booster vaccination
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Boostrix Polio Group | Anti-Polio Virus Type 1, 2 and 3 Antibody Titers | Anti-Polio 1 | 2183.3 Titers |
| Boostrix Polio Group | Anti-Polio Virus Type 1, 2 and 3 Antibody Titers | Anti-Polio 2 | 2693.1 Titers |
| Boostrix Polio Group | Anti-Polio Virus Type 1, 2 and 3 Antibody Titers | Anti-Polio 3 | 3762.4 Titers |
| Repevax Group | Anti-Polio Virus Type 1, 2 and 3 Antibody Titers | Anti-Polio 1 | 1876.1 Titers |
| Repevax Group | Anti-Polio Virus Type 1, 2 and 3 Antibody Titers | Anti-Polio 2 | 2203.8 Titers |
| Repevax Group | Anti-Polio Virus Type 1, 2 and 3 Antibody Titers | Anti-Polio 3 | 4185.1 Titers |
Comparison: Immune response difference to anti-Polio 1 antigen95% CI: [0.65, 1.28]ANCOVA
Comparison: Immune response difference to anti-Polio 2 antigen95% CI: [0.54, 1.12]ANCOVA
Comparison: Immune response difference to anti-Polio 3 antigen95% CI: [0.93, 1.84]ANCOVA
Primary
Number of Subjects With a Booster Response to Diphtheria (D) and Tetanus (T) Antigens
Booster response was defined as: For initially seronegative subjects \[i.e. pre-vaccination concentration below (\<) cut-off value of 0.1 international units per milliliter (IU/mL)\] antibody concentrations at least four times the assay cut-off \[post vaccination concentration greater than or equal to (≥) 0.4 IU/ml\]. For initially seropositive subjects (pre-vaccination concentration ≥ 0.1 IU/ml), an increase in antibody concentrations of at least four times the Pre booster vaccination concentration.
Time frame: At Month 1, one month after the booster vaccination
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Boostrix Polio Group | Number of Subjects With a Booster Response to Diphtheria (D) and Tetanus (T) Antigens | Anti-D | 176 Participants |
| Boostrix Polio Group | Number of Subjects With a Booster Response to Diphtheria (D) and Tetanus (T) Antigens | Anti-T | 173 Participants |
| Repevax Group | Number of Subjects With a Booster Response to Diphtheria (D) and Tetanus (T) Antigens | Anti-D | 90 Participants |
| Repevax Group | Number of Subjects With a Booster Response to Diphtheria (D) and Tetanus (T) Antigens | Anti-T | 90 Participants |
Comparison: Non-inferiority in terms of booster response to D95% CI: [-3.55, 3.14]Standardized asymptotic
Comparison: Non-inferiority in terms of booster response to T95% CI: [-2.43, 4.9]
Secondary
Anti-D and Anti-T Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.
Time frame: Before (Month 0) and one month after (Month 1) the booster vaccination
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Boostrix Polio Group | Anti-D and Anti-T Antibody Concentrations | Anti-D, M0 | 0.228 IU/mL |
| Boostrix Polio Group | Anti-D and Anti-T Antibody Concentrations | Anti-D, M1 | 8.113 IU/mL |
| Boostrix Polio Group | Anti-D and Anti-T Antibody Concentrations | Anti-T, M0 | 0.209 IU/mL |
| Boostrix Polio Group | Anti-D and Anti-T Antibody Concentrations | Anti-T, M1 | 6.787 IU/mL |
| Repevax Group | Anti-D and Anti-T Antibody Concentrations | Anti-T, M1 | 9.194 IU/mL |
| Repevax Group | Anti-D and Anti-T Antibody Concentrations | Anti-D, M0 | 0.259 IU/mL |
| Repevax Group | Anti-D and Anti-T Antibody Concentrations | Anti-T, M0 | 0.241 IU/mL |
| Repevax Group | Anti-D and Anti-T Antibody Concentrations | Anti-D, M1 | 11.948 IU/mL |
Secondary
Anti-measles Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.
Time frame: Before (Month 0) and one month after (Month 1) the booster vaccination
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Boostrix Polio Group | Anti-measles Antibody Concentrations | Anti-Measles, M0 | 2644 mIU/mL |
| Boostrix Polio Group | Anti-measles Antibody Concentrations | Anti-Measles, M1 | 3817.7 mIU/mL |
| Repevax Group | Anti-measles Antibody Concentrations | Anti-Measles, M0 | 2702.6 mIU/mL |
| Repevax Group | Anti-measles Antibody Concentrations | Anti-Measles, M1 | 3798 mIU/mL |
Secondary
Anti-mumps Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in U/mL.
Time frame: Before (Month 0) and one month after (Month 1) the booster vaccination
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Boostrix Polio Group | Anti-mumps Antibody Concentrations | Anti-Mumps, M0 | 1035.3 U/mL |
| Boostrix Polio Group | Anti-mumps Antibody Concentrations | Anti-Mumps, M1 | 6801.9 U/mL |
| Repevax Group | Anti-mumps Antibody Concentrations | Anti-Mumps, M0 | 971.7 U/mL |
| Repevax Group | Anti-mumps Antibody Concentrations | Anti-Mumps, M1 | 6219.4 U/mL |
Secondary
Anti-Polio Type 1, 2 and 3 Antibody Titers
Antibody titers were presented as geometric mean titers (GMTs).
Time frame: At Month 0, before the booster vaccination
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Boostrix Polio Group | Anti-Polio Type 1, 2 and 3 Antibody Titers | Anti-Polio 1 | 12.8 Titers |
| Boostrix Polio Group | Anti-Polio Type 1, 2 and 3 Antibody Titers | Anti-Polio 2 | 15.5 Titers |
| Boostrix Polio Group | Anti-Polio Type 1, 2 and 3 Antibody Titers | Anti-Polio 3 | 15.4 Titers |
| Repevax Group | Anti-Polio Type 1, 2 and 3 Antibody Titers | Anti-Polio 1 | 13.2 Titers |
| Repevax Group | Anti-Polio Type 1, 2 and 3 Antibody Titers | Anti-Polio 2 | 14.6 Titers |
| Repevax Group | Anti-Polio Type 1, 2 and 3 Antibody Titers | Anti-Polio 3 | 14.5 Titers |
Secondary
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.
Time frame: At Month 0, before the booster vaccination
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Boostrix Polio Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PT | 3.4 EL.U/mL |
| Boostrix Polio Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-FHA | 12.9 EL.U/mL |
| Boostrix Polio Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PRN | 4.3 EL.U/mL |
| Repevax Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PT | 3.2 EL.U/mL |
| Repevax Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-FHA | 10.7 EL.U/mL |
| Repevax Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PRN | 4.3 EL.U/mL |
Secondary
Anti-rubella Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.
Time frame: Before (Month 0) and one month after (Month 1) the booster vaccination
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Boostrix Polio Group | Anti-rubella Antibody Concentrations | Anti-Rubella, M0 | 66.5 IU/mL |
| Boostrix Polio Group | Anti-rubella Antibody Concentrations | Anti-Rubella, M1 | 134.3 IU/mL |
| Repevax Group | Anti-rubella Antibody Concentrations | Anti-Rubella, M0 | 72.6 IU/mL |
| Repevax Group | Anti-rubella Antibody Concentrations | Anti-Rubella, M1 | 130.3 IU/mL |
Secondary
Number of Seroconverted Subjects for Anti-measles
Seroconversion for anti-measles was defined as the appearance of antibodies after vaccination in subjects who were initially seronegative \[with antibody concentrations ≥ 150 milli-international units per millilitre (mIU/mL)\].
Time frame: Before (Month 0) and one month after (Month 1) the booster vaccination
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Boostrix Polio Group | Number of Seroconverted Subjects for Anti-measles | Anti-measles, M1 | 4 Participants |
| Boostrix Polio Group | Number of Seroconverted Subjects for Anti-measles | Anti-measles, M0 | 0 Participants |
| Repevax Group | Number of Seroconverted Subjects for Anti-measles | Anti-measles, M0 | 0 Participants |
| Repevax Group | Number of Seroconverted Subjects for Anti-measles | Anti-measles, M1 | 2 Participants |
Secondary
Number of Seroconverted Subjects for Anti-mumps
Seroconversion for anti-mumps was defined as the appearance of antibodies after vaccination in subjects who were initially seronegative \[with antibody concentrations ≥ 231 units per millilitre (U/mL)\].
Time frame: Before (Month 0) and one month after (Month 1) the booster vaccination
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Boostrix Polio Group | Number of Seroconverted Subjects for Anti-mumps | Anti-mumps, M0 | 0 Participants |
| Boostrix Polio Group | Number of Seroconverted Subjects for Anti-mumps | Anti-mumps, M1 | 11 Participants |
| Repevax Group | Number of Seroconverted Subjects for Anti-mumps | Anti-mumps, M0 | 0 Participants |
| Repevax Group | Number of Seroconverted Subjects for Anti-mumps | Anti-mumps, M1 | 6 Participants |
Secondary
Number of Seropositive Subjects for Anti-measles Antibody
A seropositive subject was defined as a subject with anti-measles antibody titers ≥ 150 mIU/mL.
Time frame: Before (Month 0) and one month after (Month 1) the booster vaccination
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Boostrix Polio Group | Number of Seropositive Subjects for Anti-measles Antibody | Anti-Measles, M0 | 155 Participants |
| Boostrix Polio Group | Number of Seropositive Subjects for Anti-measles Antibody | Anti-Measles, M1 | 136 Participants |
| Repevax Group | Number of Seropositive Subjects for Anti-measles Antibody | Anti-Measles, M0 | 74 Participants |
| Repevax Group | Number of Seropositive Subjects for Anti-measles Antibody | Anti-Measles, M1 | 68 Participants |
Secondary
Number of Seropositive Subjects for Anti-mumps Antibody
A seropositive subject was defined as a subject with anti-mumps antibody titers ≥ 231 U/mL.
Time frame: Before (Month 0) and one month after (Month 1) the booster vaccination
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Boostrix Polio Group | Number of Seropositive Subjects for Anti-mumps Antibody | Anti-Mumps, M0 | 140 Participants |
| Boostrix Polio Group | Number of Seropositive Subjects for Anti-mumps Antibody | Anti-Mumps, M1 | 133 Participants |
| Repevax Group | Number of Seropositive Subjects for Anti-mumps Antibody | Anti-Mumps, M0 | 69 Participants |
| Repevax Group | Number of Seropositive Subjects for Anti-mumps Antibody | Anti-Mumps, M1 | 68 Participants |
Secondary
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN
A seropositive subject for anti-PT, anti-FHA and anti-PRN was a subject whose antibody concentration was ≥ 5 EL.U/mL.
Time frame: Before (Month 0) and one month after (Month 1) the booster vaccination
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Boostrix Polio Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN | Anti-PT, M1 | 194 Participants |
| Boostrix Polio Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN | Anti-FHA, M1 | 195 Participants |
| Boostrix Polio Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN | Anti-PT, M0 | 31 Participants |
| Boostrix Polio Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN | Anti-PRN, M0 | 61 Participants |
| Boostrix Polio Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN | Anti-FHA, M0 | 112 Participants |
| Boostrix Polio Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN | Anti-PRN, M1 | 194 Participants |
| Repevax Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN | Anti-PRN, M1 | 94 Participants |
| Repevax Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN | Anti-PT, M0 | 18 Participants |
| Repevax Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN | Anti-PT, M1 | 96 Participants |
| Repevax Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN | Anti-FHA, M0 | 60 Participants |
| Repevax Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN | Anti-FHA, M1 | 95 Participants |
| Repevax Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN | Anti-PRN, M0 | 37 Participants |
Secondary
Number of Seropositive Subjects for Anti-rubella Antibody
A seropositive subject was defined as a subject with anti-rubella antibody titers ≥ 4 IU/mL.
Time frame: Before (Month 0) and one month after (Month 1) the booster vaccination
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Boostrix Polio Group | Number of Seropositive Subjects for Anti-rubella Antibody | Anti-Rubella, M0 | 158 Participants |
| Boostrix Polio Group | Number of Seropositive Subjects for Anti-rubella Antibody | Anti-Rubella, M1 | 134 Participants |
| Repevax Group | Number of Seropositive Subjects for Anti-rubella Antibody | Anti-Rubella, M0 | 76 Participants |
| Repevax Group | Number of Seropositive Subjects for Anti-rubella Antibody | Anti-Rubella, M1 | 68 Participants |
Secondary
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T)
A seroprotected subject was defined a subject with anti-D and anti-T antibody concentrations ≥ 0.1 international units per millilitre (IU/mL).
Time frame: Before (Month 0) and one month after (Month 1) the booster vaccination
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Boostrix Polio Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) | Anti-D, M0 | 136 Participants |
| Boostrix Polio Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) | Anti-D, M1 | 195 Participants |
| Boostrix Polio Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) | Anti-T, M0 | 116 Participants |
| Boostrix Polio Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) | Anti-T, M1 | 194 Participants |
| Repevax Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) | Anti-T, M1 | 96 Participants |
| Repevax Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) | Anti-D, M0 | 75 Participants |
| Repevax Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) | Anti-T, M0 | 63 Participants |
| Repevax Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) | Anti-D, M1 | 96 Participants |
Secondary
Number of Seroprotected Subjects Against Polio Type 1, 2 and 3
A seroprotected subject was defined as a subject with anti-polio type 1, 2 and 3 antibody titres ≥ the value of 8.
Time frame: Before (Month 0) and one month after (Month 1) the booster vaccination
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Boostrix Polio Group | Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 | Anti-polio 1, M0 | 95 Participants |
| Boostrix Polio Group | Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 | Anti-polio 1, M1 | 156 Participants |
| Boostrix Polio Group | Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 | Anti-polio 2, M0 | 109 Participants |
| Boostrix Polio Group | Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 | Anti-polio 2, M1 | 123 Participants |
| Boostrix Polio Group | Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 | Anti-polio 3, M0 | 100 Participants |
| Boostrix Polio Group | Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 | Anti-polio 3, M1 | 158 Participants |
| Repevax Group | Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 | Anti-polio 3, M0 | 47 Participants |
| Repevax Group | Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 | Anti-polio 1, M0 | 49 Participants |
| Repevax Group | Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 | Anti-polio 2, M1 | 71 Participants |
| Repevax Group | Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 | Anti-polio 1, M1 | 75 Participants |
| Repevax Group | Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 | Anti-polio 3, M1 | 81 Participants |
| Repevax Group | Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 | Anti-polio 2, M0 | 55 Participants |
Secondary
Number of Subjects With a Booster Response to PT, FHA and PRN Antigens
Booster response was defined as: For initially seronegative subjects (pre-vaccination concentration \< 5 EL.U/mL), antibody concentrations at least four times the assay cut-off (post vaccination concentration ≥ 20 EL.U/mL). For initially seropositive subjects (with pre-vaccination concentration ≥ 5 EL.U/mL and \< 20 EL.U/mL), an increase in antibody concentrations of at least four times the Pre booster vaccination concentration. For initially seropositive subjects (with pre-vaccination concentration ≥ 20 EL.U/mL), an increase in antibody concentrations of at least two times the Pre booster vaccination concentration.
Time frame: At Month 1, one month after the booster vaccination
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Boostrix Polio Group | Number of Subjects With a Booster Response to PT, FHA and PRN Antigens | Anti-PT | 154 Participants |
| Boostrix Polio Group | Number of Subjects With a Booster Response to PT, FHA and PRN Antigens | Anti-FHA | 165 Participants |
| Boostrix Polio Group | Number of Subjects With a Booster Response to PT, FHA and PRN Antigens | Anti-PRN | 169 Participants |
| Repevax Group | Number of Subjects With a Booster Response to PT, FHA and PRN Antigens | Anti-PT | 73 Participants |
| Repevax Group | Number of Subjects With a Booster Response to PT, FHA and PRN Antigens | Anti-FHA | 79 Participants |
| Repevax Group | Number of Subjects With a Booster Response to PT, FHA and PRN Antigens | Anti-PRN | 89 Participants |
Secondary
Number of Subjects With Any Solicited General Symptoms
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\]. 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 subjects with at least one vaccine administration documented, who had their symptoms sheet filled in and for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Boostrix Polio Group | Number of Subjects With Any Solicited General Symptoms | Any Irritability | 107 Participants |
| Boostrix Polio Group | Number of Subjects With Any Solicited General Symptoms | Any Drowsiness | 77 Participants |
| Boostrix Polio Group | Number of Subjects With Any Solicited General Symptoms | Any Loss of appetite | 67 Participants |
| Boostrix Polio Group | Number of Subjects With Any Solicited General Symptoms | Any Temperature | 18 Participants |
| Repevax Group | Number of Subjects With Any Solicited General Symptoms | Any Temperature | 9 Participants |
| Repevax Group | Number of Subjects With Any Solicited General Symptoms | Any Loss of appetite | 30 Participants |
| Repevax Group | Number of Subjects With Any Solicited General Symptoms | Any Drowsiness | 39 Participants |
| Repevax Group | Number of Subjects With Any Solicited General Symptoms | Any Irritability | 49 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 subjects with at least one vaccine administration documented, who had their symptoms sheet filled in and for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Boostrix Polio Group | Number of Subjects With Any Solicited Local Symptoms | Any Swelling | 92 Participants |
| Boostrix Polio Group | Number of Subjects With Any Solicited Local Symptoms | Any Pain | 127 Participants |
| Boostrix Polio Group | Number of Subjects With Any Solicited Local Symptoms | Any Redness | 146 Participants |
| Repevax Group | Number of Subjects With Any Solicited Local Symptoms | Any Pain | 70 Participants |
| Repevax Group | Number of Subjects With Any Solicited Local Symptoms | Any Redness | 73 Participants |
| Repevax Group | Number of Subjects With Any Solicited Local Symptoms | Any Swelling | 53 Participants |
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 (Days 0-30) follow-up period after booster vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Boostrix Polio Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 88 Participants |
| Repevax Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 36 Participants |
Secondary
Number of Subjects With Booster Response for Polio Type 1, 2 and 3 Antigens
Booster response defined as: For initially seronegative subjects, antibody titers at least four times the cut-off (post-vaccination titer ≥ 32); For initially seropositive subjects, an increase in antibody titers of at least four times the Pre booster vaccination titer.
Time frame: At Month 1, one month after the booster vaccination
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Boostrix Polio Group | Number of Subjects With Booster Response for Polio Type 1, 2 and 3 Antigens | Anti-Polio 1 | 129 Participants |
| Boostrix Polio Group | Number of Subjects With Booster Response for Polio Type 1, 2 and 3 Antigens | Anti-Polio 2 | 99 Participants |
| Boostrix Polio Group | Number of Subjects With Booster Response for Polio Type 1, 2 and 3 Antigens | Anti-Polio 3 | 124 Participants |
| Repevax Group | Number of Subjects With Booster Response for Polio Type 1, 2 and 3 Antigens | Anti-Polio 1 | 63 Participants |
| Repevax Group | Number of Subjects With Booster Response for Polio Type 1, 2 and 3 Antigens | Anti-Polio 2 | 59 Participants |
| Repevax Group | Number of Subjects With Booster Response for Polio Type 1, 2 and 3 Antigens | Anti-Polio 3 | 68 Participants |
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: During the entire study period (From Day 0 to Month 1)
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Boostrix Polio Group | Number of Subjects With Serious Adverse Events (SAEs) | 1 Participants |
| Repevax Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |