Acellular Pertussis, Diphtheria, Poliomyelitis, Tetanus
Conditions
Keywords
Boostrix Polio, dTpa-IPV
Brief summary
This phase 3b study will compare the immunogenicity and reactogenicity of the dTpa-IPV vaccine to that of a DTPa-IPV vaccine when administered as a booster dose in healthy children 5-6 years of age who have received three primary vaccination doses of DTPa-based vaccine according to the 3-5-11 month schedule recommended in Italy. In this study, MMRV vaccine will also be co-administered to all children.
Interventions
BIOLOGICALTetravac TM
Single dose, intramuscular administration.
BIOLOGICALBoostrix Polio™ 711866
Single dose, intramuscular administration.
BIOLOGICALPriorix Tetra TM 208136
Single dose, subcutaneously.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 6 Years
Healthy volunteers
Yes
Inclusion criteria
* A male or female child of 5 and 6 years of age at the time of vaccination. * Subjects who received a complete 3-dose vaccination with a DTPa-based combined vaccine according to a 3-5-11 month schedule in line with recommendations in Italy. * Subjects who received a first dose of a live attenuated measles-mumps-rubella vaccine in the second year of life, in line with recommendations in Italy. * Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study. * Written informed consent obtained from the parent or guardian of the subject. * Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion criteria
* Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first 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. * 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 and/or poliomyelitis since vaccination in the first two years of life. * Previous measles, mumps, rubella and/or varicella second dose vaccination. * Known history of diphtheria, tetanus, pertussis, poliomyelitis, measles, mumps, rubella and/or varicella disease. * Known exposure to measles, mumps, rubella and/or varicella within 30 days prior to study start. * 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 vaccination 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 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. * Residence in the same household as a person high risk for varicella * The following condition is temporary or self-limiting, and a subject may be vaccinated once the condition has resolved if no other
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations | At Month 1, one month post-vaccination | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL). The reference cut-off value was greater than or equal to (≥) 0.1 IU/mL. |
| Anti-poliovirus Types 1, 2 and 3 Antibody Titres | At Month 1, one month post-vaccination | Antibody titers were presented as geometric mean titers (GMTs) for the assay cut-off ≥ the value of 8. |
| Number of Seroprotected Subjects Against Polio Types 1, 2 and 3 | At Month 1, one month post-vaccination | A seroprotected subject was defined as a subject with anti-polio types 1, 2 and 3 titers ≥ the value of 8. Antibody titers have been assessed by neutralization assay. |
| Number of Seropositive Subjects for Anti-D and Anti-T Antibodies | At Month 1, one month post-vaccination | A seropositive subject was defined as a subject with anti-D and anti-T concentrations ≥ 0.1 IU/mL. Antibody concentrations have been assessed by enzyme-linked immunosorbent assay (ELISA). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anti-measles and Anti-varicella Antibody Concentrations | At Month 1, one month post-vaccination | Antibody concentrations were assessed by ELISA, presented as geometric mean concentrations (GMCs) and expressed in mIU/mL. |
| Anti-mumps Antibody Concentrations | At Month 1, one month post-vaccination | Antibody concentrations were assessed by ELISA, presented as geometric mean concentrations (GMCs) and expressed in U/mL. |
| Anti-rubella Antibody Concentrations | At Month 1, one month post-vaccination | Antibody concentrations were assessed by ELISA, presented as geometric mean concentrations (GMCs) and expressed in IU/mL. |
| Number of Subjects With Booster Responses to Anti-D and Anti-T | At Month 1, one month post-vaccination | Booster responses to anti-D and anti-T were defined as: For initially seronegative subjects (pre-vaccination concentration \< cut-off of 0.1 IU/mL), antibody concentrations at least four times the assay cut-off (post-vaccination concentration ≥ 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-vaccination concentration. |
| Number of Subjects With Booster Responses to Anti-polio Type 1, 2 and 3 | At Month 1, one month post-vaccination | Booster response to the poliovirus antigens was defined as: For initially seronegative subjects (pre-vaccination antibody titre \< cut-off of 8), antibody titre ≥ 32. For initially seropositive subjects (pre-vaccination antibody titres ≥ 8), an increase in antibody titres of at least four times the pre-vaccination titre. |
| Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens | At Month 1, one month post-vaccination | A seroprotected subject was defined as a subject with anti-D and anti-T concentrations ≥ 1.0 IU/mL. Antibody concentrations have been assessed by ELISA. |
| Number of Seroconverted Subjects for Anti-measles, Anti-mumps, Anti-rubella and Anti-varicella | At Month 1, one month post-vaccination | Seroconversion for anti-measles, anti-mumps, anti-rubella and anti-varicella was defined as the appearance of antibodies after vaccination in subjects who were seronegative before vaccination. There were no seronegative subjects for anti-rubella antibodies, prior to vaccination. |
| Number of Subjects With Any Solicited Local Symptoms | During the 4-day (Days 0-3) post-vaccination period | 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) post-vaccination period | 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. |
| Number of Subjects With Any Unsolicited Adverse Events (AEs) | During the 31-day (Days 0-30) post-vaccination period | 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 whole study period (from Month 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. |
| Number of Subjects With Booster Responses to Anti-PT, Anti-FHA and Anti-PRN | At Month 1, one month post-vaccination | Booster response to the PT, FHA and PRN antigens was defined as: For initially seronegative subjects (pre-vaccination concentration \< cut-off of 5 EL.U/mL), antibody concentrations at least four times the 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-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-vaccination concentration. |
| Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | At Month 1, one month post-vaccination | Antibody concentrations were presented as geometric mean concentrations, expressed in ELISA units per milliliter (EL.U/mL). The reference cut-off value was ≥ 5 EL.U/mL. |
| Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies | At Month 1, one month post-vaccination | A seropositive subject was defined as a subject with anti-PT, anti-FHA and anti-PRN concentrations ≥ 5.0 IU/mL. Antibody concentrations have been assessed by ELISA. |
| Number of Seropositive Subjects for Anti-measles, Anti-mumps, Anti-rubella and Anti-varicella | At Month 1, one month post-vaccination | Seropositivity was defined as: subjects with antibody concentrations ≥ 150 milli-international units per milliliter (mIU/mL), ≥ 231 units per milliliter (U/mL), ≥ 4 international units per milliliter (IU/mL) and ≥ 50 mIU/mL for anti-measles, anti-mumps, anti-rubella and anti-varicella antibodies, respectively. |
Countries
Italy
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 children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm. | 151 |
| Tetravac Group Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm. | 152 |
| Total | 303 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Tetravac Group | Total | Boostrix Polio Group |
|---|---|---|---|
| Age, Continuous | 5 Years STANDARD_DEVIATION 0.14 | 5 Years STANDARD_DEVIATION 0.14 | 5 Years STANDARD_DEVIATION 0.14 |
| Race/Ethnicity, Customized African heritage/African American | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian-Central/South Asian heritage | 4 Participants | 5 Participants | 1 Participants |
| Race/Ethnicity, Customized Not specified | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized White-Arabic/North African heritage | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized White-Caucasian/European heritage | 147 Participants | 294 Participants | 147 Participants |
| Sex: Female, Male Female | 68 Participants | 149 Participants | 81 Participants |
| Sex: Female, Male Male | 84 Participants | 154 Participants | 70 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 151 | 0 / 152 |
| other Total, other adverse events | 117 / 151 | 117 / 152 |
| serious Total, serious adverse events | 0 / 151 | 0 / 152 |
Outcome results
Primary
Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL). The reference cut-off value was greater than or equal to (≥) 0.1 IU/mL.
Time frame: At Month 1, one month post-vaccination
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and 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-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations | Anti-D | 9.207 IU/mL |
| Boostrix Polio Group | Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations | Anti-T | 12.527 IU/mL |
| Tetravac Group | Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations | Anti-D | 21.393 IU/mL |
| Tetravac Group | Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations | Anti-T | 11.07 IU/mL |
Primary
Anti-poliovirus Types 1, 2 and 3 Antibody Titres
Antibody titers were presented as geometric mean titers (GMTs) for the assay cut-off ≥ the value of 8.
Time frame: At Month 1, one month post-vaccination
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and 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-poliovirus Types 1, 2 and 3 Antibody Titres | Anti-Polio 1 | 1145.6 Titers |
| Boostrix Polio Group | Anti-poliovirus Types 1, 2 and 3 Antibody Titres | Anti-Polio 2 | 1076.4 Titers |
| Boostrix Polio Group | Anti-poliovirus Types 1, 2 and 3 Antibody Titres | Anti-Polio 3 | 1937.8 Titers |
| Tetravac Group | Anti-poliovirus Types 1, 2 and 3 Antibody Titres | Anti-Polio 1 | 948 Titers |
| Tetravac Group | Anti-poliovirus Types 1, 2 and 3 Antibody Titres | Anti-Polio 2 | 1315.3 Titers |
| Tetravac Group | Anti-poliovirus Types 1, 2 and 3 Antibody Titres | Anti-Polio 3 | 1657.3 Titers |
Primary
Number of Seropositive Subjects for Anti-D and Anti-T Antibodies
A seropositive subject was defined as a subject with anti-D and anti-T concentrations ≥ 0.1 IU/mL. Antibody concentrations have been assessed by enzyme-linked immunosorbent assay (ELISA).
Time frame: At Month 1, one month post-vaccination
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and 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-D and Anti-T Antibodies | Anti-D | 139 Participants |
| Boostrix Polio Group | Number of Seropositive Subjects for Anti-D and Anti-T Antibodies | Anti-T | 139 Participants |
| Tetravac Group | Number of Seropositive Subjects for Anti-D and Anti-T Antibodies | Anti-D | 144 Participants |
| Tetravac Group | Number of Seropositive Subjects for Anti-D and Anti-T Antibodies | Anti-T | 144 Participants |
Comparison: To demonstrate that GSK Biologicals' Boostrix Polio™ vaccine is non-inferior to Sanofi-Pasteur-MSD's Tetravac™ vaccine, in terms of seroprotection rates against diphtheria, one month after vaccination.95% CI: [-2.61, 2.7]
Comparison: To demonstrate that GSK Biologicals' Boostrix Polio™ vaccine is non-inferior to Sanofi-Pasteur-MSD's Tetravac™ vaccine, in terms of seroprotection rates against tetanus, one month after vaccination.95% CI: [-2.61, 2.7]
Primary
Number of Seroprotected Subjects Against Polio Types 1, 2 and 3
A seroprotected subject was defined as a subject with anti-polio types 1, 2 and 3 titers ≥ the value of 8. Antibody titers have been assessed by neutralization assay.
Time frame: At Month 1, one month post-vaccination
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and 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 Types 1, 2 and 3 | Anti-Polio 1 | 139 Participants |
| Boostrix Polio Group | Number of Seroprotected Subjects Against Polio Types 1, 2 and 3 | Anti-Polio 2 | 139 Participants |
| Boostrix Polio Group | Number of Seroprotected Subjects Against Polio Types 1, 2 and 3 | Anti-Polio 3 | 138 Participants |
| Tetravac Group | Number of Seroprotected Subjects Against Polio Types 1, 2 and 3 | Anti-Polio 1 | 144 Participants |
| Tetravac Group | Number of Seroprotected Subjects Against Polio Types 1, 2 and 3 | Anti-Polio 2 | 144 Participants |
| Tetravac Group | Number of Seroprotected Subjects Against Polio Types 1, 2 and 3 | Anti-Polio 3 | 144 Participants |
Comparison: To demonstrate that GSK Biologicals' Boostrix Polio™ vaccine is non-inferior to Sanofi-Pasteur-MSD's Tetravac™ vaccine, in terms of seroprotection rates against poliovirus type 1, one month after vaccination.95% CI: [-2.61, 2.7]
Comparison: To demonstrate that GSK Biologicals' Boostrix Polio™ vaccine is non-inferior to Sanofi-Pasteur-MSD's Tetravac™ vaccine, in terms of seroprotection rates against polio type 2, one month after vaccination.95% CI: [-2.61, 2.7]
Comparison: To demonstrate that GSK Biologicals' Boostrix Polio™ vaccine is non-inferior to Sanofi-Pasteur-MSD's Tetravac™ vaccine, in terms of seroprotection rates against polio type 3, one month after vaccination.95% CI: [-2.61, 2.72]
Secondary
Anti-measles and Anti-varicella Antibody Concentrations
Antibody concentrations were assessed by ELISA, presented as geometric mean concentrations (GMCs) and expressed in mIU/mL.
Time frame: At Month 1, one month post-vaccination
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and 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-measles and Anti-varicella Antibody Concentrations | Anti-varicella | 856.7 mIU/mL |
| Boostrix Polio Group | Anti-measles and Anti-varicella Antibody Concentrations | Anti-measles | 2743.9 mIU/mL |
| Tetravac Group | Anti-measles and Anti-varicella Antibody Concentrations | Anti-varicella | 909.9 mIU/mL |
| Tetravac Group | Anti-measles and Anti-varicella Antibody Concentrations | Anti-measles | 2863 mIU/mL |
Secondary
Anti-mumps Antibody Concentrations
Antibody concentrations were assessed by ELISA, presented as geometric mean concentrations (GMCs) and expressed in U/mL.
Time frame: At Month 1, one month post-vaccination
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Boostrix Polio Group | Anti-mumps Antibody Concentrations | 4141.3 U/mL |
| Tetravac Group | Anti-mumps Antibody Concentrations | 3837.6 U/mL |
Secondary
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations, expressed in ELISA units per milliliter (EL.U/mL). The reference cut-off value was ≥ 5 EL.U/mL.
Time frame: At Month 1, one month post-vaccination
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and 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-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-PT | 59.8 EL.U/mL |
| Boostrix Polio Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-FHA | 556.2 EL.U/mL |
| Boostrix Polio Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-PRN | 354.8 EL.U/mL |
| Tetravac Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-PT | 75.9 EL.U/mL |
| Tetravac Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-FHA | 613.5 EL.U/mL |
| Tetravac Group | Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-PRN | 7.8 EL.U/mL |
Secondary
Anti-rubella Antibody Concentrations
Antibody concentrations were assessed by ELISA, presented as geometric mean concentrations (GMCs) and expressed in IU/mL.
Time frame: At Month 1, one month post-vaccination
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Boostrix Polio Group | Anti-rubella Antibody Concentrations | 154.5 IU/mL |
| Tetravac Group | Anti-rubella Antibody Concentrations | 162.5 IU/mL |
Secondary
Number of Seroconverted Subjects for Anti-measles, Anti-mumps, Anti-rubella and Anti-varicella
Seroconversion for anti-measles, anti-mumps, anti-rubella and anti-varicella was defined as the appearance of antibodies after vaccination in subjects who were seronegative before vaccination. There were no seronegative subjects for anti-rubella antibodies, prior to vaccination.
Time frame: At Month 1, one month post-vaccination
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and 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 Seroconverted Subjects for Anti-measles, Anti-mumps, Anti-rubella and Anti-varicella | Anti-measles | 2 Participants |
| Boostrix Polio Group | Number of Seroconverted Subjects for Anti-measles, Anti-mumps, Anti-rubella and Anti-varicella | Anti-mumps | 13 Participants |
| Boostrix Polio Group | Number of Seroconverted Subjects for Anti-measles, Anti-mumps, Anti-rubella and Anti-varicella | Anti-rubella | 0 Participants |
| Boostrix Polio Group | Number of Seroconverted Subjects for Anti-measles, Anti-mumps, Anti-rubella and Anti-varicella | Anti-varicella | 35 Participants |
| Tetravac Group | Number of Seroconverted Subjects for Anti-measles, Anti-mumps, Anti-rubella and Anti-varicella | Anti-varicella | 32 Participants |
| Tetravac Group | Number of Seroconverted Subjects for Anti-measles, Anti-mumps, Anti-rubella and Anti-varicella | Anti-measles | 1 Participants |
| Tetravac Group | Number of Seroconverted Subjects for Anti-measles, Anti-mumps, Anti-rubella and Anti-varicella | Anti-rubella | 0 Participants |
| Tetravac Group | Number of Seroconverted Subjects for Anti-measles, Anti-mumps, Anti-rubella and Anti-varicella | Anti-mumps | 12 Participants |
Secondary
Number of Seropositive Subjects for Anti-measles, Anti-mumps, Anti-rubella and Anti-varicella
Seropositivity was defined as: subjects with antibody concentrations ≥ 150 milli-international units per milliliter (mIU/mL), ≥ 231 units per milliliter (U/mL), ≥ 4 international units per milliliter (IU/mL) and ≥ 50 mIU/mL for anti-measles, anti-mumps, anti-rubella and anti-varicella antibodies, respectively.
Time frame: At Month 1, one month post-vaccination
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and 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-measles, Anti-mumps, Anti-rubella and Anti-varicella | Anti-measles | 139 Participants |
| Boostrix Polio Group | Number of Seropositive Subjects for Anti-measles, Anti-mumps, Anti-rubella and Anti-varicella | Anti-mumps | 139 Participants |
| Boostrix Polio Group | Number of Seropositive Subjects for Anti-measles, Anti-mumps, Anti-rubella and Anti-varicella | Anti-rubella | 139 Participants |
| Boostrix Polio Group | Number of Seropositive Subjects for Anti-measles, Anti-mumps, Anti-rubella and Anti-varicella | Anti-varicella | 135 Participants |
| Tetravac Group | Number of Seropositive Subjects for Anti-measles, Anti-mumps, Anti-rubella and Anti-varicella | Anti-varicella | 140 Participants |
| Tetravac Group | Number of Seropositive Subjects for Anti-measles, Anti-mumps, Anti-rubella and Anti-varicella | Anti-measles | 146 Participants |
| Tetravac Group | Number of Seropositive Subjects for Anti-measles, Anti-mumps, Anti-rubella and Anti-varicella | Anti-rubella | 145 Participants |
| Tetravac Group | Number of Seropositive Subjects for Anti-measles, Anti-mumps, Anti-rubella and Anti-varicella | Anti-mumps | 144 Participants |
Secondary
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies
A seropositive subject was defined as a subject with anti-PT, anti-FHA and anti-PRN concentrations ≥ 5.0 IU/mL. Antibody concentrations have been assessed by ELISA.
Time frame: At Month 1, one month post-vaccination
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and 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-PT, Anti-FHA and Anti-PRN Antibodies | Anti-PT | 139 Participants |
| Boostrix Polio Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-FHA | 139 Participants |
| Boostrix Polio Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-PRN | 138 Participants |
| Tetravac Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-PT | 144 Participants |
| Tetravac Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-FHA | 144 Participants |
| Tetravac Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-PRN | 87 Participants |
Secondary
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens
A seroprotected subject was defined as a subject with anti-D and anti-T concentrations ≥ 1.0 IU/mL. Antibody concentrations have been assessed by ELISA.
Time frame: At Month 1, one month post-vaccination
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and 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 Diphteria (D) and Tetanus (T) Antigens | Anti-D | 138 Participants |
| Boostrix Polio Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens | Anti-T | 137 Participants |
| Tetravac Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens | Anti-D | 144 Participants |
| Tetravac Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens | Anti-T | 143 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.
Time frame: During the 4-day (Days 0-3) post-vaccination period
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Boostrix Polio Group | Number of Subjects With Any Solicited General Symptoms | Any Fatigue | 40 Participants |
| Boostrix Polio Group | Number of Subjects With Any Solicited General Symptoms | Any Headache | 18 Participants |
| Boostrix Polio Group | Number of Subjects With Any Solicited General Symptoms | Any Gastrointestinal | 23 Participants |
| Boostrix Polio Group | Number of Subjects With Any Solicited General Symptoms | Any Temperature | 32 Participants |
| Tetravac Group | Number of Subjects With Any Solicited General Symptoms | Any Temperature | 30 Participants |
| Tetravac Group | Number of Subjects With Any Solicited General Symptoms | Any Fatigue | 36 Participants |
| Tetravac Group | Number of Subjects With Any Solicited General Symptoms | Any Gastrointestinal | 15 Participants |
| Tetravac Group | Number of Subjects With Any Solicited General Symptoms | Any Headache | 20 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) post-vaccination period
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Boostrix Polio Group | Number of Subjects With Any Solicited Local Symptoms | Any Pain | 96 Participants |
| Boostrix Polio Group | Number of Subjects With Any Solicited Local Symptoms | Any Redness | 58 Participants |
| Boostrix Polio Group | Number of Subjects With Any Solicited Local Symptoms | Any Swelling | 55 Participants |
| Tetravac Group | Number of Subjects With Any Solicited Local Symptoms | Any Pain | 96 Participants |
| Tetravac Group | Number of Subjects With Any Solicited Local Symptoms | Any Redness | 66 Participants |
| Tetravac Group | Number of Subjects With Any Solicited Local Symptoms | Any Swelling | 62 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) post-vaccination period
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Boostrix Polio Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 23 Participants |
| Tetravac Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 20 Participants |
Secondary
Number of Subjects With Booster Responses to Anti-D and Anti-T
Booster responses to anti-D and anti-T were defined as: For initially seronegative subjects (pre-vaccination concentration \< cut-off of 0.1 IU/mL), antibody concentrations at least four times the assay cut-off (post-vaccination concentration ≥ 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-vaccination concentration.
Time frame: At Month 1, one month post-vaccination
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and 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 Responses to Anti-D and Anti-T | Anti-D | 130 Participants |
| Boostrix Polio Group | Number of Subjects With Booster Responses to Anti-D and Anti-T | Anti-T | 137 Participants |
| Tetravac Group | Number of Subjects With Booster Responses to Anti-D and Anti-T | Anti-D | 136 Participants |
| Tetravac Group | Number of Subjects With Booster Responses to Anti-D and Anti-T | Anti-T | 142 Participants |
Secondary
Number of Subjects With Booster Responses to Anti-polio Type 1, 2 and 3
Booster response to the poliovirus antigens was defined as: For initially seronegative subjects (pre-vaccination antibody titre \< cut-off of 8), antibody titre ≥ 32. For initially seropositive subjects (pre-vaccination antibody titres ≥ 8), an increase in antibody titres of at least four times the pre-vaccination titre.
Time frame: At Month 1, one month post-vaccination
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and 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 Responses to Anti-polio Type 1, 2 and 3 | Anti-Polio 1 | 115 Participants |
| Boostrix Polio Group | Number of Subjects With Booster Responses to Anti-polio Type 1, 2 and 3 | Anti-Polio 2 | 113 Participants |
| Boostrix Polio Group | Number of Subjects With Booster Responses to Anti-polio Type 1, 2 and 3 | Anti-Polio 3 | 126 Participants |
| Tetravac Group | Number of Subjects With Booster Responses to Anti-polio Type 1, 2 and 3 | Anti-Polio 1 | 112 Participants |
| Tetravac Group | Number of Subjects With Booster Responses to Anti-polio Type 1, 2 and 3 | Anti-Polio 2 | 122 Participants |
| Tetravac Group | Number of Subjects With Booster Responses to Anti-polio Type 1, 2 and 3 | Anti-Polio 3 | 127 Participants |
Secondary
Number of Subjects With Booster Responses to Anti-PT, Anti-FHA and Anti-PRN
Booster response to the PT, FHA and PRN antigens was defined as: For initially seronegative subjects (pre-vaccination concentration \< cut-off of 5 EL.U/mL), antibody concentrations at least four times the 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-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-vaccination concentration.
Time frame: At Month 1, one month post-vaccination
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and 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 Responses to Anti-PT, Anti-FHA and Anti-PRN | Anti-PT | 123 Participants |
| Boostrix Polio Group | Number of Subjects With Booster Responses to Anti-PT, Anti-FHA and Anti-PRN | Anti-FHA | 129 Participants |
| Boostrix Polio Group | Number of Subjects With Booster Responses to Anti-PT, Anti-FHA and Anti-PRN | Anti-PRN | 129 Participants |
| Tetravac Group | Number of Subjects With Booster Responses to Anti-PT, Anti-FHA and Anti-PRN | Anti-PT | 130 Participants |
| Tetravac Group | Number of Subjects With Booster Responses to Anti-PT, Anti-FHA and Anti-PRN | Anti-FHA | 134 Participants |
| Tetravac Group | Number of Subjects With Booster Responses to Anti-PT, Anti-FHA and Anti-PRN | Anti-PRN | 0 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 whole study period (from Month 0 to Month 1)
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Boostrix Polio Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
| Tetravac Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |