Whole Cell Pertussis, Diphtheria, Hepatitis B, Tetanus, Haemophilus Influenzae Type b
Conditions
Brief summary
To assess the immune memory following primary vaccination of DTPw-HBV/Hib vaccine and to assess immunogenicity and reactogenicity of a booster dose given at 15 - 18 months of age.
Detailed description
* Subjects who received DTPw-HBV/Hib in the primary vaccination without HBV at birth will be randomised (1:3 ratio) to receive either: Plain PRP at 10 months of age followed by DTPw-HBV at 15-18 months of age or DTPw-HBV/Hib at 15-18 months of age. * Subjects who received DTPw-HBV + Hib in the primary vaccination without HBV at birth will receive DTPw-HBV + Hib as a booster. * Subjects who received DTPw-HBV/Hib in the primary vaccination with HBV at birth will receive DTPw-HBV/Hib vaccine as a booster.
Interventions
BIOLOGICALTritanrix™-HepB/Hiberix™ Kft.
GlaxoSmithKline (GSK) Biologicals Korlatolt Felelossegu Tarsasag \[Kft\] (Limited Company) combined diphtheria (D), tetanus (T), whole cell Bordetella pertussis (Pw), hepatitis B vaccine with new sources of D, T and Pw antigens mixed with Haemophilus influenzae type b (Hib2.5) vaccine.
BIOLOGICALTritanrix™-HepB/Hiberix™
GSK Biologicals' combined diphtheria, tetanus, whole cell Bordetella pertussis, hepatitis B and Haemophilus Influenzae type b vaccine
BIOLOGICALHiberix™
GSK Biologicals' Haemophilus influenzae type b vaccine
BIOLOGICALPolyribosil-Ribitol-Phosphate (PRP) vaccine
plain PRP polysaccharide vaccine
BIOLOGICALTritanrix™-HepB Kft
GSK Biologicals Korlatolt Felelossegu Tarsasag \[Kft\] (Limited Company) combined diphtheria, tetanus, whole cell Bordetella pertussis, hepatitis B vaccine with new sources of D, T and Pw antigens produced at GSK Biologicals Kft., Gödöllö, Hungary.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Months to 18 Months
Healthy volunteers
Yes
Inclusion criteria
For subjects receiving Plain PRP followed by DTPw-HBV: Male or female infant, 10 to 11 months of age, who previously completed the three-dose primary vaccination course with the DTPw-HBV/Hib vaccine. For subjects receiving DTPw-HBV/Hib or DTPw-HBV + Hib: Male or female infant, 15-18 months of age, who previously completed the three-dose primary vaccination course with the DTPw-HBV/Hib vaccine. For all subjects: * Subjects who the investigator believes that their parent/guardian can and will comply with the requirements of the protocol. * Free of obvious health problems as established by medical history and clinical examination
Exclusion criteria
* Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding administration of the study vaccine, or planned use during the study period. * Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to administration of the study vaccine. * Planned administration/administration of a vaccine not foreseen by the study protocol starting 30 days before and ending 30 days after administration of the study vaccine with the exception of oral polio vaccine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anti-BPT Antibody Concentrations | At Month 1, post-booster vaccination | Anti-BPT antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL), as assessed by ELISA. |
| Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL | At Month 1, post-PRP challenge | The number of subjects with anti-PRP antibody concentrations equal to or above (≥) 0.15 μg/mL and ≥ 1.0 μg/mL, at one month after the PRP challenge. |
| Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL. | At Month 1, post-booster vaccination | The number of subjects with anti-PRP antibody concentrations equal to or above (≥) 0.15 μg/mL and ≥ 1.0 μg/mL, at one month post-booster vaccination. |
| Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) | At Month 1, post-booster vaccination | A seroprotected subject was defined as a vaccinated subject, with anti-D and anti-T antibody concentrations equal to or above (≥) 0.1 International Units per milliliter (IU/mL). |
| Seroprotection Rates for Anti-D Antibodies | At Month 1, post-booster vaccination | The seroprotection rate is defined as the estimated proportion of subjects with protective antibodies as assessed by the Enzyme-Linked Immunosorbent Assay (ELISA) (antibody concentration ≥ 0.1 IU/mL), or by Vero-cell neutralisation assay (antibody concentration ≥ 0.016 IU/mL), for subjects seronegative as assessed by ELISA. |
| Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs) | At Month 1, post-booster vaccination | A seroprotected subject was defined as a vaccinated subject with an anti-HBs antibody concentration equal to or above (≥) 10 milli International Units per milliliter (mIU/mL). |
| Number of Seroprotected Subjects Against Bordetella Pertussis (BPT) | At Month 1, post-booster vaccination | A seroprotected subject was defined as a vaccinated subject with an anti-BPT antibody concentration equal to or above (≥) 15 ELISA units per milliliter (EL.U/mL). |
| Number of Subjects With Booster Response to BPT Antigen | At Month 1, post-booster vaccination | The booster response was defined as: * an anti-BPT antibody concentration equal to or above (≥) the cut-off value (15 EL.U/mL) at post-booster vaccination in subjects seronegative (anti-BPT antibody concentration \< 15 EL.U/mL) prior to administration of the booster dose; or * at least a 2-fold increase in antibody concentration from pre- to post-vaccination time points, in subjects who were seropositive (anti-BPT antibody concentration ≥ 15 EL.U/mL) prior to the administration of the booster dose. |
| Anti-PRP Antibody Concentrations | At Month 1, post-PRP challenge | Anti-PRP antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in microgram per milliliter (μg/mL), as assessed by ELISA. |
| Anti-PRP Antibody Concentrations. | At Month 1, post-booster vaccination | Anti-PRP antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in microgram per milliliter (μg/mL), as assessed by ELISA. |
| Anti-D and Anti-T Antibody Concentrations | At Month 1, post-booster vaccination | Anti-D and anti-T antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in International Units per milliliter (IU/mL), as assessed by ELISA. |
| Anti-HBs Antibody Concentrations | At Month 1, post-booster vaccination | Anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL), as assessed by ELISA. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | During the 4-Day (Days 0-3) post-PRP challenge | Assessed solicited general symptoms were drowsiness, fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 fever = fever \> 39.5 °C. Grade 3 irritability = crying that could not be comforted and prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = symptom assessed by the investigator as related to the vaccination. |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | During the 4-Day (Days 0-3) post-booster vaccination period | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site. |
| Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL | At Month 0, prior to the PRP challenge | The number of subjects with anti-PRP antibody concentrations equal to or above (≥) 0.15 μg/mL and ≥ 1.0 μg/mL, prior to the PRP challenge. |
| Number of Subjects With Unsolicited Adverse Events (AEs) | During the 31-Day (Day 0-30) follow-up 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 entire study period (from Month 0 to Month 9.5) | SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | During the 4-Day (Days 0-3) post-booster vaccination period | Assessed solicited general symptoms were drowsiness, fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 fever = fever \> 39.5 °C. Grade 3 irritability = crying that could not be comforted and prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = symptom assessed by the investigator as related to the vaccination. |
| Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL. | At Month 0, prior to the PRP challenge | The number of subjects with anti-PRP antibody concentrations equal to or above (≥) 0.15 μg/mL and ≥ 1.0 μg/mL, prior to the booster vaccination. |
| Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ the Cut-off Value | At Month 0, prior to the PRP challenge | The number of subjects with anti-D antibody concentrations equal to or above (≥) the cut-off value of 0.1 IU/mL as assessed by ELISA, (or ≥ 0.016 IU/mL as assessed by the neutralisation assay on Vero cells in subjects seronegative by ELISA testing) and, the number of subjects with anti-T antibody concentrations ≥ the cut-off value of 0.1 IU/mL as assessed by ELISA. |
| Seroprotection Rates for Anti-D Antibodies | At Month 0, prior to the PRP challenge | The seroprotection rate is defined as the estimated proportion of subjects with protective antibodies as assessed by ELISA (antibody concentration ≥ 0.1 IU/mL), or by Vero-cell neutralisation assay (antibody concentration ≥ 0.016 IU/mL), for subjects seronegative as assessed by ELISA. |
| Number of Subjects With Anti-HBs Antibody Concentrations ≥ the Cut-off Value | At Month 0, prior to the PRP challenge | The number of subjects with anti-HBs antibody concentrations equal to or above (≥) the cut-off value of 10 mIU/mL, prior to the booster vaccination. |
| Number of Subjects With Anti-BPT Antibody Concentrations ≥ the Cut-off Value | At Month 0, prior to the PRP challenge | The number of subjects with anti-BPT antibody concentrations equal to or above (≥) the cut-off value of 15 EL.U/mL, prior to the booster vaccination. |
| Anti- PRP Antibody Concentrations | At Month 0, prior to the PRP challenge | Anti-PRP antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in microgram per milliliter (μg/mL), as assessed by ELISA. |
| Anti- PRP Antibody Concentrations. | At Month 0, prior to the PRP challenge | Anti-PRP antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in microgram per milliliter (μg/mL), as assessed by ELISA. |
| Anti-D and Anti-T Antibody Concentrations. | At Month 0, prior to the PRP challenge | Anti-D and anti-T antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in International Units per milliliter (IU/mL), as assessed by ELISA. |
| Anti-HBs Antibody Concentrations. | At Month 0, prior to the PRP challenge | Anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL), as assessed by ELISA. |
| Anti-BPT Antibody Concentrations. | At Month 0, prior to the PRP challenge | Anti-BPT antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL), as assessed by ELISA. |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | During the 4-Day (Days 0-3) post-PRP challenge | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site. |
Countries
Philippines
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tritanrix-HepB/Hiberix Kft. Mix Group Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age. | 119 |
| Tritanrix-HepB/Hiberix Kft. Ref Group Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age. | 124 |
| HB Tritanrix-HepB/Hiberix Kft. Mix Group Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix-HepB/Hiberix Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age. | 167 |
| Tritanrix-HepB Kft.+Hiberix Group Healthy male and female infants who were primed with Tritanrix-HepB Kft. and Hiberix vaccines, were boosted with Tritanrix-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age. | 250 |
| PRP Tritanrix-HepB Kft. Mix Group Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix Kft. vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age. | 42 |
| PRP Tritanrix-HepB Kft. Ref Group Healthy male and female infants who were primed with Tritanrix-HepB/Hiberix vaccine, received plain PRP polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age. | 43 |
| Total | 745 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Lost to follow-up (compl. vaccination) | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Lost to follow-up (incompl. vaccination) | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Migrated/moved from study area | 0 | 0 | 0 | 0 | 0 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Tritanrix-HepB/Hiberix Kft. Mix Group | Tritanrix-HepB/Hiberix Kft. Ref Group | HB Tritanrix-HepB/Hiberix Kft. Mix Group | Tritanrix-HepB Kft.+Hiberix Group | PRP Tritanrix-HepB Kft. Mix Group | PRP Tritanrix-HepB Kft. Ref Group | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 14.5 Months STANDARD_DEVIATION 1.44 | 14.8 Months STANDARD_DEVIATION 2.07 | 14.7 Months STANDARD_DEVIATION 1.89 | 15.0 Months STANDARD_DEVIATION 2.04 | 9.9 Months STANDARD_DEVIATION 0.68 | 9.8 Months STANDARD_DEVIATION 0.61 | 14.23 Months STANDARD_DEVIATION 1.75 |
| Race/Ethnicity, Customized East/South East Asian heritage | 119 Participants | 124 Participants | 167 Participants | 250 Participants | 42 Participants | 43 Participants | 745 Participants |
| Sex: Female, Male Female | 49 Participants | 58 Participants | 90 Participants | 120 Participants | 21 Participants | 21 Participants | 359 Participants |
| Sex: Female, Male Male | 70 Participants | 66 Participants | 77 Participants | 130 Participants | 21 Participants | 22 Participants | 386 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 85 | 0 / 410 | 0 / 250 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 77 / 85 | 379 / 410 | 231 / 250 | 37 / 42 | 40 / 43 |
| serious Total, serious adverse events | 1 / 85 | 0 / 410 | 0 / 250 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Anti-BPT Antibody Concentrations
Anti-BPT antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL), as assessed by ELISA.
Time frame: At Month 1, post-booster vaccination
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| PRP Tritanrix-HepB Kft. Mix Group | Anti-BPT Antibody Concentrations | 91.3 EL.U/mL |
| PRP Tritanrix-HepB Kft. Ref Group | Anti-BPT Antibody Concentrations | 118.8 EL.U/mL |
| HB Tritanrix-HepB/Hiberix Kft. Mix Group | Anti-BPT Antibody Concentrations | 97.6 EL.U/mL |
| Tritanrix-HepB Kft.+Hiberix Group | Anti-BPT Antibody Concentrations | 93.5 EL.U/mL |
Primary
Anti-D and Anti-T Antibody Concentrations
Anti-D and anti-T antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in International Units per milliliter (IU/mL), as assessed by ELISA.
Time frame: At Month 1, post-booster vaccination
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| PRP Tritanrix-HepB Kft. Mix Group | Anti-D and Anti-T Antibody Concentrations | Anti-D | 3.087 IU/mL |
| PRP Tritanrix-HepB Kft. Mix Group | Anti-D and Anti-T Antibody Concentrations | Anti-T | 13.371 IU/mL |
| PRP Tritanrix-HepB Kft. Ref Group | Anti-D and Anti-T Antibody Concentrations | Anti-T | 12.181 IU/mL |
| PRP Tritanrix-HepB Kft. Ref Group | Anti-D and Anti-T Antibody Concentrations | Anti-D | 1.812 IU/mL |
| HB Tritanrix-HepB/Hiberix Kft. Mix Group | Anti-D and Anti-T Antibody Concentrations | Anti-T | 12.838 IU/mL |
| HB Tritanrix-HepB/Hiberix Kft. Mix Group | Anti-D and Anti-T Antibody Concentrations | Anti-D | 3.452 IU/mL |
| Tritanrix-HepB Kft.+Hiberix Group | Anti-D and Anti-T Antibody Concentrations | Anti-D | 3.128 IU/mL |
| Tritanrix-HepB Kft.+Hiberix Group | Anti-D and Anti-T Antibody Concentrations | Anti-T | 16.822 IU/mL |
Primary
Anti-HBs Antibody Concentrations
Anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL), as assessed by ELISA.
Time frame: At Month 1, post-booster vaccination
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| PRP Tritanrix-HepB Kft. Mix Group | Anti-HBs Antibody Concentrations | 2400.0 mIU/mL |
| PRP Tritanrix-HepB Kft. Ref Group | Anti-HBs Antibody Concentrations | 1628.3 mIU/mL |
| HB Tritanrix-HepB/Hiberix Kft. Mix Group | Anti-HBs Antibody Concentrations | 2467.9 mIU/mL |
| Tritanrix-HepB Kft.+Hiberix Group | Anti-HBs Antibody Concentrations | 2465.1 mIU/mL |
Primary
Anti-PRP Antibody Concentrations
Anti-PRP antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in microgram per milliliter (μg/mL), as assessed by ELISA.
Time frame: At Month 1, post-PRP challenge
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| PRP Tritanrix-HepB Kft. Mix Group | Anti-PRP Antibody Concentrations | 33.190 μg/mL |
| PRP Tritanrix-HepB Kft. Ref Group | Anti-PRP Antibody Concentrations | 22.727 μg/mL |
Primary
Anti-PRP Antibody Concentrations.
Anti-PRP antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in microgram per milliliter (μg/mL), as assessed by ELISA.
Time frame: At Month 1, post-booster vaccination
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| PRP Tritanrix-HepB Kft. Mix Group | Anti-PRP Antibody Concentrations. | 56.670 μg/mL |
| PRP Tritanrix-HepB Kft. Ref Group | Anti-PRP Antibody Concentrations. | 81.681 μg/mL |
| HB Tritanrix-HepB/Hiberix Kft. Mix Group | Anti-PRP Antibody Concentrations. | 58.669 μg/mL |
| Tritanrix-HepB Kft.+Hiberix Group | Anti-PRP Antibody Concentrations. | 113.073 μg/mL |
Primary
Number of Seroprotected Subjects Against Bordetella Pertussis (BPT)
A seroprotected subject was defined as a vaccinated subject with an anti-BPT antibody concentration equal to or above (≥) 15 ELISA units per milliliter (EL.U/mL).
Time frame: At Month 1, post-booster vaccination
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PRP Tritanrix-HepB Kft. Mix Group | Number of Seroprotected Subjects Against Bordetella Pertussis (BPT) | 74 Participants |
| PRP Tritanrix-HepB Kft. Ref Group | Number of Seroprotected Subjects Against Bordetella Pertussis (BPT) | 65 Participants |
| HB Tritanrix-HepB/Hiberix Kft. Mix Group | Number of Seroprotected Subjects Against Bordetella Pertussis (BPT) | 85 Participants |
| Tritanrix-HepB Kft.+Hiberix Group | Number of Seroprotected Subjects Against Bordetella Pertussis (BPT) | 69 Participants |
Primary
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T)
A seroprotected subject was defined as a vaccinated subject, with anti-D and anti-T antibody concentrations equal to or above (≥) 0.1 International Units per milliliter (IU/mL).
Time frame: At Month 1, post-booster vaccination
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PRP Tritanrix-HepB Kft. Mix Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) | Anti-D | 74 Participants |
| PRP Tritanrix-HepB Kft. Mix Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) | Anti-T | 77 Participants |
| PRP Tritanrix-HepB Kft. Ref Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) | Anti-T | 71 Participants |
| PRP Tritanrix-HepB Kft. Ref Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) | Anti-D | 68 Participants |
| HB Tritanrix-HepB/Hiberix Kft. Mix Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) | Anti-D | 88 Participants |
| HB Tritanrix-HepB/Hiberix Kft. Mix Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) | Anti-T | 88 Participants |
| Tritanrix-HepB Kft.+Hiberix Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) | Anti-D | 73 Participants |
| Tritanrix-HepB Kft.+Hiberix Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) | Anti-T | 74 Participants |
Primary
Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)
A seroprotected subject was defined as a vaccinated subject with an anti-HBs antibody concentration equal to or above (≥) 10 milli International Units per milliliter (mIU/mL).
Time frame: At Month 1, post-booster vaccination
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PRP Tritanrix-HepB Kft. Mix Group | Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs) | 74 Participants |
| PRP Tritanrix-HepB Kft. Ref Group | Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs) | 69 Participants |
| HB Tritanrix-HepB/Hiberix Kft. Mix Group | Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs) | 84 Participants |
| Tritanrix-HepB Kft.+Hiberix Group | Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs) | 72 Participants |
Primary
Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL
The number of subjects with anti-PRP antibody concentrations equal to or above (≥) 0.15 μg/mL and ≥ 1.0 μg/mL, at one month after the PRP challenge.
Time frame: At Month 1, post-PRP challenge
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PRP Tritanrix-HepB Kft. Mix Group | Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL | Anti-PRP ≥ 0.15 μg/mL | 39 Participants |
| PRP Tritanrix-HepB Kft. Mix Group | Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL | Anti-PRP ≥ 1.0 μg/mL | 37 Participants |
| PRP Tritanrix-HepB Kft. Ref Group | Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL | Anti-PRP ≥ 0.15 μg/mL | 41 Participants |
| PRP Tritanrix-HepB Kft. Ref Group | Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL | Anti-PRP ≥ 1.0 μg/mL | 39 Participants |
Primary
Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL.
The number of subjects with anti-PRP antibody concentrations equal to or above (≥) 0.15 μg/mL and ≥ 1.0 μg/mL, at one month post-booster vaccination.
Time frame: At Month 1, post-booster vaccination
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PRP Tritanrix-HepB Kft. Mix Group | Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL. | Anti-PRP ≥ 0.15 μg/mL | 77 Participants |
| PRP Tritanrix-HepB Kft. Mix Group | Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL. | Anti-PRP ≥ 1.0 μg/mL | 76 Participants |
| PRP Tritanrix-HepB Kft. Ref Group | Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL. | Anti-PRP ≥ 1.0 μg/mL | 70 Participants |
| PRP Tritanrix-HepB Kft. Ref Group | Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL. | Anti-PRP ≥ 0.15 μg/mL | 71 Participants |
| HB Tritanrix-HepB/Hiberix Kft. Mix Group | Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL. | Anti-PRP ≥ 0.15 μg/mL | 88 Participants |
| HB Tritanrix-HepB/Hiberix Kft. Mix Group | Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL. | Anti-PRP ≥ 1.0 μg/mL | 88 Participants |
| Tritanrix-HepB Kft.+Hiberix Group | Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL. | Anti-PRP ≥ 0.15 μg/mL | 74 Participants |
| Tritanrix-HepB Kft.+Hiberix Group | Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL. | Anti-PRP ≥ 1.0 μg/mL | 74 Participants |
Primary
Number of Subjects With Booster Response to BPT Antigen
The booster response was defined as: * an anti-BPT antibody concentration equal to or above (≥) the cut-off value (15 EL.U/mL) at post-booster vaccination in subjects seronegative (anti-BPT antibody concentration \< 15 EL.U/mL) prior to administration of the booster dose; or * at least a 2-fold increase in antibody concentration from pre- to post-vaccination time points, in subjects who were seropositive (anti-BPT antibody concentration ≥ 15 EL.U/mL) prior to the administration of the booster dose.
Time frame: At Month 1, post-booster vaccination
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PRP Tritanrix-HepB Kft. Mix Group | Number of Subjects With Booster Response to BPT Antigen | 70 Participants |
| PRP Tritanrix-HepB Kft. Ref Group | Number of Subjects With Booster Response to BPT Antigen | 64 Participants |
| HB Tritanrix-HepB/Hiberix Kft. Mix Group | Number of Subjects With Booster Response to BPT Antigen | 79 Participants |
| Tritanrix-HepB Kft.+Hiberix Group | Number of Subjects With Booster Response to BPT Antigen | 67 Participants |
Primary
Seroprotection Rates for Anti-D Antibodies
The seroprotection rate is defined as the estimated proportion of subjects with protective antibodies as assessed by the Enzyme-Linked Immunosorbent Assay (ELISA) (antibody concentration ≥ 0.1 IU/mL), or by Vero-cell neutralisation assay (antibody concentration ≥ 0.016 IU/mL), for subjects seronegative as assessed by ELISA.
Time frame: At Month 1, post-booster vaccination
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PRP Tritanrix-HepB Kft. Mix Group | Seroprotection Rates for Anti-D Antibodies | 100 Proportion |
| PRP Tritanrix-HepB Kft. Ref Group | Seroprotection Rates for Anti-D Antibodies | 100 Proportion |
| HB Tritanrix-HepB/Hiberix Kft. Mix Group | Seroprotection Rates for Anti-D Antibodies | 100 Proportion |
| Tritanrix-HepB Kft.+Hiberix Group | Seroprotection Rates for Anti-D Antibodies | 100 Proportion |
Secondary
Anti-BPT Antibody Concentrations.
Anti-BPT antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL), as assessed by ELISA.
Time frame: At Month 0, prior to the PRP challenge
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| PRP Tritanrix-HepB Kft. Mix Group | Anti-BPT Antibody Concentrations. | 10.6 EL.U/mL |
| PRP Tritanrix-HepB Kft. Ref Group | Anti-BPT Antibody Concentrations. | 10.7 EL.U/mL |
| HB Tritanrix-HepB/Hiberix Kft. Mix Group | Anti-BPT Antibody Concentrations. | 12.8 EL.U/mL |
| Tritanrix-HepB Kft.+Hiberix Group | Anti-BPT Antibody Concentrations. | 11.9 EL.U/mL |
Secondary
Anti-D and Anti-T Antibody Concentrations.
Anti-D and anti-T antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in International Units per milliliter (IU/mL), as assessed by ELISA.
Time frame: At Month 0, prior to the PRP challenge
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| PRP Tritanrix-HepB Kft. Mix Group | Anti-D and Anti-T Antibody Concentrations. | Anti-D | 0.117 IU/mL |
| PRP Tritanrix-HepB Kft. Mix Group | Anti-D and Anti-T Antibody Concentrations. | Anti-T | 0.397 IU/mL |
| PRP Tritanrix-HepB Kft. Ref Group | Anti-D and Anti-T Antibody Concentrations. | Anti-T | 0.512 IU/mL |
| PRP Tritanrix-HepB Kft. Ref Group | Anti-D and Anti-T Antibody Concentrations. | Anti-D | 0.077 IU/mL |
| HB Tritanrix-HepB/Hiberix Kft. Mix Group | Anti-D and Anti-T Antibody Concentrations. | Anti-D | 0.162 IU/mL |
| HB Tritanrix-HepB/Hiberix Kft. Mix Group | Anti-D and Anti-T Antibody Concentrations. | Anti-T | 0.588 IU/mL |
| Tritanrix-HepB Kft.+Hiberix Group | Anti-D and Anti-T Antibody Concentrations. | Anti-D | 0.145 IU/mL |
| Tritanrix-HepB Kft.+Hiberix Group | Anti-D and Anti-T Antibody Concentrations. | Anti-T | 0.446 IU/mL |
Secondary
Anti-HBs Antibody Concentrations.
Anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL), as assessed by ELISA.
Time frame: At Month 0, prior to the PRP challenge
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| PRP Tritanrix-HepB Kft. Mix Group | Anti-HBs Antibody Concentrations. | 43.6 mIU/mL |
| PRP Tritanrix-HepB Kft. Ref Group | Anti-HBs Antibody Concentrations. | 26.1 mIU/mL |
| HB Tritanrix-HepB/Hiberix Kft. Mix Group | Anti-HBs Antibody Concentrations. | 70.5 mIU/mL |
| Tritanrix-HepB Kft.+Hiberix Group | Anti-HBs Antibody Concentrations. | 43.6 mIU/mL |
Secondary
Anti- PRP Antibody Concentrations
Anti-PRP antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in microgram per milliliter (μg/mL), as assessed by ELISA.
Time frame: At Month 0, prior to the PRP challenge
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| PRP Tritanrix-HepB Kft. Mix Group | Anti- PRP Antibody Concentrations | 4.683 μg/mL |
| PRP Tritanrix-HepB Kft. Ref Group | Anti- PRP Antibody Concentrations | 4.507 μg/mL |
Secondary
Anti- PRP Antibody Concentrations.
Anti-PRP antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in microgram per milliliter (μg/mL), as assessed by ELISA.
Time frame: At Month 0, prior to the PRP challenge
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| PRP Tritanrix-HepB Kft. Mix Group | Anti- PRP Antibody Concentrations. | 2.703 μg/mL |
| PRP Tritanrix-HepB Kft. Ref Group | Anti- PRP Antibody Concentrations. | 5.312 μg/mL |
| HB Tritanrix-HepB/Hiberix Kft. Mix Group | Anti- PRP Antibody Concentrations. | 2.837 μg/mL |
| Tritanrix-HepB Kft.+Hiberix Group | Anti- PRP Antibody Concentrations. | 2.904 μg/mL |
Secondary
Number of Subjects With Anti-BPT Antibody Concentrations ≥ the Cut-off Value
The number of subjects with anti-BPT antibody concentrations equal to or above (≥) the cut-off value of 15 EL.U/mL, prior to the booster vaccination.
Time frame: At Month 0, prior to the PRP challenge
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PRP Tritanrix-HepB Kft. Mix Group | Number of Subjects With Anti-BPT Antibody Concentrations ≥ the Cut-off Value | 23 Participants |
| PRP Tritanrix-HepB Kft. Ref Group | Number of Subjects With Anti-BPT Antibody Concentrations ≥ the Cut-off Value | 21 Participants |
| HB Tritanrix-HepB/Hiberix Kft. Mix Group | Number of Subjects With Anti-BPT Antibody Concentrations ≥ the Cut-off Value | 33 Participants |
| Tritanrix-HepB Kft.+Hiberix Group | Number of Subjects With Anti-BPT Antibody Concentrations ≥ the Cut-off Value | 27 Participants |
Secondary
Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ the Cut-off Value
The number of subjects with anti-D antibody concentrations equal to or above (≥) the cut-off value of 0.1 IU/mL as assessed by ELISA, (or ≥ 0.016 IU/mL as assessed by the neutralisation assay on Vero cells in subjects seronegative by ELISA testing) and, the number of subjects with anti-T antibody concentrations ≥ the cut-off value of 0.1 IU/mL as assessed by ELISA.
Time frame: At Month 0, prior to the PRP challenge
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PRP Tritanrix-HepB Kft. Mix Group | Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ the Cut-off Value | Anti-D | 45 Participants |
| PRP Tritanrix-HepB Kft. Mix Group | Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ the Cut-off Value | Anti-T | 72 Participants |
| PRP Tritanrix-HepB Kft. Ref Group | Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ the Cut-off Value | Anti-T | 67 Participants |
| PRP Tritanrix-HepB Kft. Ref Group | Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ the Cut-off Value | Anti-D | 24 Participants |
| HB Tritanrix-HepB/Hiberix Kft. Mix Group | Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ the Cut-off Value | Anti-D | 58 Participants |
| HB Tritanrix-HepB/Hiberix Kft. Mix Group | Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ the Cut-off Value | Anti-T | 86 Participants |
| Tritanrix-HepB Kft.+Hiberix Group | Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ the Cut-off Value | Anti-D | 46 Participants |
| Tritanrix-HepB Kft.+Hiberix Group | Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ the Cut-off Value | Anti-T | 69 Participants |
Secondary
Number of Subjects With Anti-HBs Antibody Concentrations ≥ the Cut-off Value
The number of subjects with anti-HBs antibody concentrations equal to or above (≥) the cut-off value of 10 mIU/mL, prior to the booster vaccination.
Time frame: At Month 0, prior to the PRP challenge
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PRP Tritanrix-HepB Kft. Mix Group | Number of Subjects With Anti-HBs Antibody Concentrations ≥ the Cut-off Value | 56 Participants |
| PRP Tritanrix-HepB Kft. Ref Group | Number of Subjects With Anti-HBs Antibody Concentrations ≥ the Cut-off Value | 44 Participants |
| HB Tritanrix-HepB/Hiberix Kft. Mix Group | Number of Subjects With Anti-HBs Antibody Concentrations ≥ the Cut-off Value | 69 Participants |
| Tritanrix-HepB Kft.+Hiberix Group | Number of Subjects With Anti-HBs Antibody Concentrations ≥ the Cut-off Value | 56 Participants |
Secondary
Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL
The number of subjects with anti-PRP antibody concentrations equal to or above (≥) 0.15 μg/mL and ≥ 1.0 μg/mL, prior to the PRP challenge.
Time frame: At Month 0, prior to the PRP challenge
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PRP Tritanrix-HepB Kft. Mix Group | Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL | Anti-PRP ≥ 0.15 μg/mL | 37 Participants |
| PRP Tritanrix-HepB Kft. Mix Group | Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL | Anti-PRP ≥ 1.0 μg/mL | 32 Participants |
| PRP Tritanrix-HepB Kft. Ref Group | Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL | Anti-PRP ≥ 0.15 μg/mL | 41 Participants |
| PRP Tritanrix-HepB Kft. Ref Group | Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL | Anti-PRP ≥ 1.0 μg/mL | 34 Participants |
Secondary
Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL.
The number of subjects with anti-PRP antibody concentrations equal to or above (≥) 0.15 μg/mL and ≥ 1.0 μg/mL, prior to the booster vaccination.
Time frame: At Month 0, prior to the PRP challenge
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PRP Tritanrix-HepB Kft. Mix Group | Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL. | Anti-PRP ≥ 0.15 μg/mL | 74 Participants |
| PRP Tritanrix-HepB Kft. Mix Group | Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL. | Anti-PRP ≥ 1.0 μg/mL | 53 Participants |
| PRP Tritanrix-HepB Kft. Ref Group | Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL. | Anti-PRP ≥ 1.0 μg/mL | 62 Participants |
| PRP Tritanrix-HepB Kft. Ref Group | Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL. | Anti-PRP ≥ 0.15 μg/mL | 69 Participants |
| HB Tritanrix-HepB/Hiberix Kft. Mix Group | Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL. | Anti-PRP ≥ 0.15 μg/mL | 84 Participants |
| HB Tritanrix-HepB/Hiberix Kft. Mix Group | Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL. | Anti-PRP ≥ 1.0 μg/mL | 66 Participants |
| Tritanrix-HepB Kft.+Hiberix Group | Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL. | Anti-PRP ≥ 0.15 μg/mL | 72 Participants |
| Tritanrix-HepB Kft.+Hiberix Group | Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL. | Anti-PRP ≥ 1.0 μg/mL | 49 Participants |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.
Time frame: During the 4-Day (Days 0-3) post-PRP challenge
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptoms sheet filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PRP Tritanrix-HepB Kft. Mix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain | 13 Participants |
| PRP Tritanrix-HepB Kft. Mix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain | 0 Participants |
| PRP Tritanrix-HepB Kft. Mix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness | 11 Participants |
| PRP Tritanrix-HepB Kft. Mix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness | 0 Participants |
| PRP Tritanrix-HepB Kft. Mix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling | 7 Participants |
| PRP Tritanrix-HepB Kft. Mix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling | 0 Participants |
| PRP Tritanrix-HepB Kft. Ref Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling | 11 Participants |
| PRP Tritanrix-HepB Kft. Ref Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain | 12 Participants |
| PRP Tritanrix-HepB Kft. Ref Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness | 0 Participants |
| PRP Tritanrix-HepB Kft. Ref Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain | 0 Participants |
| PRP Tritanrix-HepB Kft. Ref Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling | 0 Participants |
| PRP Tritanrix-HepB Kft. Ref Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness | 15 Participants |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.
Time frame: During the 4-Day (Days 0-3) post-booster vaccination period
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptoms sheet filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PRP Tritanrix-HepB Kft. Mix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Pain | 56 Participants |
| PRP Tritanrix-HepB Kft. Mix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Pain | 11 Participants |
| PRP Tritanrix-HepB Kft. Mix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Redness | 46 Participants |
| PRP Tritanrix-HepB Kft. Mix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Redness | 7 Participants |
| PRP Tritanrix-HepB Kft. Mix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Swelling | 44 Participants |
| PRP Tritanrix-HepB Kft. Mix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Swelling | 16 Participants |
| PRP Tritanrix-HepB Kft. Ref Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Swelling | 84 Participants |
| PRP Tritanrix-HepB Kft. Ref Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Pain | 303 Participants |
| PRP Tritanrix-HepB Kft. Ref Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Redness | 58 Participants |
| PRP Tritanrix-HepB Kft. Ref Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Swelling | 250 Participants |
| PRP Tritanrix-HepB Kft. Ref Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Pain | 57 Participants |
| PRP Tritanrix-HepB Kft. Ref Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Redness | 255 Participants |
| HB Tritanrix-HepB/Hiberix Kft. Mix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Pain | 34 Participants |
| HB Tritanrix-HepB/Hiberix Kft. Mix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Redness | 152 Participants |
| HB Tritanrix-HepB/Hiberix Kft. Mix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Swelling | 65 Participants |
| HB Tritanrix-HepB/Hiberix Kft. Mix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Redness | 50 Participants |
| HB Tritanrix-HepB/Hiberix Kft. Mix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Pain | 181 Participants |
| HB Tritanrix-HepB/Hiberix Kft. Mix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Swelling | 140 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were drowsiness, fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 fever = fever \> 39.5 °C. Grade 3 irritability = crying that could not be comforted and prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = symptom assessed by the investigator as related to the vaccination.
Time frame: During the 4-Day (Days 0-3) post-PRP challenge
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptoms sheet filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PRP Tritanrix-HepB Kft. Mix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness | 6 Participants |
| PRP Tritanrix-HepB Kft. Mix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness | 0 Participants |
| PRP Tritanrix-HepB Kft. Mix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness | 6 Participants |
| PRP Tritanrix-HepB Kft. Mix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever (Axillary) | 4 Participants |
| PRP Tritanrix-HepB Kft. Mix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever (Axillary) | 0 Participants |
| PRP Tritanrix-HepB Kft. Mix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever (Axillary) | 4 Participants |
| PRP Tritanrix-HepB Kft. Mix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability | 11 Participants |
| PRP Tritanrix-HepB Kft. Mix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability | 0 Participants |
| PRP Tritanrix-HepB Kft. Mix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability | 11 Participants |
| PRP Tritanrix-HepB Kft. Mix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite | 5 Participants |
| PRP Tritanrix-HepB Kft. Mix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite | 0 Participants |
| PRP Tritanrix-HepB Kft. Mix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite | 5 Participants |
| PRP Tritanrix-HepB Kft. Ref Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite | 0 Participants |
| PRP Tritanrix-HepB Kft. Ref Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness | 10 Participants |
| PRP Tritanrix-HepB Kft. Ref Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability | 8 Participants |
| PRP Tritanrix-HepB Kft. Ref Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness | 0 Participants |
| PRP Tritanrix-HepB Kft. Ref Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite | 7 Participants |
| PRP Tritanrix-HepB Kft. Ref Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness | 10 Participants |
| PRP Tritanrix-HepB Kft. Ref Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability | 0 Participants |
| PRP Tritanrix-HepB Kft. Ref Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever (Axillary) | 7 Participants |
| PRP Tritanrix-HepB Kft. Ref Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite | 7 Participants |
| PRP Tritanrix-HepB Kft. Ref Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever (Axillary) | 0 Participants |
| PRP Tritanrix-HepB Kft. Ref Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability | 8 Participants |
| PRP Tritanrix-HepB Kft. Ref Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever (Axillary) | 7 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Assessed solicited general symptoms were drowsiness, fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 fever = fever \> 39.5 °C. Grade 3 irritability = crying that could not be comforted and prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = symptom assessed by the investigator as related to the vaccination.
Time frame: During the 4-Day (Days 0-3) post-booster vaccination period
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptoms sheet filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PRP Tritanrix-HepB Kft. Mix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Drowsiness | 34 Participants |
| PRP Tritanrix-HepB Kft. Mix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Drowsiness | 1 Participants |
| PRP Tritanrix-HepB Kft. Mix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Drowsiness | 33 Participants |
| PRP Tritanrix-HepB Kft. Mix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Fever (Axillary) | 59 Participants |
| PRP Tritanrix-HepB Kft. Mix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fever (Axillary) | 2 Participants |
| PRP Tritanrix-HepB Kft. Mix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fever (Axillary) | 59 Participants |
| PRP Tritanrix-HepB Kft. Mix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Irritability | 54 Participants |
| PRP Tritanrix-HepB Kft. Mix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Irritability | 2 Participants |
| PRP Tritanrix-HepB Kft. Mix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Irritability | 54 Participants |
| PRP Tritanrix-HepB Kft. Mix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Loss of appetite | 25 Participants |
| PRP Tritanrix-HepB Kft. Mix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Loss of appetite | 1 Participants |
| PRP Tritanrix-HepB Kft. Mix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Loss of appetite | 25 Participants |
| PRP Tritanrix-HepB Kft. Ref Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Loss of appetite | 129 Participants |
| PRP Tritanrix-HepB Kft. Ref Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Drowsiness | 174 Participants |
| PRP Tritanrix-HepB Kft. Ref Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Irritability | 267 Participants |
| PRP Tritanrix-HepB Kft. Ref Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Irritability | 266 Participants |
| PRP Tritanrix-HepB Kft. Ref Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Drowsiness | 11 Participants |
| PRP Tritanrix-HepB Kft. Ref Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fever (Axillary) | 270 Participants |
| PRP Tritanrix-HepB Kft. Ref Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Loss of appetite | 6 Participants |
| PRP Tritanrix-HepB Kft. Ref Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Drowsiness | 174 Participants |
| PRP Tritanrix-HepB Kft. Ref Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Irritability | 17 Participants |
| PRP Tritanrix-HepB Kft. Ref Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fever (Axillary) | 10 Participants |
| PRP Tritanrix-HepB Kft. Ref Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Fever (Axillary) | 270 Participants |
| PRP Tritanrix-HepB Kft. Ref Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Loss of appetite | 129 Participants |
| HB Tritanrix-HepB/Hiberix Kft. Mix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Fever (Axillary) | 168 Participants |
| HB Tritanrix-HepB/Hiberix Kft. Mix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fever (Axillary) | 1 Participants |
| HB Tritanrix-HepB/Hiberix Kft. Mix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Loss of appetite | 79 Participants |
| HB Tritanrix-HepB/Hiberix Kft. Mix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fever (Axillary) | 168 Participants |
| HB Tritanrix-HepB/Hiberix Kft. Mix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Irritability | 162 Participants |
| HB Tritanrix-HepB/Hiberix Kft. Mix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Irritability | 11 Participants |
| HB Tritanrix-HepB/Hiberix Kft. Mix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Loss of appetite | 1 Participants |
| HB Tritanrix-HepB/Hiberix Kft. Mix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Drowsiness | 105 Participants |
| HB Tritanrix-HepB/Hiberix Kft. Mix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Drowsiness | 4 Participants |
| HB Tritanrix-HepB/Hiberix Kft. Mix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Irritability | 161 Participants |
| HB Tritanrix-HepB/Hiberix Kft. Mix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Drowsiness | 104 Participants |
| HB Tritanrix-HepB/Hiberix Kft. Mix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Loss of appetite | 79 Participants |
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
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 Month 0 to Month 9.5)
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PRP Tritanrix-HepB Kft. Mix Group | Number of Subjects With Serious Adverse Events (SAEs) | 1 Participants |
| PRP Tritanrix-HepB Kft. Ref Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
| HB Tritanrix-HepB/Hiberix Kft. Mix Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
Secondary
Number of Subjects With Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Time frame: During the 31-Day (Day 0-30) follow-up period
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PRP Tritanrix-HepB Kft. Mix Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 22 Participants |
| PRP Tritanrix-HepB Kft. Ref Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 27 Participants |
| HB Tritanrix-HepB/Hiberix Kft. Mix Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 14 Participants |
Secondary
Seroprotection Rates for Anti-D Antibodies
The seroprotection rate is defined as the estimated proportion of subjects with protective antibodies as assessed by ELISA (antibody concentration ≥ 0.1 IU/mL), or by Vero-cell neutralisation assay (antibody concentration ≥ 0.016 IU/mL), for subjects seronegative as assessed by ELISA.
Time frame: At Month 0, prior to the PRP challenge
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PRP Tritanrix-HepB Kft. Mix Group | Seroprotection Rates for Anti-D Antibodies | 85.7 Proportion |
| PRP Tritanrix-HepB Kft. Ref Group | Seroprotection Rates for Anti-D Antibodies | 71.6 Proportion |
| HB Tritanrix-HepB/Hiberix Kft. Mix Group | Seroprotection Rates for Anti-D Antibodies | 95.5 Proportion |
| Tritanrix-HepB Kft.+Hiberix Group | Seroprotection Rates for Anti-D Antibodies | 85.1 Proportion |