Acellular Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Tetanus, Diphtheria, Poliomyelitis
Conditions
Brief summary
The purpose of this study is to assess the immunogenicity, safety and reactogenicity of the booster vaccine dose of 2 new formulations of DTPa-HBV-IPV/Hib administered between 12 and 15 months of age, and the immune persistence following the primary series. All children in this booster study received a primary vaccination at 2, 3 and 4 months of age in study 113948 (NCT01248884). No new subjects will be enrolled in this booster study.
Interventions
BIOLOGICALInfanrix hexa
Single dose, licensed formulation, intramuscular into right thigh
BIOLOGICALPrevenar 13
Single co-administered dose, intramuscular into left thigh
BIOLOGICALGSK217744
Single dose, investigational formulation A or B, intramuscular into right thigh
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Months to 15 Months
Healthy volunteers
Yes
Inclusion criteria
* Subjects who participated in the study 113948 (NCT01248884) and received three doses of the new or licensed DTPa-HBV-IPV/Hib study vaccine. * A male or female child between, and including, 12 and 15 months of age at the time of the booster vaccination. * Subjects who the investigator believes that parent(s)/ Legally Acceptable Representative(s) (LAR(s)) can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visit). * Written informed consent obtained from the parent(s)/LAR(s) of the subject. * Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion criteria
* Child in care. * Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the booster dose of study vaccine, or planned use during the study period. * Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster dose. * Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period. * Participation in another clinical study within three months prior to enrolment in the present booster study or at any time during the present booster study, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). * Evidence of previous or intercurrent diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Hib vaccination or disease since the conclusion visit of study 113948 (NCT01248884). * Serious chronic illness. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). * History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines. * History of any neurological disorders or seizures. * Administration of immunoglobulins and/or any blood products within the 3 months preceding the booster dose of study vaccine or planned administration during the study period. * Occurrence of any of the following events following previous administration of the study vaccine constitutes an absolute contraindication to further dosing. * Anaphylactic or other hypersensitivity reaction. * Encephalopathy defined as an acute, severe central nervous system disorder occurring within 7 days following vaccination and generally consisting of major alterations in consciousness, unresponsiveness, generalized or focal seizures that persist more than a few hours, with failure to recover within 24 hours. * Temperature of ≥ 40.0°C (axillary) or 40.5°C (rectal) within 48 hours of vaccination, not due to another identifiable cause. * Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours of vaccination. * Persistent, inconsolable crying occurring within 48 hours of vaccination and lasting ≥ 3 hours. * Seizures with or without fever occurring within 3 days of vaccination. 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 |
|---|---|---|
| Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies | 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2) | A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL). |
| Number of Seroprotected Subjects for Anti-D and Anti-T Antibodies | 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2) | A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL). |
| Number of Seroprotected Subjects Against Anti-Hepatitis B (Anti-HBs) Antigens | 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2) | A seroprotected subject was a subject whose antibody concentration was greater than or equal to the level defining clinical protection of 10 milli-international units per millilitre (mIU/mL). |
| Number of Seroprotected Subjects Against Anti-HBs Antigens | 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2) | A seroprotected subject was a subject whose antibody concentration was greater than or equal to the level defining clinical protection of 10 milli-international units per millilitre (mIU/mL). |
| Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3 | 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2) | A seroprotected subject was a subject whose antibody titre was greater than or equal to the level defining clinical protection of 8. |
| Number of Seroprotected Subjects for Anti-poliovirus Type 1, 2 and 3 | 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2) | A seroprotected subject was a subject whose antibody titre was greater than or equal to the level defining clinical protection of 8. |
| Number of Seroprotected Subjects for Anti-polyribosyl-ribitol Phosphate (Anti-PRP) | 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2) | A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL). |
| Number of Seroprotected Subjects for Anti-PRP | 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2) | A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL). |
| Concentrations for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN) | 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2) | Concentrations were expressed as geometric mean concentrations (GMCs). Seropositivity cut-off assay was 5 EL.U/mL. |
| Concentrations for Anti-PT, Anti-FHA and Anti-PRN | 1 month post booster vaccination (subjects enrolled after protocol amendment 2) | Concentrations were expressed as geometric mean concentrations (GMCs). Seropositivity cut-off assay was 5 EL.U/mL. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anti-Hepatitis B (Anti-HBs) Antibody Concentration | Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2) | Concentrations were expressed as geometric mean concentrations (GMCs). Seroprotection cut-off assay was 10 mIU/mL. |
| Number of Seroprotected Subjects Against Anti-Hepatitis B (Anti-HBs) Antigens | Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2) | A seroprotected subject was a subject whose antibody concentration was greater than or equal to the level defining clinical protection of 10 milli-international units per millilitre (mIU/mL). |
| Number of Seroprotected Subjects Against Anti-HBs Antigens | Before (PRE) booaster vaccination (subjects enrolled after protocol amendment 2) | A seroprotected subject was a subject whose antibody concentration was greater than or equal to the level defining clinical protection of 10 milli-international units per millilitre (mIU/mL). |
| Concentrations for Anti-poliovirus Types 1, 2, 3 | Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2) | Concentrations were expressed as geometric mean titers (GMTs). The seroprotection cut-off of the assay was 8. |
| Concentration for Anti-poliovirus Types 1, 2, 3 | 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2) | Concentrations were expressed as geometric mean titers (GMTs). The seroprotection cut-off of the assay was 8. |
| Concentrations for Anti-poliovirus Types 1, 2 and 3 | 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2) | Concentrations were expressed as geometric mean titers (GMTs). The seroprotection cut-off of the assay was 8. |
| Concentration for Anti-poliovirus Type 1, 2 and 3 | Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2) | Concentrations were expressed as geometric mean titers (GMTs). The seroprotection cut-off of the assay was 8. |
| Number of Seroprotected Subjects for Anti-poliovirus Type 1, 2 and 3 | Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2) | A seroprotected subject was a subject whose antibody titre was greater than or equal to the level defining clinical protection of 8. |
| Number of Seroprotected Subjects Against Anti-Poliovirus Type 1, 2 and 3 | Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2) | A seroprotected subject was a subject whose antibody titre was greater than or equal to the level defining clinical protection of 8. |
| Concentrations for Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibodies | 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2) | Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.15 µg /mL. |
| Concentrations for Anti-PRP Antibodies | 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2) | Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.15 µg /mL. |
| Concentrations for Anti-polyribosyl-ribitol Phosphate Antibodies | Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)) | Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.15 µg /mL. |
| Number of Seroprotected Subjects for Anti-polyribosyl-ribitol Phosphate (Anti-PRP) | Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2) | A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL). |
| Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes | 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2) | A seropositive subject was defined as a vaccinated subject who had anti- pneumococcal antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL). The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F. |
| Number of Seroprotected Subjects for Anti-PRP | Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2) | A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL). |
| Concentrations for Anti-pneumococcal (Anti-PNE) Antibodies | 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2) | Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 0.15 µg /mL. The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F. |
| Concentrations for Anti-PNE Antibodies | 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2) | Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 0.15 µg /mL. The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F. |
| Number of Seropositive Subjects for Anti-PNE Serotypes | 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2) | A seropositive subject was defined as a vaccinated subject who had anti- pneumococcal antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL). The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F. |
| Number of Subjects With Booster Response to Anti-pertussis Antigens (Anti-PT, Anti-FHA and Anti-PRN) | 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2) | Booster response defined as : - For initially seronegative subjects, antibody concentration ≥ 5 EL.U/mL one month after booster vaccination - For initially seropositive subjects, antibody concentration at Post-booster ≥ 2 fold the pre-vaccination antibody concentration |
| Number of Subjects With Booster Response to Anti-pertussis Antigens | 1 month poste booster vaccination (POST) (subjects enrolled after protocol amendment 2) | Booster response defined as : - For initially seronegative subjects, antibody concentration ≥ 5 EL.U/mL one month after booster vaccination - For initially seropositive subjects, antibody concentration at Post-booster ≥ 2 fold the pre-vaccination antibody concentration |
| Concentrations for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies | Before (PRE) and 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2) | Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL. |
| Number of Subjects Reporting Any Solicited Local Symptom | During the 4-day (Days 0-3) post-vaccination period. (subjects enrolled after protocol amendment 2) | Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. |
| Number of Subjects Reporting Any Solicited General Symptoms | During the 4-day (Days 0-3) post-vaccination period. (subjects enrolled before protocol amendment 2) | Solicited local symptoms assessed were drowsiness, irritability/fussiness, loss of appetite and fever \[axillary temperature above (≥) 37.5 degrees Celsius (°C)\]. Any = occurrence of any local symptom regardless of intensity grade. |
| Number of Subjects Reporting Any Solicited General Symptom | During the 4-day (Days 0-3) post-vaccination period. (subjects enrolled after protocol amendment 2) | Solicited local symptoms assessed were drowsiness, irritability/fussiness, loss of appetite and fever \[axillary temperature above (≥) 37.5 degrees Celsius (°C)\]. Any = occurrence of any local symptom regardless of intensity grade. |
| Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) | Within the 31-day (Days 0-30) follow up period after vaccination. (subjects enrolled before protocol amendment 2) | An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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 = occurrence of an AE regardless of intensity grade or relationship to study vaccination. |
| Number of Subjects Reporting Any Unsolicited AEs | Within the 31-day (Days 0-30) follow up period after vaccination. (subjects enrolled after protocol amendment 2) | An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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 = occurrence of an AE regardless of intensity grade or relationship to study vaccination. |
| Number of Subjects Reporting Any Serious Adverse Events (SAEs) | During the entire study period (Days 0-30). (subjects enrolled before protocol amendment 2) | SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Any SAE = any SAE regardless of assessment of relationship to study vaccination. |
| Number of Subjects Reporting Any SAEs | During the entire study period (Days 0-30). (subjects enrolled after protocol amendment 2) | SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Any SAE = any SAE regardless of assessment of relationship to study vaccination. |
| Number of Subjects Reporting Any Solicited Local Symptoms | During the 4-day (Days 0-3) post-vaccination period. (subjects enrolled before protocol amendment 2) | Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. |
| Concentrations for Anti-D and Anti-T Antibodies | Before (PRE) 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2) | Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL. |
| Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies | Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2) | A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL). |
| Number of Seroprotected Subjects for Anti-D and Anti-T Antibodies | Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2) | A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL). |
| Concentrations for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN) | Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2) | Concentrations were expressed as geometric mean concentrations (GMCs). Seropositivity cut-off assay was 5 EL.U/mL. |
| Concentrations for Anti-PT, Anti-FHA and Anti-PRN | Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2) | Concentrations were expressed as geometric mean concentrations (GMCs). Seropositivity cut-off assay was 5 EL.U/mL. |
| Number of Seropositive Subjects for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN) | 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2) | A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the assay cut-off of 5 ELISA units per milliliter (EL.U/mL). |
| Number of Seropositive Subjects for Anti-PT, Anti-FHA, Anti-PRN | 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2) | A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the assay cut-off of 5 ELISA units per milliliter (EL.U/mL). |
| Anti-Hepatitis B (Anti-HBs) Antibody Concentrations | 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)) | Concentrations were expressed as geometric mean concentrations (GMCs). Seroprotection cut-off assay was 10 mIU/mL. |
| Anti-HBs Antibody Concentrations | 1 month post booster vaccination (POST) ( subjects enrolled after protocol amendment 2) | Concentrations were expressed as geometric mean concentrations (GMCs). Seroprotection cut-off assay was 10 mIU/mL. |
Countries
Dominican Republic, Finland
Participant flow
Recruitment details
A total of 272 subjects were enrolled in the study before the second protocol amendment and total of 385 after the amendment. After amendment 2, all subjects yet to receive a booster dose of a GSK217744 formulation, were administered the Infanrix hexa vaccine.
Participants by arm
| Arm | Count |
|---|---|
| GSK217744 Group 1 Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. | 216 |
| GSK217744 Group 2 Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. | 218 |
| Infanrix Hexa Group Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. | 223 |
| Total | 657 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| After Protocol Amendment 2. | Withdrawal by Subject | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | GSK217744 Group 1 | GSK217744 Group 2 | Infanrix Hexa Group | Total |
|---|---|---|---|---|
| Age, Continuous | 14.1 Months STANDARD_DEVIATION 0.6 | 13.9 Months STANDARD_DEVIATION 0.6 | 14.0 Months STANDARD_DEVIATION 0.6 | 14.00 Months STANDARD_DEVIATION 0.61 |
| Race/Ethnicity, Customized African heritage / African American | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Other: Mixed | 81 Participants | 84 Participants | 81 Participants | 13 Participants |
| Race/Ethnicity, Customized White - Arabic / north African heritage | 0 Participants | 0 Participants | 3 Participants | 3 Participants |
| Race/Ethnicity, Customized White - caucasian / European heritage | 49 Participants | 46 Participants | 39 Participants | 134 Participants |
| Race/Ethnicity, Customized White - Caucasian / European heritage | 79 Participants | 83 Participants | 91 Participants | 253 Participants |
| Sex: Female, Male Female | 47 Participants | 76 Participants | 38 Participants | 190 Participants |
| Sex: Female, Male Male | 70 Participants | 39 Participants | 61 Participants | 138 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 | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 85 | 0 / 88 | 0 / 99 | 0 / 131 | 0 / 130 | 0 / 124 |
| other Total, other adverse events | 85 / 85 | 85 / 88 | 96 / 99 | 118 / 131 | 103 / 130 | 104 / 124 |
| serious Total, serious adverse events | 0 / 85 | 0 / 88 | 0 / 99 | 0 / 131 | 2 / 130 | 0 / 124 |
Outcome results
Primary
Concentrations for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN)
Concentrations were expressed as geometric mean concentrations (GMCs). Seropositivity cut-off assay was 5 EL.U/mL.
Time frame: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK217744 Group 1 | Concentrations for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN) | Anti-FHA, POST | 393.7 EL.U/mL |
| GSK217744 Group 1 | Concentrations for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN) | Anti-PT, POST | 76.1 EL.U/mL |
| GSK217744 Group 1 | Concentrations for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN) | Anti-PRN, POST | 213.0 EL.U/mL |
| GSK217744 Group 2 | Concentrations for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN) | Anti-FHA, POST | 372.4 EL.U/mL |
| GSK217744 Group 2 | Concentrations for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN) | Anti-PT, POST | 74.3 EL.U/mL |
| GSK217744 Group 2 | Concentrations for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN) | Anti-PRN, POST | 180.0 EL.U/mL |
| Infanrix Hexa Group | Concentrations for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN) | Anti-PT, POST | 96.0 EL.U/mL |
| Infanrix Hexa Group | Concentrations for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN) | Anti-PRN, POST | 372.9 EL.U/mL |
| Infanrix Hexa Group | Concentrations for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN) | Anti-FHA, POST | 423.0 EL.U/mL |
Primary
Concentrations for Anti-PT, Anti-FHA and Anti-PRN
Concentrations were expressed as geometric mean concentrations (GMCs). Seropositivity cut-off assay was 5 EL.U/mL.
Time frame: 1 month post booster vaccination (subjects enrolled after protocol amendment 2)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK217744 Group 1 | Concentrations for Anti-PT, Anti-FHA and Anti-PRN | Anti-FHA, POST | 467.3 EL.U/mL |
| GSK217744 Group 1 | Concentrations for Anti-PT, Anti-FHA and Anti-PRN | Anti-PT, POST | 92.4 EL.U/mL |
| GSK217744 Group 1 | Concentrations for Anti-PT, Anti-FHA and Anti-PRN | Anti-PRN, POST | 253.2 EL.U/mL |
| GSK217744 Group 2 | Concentrations for Anti-PT, Anti-FHA and Anti-PRN | Anti-FHA, POST | 446.2 EL.U/mL |
| GSK217744 Group 2 | Concentrations for Anti-PT, Anti-FHA and Anti-PRN | Anti-PT, POST | 93.6 EL.U/mL |
| GSK217744 Group 2 | Concentrations for Anti-PT, Anti-FHA and Anti-PRN | Anti-PRN, POST | 181.0 EL.U/mL |
| Infanrix Hexa Group | Concentrations for Anti-PT, Anti-FHA and Anti-PRN | Anti-PT, POST | 132.6 EL.U/mL |
| Infanrix Hexa Group | Concentrations for Anti-PT, Anti-FHA and Anti-PRN | Anti-PRN, POST | 401.1 EL.U/mL |
| Infanrix Hexa Group | Concentrations for Anti-PT, Anti-FHA and Anti-PRN | Anti-FHA, POST | 582.9 EL.U/mL |
Primary
Number of Seroprotected Subjects Against Anti-HBs Antigens
A seroprotected subject was a subject whose antibody concentration was greater than or equal to the level defining clinical protection of 10 milli-international units per millilitre (mIU/mL).
Time frame: 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK217744 Group 1 | Number of Seroprotected Subjects Against Anti-HBs Antigens | 121 Participants |
| GSK217744 Group 2 | Number of Seroprotected Subjects Against Anti-HBs Antigens | 113 Participants |
| Infanrix Hexa Group | Number of Seroprotected Subjects Against Anti-HBs Antigens | 114 Participants |
Primary
Number of Seroprotected Subjects Against Anti-Hepatitis B (Anti-HBs) Antigens
A seroprotected subject was a subject whose antibody concentration was greater than or equal to the level defining clinical protection of 10 milli-international units per millilitre (mIU/mL).
Time frame: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK217744 Group 1 | Number of Seroprotected Subjects Against Anti-Hepatitis B (Anti-HBs) Antigens | 78 Participants |
| GSK217744 Group 2 | Number of Seroprotected Subjects Against Anti-Hepatitis B (Anti-HBs) Antigens | 78 Participants |
| Infanrix Hexa Group | Number of Seroprotected Subjects Against Anti-Hepatitis B (Anti-HBs) Antigens | 84 Participants |
Primary
Number of Seroprotected Subjects for Anti-D and Anti-T Antibodies
A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).
Time frame: 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK217744 Group 1 | Number of Seroprotected Subjects for Anti-D and Anti-T Antibodies | Anti-D, POST | 123 Participants |
| GSK217744 Group 1 | Number of Seroprotected Subjects for Anti-D and Anti-T Antibodies | Anti-T, POST | 123 Participants |
| GSK217744 Group 2 | Number of Seroprotected Subjects for Anti-D and Anti-T Antibodies | Anti-D, POST | 122 Participants |
| GSK217744 Group 2 | Number of Seroprotected Subjects for Anti-D and Anti-T Antibodies | Anti-T, POST | 122 Participants |
| Infanrix Hexa Group | Number of Seroprotected Subjects for Anti-D and Anti-T Antibodies | Anti-D, POST | 118 Participants |
| Infanrix Hexa Group | Number of Seroprotected Subjects for Anti-D and Anti-T Antibodies | Anti-T, POST | 118 Participants |
Primary
Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies
A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).
Time frame: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK217744 Group 1 | Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies | Anti-D, POST | 81 Participants |
| GSK217744 Group 1 | Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies | Anti-T, POST | 81 Participants |
| GSK217744 Group 2 | Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies | Anti-D, POST | 82 Participants |
| GSK217744 Group 2 | Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies | Anti-T, POST | 82 Participants |
| Infanrix Hexa Group | Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies | Anti-D, POST | 90 Participants |
| Infanrix Hexa Group | Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies | Anti-T, POST | 90 Participants |
Primary
Number of Seroprotected Subjects for Anti-poliovirus Type 1, 2 and 3
A seroprotected subject was a subject whose antibody titre was greater than or equal to the level defining clinical protection of 8.
Time frame: 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK217744 Group 1 | Number of Seroprotected Subjects for Anti-poliovirus Type 1, 2 and 3 | Anti-Polio 2, POST | 96 Participants |
| GSK217744 Group 1 | Number of Seroprotected Subjects for Anti-poliovirus Type 1, 2 and 3 | Anti-Polio 1, POST | 111 Participants |
| GSK217744 Group 1 | Number of Seroprotected Subjects for Anti-poliovirus Type 1, 2 and 3 | Anti-Polio 3, POST | 113 Participants |
| GSK217744 Group 2 | Number of Seroprotected Subjects for Anti-poliovirus Type 1, 2 and 3 | Anti-Polio 2, POST | 96 Participants |
| GSK217744 Group 2 | Number of Seroprotected Subjects for Anti-poliovirus Type 1, 2 and 3 | Anti-Polio 1, POST | 107 Participants |
| GSK217744 Group 2 | Number of Seroprotected Subjects for Anti-poliovirus Type 1, 2 and 3 | Anti-Polio 3, POST | 103 Participants |
| Infanrix Hexa Group | Number of Seroprotected Subjects for Anti-poliovirus Type 1, 2 and 3 | Anti-Polio 1, POST | 102 Participants |
| Infanrix Hexa Group | Number of Seroprotected Subjects for Anti-poliovirus Type 1, 2 and 3 | Anti-Polio 3, POST | 98 Participants |
| Infanrix Hexa Group | Number of Seroprotected Subjects for Anti-poliovirus Type 1, 2 and 3 | Anti-Polio 2, POST | 87 Participants |
Primary
Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3
A seroprotected subject was a subject whose antibody titre was greater than or equal to the level defining clinical protection of 8.
Time frame: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK217744 Group 1 | Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3 | Anti-Polio 2, POST | 62 Participants |
| GSK217744 Group 1 | Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3 | Anti-Polio 1, POST | 76 Participants |
| GSK217744 Group 1 | Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3 | Anti-Polio 3, POST | 64 Participants |
| GSK217744 Group 2 | Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3 | Anti-Polio 2, POST | 60 Participants |
| GSK217744 Group 2 | Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3 | Anti-Polio 1, POST | 72 Participants |
| GSK217744 Group 2 | Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3 | Anti-Polio 3, POST | 63 Participants |
| Infanrix Hexa Group | Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3 | Anti-Polio 1, POST | 85 Participants |
| Infanrix Hexa Group | Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3 | Anti-Polio 3, POST | 71 Participants |
| Infanrix Hexa Group | Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3 | Anti-Polio 2, POST | 76 Participants |
Primary
Number of Seroprotected Subjects for Anti-polyribosyl-ribitol Phosphate (Anti-PRP)
A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).
Time frame: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK217744 Group 1 | Number of Seroprotected Subjects for Anti-polyribosyl-ribitol Phosphate (Anti-PRP) | 81 Participants |
| GSK217744 Group 2 | Number of Seroprotected Subjects for Anti-polyribosyl-ribitol Phosphate (Anti-PRP) | 82 Participants |
| Infanrix Hexa Group | Number of Seroprotected Subjects for Anti-polyribosyl-ribitol Phosphate (Anti-PRP) | 90 Participants |
Primary
Number of Seroprotected Subjects for Anti-PRP
A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).
Time frame: 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK217744 Group 1 | Number of Seroprotected Subjects for Anti-PRP | 122 Participants |
| GSK217744 Group 2 | Number of Seroprotected Subjects for Anti-PRP | 122 Participants |
| Infanrix Hexa Group | Number of Seroprotected Subjects for Anti-PRP | 117 Participants |
Secondary
Anti-HBs Antibody Concentrations
Concentrations were expressed as geometric mean concentrations (GMCs). Seroprotection cut-off assay was 10 mIU/mL.
Time frame: 1 month post booster vaccination (POST) ( subjects enrolled after protocol amendment 2)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK217744 Group 1 | Anti-HBs Antibody Concentrations | 2229.3 mIU/mL |
| GSK217744 Group 2 | Anti-HBs Antibody Concentrations | 1729.8 mIU/mL |
| Infanrix Hexa Group | Anti-HBs Antibody Concentrations | 3711.4 mIU/mL |
Secondary
Anti-HBs Antibody Concentrations
Concentrations were expressed as geometric mean concentrations (GMCs). Seroprotection cut-off assay was 10 mIU/mL.
Time frame: Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK217744 Group 1 | Anti-HBs Antibody Concentrations | 94.9 mIU/mL |
| GSK217744 Group 2 | Anti-HBs Antibody Concentrations | 61.8 mIU/mL |
| Infanrix Hexa Group | Anti-HBs Antibody Concentrations | 125.9 mIU/mL |
Secondary
Anti-Hepatitis B (Anti-HBs) Antibody Concentration
Concentrations were expressed as geometric mean concentrations (GMCs). Seroprotection cut-off assay was 10 mIU/mL.
Time frame: Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK217744 Group 1 | Anti-Hepatitis B (Anti-HBs) Antibody Concentration | 130.3 mIU/mL |
| GSK217744 Group 2 | Anti-Hepatitis B (Anti-HBs) Antibody Concentration | 124.4 mIU/mL |
| Infanrix Hexa Group | Anti-Hepatitis B (Anti-HBs) Antibody Concentration | 166.4 mIU/mL |
Secondary
Anti-Hepatitis B (Anti-HBs) Antibody Concentrations
Concentrations were expressed as geometric mean concentrations (GMCs). Seroprotection cut-off assay was 10 mIU/mL.
Time frame: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2))
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK217744 Group 1 | Anti-Hepatitis B (Anti-HBs) Antibody Concentrations | 2233.3 mIU/mL |
| GSK217744 Group 2 | Anti-Hepatitis B (Anti-HBs) Antibody Concentrations | 2026.3 mIU/mL |
| Infanrix Hexa Group | Anti-Hepatitis B (Anti-HBs) Antibody Concentrations | 2685.7 mIU/mL |
Secondary
Concentration for Anti-poliovirus Type 1, 2 and 3
Concentrations were expressed as geometric mean titers (GMTs). The seroprotection cut-off of the assay was 8.
Time frame: Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK217744 Group 1 | Concentration for Anti-poliovirus Type 1, 2 and 3 | Anti-Polio 2, PRE | 76.6 Titers |
| GSK217744 Group 1 | Concentration for Anti-poliovirus Type 1, 2 and 3 | Anti-Polio 1, PRE | 53.5 Titers |
| GSK217744 Group 1 | Concentration for Anti-poliovirus Type 1, 2 and 3 | Anti-Polio, 3 PRE | 67.8 Titers |
| GSK217744 Group 2 | Concentration for Anti-poliovirus Type 1, 2 and 3 | Anti-Polio 2, PRE | 55.0 Titers |
| GSK217744 Group 2 | Concentration for Anti-poliovirus Type 1, 2 and 3 | Anti-Polio 1, PRE | 50.7 Titers |
| GSK217744 Group 2 | Concentration for Anti-poliovirus Type 1, 2 and 3 | Anti-Polio, 3 PRE | 73.8 Titers |
| Infanrix Hexa Group | Concentration for Anti-poliovirus Type 1, 2 and 3 | Anti-Polio 1, PRE | 70.8 Titers |
| Infanrix Hexa Group | Concentration for Anti-poliovirus Type 1, 2 and 3 | Anti-Polio, 3 PRE | 93.9 Titers |
| Infanrix Hexa Group | Concentration for Anti-poliovirus Type 1, 2 and 3 | Anti-Polio 2, PRE | 82.7 Titers |
Secondary
Concentration for Anti-poliovirus Types 1, 2, 3
Concentrations were expressed as geometric mean titers (GMTs). The seroprotection cut-off of the assay was 8.
Time frame: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK217744 Group 1 | Concentration for Anti-poliovirus Types 1, 2, 3 | Anti-Polio 2, POST | 629.7 Titers |
| GSK217744 Group 1 | Concentration for Anti-poliovirus Types 1, 2, 3 | Anti-Polio 1, POST | 572.9 Titers |
| GSK217744 Group 1 | Concentration for Anti-poliovirus Types 1, 2, 3 | Anti-Polio 3, POST | 1147.5 Titers |
| GSK217744 Group 2 | Concentration for Anti-poliovirus Types 1, 2, 3 | Anti-Polio 2, POST | 668.7 Titers |
| GSK217744 Group 2 | Concentration for Anti-poliovirus Types 1, 2, 3 | Anti-Polio 1, POST | 558.3 Titers |
| GSK217744 Group 2 | Concentration for Anti-poliovirus Types 1, 2, 3 | Anti-Polio 3, POST | 614.0 Titers |
| Infanrix Hexa Group | Concentration for Anti-poliovirus Types 1, 2, 3 | Anti-Polio 1, POST | 902.1 Titers |
| Infanrix Hexa Group | Concentration for Anti-poliovirus Types 1, 2, 3 | Anti-Polio 3, POST | 1120.7 Titers |
| Infanrix Hexa Group | Concentration for Anti-poliovirus Types 1, 2, 3 | Anti-Polio 2, POST | 1184.9 Titers |
Secondary
Concentrations for Anti-D and Anti-T Antibodies
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL.
Time frame: Before (PRE) 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK217744 Group 1 | Concentrations for Anti-D and Anti-T Antibodies | Anti-D, POST | 6.327 IU/mL |
| GSK217744 Group 1 | Concentrations for Anti-D and Anti-T Antibodies | Anti-T, POST | 5.986 IU/mL |
| GSK217744 Group 1 | Concentrations for Anti-D and Anti-T Antibodies | Anti-D, PRE | 0.247 IU/mL |
| GSK217744 Group 1 | Concentrations for Anti-D and Anti-T Antibodies | Anti-T, PRE | 0.364 IU/mL |
| GSK217744 Group 2 | Concentrations for Anti-D and Anti-T Antibodies | Anti-T, PRE | 0.332 IU/mL |
| GSK217744 Group 2 | Concentrations for Anti-D and Anti-T Antibodies | Anti-D, POST | 5.452 IU/mL |
| GSK217744 Group 2 | Concentrations for Anti-D and Anti-T Antibodies | Anti-D, PRE | 0.278 IU/mL |
| GSK217744 Group 2 | Concentrations for Anti-D and Anti-T Antibodies | Anti-T, POST | 5.316 IU/mL |
| Infanrix Hexa Group | Concentrations for Anti-D and Anti-T Antibodies | Anti-T, PRE | 0.331 IU/mL |
| Infanrix Hexa Group | Concentrations for Anti-D and Anti-T Antibodies | Anti-T, POST | 5.993 IU/mL |
| Infanrix Hexa Group | Concentrations for Anti-D and Anti-T Antibodies | Anti-D, PRE | 0.304 IU/mL |
| Infanrix Hexa Group | Concentrations for Anti-D and Anti-T Antibodies | Anti-D, POST | 7.192 IU/mL |
Secondary
Concentrations for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL.
Time frame: Before (PRE) and 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK217744 Group 1 | Concentrations for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies | Anti-D, POST | 5.652 IU/mL |
| GSK217744 Group 1 | Concentrations for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies | Anti-T, POST | 5.015 IU/mL |
| GSK217744 Group 1 | Concentrations for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies | Anti-D, PRE | 0.357 IU/mL |
| GSK217744 Group 1 | Concentrations for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies | Anti-T, PRE | 0.358 IU/mL |
| GSK217744 Group 2 | Concentrations for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies | Anti-T, PRE | 0.362 IU/mL |
| GSK217744 Group 2 | Concentrations for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies | Anti-D, POST | 5.494 IU/mL |
| GSK217744 Group 2 | Concentrations for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies | Anti-D, PRE | 0.445 IU/mL |
| GSK217744 Group 2 | Concentrations for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies | Anti-T, POST | 5.034 IU/mL |
| Infanrix Hexa Group | Concentrations for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies | Anti-T, PRE | 0.394 IU/mL |
| Infanrix Hexa Group | Concentrations for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies | Anti-T, POST | 5.571 IU/mL |
| Infanrix Hexa Group | Concentrations for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies | Anti-D, PRE | 0.401 IU/mL |
| Infanrix Hexa Group | Concentrations for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies | Anti-D, POST | 6.772 IU/mL |
Secondary
Concentrations for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN)
Concentrations were expressed as geometric mean concentrations (GMCs). Seropositivity cut-off assay was 5 EL.U/mL.
Time frame: Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK217744 Group 1 | Concentrations for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN) | Anti-PT, PRE | 10.5 EL.U/mL. |
| GSK217744 Group 1 | Concentrations for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN) | Anti-PRN, PRE | 12.8 EL.U/mL. |
| GSK217744 Group 1 | Concentrations for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN) | Anti-FHA, PRE | 41.7 EL.U/mL. |
| GSK217744 Group 2 | Concentrations for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN) | Anti-FHA, PRE | 36.9 EL.U/mL. |
| GSK217744 Group 2 | Concentrations for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN) | Anti-PRN, PRE | 10.8 EL.U/mL. |
| GSK217744 Group 2 | Concentrations for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN) | Anti-PT, PRE | 9.5 EL.U/mL. |
| Infanrix Hexa Group | Concentrations for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN) | Anti-PRN, PRE | 18.2 EL.U/mL. |
| Infanrix Hexa Group | Concentrations for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN) | Anti-PT, PRE | 12.7 EL.U/mL. |
| Infanrix Hexa Group | Concentrations for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN) | Anti-FHA, PRE | 47.1 EL.U/mL. |
Secondary
Concentrations for Anti-PNE Antibodies
Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 0.15 µg /mL. The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
Time frame: 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK217744 Group 1 | Concentrations for Anti-PNE Antibodies | Anti-PNE 19F | 8.09 µg /mL |
| GSK217744 Group 1 | Concentrations for Anti-PNE Antibodies | Anti-PNE 14 | 7.47 µg /mL |
| GSK217744 Group 1 | Concentrations for Anti-PNE Antibodies | Anti-PNE 6B | 5.04 µg /mL |
| GSK217744 Group 1 | Concentrations for Anti-PNE Antibodies | Anti-PNE 4 | 2.03 µg /mL |
| GSK217744 Group 1 | Concentrations for Anti-PNE Antibodies | Anti-PNE 9V | 2.20 µg /mL |
| GSK217744 Group 1 | Concentrations for Anti-PNE Antibodies | Anti-PNE 7F | 4.20 µg /mL |
| GSK217744 Group 1 | Concentrations for Anti-PNE Antibodies | Anti- PNE 1 | 2.54 µg /mL |
| GSK217744 Group 1 | Concentrations for Anti-PNE Antibodies | Anti- PNE 3 | 0.76 µg /mL |
| GSK217744 Group 1 | Concentrations for Anti-PNE Antibodies | Anti-PNE 19A | 8.79 µg /mL |
| GSK217744 Group 1 | Concentrations for Anti-PNE Antibodies | Anti-PNE 5 | 1.26 µg /mL |
| GSK217744 Group 1 | Concentrations for Anti-PNE Antibodies | Anti-PNE 23F | 5.31 µg /mL |
| GSK217744 Group 1 | Concentrations for Anti-PNE Antibodies | Anti-PNE 18C | 1.80 µg /mL |
| GSK217744 Group 1 | Concentrations for Anti-PNE Antibodies | Anti-PNE 6A | 10.64 µg /mL |
| GSK217744 Group 2 | Concentrations for Anti-PNE Antibodies | Anti-PNE 7F | 3.97 µg /mL |
| GSK217744 Group 2 | Concentrations for Anti-PNE Antibodies | Anti- PNE 1 | 2.47 µg /mL |
| GSK217744 Group 2 | Concentrations for Anti-PNE Antibodies | Anti- PNE 3 | 0.82 µg /mL |
| GSK217744 Group 2 | Concentrations for Anti-PNE Antibodies | Anti-PNE 4 | 2.10 µg /mL |
| GSK217744 Group 2 | Concentrations for Anti-PNE Antibodies | Anti-PNE 5 | 1.24 µg /mL |
| GSK217744 Group 2 | Concentrations for Anti-PNE Antibodies | Anti-PNE 6A | 7.67 µg /mL |
| GSK217744 Group 2 | Concentrations for Anti-PNE Antibodies | Anti-PNE 6B | 4.56 µg /mL |
| GSK217744 Group 2 | Concentrations for Anti-PNE Antibodies | Anti-PNE 9V | 1.42 µg /mL |
| GSK217744 Group 2 | Concentrations for Anti-PNE Antibodies | Anti-PNE 14 | 8.12 µg /mL |
| GSK217744 Group 2 | Concentrations for Anti-PNE Antibodies | Anti-PNE 18C | 1.52 µg /mL |
| GSK217744 Group 2 | Concentrations for Anti-PNE Antibodies | Anti-PNE 19A | 6.22 µg /mL |
| GSK217744 Group 2 | Concentrations for Anti-PNE Antibodies | Anti-PNE 19F | 7.11 µg /mL |
| GSK217744 Group 2 | Concentrations for Anti-PNE Antibodies | Anti-PNE 23F | 4.00 µg /mL |
| Infanrix Hexa Group | Concentrations for Anti-PNE Antibodies | Anti-PNE 14 | 9.28 µg /mL |
| Infanrix Hexa Group | Concentrations for Anti-PNE Antibodies | Anti-PNE 5 | 1.29 µg /mL |
| Infanrix Hexa Group | Concentrations for Anti-PNE Antibodies | Anti-PNE 19F | 5.56 µg /mL |
| Infanrix Hexa Group | Concentrations for Anti-PNE Antibodies | Anti-PNE 18C | 2.09 µg /mL |
| Infanrix Hexa Group | Concentrations for Anti-PNE Antibodies | Anti-PNE 4 | 2.57 µg /mL |
| Infanrix Hexa Group | Concentrations for Anti-PNE Antibodies | Anti- PNE 1 | 3.47 µg /mL |
| Infanrix Hexa Group | Concentrations for Anti-PNE Antibodies | Anti-PNE 19A | 9.10 µg /mL |
| Infanrix Hexa Group | Concentrations for Anti-PNE Antibodies | Anti-PNE 7F | 4.67 µg /mL |
| Infanrix Hexa Group | Concentrations for Anti-PNE Antibodies | Anti-PNE 6B | 6.62 µg /mL |
| Infanrix Hexa Group | Concentrations for Anti-PNE Antibodies | Anti- PNE 3 | 0.92 µg /mL |
| Infanrix Hexa Group | Concentrations for Anti-PNE Antibodies | Anti-PNE 9V | 1.85 µg /mL |
| Infanrix Hexa Group | Concentrations for Anti-PNE Antibodies | Anti-PNE 6A | 7.47 µg /mL |
| Infanrix Hexa Group | Concentrations for Anti-PNE Antibodies | Anti-PNE 23F | 5.82 µg /mL |
Secondary
Concentrations for Anti-pneumococcal (Anti-PNE) Antibodies
Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 0.15 µg /mL. The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
Time frame: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK217744 Group 1 | Concentrations for Anti-pneumococcal (Anti-PNE) Antibodies | Anti- PNE 19F | 7.15 µg /mL |
| GSK217744 Group 1 | Concentrations for Anti-pneumococcal (Anti-PNE) Antibodies | Anti- PNE 14 | 8.22 µg /mL |
| GSK217744 Group 1 | Concentrations for Anti-pneumococcal (Anti-PNE) Antibodies | Anti- PNE 6B | 4.24 µg /mL |
| GSK217744 Group 1 | Concentrations for Anti-pneumococcal (Anti-PNE) Antibodies | Anti- PNE 4 | 1.87 µg /mL |
| GSK217744 Group 1 | Concentrations for Anti-pneumococcal (Anti-PNE) Antibodies | Anti- PNE 9V | 1.68 µg /mL |
| GSK217744 Group 1 | Concentrations for Anti-pneumococcal (Anti-PNE) Antibodies | Anti- PNE 7F | 3.27 µg /mL |
| GSK217744 Group 1 | Concentrations for Anti-pneumococcal (Anti-PNE) Antibodies | Anti- PNE 1 | 2.07 µg /mL |
| GSK217744 Group 1 | Concentrations for Anti-pneumococcal (Anti-PNE) Antibodies | Anti- PNE 3 | 0.76 µg /mL |
| GSK217744 Group 1 | Concentrations for Anti-pneumococcal (Anti-PNE) Antibodies | Anti- PNE 19A | 7.00 µg /mL |
| GSK217744 Group 1 | Concentrations for Anti-pneumococcal (Anti-PNE) Antibodies | Anti- PNE 5 | 1.18 µg /mL |
| GSK217744 Group 1 | Concentrations for Anti-pneumococcal (Anti-PNE) Antibodies | Anti- PNE 23F | 3.74 µg /mL |
| GSK217744 Group 1 | Concentrations for Anti-pneumococcal (Anti-PNE) Antibodies | Anti- PNE 18C | 1.50 µg /mL |
| GSK217744 Group 1 | Concentrations for Anti-pneumococcal (Anti-PNE) Antibodies | Anti- PNE 6A | 7.71 µg /mL |
| GSK217744 Group 2 | Concentrations for Anti-pneumococcal (Anti-PNE) Antibodies | Anti- PNE 7F | 3.42 µg /mL |
| GSK217744 Group 2 | Concentrations for Anti-pneumococcal (Anti-PNE) Antibodies | Anti- PNE 1 | 2.16 µg /mL |
| GSK217744 Group 2 | Concentrations for Anti-pneumococcal (Anti-PNE) Antibodies | Anti- PNE 3 | 0.87 µg /mL |
| GSK217744 Group 2 | Concentrations for Anti-pneumococcal (Anti-PNE) Antibodies | Anti- PNE 4 | 1.83 µg /mL |
| GSK217744 Group 2 | Concentrations for Anti-pneumococcal (Anti-PNE) Antibodies | Anti- PNE 5 | 1.10 µg /mL |
| GSK217744 Group 2 | Concentrations for Anti-pneumococcal (Anti-PNE) Antibodies | Anti- PNE 6A | 6.92 µg /mL |
| GSK217744 Group 2 | Concentrations for Anti-pneumococcal (Anti-PNE) Antibodies | Anti- PNE 6B | 4.21 µg /mL |
| GSK217744 Group 2 | Concentrations for Anti-pneumococcal (Anti-PNE) Antibodies | Anti- PNE 9V | 1.52 µg /mL |
| GSK217744 Group 2 | Concentrations for Anti-pneumococcal (Anti-PNE) Antibodies | Anti- PNE 14 | 8.80 µg /mL |
| GSK217744 Group 2 | Concentrations for Anti-pneumococcal (Anti-PNE) Antibodies | Anti- PNE 18C | 1.63 µg /mL |
| GSK217744 Group 2 | Concentrations for Anti-pneumococcal (Anti-PNE) Antibodies | Anti- PNE 19A | 8.05 µg /mL |
| GSK217744 Group 2 | Concentrations for Anti-pneumococcal (Anti-PNE) Antibodies | Anti- PNE 19F | 7.34 µg /mL |
| GSK217744 Group 2 | Concentrations for Anti-pneumococcal (Anti-PNE) Antibodies | Anti- PNE 23F | 4.54 µg /mL |
| Infanrix Hexa Group | Concentrations for Anti-pneumococcal (Anti-PNE) Antibodies | Anti- PNE 14 | 8.97 µg /mL |
| Infanrix Hexa Group | Concentrations for Anti-pneumococcal (Anti-PNE) Antibodies | Anti- PNE 5 | 1.21 µg /mL |
| Infanrix Hexa Group | Concentrations for Anti-pneumococcal (Anti-PNE) Antibodies | Anti- PNE 19F | 6.72 µg /mL |
| Infanrix Hexa Group | Concentrations for Anti-pneumococcal (Anti-PNE) Antibodies | Anti- PNE 18C | 1.64 µg /mL |
| Infanrix Hexa Group | Concentrations for Anti-pneumococcal (Anti-PNE) Antibodies | Anti- PNE 4 | 2.14 µg /mL |
| Infanrix Hexa Group | Concentrations for Anti-pneumococcal (Anti-PNE) Antibodies | Anti- PNE 1 | 2.27 µg /mL |
| Infanrix Hexa Group | Concentrations for Anti-pneumococcal (Anti-PNE) Antibodies | Anti- PNE 19A | 6.70 µg /mL |
| Infanrix Hexa Group | Concentrations for Anti-pneumococcal (Anti-PNE) Antibodies | Anti- PNE 7F | 4.27 µg /mL |
| Infanrix Hexa Group | Concentrations for Anti-pneumococcal (Anti-PNE) Antibodies | Anti- PNE 6B | 4.58 µg /mL |
| Infanrix Hexa Group | Concentrations for Anti-pneumococcal (Anti-PNE) Antibodies | Anti- PNE 3 | 0.88 µg /mL |
| Infanrix Hexa Group | Concentrations for Anti-pneumococcal (Anti-PNE) Antibodies | Anti- PNE 9V | 1.63 µg /mL |
| Infanrix Hexa Group | Concentrations for Anti-pneumococcal (Anti-PNE) Antibodies | Anti- PNE 6A | 8.63 µg /mL |
| Infanrix Hexa Group | Concentrations for Anti-pneumococcal (Anti-PNE) Antibodies | Anti- PNE 23F | 3.94 µg /mL |
Secondary
Concentrations for Anti-poliovirus Types 1, 2, 3
Concentrations were expressed as geometric mean titers (GMTs). The seroprotection cut-off of the assay was 8.
Time frame: Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK217744 Group 1 | Concentrations for Anti-poliovirus Types 1, 2, 3 | Anti-Polio 2, PRE | 12.7 Titers |
| GSK217744 Group 1 | Concentrations for Anti-poliovirus Types 1, 2, 3 | Anti-Polio 1, PRE | 18.2 Titers |
| GSK217744 Group 1 | Concentrations for Anti-poliovirus Types 1, 2, 3 | Anti-Polio, 3 PRE | 24.7 Titers |
| GSK217744 Group 2 | Concentrations for Anti-poliovirus Types 1, 2, 3 | Anti-Polio 2, PRE | 17.1 Titers |
| GSK217744 Group 2 | Concentrations for Anti-poliovirus Types 1, 2, 3 | Anti-Polio 1, PRE | 17.8 Titers |
| GSK217744 Group 2 | Concentrations for Anti-poliovirus Types 1, 2, 3 | Anti-Polio, 3 PRE | 16.8 Titers |
| Infanrix Hexa Group | Concentrations for Anti-poliovirus Types 1, 2, 3 | Anti-Polio 1, PRE | 22.4 Titers |
| Infanrix Hexa Group | Concentrations for Anti-poliovirus Types 1, 2, 3 | Anti-Polio, 3 PRE | 26.6 Titers |
| Infanrix Hexa Group | Concentrations for Anti-poliovirus Types 1, 2, 3 | Anti-Polio 2, PRE | 16.6 Titers |
Secondary
Concentrations for Anti-poliovirus Types 1, 2 and 3
Concentrations were expressed as geometric mean titers (GMTs). The seroprotection cut-off of the assay was 8.
Time frame: 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK217744 Group 1 | Concentrations for Anti-poliovirus Types 1, 2 and 3 | Anti-Polio 2, POST | 1485.3 Titers |
| GSK217744 Group 1 | Concentrations for Anti-poliovirus Types 1, 2 and 3 | Anti-Polio 1, POST | 1121.0 Titers |
| GSK217744 Group 1 | Concentrations for Anti-poliovirus Types 1, 2 and 3 | Anti-Polio 3, POST | 1851.2 Titers |
| GSK217744 Group 2 | Concentrations for Anti-poliovirus Types 1, 2 and 3 | Anti-Polio 2, POST | 1215.6 Titers |
| GSK217744 Group 2 | Concentrations for Anti-poliovirus Types 1, 2 and 3 | Anti-Polio 1, POST | 1099.6 Titers |
| GSK217744 Group 2 | Concentrations for Anti-poliovirus Types 1, 2 and 3 | Anti-Polio 3, POST | 1960.4 Titers |
| Infanrix Hexa Group | Concentrations for Anti-poliovirus Types 1, 2 and 3 | Anti-Polio 1, POST | 1386.2 Titers |
| Infanrix Hexa Group | Concentrations for Anti-poliovirus Types 1, 2 and 3 | Anti-Polio 3, POST | 2376.4 Titers |
| Infanrix Hexa Group | Concentrations for Anti-poliovirus Types 1, 2 and 3 | Anti-Polio 2, POST | 1537.2 Titers |
Secondary
Concentrations for Anti-polyribosyl-ribitol Phosphate Antibodies
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.15 µg /mL.
Time frame: Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2))
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK217744 Group 1 | Concentrations for Anti-polyribosyl-ribitol Phosphate Antibodies | 0.328 µg /mL |
| GSK217744 Group 2 | Concentrations for Anti-polyribosyl-ribitol Phosphate Antibodies | 0.288 µg /mL |
| Infanrix Hexa Group | Concentrations for Anti-polyribosyl-ribitol Phosphate Antibodies | 0.334 µg /mL |
Secondary
Concentrations for Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibodies
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.15 µg /mL.
Time frame: Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK217744 Group 1 | Concentrations for Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibodies | 0.173 µg /mL |
| GSK217744 Group 2 | Concentrations for Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibodies | 0.175 µg /mL |
| Infanrix Hexa Group | Concentrations for Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibodies | 0.236 µg /mL |
Secondary
Concentrations for Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibodies
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.15 µg /mL.
Time frame: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK217744 Group 1 | Concentrations for Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibodies | 12.765 µg /mL |
| GSK217744 Group 2 | Concentrations for Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibodies | 15.904 µg /mL |
| Infanrix Hexa Group | Concentrations for Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibodies | 17.099 µg /mL |
Secondary
Concentrations for Anti-PRP Antibodies
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.15 µg /mL.
Time frame: 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK217744 Group 1 | Concentrations for Anti-PRP Antibodies | 21.462 µg /mL |
| GSK217744 Group 2 | Concentrations for Anti-PRP Antibodies | 15.903 µg /mL |
| Infanrix Hexa Group | Concentrations for Anti-PRP Antibodies | 17.429 µg /mL |
Secondary
Concentrations for Anti-PT, Anti-FHA and Anti-PRN
Concentrations were expressed as geometric mean concentrations (GMCs). Seropositivity cut-off assay was 5 EL.U/mL.
Time frame: Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK217744 Group 1 | Concentrations for Anti-PT, Anti-FHA and Anti-PRN | Anti-FHA, PRE | 37.6 EL.U/mL |
| GSK217744 Group 1 | Concentrations for Anti-PT, Anti-FHA and Anti-PRN | Anti-PT, PRE | 8.3 EL.U/mL |
| GSK217744 Group 1 | Concentrations for Anti-PT, Anti-FHA and Anti-PRN | Anti-PRN, PRE | 11.6 EL.U/mL |
| GSK217744 Group 2 | Concentrations for Anti-PT, Anti-FHA and Anti-PRN | Anti-FHA, PRE | 34.0 EL.U/mL |
| GSK217744 Group 2 | Concentrations for Anti-PT, Anti-FHA and Anti-PRN | Anti-PT, PRE | 7.9 EL.U/mL |
| GSK217744 Group 2 | Concentrations for Anti-PT, Anti-FHA and Anti-PRN | Anti-PRN, PRE | 9.7 EL.U/mL |
| Infanrix Hexa Group | Concentrations for Anti-PT, Anti-FHA and Anti-PRN | Anti-PT, PRE | 9.9 EL.U/mL |
| Infanrix Hexa Group | Concentrations for Anti-PT, Anti-FHA and Anti-PRN | Anti-PRN, PRE | 15.6 EL.U/mL |
| Infanrix Hexa Group | Concentrations for Anti-PT, Anti-FHA and Anti-PRN | Anti-FHA, PRE | 45.7 EL.U/mL |
Secondary
Number of Seropositive Subjects for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN)
A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the assay cut-off of 5 ELISA units per milliliter (EL.U/mL).
Time frame: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK217744 Group 1 | Number of Seropositive Subjects for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN) | Anti-FHA, POST | 81 Participants |
| GSK217744 Group 1 | Number of Seropositive Subjects for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN) | Anti-PT, POST | 79 Participants |
| GSK217744 Group 1 | Number of Seropositive Subjects for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN) | Anti-PRN, POST | 81 Participants |
| GSK217744 Group 2 | Number of Seropositive Subjects for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN) | Anti-FHA, POST | 82 Participants |
| GSK217744 Group 2 | Number of Seropositive Subjects for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN) | Anti-PT, POST | 81 Participants |
| GSK217744 Group 2 | Number of Seropositive Subjects for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN) | Anti-PRN, POST | 81 Participants |
| Infanrix Hexa Group | Number of Seropositive Subjects for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN) | Anti-PT, POST | 89 Participants |
| Infanrix Hexa Group | Number of Seropositive Subjects for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN) | Anti-PRN, POST | 89 Participants |
| Infanrix Hexa Group | Number of Seropositive Subjects for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN) | Anti-FHA, POST | 90 Participants |
Secondary
Number of Seropositive Subjects for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN)
A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the assay cut-off of 5 ELISA units per milliliter (EL.U/mL).
Time frame: Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK217744 Group 1 | Number of Seropositive Subjects for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN) | Anti-FHA, PRE | 81 Participants |
| GSK217744 Group 1 | Number of Seropositive Subjects for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN) | Anti-PT, PRE | 68 Participants |
| GSK217744 Group 1 | Number of Seropositive Subjects for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN) | Anti-PRN, PRE | 68 Participants |
| GSK217744 Group 2 | Number of Seropositive Subjects for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN) | Anti-FHA, PRE | 81 Participants |
| GSK217744 Group 2 | Number of Seropositive Subjects for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN) | Anti-PT, PRE | 65 Participants |
| GSK217744 Group 2 | Number of Seropositive Subjects for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN) | Anti-PRN, PRE | 69 Participants |
| Infanrix Hexa Group | Number of Seropositive Subjects for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN) | Anti-PT, PRE | 78 Participants |
| Infanrix Hexa Group | Number of Seropositive Subjects for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN) | Anti-PRN, PRE | 83 Participants |
| Infanrix Hexa Group | Number of Seropositive Subjects for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN) | Anti-FHA, PRE | 88 Participants |
Secondary
Number of Seropositive Subjects for Anti-PNE Serotypes
A seropositive subject was defined as a vaccinated subject who had anti- pneumococcal antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL). The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
Time frame: 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK217744 Group 1 | Number of Seropositive Subjects for Anti-PNE Serotypes | Anti-PNE 4 | 23 Participants |
| GSK217744 Group 1 | Number of Seropositive Subjects for Anti-PNE Serotypes | Anti-PNE 19F | 23 Participants |
| GSK217744 Group 1 | Number of Seropositive Subjects for Anti-PNE Serotypes | Anti-PNE 6B | 23 Participants |
| GSK217744 Group 1 | Number of Seropositive Subjects for Anti-PNE Serotypes | Anti-PNE 19A | 23 Participants |
| GSK217744 Group 1 | Number of Seropositive Subjects for Anti-PNE Serotypes | Anti-PNE 5 | 23 Participants |
| GSK217744 Group 1 | Number of Seropositive Subjects for Anti-PNE Serotypes | Anti-PNE 7F | 23 Participants |
| GSK217744 Group 1 | Number of Seropositive Subjects for Anti-PNE Serotypes | Anti-PNE 23F | 23 Participants |
| GSK217744 Group 1 | Number of Seropositive Subjects for Anti-PNE Serotypes | Anti- PNE 3 | 21 Participants |
| GSK217744 Group 1 | Number of Seropositive Subjects for Anti-PNE Serotypes | Anti-PNE 9V | 23 Participants |
| GSK217744 Group 1 | Number of Seropositive Subjects for Anti-PNE Serotypes | Anti- PNE 1 | 23 Participants |
| GSK217744 Group 1 | Number of Seropositive Subjects for Anti-PNE Serotypes | Anti-PNE 18C | 23 Participants |
| GSK217744 Group 1 | Number of Seropositive Subjects for Anti-PNE Serotypes | Anti-PNE 14 | 23 Participants |
| GSK217744 Group 1 | Number of Seropositive Subjects for Anti-PNE Serotypes | Anti-PNE 6A | 23 Participants |
| GSK217744 Group 2 | Number of Seropositive Subjects for Anti-PNE Serotypes | Anti-PNE 14 | 21 Participants |
| GSK217744 Group 2 | Number of Seropositive Subjects for Anti-PNE Serotypes | Anti-PNE 18C | 21 Participants |
| GSK217744 Group 2 | Number of Seropositive Subjects for Anti-PNE Serotypes | Anti-PNE 19A | 21 Participants |
| GSK217744 Group 2 | Number of Seropositive Subjects for Anti-PNE Serotypes | Anti-PNE 4 | 21 Participants |
| GSK217744 Group 2 | Number of Seropositive Subjects for Anti-PNE Serotypes | Anti-PNE 19F | 21 Participants |
| GSK217744 Group 2 | Number of Seropositive Subjects for Anti-PNE Serotypes | Anti-PNE 23F | 21 Participants |
| GSK217744 Group 2 | Number of Seropositive Subjects for Anti-PNE Serotypes | Anti-PNE 6A | 21 Participants |
| GSK217744 Group 2 | Number of Seropositive Subjects for Anti-PNE Serotypes | Anti- PNE 1 | 21 Participants |
| GSK217744 Group 2 | Number of Seropositive Subjects for Anti-PNE Serotypes | Anti-PNE 6B | 21 Participants |
| GSK217744 Group 2 | Number of Seropositive Subjects for Anti-PNE Serotypes | Anti-PNE 7F | 21 Participants |
| GSK217744 Group 2 | Number of Seropositive Subjects for Anti-PNE Serotypes | Anti-PNE 9V | 21 Participants |
| GSK217744 Group 2 | Number of Seropositive Subjects for Anti-PNE Serotypes | Anti- PNE 3 | 18 Participants |
| GSK217744 Group 2 | Number of Seropositive Subjects for Anti-PNE Serotypes | Anti-PNE 5 | 21 Participants |
| Infanrix Hexa Group | Number of Seropositive Subjects for Anti-PNE Serotypes | Anti-PNE 23F | 20 Participants |
| Infanrix Hexa Group | Number of Seropositive Subjects for Anti-PNE Serotypes | Anti- PNE 1 | 20 Participants |
| Infanrix Hexa Group | Number of Seropositive Subjects for Anti-PNE Serotypes | Anti- PNE 3 | 16 Participants |
| Infanrix Hexa Group | Number of Seropositive Subjects for Anti-PNE Serotypes | Anti-PNE 5 | 20 Participants |
| Infanrix Hexa Group | Number of Seropositive Subjects for Anti-PNE Serotypes | Anti-PNE 6A | 20 Participants |
| Infanrix Hexa Group | Number of Seropositive Subjects for Anti-PNE Serotypes | Anti-PNE 6B | 20 Participants |
| Infanrix Hexa Group | Number of Seropositive Subjects for Anti-PNE Serotypes | Anti-PNE 7F | 20 Participants |
| Infanrix Hexa Group | Number of Seropositive Subjects for Anti-PNE Serotypes | Anti-PNE 9V | 20 Participants |
| Infanrix Hexa Group | Number of Seropositive Subjects for Anti-PNE Serotypes | Anti-PNE 14 | 20 Participants |
| Infanrix Hexa Group | Number of Seropositive Subjects for Anti-PNE Serotypes | Anti-PNE 18C | 20 Participants |
| Infanrix Hexa Group | Number of Seropositive Subjects for Anti-PNE Serotypes | Anti-PNE 19A | 19 Participants |
| Infanrix Hexa Group | Number of Seropositive Subjects for Anti-PNE Serotypes | Anti-PNE 19F | 20 Participants |
| Infanrix Hexa Group | Number of Seropositive Subjects for Anti-PNE Serotypes | Anti-PNE 4 | 20 Participants |
Secondary
Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes
A seropositive subject was defined as a vaccinated subject who had anti- pneumococcal antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL). The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
Time frame: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK217744 Group 1 | Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes | Anti- PNE 6A | 50 Participants |
| GSK217744 Group 1 | Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes | Anti- PNE 14 | 49 Participants |
| GSK217744 Group 1 | Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes | Anti- PNE 6B | 50 Participants |
| GSK217744 Group 1 | Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes | Anti- PNE 23F | 50 Participants |
| GSK217744 Group 1 | Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes | Anti- PNE 9V | 50 Participants |
| GSK217744 Group 1 | Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes | Anti- PNE 7F | 50 Participants |
| GSK217744 Group 1 | Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes | Anti- PNE 1 | 50 Participants |
| GSK217744 Group 1 | Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes | Anti- PNE 5 | 50 Participants |
| GSK217744 Group 1 | Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes | Anti- PNE 19A | 49 Participants |
| GSK217744 Group 1 | Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes | Anti- PNE 3 | 40 Participants |
| GSK217744 Group 1 | Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes | Anti- PNE 19F | 50 Participants |
| GSK217744 Group 1 | Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes | Anti- PNE 18C | 49 Participants |
| GSK217744 Group 1 | Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes | Anti- PNE 4 | 50 Participants |
| GSK217744 Group 2 | Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes | Anti- PNE 4 | 50 Participants |
| GSK217744 Group 2 | Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes | Anti- PNE 6A | 50 Participants |
| GSK217744 Group 2 | Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes | Anti- PNE 1 | 50 Participants |
| GSK217744 Group 2 | Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes | Anti- PNE 3 | 43 Participants |
| GSK217744 Group 2 | Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes | Anti- PNE 5 | 50 Participants |
| GSK217744 Group 2 | Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes | Anti- PNE 6B | 49 Participants |
| GSK217744 Group 2 | Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes | Anti- PNE 7F | 50 Participants |
| GSK217744 Group 2 | Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes | Anti- PNE 9V | 50 Participants |
| GSK217744 Group 2 | Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes | Anti- PNE 14 | 50 Participants |
| GSK217744 Group 2 | Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes | Anti- PNE 18C | 50 Participants |
| GSK217744 Group 2 | Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes | Anti- PNE 19A | 50 Participants |
| GSK217744 Group 2 | Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes | Anti- PNE 19F | 50 Participants |
| GSK217744 Group 2 | Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes | Anti- PNE 23F | 47 Participants |
| Infanrix Hexa Group | Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes | Anti- PNE 14 | 53 Participants |
| Infanrix Hexa Group | Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes | Anti- PNE 3 | 43 Participants |
| Infanrix Hexa Group | Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes | Anti- PNE 19F | 53 Participants |
| Infanrix Hexa Group | Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes | Anti- PNE 18C | 53 Participants |
| Infanrix Hexa Group | Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes | Anti- PNE 1 | 53 Participants |
| Infanrix Hexa Group | Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes | Anti- PNE 4 | 53 Participants |
| Infanrix Hexa Group | Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes | Anti- PNE 19A | 53 Participants |
| Infanrix Hexa Group | Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes | Anti- PNE 7F | 53 Participants |
| Infanrix Hexa Group | Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes | Anti- PNE 6B | 53 Participants |
| Infanrix Hexa Group | Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes | Anti- PNE 5 | 53 Participants |
| Infanrix Hexa Group | Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes | Anti- PNE 9V | 53 Participants |
| Infanrix Hexa Group | Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes | Anti- PNE 6A | 53 Participants |
| Infanrix Hexa Group | Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes | Anti- PNE 23F | 52 Participants |
Secondary
Number of Seropositive Subjects for Anti-PT, Anti-FHA, Anti-PRN
A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the assay cut-off of 5 ELISA units per milliliter (EL.U/mL).
Time frame: 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK217744 Group 1 | Number of Seropositive Subjects for Anti-PT, Anti-FHA, Anti-PRN | Anti-FHA, POST | 123 Participants |
| GSK217744 Group 1 | Number of Seropositive Subjects for Anti-PT, Anti-FHA, Anti-PRN | Anti-PT, POST | 118 Participants |
| GSK217744 Group 1 | Number of Seropositive Subjects for Anti-PT, Anti-FHA, Anti-PRN | Anti-PRN, POST | 122 Participants |
| GSK217744 Group 2 | Number of Seropositive Subjects for Anti-PT, Anti-FHA, Anti-PRN | Anti-FHA, POST | 122 Participants |
| GSK217744 Group 2 | Number of Seropositive Subjects for Anti-PT, Anti-FHA, Anti-PRN | Anti-PT, POST | 121 Participants |
| GSK217744 Group 2 | Number of Seropositive Subjects for Anti-PT, Anti-FHA, Anti-PRN | Anti-PRN, POST | 122 Participants |
| Infanrix Hexa Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA, Anti-PRN | Anti-PT, POST | 116 Participants |
| Infanrix Hexa Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA, Anti-PRN | Anti-PRN, POST | 117 Participants |
| Infanrix Hexa Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA, Anti-PRN | Anti-FHA, POST | 117 Participants |
Secondary
Number of Seropositive Subjects for Anti-PT, Anti-FHA, Anti-PRN
A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the assay cut-off of 5 ELISA units per milliliter (EL.U/mL).
Time frame: Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK217744 Group 1 | Number of Seropositive Subjects for Anti-PT, Anti-FHA, Anti-PRN | Anti-FHA, PRE | 122 Participants |
| GSK217744 Group 1 | Number of Seropositive Subjects for Anti-PT, Anti-FHA, Anti-PRN | Anti-PT, PRE | 95 Participants |
| GSK217744 Group 1 | Number of Seropositive Subjects for Anti-PT, Anti-FHA, Anti-PRN | Anti-PRN, PRE | 98 Participants |
| GSK217744 Group 2 | Number of Seropositive Subjects for Anti-PT, Anti-FHA, Anti-PRN | Anti-FHA, PRE | 117 Participants |
| GSK217744 Group 2 | Number of Seropositive Subjects for Anti-PT, Anti-FHA, Anti-PRN | Anti-PT, PRE | 94 Participants |
| GSK217744 Group 2 | Number of Seropositive Subjects for Anti-PT, Anti-FHA, Anti-PRN | Anti-PRN, PRE | 92 Participants |
| Infanrix Hexa Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA, Anti-PRN | Anti-PT, PRE | 97 Participants |
| Infanrix Hexa Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA, Anti-PRN | Anti-PRN, PRE | 105 Participants |
| Infanrix Hexa Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA, Anti-PRN | Anti-FHA, PRE | 116 Participants |
Secondary
Number of Seroprotected Subjects Against Anti-HBs Antigens
A seroprotected subject was a subject whose antibody concentration was greater than or equal to the level defining clinical protection of 10 milli-international units per millilitre (mIU/mL).
Time frame: Before (PRE) booaster vaccination (subjects enrolled after protocol amendment 2)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK217744 Group 1 | Number of Seroprotected Subjects Against Anti-HBs Antigens | 108 Participants |
| GSK217744 Group 2 | Number of Seroprotected Subjects Against Anti-HBs Antigens | 100 Participants |
| Infanrix Hexa Group | Number of Seroprotected Subjects Against Anti-HBs Antigens | 106 Participants |
Secondary
Number of Seroprotected Subjects Against Anti-Hepatitis B (Anti-HBs) Antigens
A seroprotected subject was a subject whose antibody concentration was greater than or equal to the level defining clinical protection of 10 milli-international units per millilitre (mIU/mL).
Time frame: Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK217744 Group 1 | Number of Seroprotected Subjects Against Anti-Hepatitis B (Anti-HBs) Antigens | 68 Participants |
| GSK217744 Group 2 | Number of Seroprotected Subjects Against Anti-Hepatitis B (Anti-HBs) Antigens | 74 Participants |
| Infanrix Hexa Group | Number of Seroprotected Subjects Against Anti-Hepatitis B (Anti-HBs) Antigens | 78 Participants |
Secondary
Number of Seroprotected Subjects Against Anti-Poliovirus Type 1, 2 and 3
A seroprotected subject was a subject whose antibody titre was greater than or equal to the level defining clinical protection of 8.
Time frame: Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK217744 Group 1 | Number of Seroprotected Subjects Against Anti-Poliovirus Type 1, 2 and 3 | Anti-Polio 2, PRE | 78 Participants |
| GSK217744 Group 1 | Number of Seroprotected Subjects Against Anti-Poliovirus Type 1, 2 and 3 | Anti-Polio 1, PRE | 95 Participants |
| GSK217744 Group 1 | Number of Seroprotected Subjects Against Anti-Poliovirus Type 1, 2 and 3 | Anti-Polio, 3 PRE | 96 Participants |
| GSK217744 Group 2 | Number of Seroprotected Subjects Against Anti-Poliovirus Type 1, 2 and 3 | Anti-Polio 2, PRE | 81 Participants |
| GSK217744 Group 2 | Number of Seroprotected Subjects Against Anti-Poliovirus Type 1, 2 and 3 | Anti-Polio 1, PRE | 91 Participants |
| GSK217744 Group 2 | Number of Seroprotected Subjects Against Anti-Poliovirus Type 1, 2 and 3 | Anti-Polio, 3 PRE | 99 Participants |
| Infanrix Hexa Group | Number of Seroprotected Subjects Against Anti-Poliovirus Type 1, 2 and 3 | Anti-Polio 1, PRE | 92 Participants |
| Infanrix Hexa Group | Number of Seroprotected Subjects Against Anti-Poliovirus Type 1, 2 and 3 | Anti-Polio, 3 PRE | 91 Participants |
| Infanrix Hexa Group | Number of Seroprotected Subjects Against Anti-Poliovirus Type 1, 2 and 3 | Anti-Polio 2, PRE | 74 Participants |
Secondary
Number of Seroprotected Subjects for Anti-D and Anti-T Antibodies
A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).
Time frame: Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK217744 Group 1 | Number of Seroprotected Subjects for Anti-D and Anti-T Antibodies | Anti-D, PRE | 107 Participants |
| GSK217744 Group 1 | Number of Seroprotected Subjects for Anti-D and Anti-T Antibodies | Anti-T, PRE | 116 Participants |
| GSK217744 Group 2 | Number of Seroprotected Subjects for Anti-D and Anti-T Antibodies | Anti-D, PRE | 114 Participants |
| GSK217744 Group 2 | Number of Seroprotected Subjects for Anti-D and Anti-T Antibodies | Anti-T, PRE | 114 Participants |
| Infanrix Hexa Group | Number of Seroprotected Subjects for Anti-D and Anti-T Antibodies | Anti-D, PRE | 104 Participants |
| Infanrix Hexa Group | Number of Seroprotected Subjects for Anti-D and Anti-T Antibodies | Anti-T, PRE | 111 Participants |
Secondary
Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies
A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).
Time frame: Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK217744 Group 1 | Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies | Anti-D, PRE | 78 Participants |
| GSK217744 Group 1 | Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies | Anti-T, PRE | 76 Participants |
| GSK217744 Group 2 | Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies | Anti-D, PRE | 80 Participants |
| GSK217744 Group 2 | Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies | Anti-T, PRE | 78 Participants |
| Infanrix Hexa Group | Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies | Anti-T, PRE | 85 Participants |
| Infanrix Hexa Group | Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies | Anti-D, PRE | 84 Participants |
Secondary
Number of Seroprotected Subjects for Anti-poliovirus Type 1, 2 and 3
A seroprotected subject was a subject whose antibody titre was greater than or equal to the level defining clinical protection of 8.
Time frame: Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK217744 Group 1 | Number of Seroprotected Subjects for Anti-poliovirus Type 1, 2 and 3 | Anti-Polio 2, PRE | 38 Participants |
| GSK217744 Group 1 | Number of Seroprotected Subjects for Anti-poliovirus Type 1, 2 and 3 | Anti-Polio 1, PRE | 50 Participants |
| GSK217744 Group 1 | Number of Seroprotected Subjects for Anti-poliovirus Type 1, 2 and 3 | Anti-Polio, 3 PRE | 51 Participants |
| GSK217744 Group 2 | Number of Seroprotected Subjects for Anti-poliovirus Type 1, 2 and 3 | Anti-Polio 2, PRE | 44 Participants |
| GSK217744 Group 2 | Number of Seroprotected Subjects for Anti-poliovirus Type 1, 2 and 3 | Anti-Polio 1, PRE | 54 Participants |
| GSK217744 Group 2 | Number of Seroprotected Subjects for Anti-poliovirus Type 1, 2 and 3 | Anti-Polio, 3 PRE | 43 Participants |
| Infanrix Hexa Group | Number of Seroprotected Subjects for Anti-poliovirus Type 1, 2 and 3 | Anti-Polio 1, PRE | 56 Participants |
| Infanrix Hexa Group | Number of Seroprotected Subjects for Anti-poliovirus Type 1, 2 and 3 | Anti-Polio, 3 PRE | 61 Participants |
| Infanrix Hexa Group | Number of Seroprotected Subjects for Anti-poliovirus Type 1, 2 and 3 | Anti-Polio 2, PRE | 44 Participants |
Secondary
Number of Seroprotected Subjects for Anti-polyribosyl-ribitol Phosphate (Anti-PRP)
A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).
Time frame: Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK217744 Group 1 | Number of Seroprotected Subjects for Anti-polyribosyl-ribitol Phosphate (Anti-PRP) | 41 Participants |
| GSK217744 Group 2 | Number of Seroprotected Subjects for Anti-polyribosyl-ribitol Phosphate (Anti-PRP) | 45 Participants |
| Infanrix Hexa Group | Number of Seroprotected Subjects for Anti-polyribosyl-ribitol Phosphate (Anti-PRP) | 52 Participants |
Secondary
Number of Seroprotected Subjects for Anti-PRP
A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).
Time frame: Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK217744 Group 1 | Number of Seroprotected Subjects for Anti-PRP | 92 Participants |
| GSK217744 Group 2 | Number of Seroprotected Subjects for Anti-PRP | 78 Participants |
| Infanrix Hexa Group | Number of Seroprotected Subjects for Anti-PRP | 81 Participants |
Secondary
Number of Subjects Reporting Any SAEs
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Any SAE = any SAE regardless of assessment of relationship to study vaccination.
Time frame: During the entire study period (Days 0-30). (subjects enrolled after protocol amendment 2)
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the booster vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK217744 Group 1 | Number of Subjects Reporting Any SAEs | 0 Participants |
| GSK217744 Group 2 | Number of Subjects Reporting Any SAEs | 2 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any SAEs | 0 Participants |
Secondary
Number of Subjects Reporting Any Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Any SAE = any SAE regardless of assessment of relationship to study vaccination.
Time frame: During the entire study period (Days 0-30). (subjects enrolled before protocol amendment 2)
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the booster vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK217744 Group 1 | Number of Subjects Reporting Any Serious Adverse Events (SAEs) | 0 Participants |
| GSK217744 Group 2 | Number of Subjects Reporting Any Serious Adverse Events (SAEs) | 0 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any Serious Adverse Events (SAEs) | 0 Participants |
Secondary
Number of Subjects Reporting Any Solicited General Symptom
Solicited local symptoms assessed were drowsiness, irritability/fussiness, loss of appetite and fever \[axillary temperature above (≥) 37.5 degrees Celsius (°C)\]. Any = occurrence of any local symptom regardless of intensity grade.
Time frame: During the 4-day (Days 0-3) post-vaccination period. (subjects enrolled after protocol amendment 2)
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the booster vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK217744 Group 1 | Number of Subjects Reporting Any Solicited General Symptom | Any drowsiness | 52 Participants |
| GSK217744 Group 1 | Number of Subjects Reporting Any Solicited General Symptom | Any irritability/fussiness | 66 Participants |
| GSK217744 Group 1 | Number of Subjects Reporting Any Solicited General Symptom | Any loss of appetite | 42 Participants |
| GSK217744 Group 1 | Number of Subjects Reporting Any Solicited General Symptom | Any fever | 58 Participants |
| GSK217744 Group 2 | Number of Subjects Reporting Any Solicited General Symptom | Any fever | 50 Participants |
| GSK217744 Group 2 | Number of Subjects Reporting Any Solicited General Symptom | Any drowsiness | 40 Participants |
| GSK217744 Group 2 | Number of Subjects Reporting Any Solicited General Symptom | Any loss of appetite | 37 Participants |
| GSK217744 Group 2 | Number of Subjects Reporting Any Solicited General Symptom | Any irritability/fussiness | 58 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any Solicited General Symptom | Any fever | 52 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any Solicited General Symptom | Any irritability/fussiness | 62 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any Solicited General Symptom | Any loss of appetite | 34 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any Solicited General Symptom | Any drowsiness | 40 Participants |
Secondary
Number of Subjects Reporting Any Solicited General Symptoms
Solicited local symptoms assessed were drowsiness, irritability/fussiness, loss of appetite and fever \[axillary temperature above (≥) 37.5 degrees Celsius (°C)\]. Any = occurrence of any local symptom regardless of intensity grade.
Time frame: During the 4-day (Days 0-3) post-vaccination period. (subjects enrolled before protocol amendment 2)
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the booster vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK217744 Group 1 | Number of Subjects Reporting Any Solicited General Symptoms | Any loss of appetite | 43 Participants |
| GSK217744 Group 1 | Number of Subjects Reporting Any Solicited General Symptoms | Any drowsiness | 54 Participants |
| GSK217744 Group 1 | Number of Subjects Reporting Any Solicited General Symptoms | Any irritability/fussiness | 69 Participants |
| GSK217744 Group 1 | Number of Subjects Reporting Any Solicited General Symptoms | Any fever | 42 Participants |
| GSK217744 Group 2 | Number of Subjects Reporting Any Solicited General Symptoms | Any fever | 41 Participants |
| GSK217744 Group 2 | Number of Subjects Reporting Any Solicited General Symptoms | Any loss of appetite | 45 Participants |
| GSK217744 Group 2 | Number of Subjects Reporting Any Solicited General Symptoms | Any irritability/fussiness | 73 Participants |
| GSK217744 Group 2 | Number of Subjects Reporting Any Solicited General Symptoms | Any drowsiness | 47 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any Solicited General Symptoms | Any fever | 37 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any Solicited General Symptoms | Any drowsiness | 47 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any Solicited General Symptoms | Any irritability/fussiness | 74 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any Solicited General Symptoms | Any loss of appetite | 46 Participants |
Secondary
Number of Subjects Reporting Any Solicited Local Symptom
Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.
Time frame: During the 4-day (Days 0-3) post-vaccination period. (subjects enrolled after protocol amendment 2)
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the booster vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK217744 Group 1 | Number of Subjects Reporting Any Solicited Local Symptom | Any redness | 47 Participants |
| GSK217744 Group 1 | Number of Subjects Reporting Any Solicited Local Symptom | Any pain | 76 Participants |
| GSK217744 Group 1 | Number of Subjects Reporting Any Solicited Local Symptom | Any swelling | 43 Participants |
| GSK217744 Group 2 | Number of Subjects Reporting Any Solicited Local Symptom | Any redness | 36 Participants |
| GSK217744 Group 2 | Number of Subjects Reporting Any Solicited Local Symptom | Any pain | 66 Participants |
| GSK217744 Group 2 | Number of Subjects Reporting Any Solicited Local Symptom | Any swelling | 34 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any Solicited Local Symptom | Any pain | 64 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any Solicited Local Symptom | Any swelling | 38 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any Solicited Local Symptom | Any redness | 40 Participants |
Secondary
Number of Subjects Reporting Any Solicited Local Symptoms
Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.
Time frame: During the 4-day (Days 0-3) post-vaccination period. (subjects enrolled before protocol amendment 2)
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the booster vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK217744 Group 1 | Number of Subjects Reporting Any Solicited Local Symptoms | Any redness | 55 Participants |
| GSK217744 Group 1 | Number of Subjects Reporting Any Solicited Local Symptoms | Any pain | 56 Participants |
| GSK217744 Group 1 | Number of Subjects Reporting Any Solicited Local Symptoms | Any swelling | 45 Participants |
| GSK217744 Group 2 | Number of Subjects Reporting Any Solicited Local Symptoms | Any redness | 56 Participants |
| GSK217744 Group 2 | Number of Subjects Reporting Any Solicited Local Symptoms | Any pain | 67 Participants |
| GSK217744 Group 2 | Number of Subjects Reporting Any Solicited Local Symptoms | Any swelling | 43 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any Solicited Local Symptoms | Any pain | 63 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any Solicited Local Symptoms | Any swelling | 48 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any Solicited Local Symptoms | Any redness | 59 Participants |
Secondary
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)
An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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 = occurrence of an AE regardless of intensity grade or relationship to study vaccination.
Time frame: Within the 31-day (Days 0-30) follow up period after vaccination. (subjects enrolled before protocol amendment 2)
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the booster vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK217744 Group 1 | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) | 42 Participants |
| GSK217744 Group 2 | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) | 39 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) | 67 Participants |
Secondary
Number of Subjects Reporting Any Unsolicited AEs
An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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 = occurrence of an AE regardless of intensity grade or relationship to study vaccination.
Time frame: Within the 31-day (Days 0-30) follow up period after vaccination. (subjects enrolled after protocol amendment 2)
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the booster vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK217744 Group 1 | Number of Subjects Reporting Any Unsolicited AEs | 38 Participants |
| GSK217744 Group 2 | Number of Subjects Reporting Any Unsolicited AEs | 27 Participants |
| Infanrix Hexa Group | Number of Subjects Reporting Any Unsolicited AEs | 31 Participants |
Secondary
Number of Subjects With Booster Response to Anti-pertussis Antigens
Booster response defined as : - For initially seronegative subjects, antibody concentration ≥ 5 EL.U/mL one month after booster vaccination - For initially seropositive subjects, antibody concentration at Post-booster ≥ 2 fold the pre-vaccination antibody concentration
Time frame: 1 month poste booster vaccination (POST) (subjects enrolled after protocol amendment 2)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK217744 Group 1 | Number of Subjects With Booster Response to Anti-pertussis Antigens | Anti-FHA | 120 Subjects |
| GSK217744 Group 1 | Number of Subjects With Booster Response to Anti-pertussis Antigens | Anti-PT | 118 Subjects |
| GSK217744 Group 1 | Number of Subjects With Booster Response to Anti-pertussis Antigens | Anti-PRN | 121 Subjects |
| GSK217744 Group 2 | Number of Subjects With Booster Response to Anti-pertussis Antigens | Anti-FHA | 115 Subjects |
| GSK217744 Group 2 | Number of Subjects With Booster Response to Anti-pertussis Antigens | Anti-PT | 119 Subjects |
| GSK217744 Group 2 | Number of Subjects With Booster Response to Anti-pertussis Antigens | Anti-PRN | 120 Subjects |
| Infanrix Hexa Group | Number of Subjects With Booster Response to Anti-pertussis Antigens | Anti-PT | 110 Subjects |
| Infanrix Hexa Group | Number of Subjects With Booster Response to Anti-pertussis Antigens | Anti-PRN | 115 Subjects |
| Infanrix Hexa Group | Number of Subjects With Booster Response to Anti-pertussis Antigens | Anti-FHA | 113 Subjects |
Secondary
Number of Subjects With Booster Response to Anti-pertussis Antigens (Anti-PT, Anti-FHA and Anti-PRN)
Booster response defined as : - For initially seronegative subjects, antibody concentration ≥ 5 EL.U/mL one month after booster vaccination - For initially seropositive subjects, antibody concentration at Post-booster ≥ 2 fold the pre-vaccination antibody concentration
Time frame: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK217744 Group 1 | Number of Subjects With Booster Response to Anti-pertussis Antigens (Anti-PT, Anti-FHA and Anti-PRN) | Anti-FHA | 79 Participants |
| GSK217744 Group 1 | Number of Subjects With Booster Response to Anti-pertussis Antigens (Anti-PT, Anti-FHA and Anti-PRN) | Anti-PT | 72 Participants |
| GSK217744 Group 1 | Number of Subjects With Booster Response to Anti-pertussis Antigens (Anti-PT, Anti-FHA and Anti-PRN) | Anti-PRN | 81 Participants |
| GSK217744 Group 2 | Number of Subjects With Booster Response to Anti-pertussis Antigens (Anti-PT, Anti-FHA and Anti-PRN) | Anti-FHA | 81 Participants |
| GSK217744 Group 2 | Number of Subjects With Booster Response to Anti-pertussis Antigens (Anti-PT, Anti-FHA and Anti-PRN) | Anti-PT | 77 Participants |
| GSK217744 Group 2 | Number of Subjects With Booster Response to Anti-pertussis Antigens (Anti-PT, Anti-FHA and Anti-PRN) | Anti-PRN | 80 Participants |
| Infanrix Hexa Group | Number of Subjects With Booster Response to Anti-pertussis Antigens (Anti-PT, Anti-FHA and Anti-PRN) | Anti-PT | 86 Participants |
| Infanrix Hexa Group | Number of Subjects With Booster Response to Anti-pertussis Antigens (Anti-PT, Anti-FHA and Anti-PRN) | Anti-PRN | 87 Participants |
| Infanrix Hexa Group | Number of Subjects With Booster Response to Anti-pertussis Antigens (Anti-PT, Anti-FHA and Anti-PRN) | Anti-FHA | 87 Participants |