Diphtheria, Haemophilus Influenzae Type b, Hepatitis B, Poliomyelitis Vaccines, Tetanus, Whole Cell Pertussis
Conditions
Brief summary
The purpose of the study is to assess the immunogenicity and safety of three formulations of GSK Biologicals' GSK2036874A vaccine compared to Zilbrix™/Hib and Poliorix™ vaccines administered concomitantly, when administered as a single booster dose to healthy poliovirus-primed toddlers aged 12-24 months.
Detailed description
The study will be conducted in a partially double-blinded manner. The study will be double-blinded with respect to the three GSK2036874A formulation groups and open-label with respect to the Control Group.
Interventions
BIOLOGICALGSK2036874A vaccine
Intramuscular, single dose
BIOLOGICALZilbrix™/Hib vaccine
Intramuscular, single dose
BIOLOGICALPoliorix™
Intramuscular, single dose
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Months to 24 Months
Healthy volunteers
Yes
Inclusion criteria
* A male or female subject, between and including 12 and 24 months of age at the time of booster vaccination. * Subjects who have received three doses of polio vaccine as primary vaccination along with the routine vaccinations indicated during the first year of life. * Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative (s) can and will comply with the requirements of the protocol. * Written informed consent obtained from the parent(s)/Legally Acceptable Representative (s) of the subject. * Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion criteria
* Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the 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 booster vaccination, or planned administration during the active study period (up to Visit 2). * Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product. * History of diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and/or Haemophilus influenza type b diseases. * Previous booster vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B or H. influenzae diseases. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). * A family history of congenital or hereditary immunodeficiency. * Major congenital defects or serious chronic illness. * History of neurologic disorders or seizures. * History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines. * Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period. * Occurrence of transient thrombocytopenia or neurological complications following an earlier immunisation against diphtheria and/or tetanus. * Child in care. * Occurrence of any of the following adverse events after a previous administration of a diphtheria-tetanus-pertussis vaccine: * encephalopathy of unknown aetiology occurring within seven days following previous vaccination with pertussis-containing vaccine, * fever \>= 40 °C within 48 hours of vaccination not due to another identifiable cause, * collapse or shock-like state within 48 hours of vaccination, * convulsions with or without fever, occurring within 3 days of vaccination. * Acute disease and/or fever at the time of enrolment. * Fever is defined as temperature \>= 37.5°C on oral, axillary or tympanic setting, or \>= 38.0°C on rectal setting. * Subjects with a minor illness without fever may, be enrolled at the discretion of the investigator. * Other conditions which, in the opinion of the investigator, may potentially interfere with interpretation of study results.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 | One month after booster vaccination (At Month 1) | Seroprotection was defined as anti-polio types 1, 2 and 3 antibody titres ≥ 8 effective dose (ED50), for 50% of vaccinated subjects. |
| Anti-polio Types 1, 2 and 3 Antibody Titers | Prior to booster vaccination (At Month 0) | Antibody titers were presented as geometric mean titers (GMTs). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) | Prior to (At Month 0) and one month after booster vaccination (At Month 1) | Seroprotection was defined as anti-D and anti-T antibody concentration ≥ 0.1 international units per milliliter (IU/mL). |
| Anti-D and Anti-T Antibody Concentrations | Prior to (At Month 0) and one month after booster vaccination (At Month 1) | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL. |
| Number of Seroprotected and Seropositive Subjects for Anti-hepatitis B (Anti-HBs) | Prior to (At Month 0) and one month after the booster vaccination (At Month 1) | Seropositivity was defined as anti-HBs antibody concentration ≥ 3.3 milli-international units per milliliter (mIU/mL). Seprotection was defined as anti-HBs antibody concentration ≥ 10 mIU/mL. Note that percentage of subjects with concentration ≥ 10 mIU/mL was over-estimated due to the use of in-house assay overestimating concentrations between 10-100 mIU/mL. Accordingly GMCs were also overestimated. A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis. Some of the available blood samples initially tested with ELISA were re-tested using the new assay, CLIA. |
| Anti-HBs Antibody Concentrations | Prior to (At Month 0) and one month after the booster vaccination (At Month 1) | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL. |
| Number of Seroprotected Subjects Against Polyribosil-ribitol-phosphate (PRP) | Prior to (At Month 0) and one month after booster vaccination (At Month 1) | Seprotection was defined as anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (μg/mL). |
| Anti-PRP Antibody Concentrations | Prior to (At Month 0) and one month after booster vaccination (At Month 1) | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in μg/mL. |
| Number of Seroconverted Subjects for Anti-polio Types 1, 2 and 3 | One month after booster vaccination (At Month 1) | Seroconversion was defined as: For initially seronegative subjects, antibody titer ≥ 8 ED50 one month after the booster dose. For initially seropositive subjects: antibody titer one month after the booster dose ≥ 4 fold the pre-booster antibody titer. For subjects with pre-booster antibody titer below the highest dilution tested (reciprocal \< 8192 ED50): highest dilution tested one month after the booster dose (reciprocal \> 8192 ED50). |
| Anti-BPT Antibody Concentrations | Prior to (At Month 0) and one month after booster vaccination (At Month 1) | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL. |
| Number of Subjects With a Booster Response for Anti-BPT | One month after booster vaccination (At Month 1) | Booster response was defined as: For initially seronegative subjects, antibody concentration ≥ 15 EL.U/mL one month after the booster dose. For initially seropositive subjects: antibody concentration one month after the booster dose ≥ 2 fold the pre-booster antibody concentration. |
| Number of Subjects With Any Solicited Local Symptoms | During the 8-day (Days 0-7) post-vaccination period | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. |
| Number of Subjects With Any Solicited General Symptoms | During the 8-day (Days 0-7) post-vaccination period | Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. |
| Number of Subjects With Any Unsolicited Adverse Events (AEs) | During the 31-day (Day 0-Day 30) post-vaccination period | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. |
| Number of Subjects With Serious Adverse Events (SAEs) | During the entire study period (from Month 0 to Month 1) | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
| Number of Seropositive Subjects for Anti-Bordetella Pertussis (Anti-BPT) | Prior to (At Month 0) and one month after the booster vaccination (At Month 1) | Seropositivity was defined as anti-BPT antibody concentration ≥ 15 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). |
| Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 | Prior to booster vaccination (At Month 0) | Seroprotection was defined as anti-polio types 1, 2 and 3 antibody titres ≥ 8 effective dose (ED50), for 50% of vaccinated subjects. |
Countries
Philippines
Participant flow
Pre-assignment details
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
Participants by arm
| Arm | Count |
|---|---|
| GSK2036874A Group 1 Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0. | 78 |
| GSK2036874A Group 2 Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0. | 78 |
| GSK2036874A Group 3 Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0. | 78 |
| Zilbrix/Hib/Poliorix Group Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively. | 78 |
| Total | 312 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | GSK2036874A Group 1 | GSK2036874A Group 2 | GSK2036874A Group 3 | Zilbrix/Hib/Poliorix Group | Total |
|---|---|---|---|---|---|
| Age, Continuous | 17.4 Months STANDARD_DEVIATION 3.81 | 18 Months STANDARD_DEVIATION 2.96 | 17.7 Months STANDARD_DEVIATION 3.38 | 17.5 Months STANDARD_DEVIATION 3.59 | 17.65 Months STANDARD_DEVIATION 3.44 |
| Race/Ethnicity, Customized Asian-South East Asian heritage | 78 Participants | 78 Participants | 78 Participants | 78 Participants | 312 Participants |
| Sex: Female, Male Female | 37 Participants | 31 Participants | 35 Participants | 40 Participants | 143 Participants |
| Sex: Female, Male Male | 41 Participants | 47 Participants | 43 Participants | 38 Participants | 169 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 78 | 0 / 78 | 0 / 78 | 0 / 78 |
| other Total, other adverse events | 75 / 78 | 74 / 78 | 76 / 78 | 77 / 78 |
| serious Total, serious adverse events | 1 / 78 | 3 / 78 | 2 / 78 | 1 / 78 |
Outcome results
Primary
Anti-polio Types 1, 2 and 3 Antibody Titers
Antibody titers were presented as geometric mean titers (GMTs).
Time frame: Prior to booster vaccination (At Month 0)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2036874A Group 1 | Anti-polio Types 1, 2 and 3 Antibody Titers | Anti-polio 1 | 321.1 Titers |
| GSK2036874A Group 1 | Anti-polio Types 1, 2 and 3 Antibody Titers | Anti-polio 3 | 74.5 Titers |
| GSK2036874A Group 1 | Anti-polio Types 1, 2 and 3 Antibody Titers | Anti-polio 2 | 186.8 Titers |
| GSK2036874A Group 2 | Anti-polio Types 1, 2 and 3 Antibody Titers | Anti-polio 1 | 219.1 Titers |
| GSK2036874A Group 2 | Anti-polio Types 1, 2 and 3 Antibody Titers | Anti-polio 3 | 82.1 Titers |
| GSK2036874A Group 2 | Anti-polio Types 1, 2 and 3 Antibody Titers | Anti-polio 2 | 152.2 Titers |
| GSK2036874A Group 3 | Anti-polio Types 1, 2 and 3 Antibody Titers | Anti-polio 2 | 183.4 Titers |
| GSK2036874A Group 3 | Anti-polio Types 1, 2 and 3 Antibody Titers | Anti-polio 1 | 296.6 Titers |
| GSK2036874A Group 3 | Anti-polio Types 1, 2 and 3 Antibody Titers | Anti-polio 3 | 102.1 Titers |
| Zilbrix/Hib/Poliorix Group | Anti-polio Types 1, 2 and 3 Antibody Titers | Anti-polio 1 | 296.9 Titers |
| Zilbrix/Hib/Poliorix Group | Anti-polio Types 1, 2 and 3 Antibody Titers | Anti-polio 3 | 79.1 Titers |
| Zilbrix/Hib/Poliorix Group | Anti-polio Types 1, 2 and 3 Antibody Titers | Anti-polio 2 | 148.0 Titers |
Primary
Anti-polio Types 1, 2 and 3 Antibody Titers
Antibody titers were presented as geometric mean titers (GMTs).
Time frame: One month after booster vaccination (At Month 1)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2036874A Group 1 | Anti-polio Types 1, 2 and 3 Antibody Titers | Anti-polio 3 | 2820 Titers |
| GSK2036874A Group 1 | Anti-polio Types 1, 2 and 3 Antibody Titers | Anti-polio 2 | 1598.8 Titers |
| GSK2036874A Group 1 | Anti-polio Types 1, 2 and 3 Antibody Titers | Anti-polio 1 | 2218.4 Titers |
| GSK2036874A Group 2 | Anti-polio Types 1, 2 and 3 Antibody Titers | Anti-polio 3 | 2217.7 Titers |
| GSK2036874A Group 2 | Anti-polio Types 1, 2 and 3 Antibody Titers | Anti-polio 1 | 1486.7 Titers |
| GSK2036874A Group 2 | Anti-polio Types 1, 2 and 3 Antibody Titers | Anti-polio 2 | 1056.4 Titers |
| GSK2036874A Group 3 | Anti-polio Types 1, 2 and 3 Antibody Titers | Anti-polio 1 | 1245.1 Titers |
| GSK2036874A Group 3 | Anti-polio Types 1, 2 and 3 Antibody Titers | Anti-polio 3 | 1915.8 Titers |
| GSK2036874A Group 3 | Anti-polio Types 1, 2 and 3 Antibody Titers | Anti-polio 2 | 966.5 Titers |
| Zilbrix/Hib/Poliorix Group | Anti-polio Types 1, 2 and 3 Antibody Titers | Anti-polio 2 | 2883.2 Titers |
| Zilbrix/Hib/Poliorix Group | Anti-polio Types 1, 2 and 3 Antibody Titers | Anti-polio 3 | 3626.4 Titers |
| Zilbrix/Hib/Poliorix Group | Anti-polio Types 1, 2 and 3 Antibody Titers | Anti-polio 1 | 3760.2 Titers |
Primary
Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3
Seroprotection was defined as anti-polio types 1, 2 and 3 antibody titres ≥ 8 effective dose (ED50), for 50% of vaccinated subjects.
Time frame: One month after booster vaccination (At Month 1)
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2036874A Group 1 | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 | Anti-polio 1 | 78 Participants |
| GSK2036874A Group 1 | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 | Anti-polio 3 | 77 Participants |
| GSK2036874A Group 1 | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 | Anti-polio 2 | 77 Participants |
| GSK2036874A Group 2 | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 | Anti-polio 1 | 77 Participants |
| GSK2036874A Group 2 | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 | Anti-polio 3 | 77 Participants |
| GSK2036874A Group 2 | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 | Anti-polio 2 | 78 Participants |
| GSK2036874A Group 3 | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 | Anti-polio 2 | 78 Participants |
| GSK2036874A Group 3 | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 | Anti-polio 1 | 78 Participants |
| GSK2036874A Group 3 | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 | Anti-polio 3 | 78 Participants |
| Zilbrix/Hib/Poliorix Group | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 | Anti-polio 1 | 77 Participants |
| Zilbrix/Hib/Poliorix Group | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 | Anti-polio 3 | 77 Participants |
| Zilbrix/Hib/Poliorix Group | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 | Anti-polio 2 | 77 Participants |
Comparison: To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 1) compared to Poliorix™ vaccine co-administered with Zilbrix™/Hib vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 1 antibodies, one month after vaccination.95% CI: [-4.78, 4.72]
Comparison: To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 2) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 1 antibodies, one month after vaccination.95% CI: [-3.53, 6.94]
Comparison: To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 3) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 1 antibodies, one month after vaccination.95% CI: [-4.78, 4.72]
Comparison: To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 1) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 2 antibodies, one month after vaccination.95% CI: [-4.78, 4.78]
Comparison: To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 2) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 2 antibodies, one month after vaccination.95% CI: [-4.78, 4.72]
Comparison: To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 3) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 2 antibodies, one month after vaccination.95% CI: [-4.78, 4.72]
Comparison: To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 1) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 3 antibodies, one month after vaccination.95% CI: [-3.53, 6.94]
Comparison: To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 2) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 3 antibodies, one month after vaccination.95% CI: [-3.53, 6.94]
Comparison: To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 3) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 3 antibodies, one month after vaccination.95% CI: [-4.78, 4.72]
Secondary
Anti-BPT Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.
Time frame: Prior to (At Month 0) and one month after booster vaccination (At Month 1)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2036874A Group 1 | Anti-BPT Antibody Concentrations | Anti-BPT, M0 | 19.6 EL.U/mL |
| GSK2036874A Group 1 | Anti-BPT Antibody Concentrations | Anti-BPT, M1 | 161.8 EL.U/mL |
| GSK2036874A Group 2 | Anti-BPT Antibody Concentrations | Anti-BPT, M1 | 182.9 EL.U/mL |
| GSK2036874A Group 2 | Anti-BPT Antibody Concentrations | Anti-BPT, M0 | 20.1 EL.U/mL |
| GSK2036874A Group 3 | Anti-BPT Antibody Concentrations | Anti-BPT, M0 | 18.9 EL.U/mL |
| GSK2036874A Group 3 | Anti-BPT Antibody Concentrations | Anti-BPT, M1 | 211 EL.U/mL |
| Zilbrix/Hib/Poliorix Group | Anti-BPT Antibody Concentrations | Anti-BPT, M0 | 19.5 EL.U/mL |
| Zilbrix/Hib/Poliorix Group | Anti-BPT Antibody Concentrations | Anti-BPT, M1 | 194.7 EL.U/mL |
Secondary
Anti-D and Anti-T Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.
Time frame: Prior to (At Month 0) and one month after booster vaccination (At Month 1)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2036874A Group 1 | Anti-D and Anti-T Antibody Concentrations | Anti-D, M0 | 0.301 IU/mL |
| GSK2036874A Group 1 | Anti-D and Anti-T Antibody Concentrations | Anti-D, M1 | 6.519 IU/mL |
| GSK2036874A Group 1 | Anti-D and Anti-T Antibody Concentrations | Anti-T, M1 | 26.12 IU/mL |
| GSK2036874A Group 1 | Anti-D and Anti-T Antibody Concentrations | Anti-T, M0 | 0.776 IU/mL |
| GSK2036874A Group 2 | Anti-D and Anti-T Antibody Concentrations | Anti-D, M1 | 7.687 IU/mL |
| GSK2036874A Group 2 | Anti-D and Anti-T Antibody Concentrations | Anti-T, M1 | 31.047 IU/mL |
| GSK2036874A Group 2 | Anti-D and Anti-T Antibody Concentrations | Anti-D, M0 | 0.331 IU/mL |
| GSK2036874A Group 2 | Anti-D and Anti-T Antibody Concentrations | Anti-T, M0 | 0.766 IU/mL |
| GSK2036874A Group 3 | Anti-D and Anti-T Antibody Concentrations | Anti-T, M0 | 0.833 IU/mL |
| GSK2036874A Group 3 | Anti-D and Anti-T Antibody Concentrations | Anti-D, M0 | 0.330 IU/mL |
| GSK2036874A Group 3 | Anti-D and Anti-T Antibody Concentrations | Anti-T, M1 | 31.054 IU/mL |
| GSK2036874A Group 3 | Anti-D and Anti-T Antibody Concentrations | Anti-D, M1 | 8.659 IU/mL |
| Zilbrix/Hib/Poliorix Group | Anti-D and Anti-T Antibody Concentrations | Anti-T, M1 | 24.402 IU/mL |
| Zilbrix/Hib/Poliorix Group | Anti-D and Anti-T Antibody Concentrations | Anti-D, M0 | 0.374 IU/mL |
| Zilbrix/Hib/Poliorix Group | Anti-D and Anti-T Antibody Concentrations | Anti-D, M1 | 6.807 IU/mL |
| Zilbrix/Hib/Poliorix Group | Anti-D and Anti-T Antibody Concentrations | Anti-T, M0 | 0.932 IU/mL |
Secondary
Anti-HBs Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.
Time frame: Prior to (At Month 0) and one month after the booster vaccination (At Month 1)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2036874A Group 1 | Anti-HBs Antibody Concentrations | Anti-HBs, M1 | 2713.4 mIU/mL |
| GSK2036874A Group 1 | Anti-HBs Antibody Concentrations | Anti-HBs, M0 | 59.9 mIU/mL |
| GSK2036874A Group 2 | Anti-HBs Antibody Concentrations | Anti-HBs, M0 | 46.9 mIU/mL |
| GSK2036874A Group 2 | Anti-HBs Antibody Concentrations | Anti-HBs, M1 | 2395.1 mIU/mL |
| GSK2036874A Group 3 | Anti-HBs Antibody Concentrations | Anti-HBs, M0 | 61.9 mIU/mL |
| GSK2036874A Group 3 | Anti-HBs Antibody Concentrations | Anti-HBs, M1 | 3992.8 mIU/mL |
| Zilbrix/Hib/Poliorix Group | Anti-HBs Antibody Concentrations | Anti-HBs, M1 | 3484.3 mIU/mL |
| Zilbrix/Hib/Poliorix Group | Anti-HBs Antibody Concentrations | Anti-HBs, M0 | 88.5 mIU/mL |
Secondary
Anti-PRP Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in μg/mL.
Time frame: Prior to (At Month 0) and one month after booster vaccination (At Month 1)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK2036874A Group 1 | Anti-PRP Antibody Concentrations | Anti-PRP, M0 | 0.134 μg/mL |
| GSK2036874A Group 1 | Anti-PRP Antibody Concentrations | Anti-PRP, M1 | 2.871 μg/mL |
| GSK2036874A Group 2 | Anti-PRP Antibody Concentrations | Anti-PRP, M1 | 2.243 μg/mL |
| GSK2036874A Group 2 | Anti-PRP Antibody Concentrations | Anti-PRP, M0 | 0.137 μg/mL |
| GSK2036874A Group 3 | Anti-PRP Antibody Concentrations | Anti-PRP, M0 | 0.152 μg/mL |
| GSK2036874A Group 3 | Anti-PRP Antibody Concentrations | Anti-PRP, M1 | 1.575 μg/mL |
| Zilbrix/Hib/Poliorix Group | Anti-PRP Antibody Concentrations | Anti-PRP, M0 | 0.171 μg/mL |
| Zilbrix/Hib/Poliorix Group | Anti-PRP Antibody Concentrations | Anti-PRP, M1 | 3.305 μg/mL |
Secondary
Number of Seroconverted Subjects for Anti-polio Types 1, 2 and 3
Seroconversion was defined as: For initially seronegative subjects, antibody titer ≥ 8 ED50 one month after the booster dose. For initially seropositive subjects: antibody titer one month after the booster dose ≥ 4 fold the pre-booster antibody titer. For subjects with pre-booster antibody titer below the highest dilution tested (reciprocal \< 8192 ED50): highest dilution tested one month after the booster dose (reciprocal \> 8192 ED50).
Time frame: One month after booster vaccination (At Month 1)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2036874A Group 1 | Number of Seroconverted Subjects for Anti-polio Types 1, 2 and 3 | Anti-polio 1 | 70 Participants |
| GSK2036874A Group 1 | Number of Seroconverted Subjects for Anti-polio Types 1, 2 and 3 | Anti-polio 3 | 74 Participants |
| GSK2036874A Group 1 | Number of Seroconverted Subjects for Anti-polio Types 1, 2 and 3 | Anti-polio 2 | 68 Participants |
| GSK2036874A Group 2 | Number of Seroconverted Subjects for Anti-polio Types 1, 2 and 3 | Anti-polio 1 | 64 Participants |
| GSK2036874A Group 2 | Number of Seroconverted Subjects for Anti-polio Types 1, 2 and 3 | Anti-polio 3 | 74 Participants |
| GSK2036874A Group 2 | Number of Seroconverted Subjects for Anti-polio Types 1, 2 and 3 | Anti-polio 2 | 66 Participants |
| GSK2036874A Group 3 | Number of Seroconverted Subjects for Anti-polio Types 1, 2 and 3 | Anti-polio 2 | 70 Participants |
| GSK2036874A Group 3 | Number of Seroconverted Subjects for Anti-polio Types 1, 2 and 3 | Anti-polio 1 | 60 Participants |
| GSK2036874A Group 3 | Number of Seroconverted Subjects for Anti-polio Types 1, 2 and 3 | Anti-polio 3 | 73 Participants |
| Zilbrix/Hib/Poliorix Group | Number of Seroconverted Subjects for Anti-polio Types 1, 2 and 3 | Anti-polio 1 | 69 Participants |
| Zilbrix/Hib/Poliorix Group | Number of Seroconverted Subjects for Anti-polio Types 1, 2 and 3 | Anti-polio 3 | 75 Participants |
| Zilbrix/Hib/Poliorix Group | Number of Seroconverted Subjects for Anti-polio Types 1, 2 and 3 | Anti-polio 2 | 72 Participants |
Secondary
Number of Seropositive Subjects for Anti-Bordetella Pertussis (Anti-BPT)
Seropositivity was defined as anti-BPT antibody concentration ≥ 15 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Time frame: Prior to (At Month 0) and one month after the booster vaccination (At Month 1)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2036874A Group 1 | Number of Seropositive Subjects for Anti-Bordetella Pertussis (Anti-BPT) | Anti-BPT, M0 | 50 Participants |
| GSK2036874A Group 1 | Number of Seropositive Subjects for Anti-Bordetella Pertussis (Anti-BPT) | Anti-BPT, M1 | 76 Participants |
| GSK2036874A Group 2 | Number of Seropositive Subjects for Anti-Bordetella Pertussis (Anti-BPT) | Anti-BPT, M0 | 50 Participants |
| GSK2036874A Group 2 | Number of Seropositive Subjects for Anti-Bordetella Pertussis (Anti-BPT) | Anti-BPT, M1 | 73 Participants |
| GSK2036874A Group 3 | Number of Seropositive Subjects for Anti-Bordetella Pertussis (Anti-BPT) | Anti-BPT, M1 | 77 Participants |
| GSK2036874A Group 3 | Number of Seropositive Subjects for Anti-Bordetella Pertussis (Anti-BPT) | Anti-BPT, M0 | 51 Participants |
| Zilbrix/Hib/Poliorix Group | Number of Seropositive Subjects for Anti-Bordetella Pertussis (Anti-BPT) | Anti-BPT, M0 | 49 Participants |
| Zilbrix/Hib/Poliorix Group | Number of Seropositive Subjects for Anti-Bordetella Pertussis (Anti-BPT) | Anti-BPT, M1 | 75 Participants |
Secondary
Number of Seroprotected and Seropositive Subjects for Anti-hepatitis B (Anti-HBs)
Seropositivity was defined as anti-HBs antibody concentration ≥ 3.3 milli-international units per milliliter (mIU/mL). Seprotection was defined as anti-HBs antibody concentration ≥ 10 mIU/mL. Note that percentage of subjects with concentration ≥ 10 mIU/mL was over-estimated due to the use of in-house assay overestimating concentrations between 10-100 mIU/mL. Accordingly GMCs were also overestimated. A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis. Some of the available blood samples initially tested with ELISA were re-tested using the new assay, CLIA.
Time frame: Prior to (At Month 0) and one month after the booster vaccination (At Month 1)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2036874A Group 1 | Number of Seroprotected and Seropositive Subjects for Anti-hepatitis B (Anti-HBs) | Anti-HBs ≥ 3.3 mIU/mL, M0 | 71 Participants |
| GSK2036874A Group 1 | Number of Seroprotected and Seropositive Subjects for Anti-hepatitis B (Anti-HBs) | Anti-HBs ≥ 3.3 mIU/mL, M1 | 78 Participants |
| GSK2036874A Group 1 | Number of Seroprotected and Seropositive Subjects for Anti-hepatitis B (Anti-HBs) | Anti-HBs ≥ 10 mIU/mL, M0 | 64 Participants |
| GSK2036874A Group 1 | Number of Seroprotected and Seropositive Subjects for Anti-hepatitis B (Anti-HBs) | Anti-HBs ≥ 10 mIU/mL, M1 | 77 Participants |
| GSK2036874A Group 2 | Number of Seroprotected and Seropositive Subjects for Anti-hepatitis B (Anti-HBs) | Anti-HBs ≥ 3.3 mIU/mL, M1 | 77 Participants |
| GSK2036874A Group 2 | Number of Seroprotected and Seropositive Subjects for Anti-hepatitis B (Anti-HBs) | Anti-HBs ≥ 10 mIU/mL, M0 | 67 Participants |
| GSK2036874A Group 2 | Number of Seroprotected and Seropositive Subjects for Anti-hepatitis B (Anti-HBs) | Anti-HBs ≥ 10 mIU/mL, M1 | 77 Participants |
| GSK2036874A Group 2 | Number of Seroprotected and Seropositive Subjects for Anti-hepatitis B (Anti-HBs) | Anti-HBs ≥ 3.3 mIU/mL, M0 | 70 Participants |
| GSK2036874A Group 3 | Number of Seroprotected and Seropositive Subjects for Anti-hepatitis B (Anti-HBs) | Anti-HBs ≥ 10 mIU/mL, M0 | 62 Participants |
| GSK2036874A Group 3 | Number of Seroprotected and Seropositive Subjects for Anti-hepatitis B (Anti-HBs) | Anti-HBs ≥ 3.3 mIU/mL, M1 | 78 Participants |
| GSK2036874A Group 3 | Number of Seroprotected and Seropositive Subjects for Anti-hepatitis B (Anti-HBs) | Anti-HBs ≥ 10 mIU/mL, M1 | 78 Participants |
| GSK2036874A Group 3 | Number of Seroprotected and Seropositive Subjects for Anti-hepatitis B (Anti-HBs) | Anti-HBs ≥ 3.3 mIU/mL, M0 | 73 Participants |
| Zilbrix/Hib/Poliorix Group | Number of Seroprotected and Seropositive Subjects for Anti-hepatitis B (Anti-HBs) | Anti-HBs ≥ 10 mIU/mL, M1 | 77 Participants |
| Zilbrix/Hib/Poliorix Group | Number of Seroprotected and Seropositive Subjects for Anti-hepatitis B (Anti-HBs) | Anti-HBs ≥ 3.3 mIU/mL, M1 | 77 Participants |
| Zilbrix/Hib/Poliorix Group | Number of Seroprotected and Seropositive Subjects for Anti-hepatitis B (Anti-HBs) | Anti-HBs ≥ 3.3 mIU/mL, M0 | 73 Participants |
| Zilbrix/Hib/Poliorix Group | Number of Seroprotected and Seropositive Subjects for Anti-hepatitis B (Anti-HBs) | Anti-HBs ≥ 10 mIU/mL, M0 | 70 Participants |
Secondary
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T)
Seroprotection was defined as anti-D and anti-T antibody concentration ≥ 0.1 international units per milliliter (IU/mL).
Time frame: Prior to (At Month 0) and one month after booster vaccination (At Month 1)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2036874A Group 1 | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) | Anti-D, M0 | 69 Participants |
| GSK2036874A Group 1 | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) | Anti-D, M1 | 78 Participants |
| GSK2036874A Group 1 | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) | Anti-T, M0 | 78 Participants |
| GSK2036874A Group 1 | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) | Anti-T, M1 | 78 Participants |
| GSK2036874A Group 2 | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) | Anti-D, M1 | 78 Participants |
| GSK2036874A Group 2 | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) | Anti-T, M0 | 77 Participants |
| GSK2036874A Group 2 | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) | Anti-T, M1 | 78 Participants |
| GSK2036874A Group 2 | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) | Anti-D, M0 | 69 Participants |
| GSK2036874A Group 3 | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) | Anti-T, M0 | 77 Participants |
| GSK2036874A Group 3 | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) | Anti-D, M1 | 78 Participants |
| GSK2036874A Group 3 | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) | Anti-T, M1 | 78 Participants |
| GSK2036874A Group 3 | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) | Anti-D, M0 | 69 Participants |
| Zilbrix/Hib/Poliorix Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) | Anti-T, M1 | 77 Participants |
| Zilbrix/Hib/Poliorix Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) | Anti-D, M1 | 77 Participants |
| Zilbrix/Hib/Poliorix Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) | Anti-D, M0 | 65 Participants |
| Zilbrix/Hib/Poliorix Group | Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) | Anti-T, M0 | 76 Participants |
Secondary
Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3
Seroprotection was defined as anti-polio types 1, 2 and 3 antibody titres ≥ 8 effective dose (ED50), for 50% of vaccinated subjects.
Time frame: Prior to booster vaccination (At Month 0)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2036874A Group 1 | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 | Anti-polio 3 | 74 Participants |
| GSK2036874A Group 1 | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 | Anti-polio 1 | 76 Participants |
| GSK2036874A Group 1 | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 | Anti-polio 2 | 77 Participants |
| GSK2036874A Group 2 | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 | Anti-polio 2 | 75 Participants |
| GSK2036874A Group 2 | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 | Anti-polio 1 | 70 Participants |
| GSK2036874A Group 2 | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 | Anti-polio 3 | 76 Participants |
| GSK2036874A Group 3 | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 | Anti-polio 2 | 78 Participants |
| GSK2036874A Group 3 | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 | Anti-polio 1 | 74 Participants |
| GSK2036874A Group 3 | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 | Anti-polio 3 | 76 Participants |
| Zilbrix/Hib/Poliorix Group | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 | Anti-polio 1 | 75 Participants |
| Zilbrix/Hib/Poliorix Group | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 | Anti-polio 3 | 70 Participants |
| Zilbrix/Hib/Poliorix Group | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 | Anti-polio 2 | 74 Participants |
Secondary
Number of Seroprotected Subjects Against Polyribosil-ribitol-phosphate (PRP)
Seprotection was defined as anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (μg/mL).
Time frame: Prior to (At Month 0) and one month after booster vaccination (At Month 1)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subject for whom immunogenicity data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2036874A Group 1 | Number of Seroprotected Subjects Against Polyribosil-ribitol-phosphate (PRP) | Anti-PRP, M0 | 28 Participants |
| GSK2036874A Group 1 | Number of Seroprotected Subjects Against Polyribosil-ribitol-phosphate (PRP) | Anti-PRP, M1 | 77 Participants |
| GSK2036874A Group 2 | Number of Seroprotected Subjects Against Polyribosil-ribitol-phosphate (PRP) | Anti-PRP, M1 | 76 Participants |
| GSK2036874A Group 2 | Number of Seroprotected Subjects Against Polyribosil-ribitol-phosphate (PRP) | Anti-PRP, M0 | 27 Participants |
| GSK2036874A Group 3 | Number of Seroprotected Subjects Against Polyribosil-ribitol-phosphate (PRP) | Anti-PRP, M0 | 30 Participants |
| GSK2036874A Group 3 | Number of Seroprotected Subjects Against Polyribosil-ribitol-phosphate (PRP) | Anti-PRP, M1 | 71 Participants |
| Zilbrix/Hib/Poliorix Group | Number of Seroprotected Subjects Against Polyribosil-ribitol-phosphate (PRP) | Anti-PRP, M0 | 35 Participants |
| Zilbrix/Hib/Poliorix Group | Number of Seroprotected Subjects Against Polyribosil-ribitol-phosphate (PRP) | Anti-PRP, M1 | 76 Participants |
Secondary
Number of Subjects With a Booster Response for Anti-BPT
Booster response was defined as: For initially seronegative subjects, antibody concentration ≥ 15 EL.U/mL one month after the booster dose. For initially seropositive subjects: antibody concentration one month after the booster dose ≥ 2 fold the pre-booster antibody concentration.
Time frame: One month after booster vaccination (At Month 1)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2036874A Group 1 | Number of Subjects With a Booster Response for Anti-BPT | 72 Participants |
| GSK2036874A Group 2 | Number of Subjects With a Booster Response for Anti-BPT | 72 Participants |
| GSK2036874A Group 3 | Number of Subjects With a Booster Response for Anti-BPT | 77 Participants |
| Zilbrix/Hib/Poliorix Group | Number of Subjects With a Booster Response for Anti-BPT | 72 Participants |
Secondary
Number of Subjects With Any Solicited General Symptoms
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade.
Time frame: During the 8-day (Days 0-7) post-vaccination period
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2036874A Group 1 | Number of Subjects With Any Solicited General Symptoms | Any Loss of appetite | 33 Participants |
| GSK2036874A Group 1 | Number of Subjects With Any Solicited General Symptoms | Any Irritability | 53 Participants |
| GSK2036874A Group 1 | Number of Subjects With Any Solicited General Symptoms | Any Drowsiness | 43 Participants |
| GSK2036874A Group 1 | Number of Subjects With Any Solicited General Symptoms | Any Temperature (Axillary) | 59 Participants |
| GSK2036874A Group 2 | Number of Subjects With Any Solicited General Symptoms | Any Irritability | 60 Participants |
| GSK2036874A Group 2 | Number of Subjects With Any Solicited General Symptoms | Any Drowsiness | 42 Participants |
| GSK2036874A Group 2 | Number of Subjects With Any Solicited General Symptoms | Any Loss of appetite | 36 Participants |
| GSK2036874A Group 2 | Number of Subjects With Any Solicited General Symptoms | Any Temperature (Axillary) | 60 Participants |
| GSK2036874A Group 3 | Number of Subjects With Any Solicited General Symptoms | Any Drowsiness | 46 Participants |
| GSK2036874A Group 3 | Number of Subjects With Any Solicited General Symptoms | Any Loss of appetite | 36 Participants |
| GSK2036874A Group 3 | Number of Subjects With Any Solicited General Symptoms | Any Irritability | 57 Participants |
| GSK2036874A Group 3 | Number of Subjects With Any Solicited General Symptoms | Any Temperature (Axillary) | 57 Participants |
| Zilbrix/Hib/Poliorix Group | Number of Subjects With Any Solicited General Symptoms | Any Irritability | 65 Participants |
| Zilbrix/Hib/Poliorix Group | Number of Subjects With Any Solicited General Symptoms | Any Loss of appetite | 38 Participants |
| Zilbrix/Hib/Poliorix Group | Number of Subjects With Any Solicited General Symptoms | Any Temperature (Axillary) | 63 Participants |
| Zilbrix/Hib/Poliorix Group | Number of Subjects With Any Solicited General Symptoms | Any Drowsiness | 41 Participants |
Secondary
Number of Subjects With Any Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Time frame: During the 8-day (Days 0-7) post-vaccination period
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2036874A Group 1 | Number of Subjects With Any Solicited Local Symptoms | Any Pain | 67 Participants |
| GSK2036874A Group 1 | Number of Subjects With Any Solicited Local Symptoms | Any Swelling | 33 Participants |
| GSK2036874A Group 1 | Number of Subjects With Any Solicited Local Symptoms | Any Redness | 28 Participants |
| GSK2036874A Group 2 | Number of Subjects With Any Solicited Local Symptoms | Any Pain | 65 Participants |
| GSK2036874A Group 2 | Number of Subjects With Any Solicited Local Symptoms | Any Swelling | 32 Participants |
| GSK2036874A Group 2 | Number of Subjects With Any Solicited Local Symptoms | Any Redness | 29 Participants |
| GSK2036874A Group 3 | Number of Subjects With Any Solicited Local Symptoms | Any Redness | 35 Participants |
| GSK2036874A Group 3 | Number of Subjects With Any Solicited Local Symptoms | Any Pain | 66 Participants |
| GSK2036874A Group 3 | Number of Subjects With Any Solicited Local Symptoms | Any Swelling | 36 Participants |
| Zilbrix/Hib/Poliorix Group | Number of Subjects With Any Solicited Local Symptoms | Any Pain | 68 Participants |
| Zilbrix/Hib/Poliorix Group | Number of Subjects With Any Solicited Local Symptoms | Any Swelling | 35 Participants |
| Zilbrix/Hib/Poliorix Group | Number of Subjects With Any Solicited Local Symptoms | Any Redness | 35 Participants |
Secondary
Number of Subjects With Any Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Time frame: During the 31-day (Day 0-Day 30) post-vaccination period
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2036874A Group 1 | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 30 Participants |
| GSK2036874A Group 2 | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 44 Participants |
| GSK2036874A Group 3 | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 30 Participants |
| Zilbrix/Hib/Poliorix Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 40 Participants |
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: During the entire study period (from Month 0 to Month 1)
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK2036874A Group 1 | Number of Subjects With Serious Adverse Events (SAEs) | 1 Participants |
| GSK2036874A Group 2 | Number of Subjects With Serious Adverse Events (SAEs) | 3 Participants |
| GSK2036874A Group 3 | Number of Subjects With Serious Adverse Events (SAEs) | 2 Participants |
| Zilbrix/Hib/Poliorix Group | Number of Subjects With Serious Adverse Events (SAEs) | 1 Participants |