Malaria
Conditions
Keywords
Malaria, Plasmodium, RTS, S/AS01, Falciparum
Brief summary
This phase IIb trial is being done to find out if the RTS,S/AS01 vaccine helps to prevent children from falling ill with malaria and to evaluate vaccine safety. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Interventions
BIOLOGICALGSK malaria vaccine 257049 Vaccine
3 dose intramuscular injection
BIOLOGICALSanofi-Pasteur's Human Diploid Cell Rabies Vaccine
3 dose intramuscular injection
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Months to 17 Months
Healthy volunteers
Yes
Inclusion criteria
* A male or female child of between 5 months and 17 months of age at the time of first vaccination. * Written or oral, signed or thumb-printed and witnessed informed consent obtained from the parent(s)/guardian(s) of the child.. * Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
Exclusion criteria
* Acute disease at the time of enrolment. * Serious acute or chronic illness determined by clinical or physical examination and laboratory screening tests. * Laboratory screening tests for haemoglobin, total white cell count, platelets, ALT and creatinine out of acceptable limits. * Planned administration/administration of a vaccine not foreseen by the study within 30 days of the first dose of vaccine(s) with the exception of tetanus toxoid or scheduled diphtheria, pertussis or measles vaccine. * Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. * Administration of immunoglobulins, blood transfusions or other blood products within the three months preceding the first dose of study vaccine or planned administration during the study period. * Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose * Previous participation in any other malaria vaccine trial. * Simultaneous participation in any other clinical trial. * Same sex twin. * History of allergic reactions (significant IgE-mediated events) or anaphylaxis to previous immunizations. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of First Case of Malaria Meeting the Primary Case Definition | Assessed over average of 7.8 months post Dose 3 (range 4.3 to 10.3 months) | The first case of malaria meeting the primary case definition was defined as the first or only episodes with the presence of Plasmodium falciparum asexual parasitemia above (\>) 2500 per microliter (μL) and the presence of fever greater than or equal to (≥) 37.5°C by active case detection (ACD) or passive case detection (PCD). Number of first case of malaria were assessed through estimate of vaccine efficacy (VE) adjusted or unadjusted for covariates, and are expressed in PYAR= number of episodes/Person Years at Risk. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Multiple Events of Malaria Meeting the Primary Case Definition | Assessed over average of 7.8 months post Dose 3 (range 4.3 to 10.3 months) | Multiple episodes of malaria meeting the primary case definition was defined as episodes with the presence of P.falciparum asexual parasitemia \> 25000 per μL and the presence of fever ≥ 37.5°C by active case detection (ACD) or passive case detection (PCD). Number of primary case of malaria were assessed through estimate of vaccine efficacy (VE) adjusted or unadjusted for covariates, and are expressed in PYAR= number of episodes/Person Years at Risk. |
| Multiple Events of Malaria Meeting the Secondary Case Definition | Assessed over average of 7.8 months post Dose 3 (range 4.3 to 10.3 months) | Multiple episodes of malaria meeting the secondary case definition was defined as episodes with the presence of P.falciparum asexual parasitemia \> 0 per μL and the presence of fever ≥ 37.5°C by active case detection (ACD) or passive case detection (PCD). Number of secondary case of malaria were assessed through estimate of vaccine efficacy (VE) adjusted or unadjusted for covariates, and are expressed in PYAR= number of episodes/Person Years at Risk. |
| Number of Subjects Positive for P. Falciparum Parasitaemia | At the Cross-Sectional Visit that took place for each participant at on average 7.8 months post Dose 3 (range 4.3 to 10.3 months) | — |
| Geometric Mean Density of Asexual P. Falciparum Parasite | At the Cross-Sectional Visit that took place for each participant at on average 7.8 months post Dose 3 (range 4.3 to 10.3 months) | Estimates of asexual P. falciparum parasite density were made at the investigator's sites according to laboratory standard operating procedures. Parasite density was presented as a geometric mean (GMean), expressed in parasite per microliters (μL). |
| Haemoglobin Values at Cross-Sectional Visit | At the Cross-Sectional Visit that took place for each participant at on average 7.8 months post Dose 3 (range 4.3 to 10.3 months) | Haemoglobin values are expressed in grams per deciliter (g/dL). |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | During the 7-day (Days 0-6) post-vaccination period following each dose and across doses | Assessed solicited local symptoms were pain and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 swelling = swelling spreading beyond 20 millimeters (mm) of injection site. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | During the 7-day (Days 0-6) post-vaccination period following each dose and across doses | Assessed solicited general symptoms were drowsiness, fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever higher than (\>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. |
| Number of Subjects With Any Unsolicited Adverse Events (AEs) | Within the 30-day (Days 0-29) post-vaccination follow-up period | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. |
| Number of Subjects With Serious Adverse Events (SAEs) | Throughout the study period (Day 0 - Month 14) | 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. |
| Frequency of First Case Malaria Meeting the Secondary Case Definition | Assessed over average of 7.8 months post Dose 3 (range 4.3 to 10.3 months) | The first case of malaria meeting the secondary case definition was defined as the first or only episodes with the presence of P.falciparum asexual parasitemia \> 0 per μL and the presence of fever ≥ 37.5°C by active case detection (ACD) or passive case detection (PCD). Number of first case of malaria were assessed through estimate of vaccine efficacy (VE) adjusted or unadjusted for covariates, and are expressed in PYAR= number of episodes/Person Years at Risk. |
| Number of Subjects With White Blood Cell (WBC) Values Outside Normal Ranges With Toxicity Grades | At Day 0, Month 3 and at Cross-sectional Visit (took place between 7 and 13 months post Dose 1, mean: 10 months, standard deviation: 1.29) | Definitions for toxicity grading for WBC were: Normal WBC = ≥ 4.0 x 10\^3 cells per microliters (cells/μL) or \< 17 x 10\^3 cells /μL; Grade 1 WBC = 2.5 to 4.0 x 10\^3 cells/μL. |
| Number of Subjects With Platelet Values Outside Normal Ranges With Toxicity Grades | At Day 0, Month 3 and at Cross-sectional Visit (took place between 7 and 13 months post Dose 1, mean: 10 months, standard deviation: 1.29) | Definitions for toxicity grading for platelets were: Normal Platelets = ≥ 75 x 10\^3 cells/μL; Grade 1 Platelets = 50 to 74 x 10\^3 /μL; Grade 2 Platelets = 25 to 49 x 10\^3 /μL; Grade 3 Platelets = \< 25 x 10\^3 /μL. |
| Number of Subjects With Alanine Aminotransferase (ALT) Values Outside Normal Ranges With Toxicity Grades | At Day 0, Month 3 and at Cross-sectional Visit (took place between 7 and 13 months post Dose 1, mean: 10 months, standard deviation: 1.29) | Definition for toxicity grading for ALT were: Normal ALT = ≤ 60 international units per liter (IU/L); Grade 1 ALT = 1.1 to 2.5 x Upper Limit of Normal (ULN); Grade 2 ALT = 2.6 to 5.0 x ULN. |
| Number of Subjects With Creatinine Values Outside Normal Ranges With Toxicity Grades | At Day 0, Month 3 and at Cross-sectional Visit (took place between 7 and 13 months post Dose 1, mean: 10 months, standard deviation: 1.29) | Definition for toxicity grading for creatinine were: Normal Creatinine = ≤ 60 micromols per liter (μmol/L); Grade 1 Creatinine = 1.1 to 1.5 x ULN; Grade 2 Creatinine = 1.6 to 3.0 x ULN. |
| Concentration of Antibodies Against the P. Falciparum Circumsporozoite (CS) Repeat Domain (Anti-CS) | At Day 0, Month 3 and at Cross-sectional Visit (took place between 7 and 13 months post Dose 1, mean: 10 months, standard deviation: 1.29) | Concentrations are presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EU/mL). |
| Concentration of Antibodies Against Hepatitis B Surface Antigen (Anti-HBs) | At Day 0 and at Month 3 | Concentrations are presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EU/mL). |
| Frequency of Cluster of Differentiation 4 (CD4+) CS-specific T-cells | Prior to vaccination (Day 0) | T-cells expressing at least one of the following cytokines are presented here: interleukin-2 \[IL-2\], tumor-necrosis factor-alpha \[TNF-α\] and interferon-gamma \[IFN-γ\]. Frequency is expressed in cells/million, as assessed by Intracellular Cytokine Assay (ICA). |
| Frequency of Cluster of Differentiation 8 (CD8+) CS-specific T-cells | Prior to vaccination (Day 0) | T-cells expressing at least one of the following cytokines are presented here: interleukin-2 \[IL-2\], tumor-necrosis factor-alpha \[TNF-α\] and interferon-gamma \[IFN-γ\]. Frequency is expressed in cells/million, as assessed by Intracellular Cytokine Assay (ICA). |
| Number of Subjects With Hemoglobin Values Outside Normal Ranges With Toxicity Grades | At Day 0, Month 3 and at Cross-sectional Visit (took place between 7 and 13 months post Dose 1, mean: 10 months, standard deviation: 1.29) | Definitions for toxicity grading for hemoglobin were: Normal Hemoglobin = equal to or above (≥) 8.0 g/dL; Grade 1 Hemoglobin = under (\<) 8.0 g/dL and above (\>) 6.0 g/dL.; Grade 2 Hemoglobin = under (\<) 6.0 g/dL. |
Countries
Kenya, Tanzania
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GSK257049 Group Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60. | 447 |
| Rabipur Group Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60. | 447 |
| Total | 894 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Month 14 | Death | 1 | 0 |
| Month 14 | Lost to Follow-up | 0 | 1 |
| Month 14 | Migrated/moved from study area | 39 | 42 |
| Month 14 | Others | 6 | 6 |
| Month 14 | Protocol Violation | 2 | 0 |
| Month 14 | Withdrawal by Subject | 9 | 7 |
| Month 8 (Cross-sectional Visit) | Lost to Follow-up | 0 | 1 |
| Month 8 (Cross-sectional Visit) | Migrated/moved from study area | 37 | 29 |
| Month 8 (Cross-sectional Visit) | Others | 5 | 4 |
| Month 8 (Cross-sectional Visit) | Serious Adverse Event | 1 | 1 |
| Month 8 (Cross-sectional Visit) | Withdrawal by Subject | 6 | 5 |
Baseline characteristics
| Characteristic | GSK257049 Group | Rabipur Group | Total |
|---|---|---|---|
| Age, Continuous | 11.4 Months STANDARD_DEVIATION 3.6 | 11.4 Months STANDARD_DEVIATION 3.4 | 11.4 Months STANDARD_DEVIATION 3.5 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 229 Participants | 222 Participants | 451 Participants |
| Sex: Female, Male Male | 218 Participants | 225 Participants | 443 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 447 | 0 / 447 |
| other Total, other adverse events | 385 / 447 | 396 / 447 |
| serious Total, serious adverse events | 51 / 447 | 88 / 447 |
Outcome results
Primary
Frequency of First Case of Malaria Meeting the Primary Case Definition
The first case of malaria meeting the primary case definition was defined as the first or only episodes with the presence of Plasmodium falciparum asexual parasitemia above (\>) 2500 per microliter (μL) and the presence of fever greater than or equal to (≥) 37.5°C by active case detection (ACD) or passive case detection (PCD). Number of first case of malaria were assessed through estimate of vaccine efficacy (VE) adjusted or unadjusted for covariates, and are expressed in PYAR= number of episodes/Person Years at Risk.
Time frame: Assessed over average of 7.8 months post Dose 3 (range 4.3 to 10.3 months)
Population: The analyses were performed on the According-To-Protocol (ATP) cohort for efficacy, which included all evaluable for whom data concerning efficacy outcome measures were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK257049 Group | Frequency of First Case of Malaria Meeting the Primary Case Definition | With estimate of VE adjusted for covariates | 244.77 PYAR |
| GSK257049 Group | Frequency of First Case of Malaria Meeting the Primary Case Definition | With estimate of VE unadjusted for covariates | 249.23 PYAR |
| Rabipur Group | Frequency of First Case of Malaria Meeting the Primary Case Definition | With estimate of VE adjusted for covariates | 238.51 PYAR |
| Rabipur Group | Frequency of First Case of Malaria Meeting the Primary Case Definition | With estimate of VE unadjusted for covariates | 242.06 PYAR |
Comparison: Vaccine efficacy against P. falciparump-value: <0.00195% CI: [28.1, 69.1]Regression, Cox
Comparison: Vaccine efficacy against P. falciparump-value: <0.00195% CI: [31.4, 70.4]Regression, Cox
Secondary
Concentration of Antibodies Against Hepatitis B Surface Antigen (Anti-HBs)
Concentrations are presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EU/mL).
Time frame: At Day 0 and at Month 3
Population: The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK257049 Group | Concentration of Antibodies Against Hepatitis B Surface Antigen (Anti-HBs) | At Day 0 | 155.4 EU/mL |
| GSK257049 Group | Concentration of Antibodies Against Hepatitis B Surface Antigen (Anti-HBs) | At Month 3 | 46776.3 EU/mL |
| Rabipur Group | Concentration of Antibodies Against Hepatitis B Surface Antigen (Anti-HBs) | At Day 0 | 187.4 EU/mL |
| Rabipur Group | Concentration of Antibodies Against Hepatitis B Surface Antigen (Anti-HBs) | At Month 3 | 168.0 EU/mL |
Secondary
Concentration of Antibodies Against the P. Falciparum Circumsporozoite (CS) Repeat Domain (Anti-CS)
Concentrations are presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EU/mL).
Time frame: At Day 0, Month 3 and at Cross-sectional Visit (took place between 7 and 13 months post Dose 1, mean: 10 months, standard deviation: 1.29)
Population: The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK257049 Group | Concentration of Antibodies Against the P. Falciparum Circumsporozoite (CS) Repeat Domain (Anti-CS) | At Day 0 | 0.3 EU/mL |
| GSK257049 Group | Concentration of Antibodies Against the P. Falciparum Circumsporozoite (CS) Repeat Domain (Anti-CS) | At Month 3 | 539.6 EU/mL |
| GSK257049 Group | Concentration of Antibodies Against the P. Falciparum Circumsporozoite (CS) Repeat Domain (Anti-CS) | At Cross-sectional Visit | 71.9 EU/mL |
| Rabipur Group | Concentration of Antibodies Against the P. Falciparum Circumsporozoite (CS) Repeat Domain (Anti-CS) | At Day 0 | 0.3 EU/mL |
| Rabipur Group | Concentration of Antibodies Against the P. Falciparum Circumsporozoite (CS) Repeat Domain (Anti-CS) | At Month 3 | 0.3 EU/mL |
| Rabipur Group | Concentration of Antibodies Against the P. Falciparum Circumsporozoite (CS) Repeat Domain (Anti-CS) | At Cross-sectional Visit | 0.3 EU/mL |
Secondary
Frequency of Cluster of Differentiation 4 (CD4+) CS-specific T-cells
T-cells expressing at least one of the following cytokines are presented here: interleukin-2 \[IL-2\], tumor-necrosis factor-alpha \[TNF-α\] and interferon-gamma \[IFN-γ\]. Frequency is expressed in cells/million, as assessed by Intracellular Cytokine Assay (ICA).
Time frame: At Month 3
Population: The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK257049 Group | Frequency of Cluster of Differentiation 4 (CD4+) CS-specific T-cells | CD4-IFN-γ | 33 cells/million |
| GSK257049 Group | Frequency of Cluster of Differentiation 4 (CD4+) CS-specific T-cells | CD4-IL-2 | 648 cells/million |
| GSK257049 Group | Frequency of Cluster of Differentiation 4 (CD4+) CS-specific T-cells | CD4-TNF-α | 416 cells/million |
| Rabipur Group | Frequency of Cluster of Differentiation 4 (CD4+) CS-specific T-cells | CD4-IFN-γ | 13 cells/million |
| Rabipur Group | Frequency of Cluster of Differentiation 4 (CD4+) CS-specific T-cells | CD4-IL-2 | 139 cells/million |
| Rabipur Group | Frequency of Cluster of Differentiation 4 (CD4+) CS-specific T-cells | CD4-TNF-α | 172 cells/million |
Secondary
Frequency of Cluster of Differentiation 4 (CD4+) CS-specific T-cells
T-cells expressing at least one of the following cytokines are presented here: interleukin-2 \[IL-2\], tumor-necrosis factor-alpha \[TNF-α\] and interferon-gamma \[IFN-γ\]. Frequency is expressed in cells/million, as assessed by Intracellular Cytokine Assay (ICA).
Time frame: Prior to vaccination (Day 0)
Population: The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK257049 Group | Frequency of Cluster of Differentiation 4 (CD4+) CS-specific T-cells | CD4-IFN-γ | 15 cells/million |
| GSK257049 Group | Frequency of Cluster of Differentiation 4 (CD4+) CS-specific T-cells | CD4-IL-2 | 111 cells/million |
| GSK257049 Group | Frequency of Cluster of Differentiation 4 (CD4+) CS-specific T-cells | CD4-TNF-α | 94 cells/million |
| Rabipur Group | Frequency of Cluster of Differentiation 4 (CD4+) CS-specific T-cells | CD4-IFN-γ | 14 cells/million |
| Rabipur Group | Frequency of Cluster of Differentiation 4 (CD4+) CS-specific T-cells | CD4-IL-2 | 113 cells/million |
| Rabipur Group | Frequency of Cluster of Differentiation 4 (CD4+) CS-specific T-cells | CD4-TNF-α | 92 cells/million |
Secondary
Frequency of Cluster of Differentiation 8 (CD8+) CS-specific T-cells
T-cells expressing at least one of the following cytokines are presented here: interleukin-2 \[IL-2\], tumor-necrosis factor-alpha \[TNF-α\] and interferon-gamma \[IFN-γ\]. Frequency is expressed in cells/million, as assessed by Intracellular Cytokine Assay (ICA).
Time frame: At Month 3
Population: The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK257049 Group | Frequency of Cluster of Differentiation 8 (CD8+) CS-specific T-cells | CD8-IFN-γ | 36 cells/million |
| GSK257049 Group | Frequency of Cluster of Differentiation 8 (CD8+) CS-specific T-cells | CD8-IL-2 | 248 cells/million |
| GSK257049 Group | Frequency of Cluster of Differentiation 8 (CD8+) CS-specific T-cells | CD8-TNF-α | 201 cells/million |
| Rabipur Group | Frequency of Cluster of Differentiation 8 (CD8+) CS-specific T-cells | CD8-IFN-γ | 32 cells/million |
| Rabipur Group | Frequency of Cluster of Differentiation 8 (CD8+) CS-specific T-cells | CD8-IL-2 | 219 cells/million |
| Rabipur Group | Frequency of Cluster of Differentiation 8 (CD8+) CS-specific T-cells | CD8-TNF-α | 185 cells/million |
Secondary
Frequency of Cluster of Differentiation 8 (CD8+) CS-specific T-cells
T-cells expressing at least one of the following cytokines are presented here: interleukin-2 \[IL-2\], tumor-necrosis factor-alpha \[TNF-α\] and interferon-gamma \[IFN-γ\]. Frequency is expressed in cells/million, as assessed by Intracellular Cytokine Assay (ICA).
Time frame: Prior to vaccination (Day 0)
Population: The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK257049 Group | Frequency of Cluster of Differentiation 8 (CD8+) CS-specific T-cells | CD8-IFN-γ | 1 cells/million |
| GSK257049 Group | Frequency of Cluster of Differentiation 8 (CD8+) CS-specific T-cells | CD8-IL-2 | 219 cells/million |
| GSK257049 Group | Frequency of Cluster of Differentiation 8 (CD8+) CS-specific T-cells | CD8-TNF-α | 100 cells/million |
| Rabipur Group | Frequency of Cluster of Differentiation 8 (CD8+) CS-specific T-cells | CD8-IFN-γ | 37 cells/million |
| Rabipur Group | Frequency of Cluster of Differentiation 8 (CD8+) CS-specific T-cells | CD8-IL-2 | 222 cells/million |
| Rabipur Group | Frequency of Cluster of Differentiation 8 (CD8+) CS-specific T-cells | CD8-TNF-α | 82 cells/million |
Secondary
Frequency of First Case Malaria Meeting the Secondary Case Definition
The first case of malaria meeting the secondary case definition was defined as the first or only episodes with the presence of P.falciparum asexual parasitemia \> 0 per μL and the presence of fever ≥ 37.5°C by active case detection (ACD) or passive case detection (PCD). Number of first case of malaria were assessed through estimate of vaccine efficacy (VE) adjusted or unadjusted for covariates, and are expressed in PYAR= number of episodes/Person Years at Risk.
Time frame: Assessed over average of 7.8 months post Dose 3 (range 4.3 to 10.3 months)
Population: The analyses were performed on the According-To-Protocol (ATP) cohort for efficacy, which included all evaluable for whom data concerning efficacy outcome measures were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK257049 Group | Frequency of First Case Malaria Meeting the Secondary Case Definition | With estimate of VE adjusted for covariates | 244.72 PYAR |
| GSK257049 Group | Frequency of First Case Malaria Meeting the Secondary Case Definition | With estimate of VE unadjusted for covariates | 249.17 PYAR |
| Rabipur Group | Frequency of First Case Malaria Meeting the Secondary Case Definition | With estimate of VE adjusted for covariates | 237.21 PYAR |
| Rabipur Group | Frequency of First Case Malaria Meeting the Secondary Case Definition | With estimate of VE unadjusted for covariates | 240.76 PYAR |
Comparison: Vaccine efficacy against P. falciparum.p-value: <0.00195% CI: [31.2, 70]Regression, Cox
Comparison: Vaccine efficacy against P. falciparum.p-value: <0.00195% CI: [34.2, 71.2]Regression, Cox
Secondary
Geometric Mean Density of Asexual P. Falciparum Parasite
Estimates of asexual P. falciparum parasite density were made at the investigator's sites according to laboratory standard operating procedures. Parasite density was presented as a geometric mean (GMean), expressed in parasite per microliters (μL).
Time frame: At the Cross-Sectional Visit that took place for each participant at on average 7.8 months post Dose 3 (range 4.3 to 10.3 months)
Population: The analyses were performed on the According-To-Protocol (ATP) cohort for efficacy, which included all evaluable for whom data concerning efficacy outcome measures were available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK257049 Group | Geometric Mean Density of Asexual P. Falciparum Parasite | 1020 parasites/μL |
| Rabipur Group | Geometric Mean Density of Asexual P. Falciparum Parasite | 3486 parasites/μL |
Secondary
Haemoglobin Values at Cross-Sectional Visit
Haemoglobin values are expressed in grams per deciliter (g/dL).
Time frame: At the Cross-Sectional Visit that took place for each participant at on average 7.8 months post Dose 3 (range 4.3 to 10.3 months)
Population: The analyses were performed on the According-To-Protocol (ATP) cohort for efficacy, which included all evaluable for whom data concerning efficacy outcome measures were available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GSK257049 Group | Haemoglobin Values at Cross-Sectional Visit | 10.32 g/dL | Standard Deviation 1.01 |
| Rabipur Group | Haemoglobin Values at Cross-Sectional Visit | 10.37 g/dL | Standard Deviation 1.03 |
Secondary
Multiple Events of Malaria Meeting the Primary Case Definition
Multiple episodes of malaria meeting the primary case definition was defined as episodes with the presence of P.falciparum asexual parasitemia \> 25000 per μL and the presence of fever ≥ 37.5°C by active case detection (ACD) or passive case detection (PCD). Number of primary case of malaria were assessed through estimate of vaccine efficacy (VE) adjusted or unadjusted for covariates, and are expressed in PYAR= number of episodes/Person Years at Risk.
Time frame: Assessed over average of 7.8 months post Dose 3 (range 4.3 to 10.3 months)
Population: The analyses were performed on the According-To-Protocol (ATP) cohort for efficacy, which included all evaluable for whom data concerning efficacy outcome measures were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK257049 Group | Multiple Events of Malaria Meeting the Primary Case Definition | With estimate of VE adjusted for covariates | 253.69 PYAR |
| GSK257049 Group | Multiple Events of Malaria Meeting the Primary Case Definition | With estimate of VE unadjusted for covariates | 258.15 PYAR |
| Rabipur Group | Multiple Events of Malaria Meeting the Primary Case Definition | With estimate of VE adjusted for covariates | 255.36 PYAR |
| Rabipur Group | Multiple Events of Malaria Meeting the Primary Case Definition | With estimate of VE unadjusted for covariates | 259.61 PYAR |
Comparison: Vaccine efficacy against P. falciparum.p-value: 0.000395% CI: [31, 71.7]Regression, Cox
Comparison: Vaccine efficacy against P. falciparum.p-value: <0.00195% CI: [34.3, 73]Regression, Cox
Secondary
Multiple Events of Malaria Meeting the Secondary Case Definition
Multiple episodes of malaria meeting the secondary case definition was defined as episodes with the presence of P.falciparum asexual parasitemia \> 0 per μL and the presence of fever ≥ 37.5°C by active case detection (ACD) or passive case detection (PCD). Number of secondary case of malaria were assessed through estimate of vaccine efficacy (VE) adjusted or unadjusted for covariates, and are expressed in PYAR= number of episodes/Person Years at Risk.
Time frame: Assessed over average of 7.8 months post Dose 3 (range 4.3 to 10.3 months)
Population: The analyses were performed on the According-To-Protocol (ATP) cohort for efficacy, which included all evaluable for whom data concerning efficacy outcome measures were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK257049 Group | Multiple Events of Malaria Meeting the Secondary Case Definition | With estimate of VE adjusted for covariates | 253.62 PYAR |
| GSK257049 Group | Multiple Events of Malaria Meeting the Secondary Case Definition | With estimate of VE unadjusted for covariates | 258.07 PYAR |
| Rabipur Group | Multiple Events of Malaria Meeting the Secondary Case Definition | With estimate of VE adjusted for covariates | 255.06 PYAR |
| Rabipur Group | Multiple Events of Malaria Meeting the Secondary Case Definition | With estimate of VE unadjusted for covariates | 259.31 PYAR |
Comparison: Vaccine efficacy against P. falciparum.p-value: <0.00195% CI: [34.8, 73]Regression, Cox
Comparison: Vaccine efficacy against P. falciparum.p-value: <0.00195% CI: [37.1, 73.9]Regression, Cox
Secondary
Number of Subjects Positive for P. Falciparum Parasitaemia
Time frame: At the Cross-Sectional Visit that took place for each participant at on average 7.8 months post Dose 3 (range 4.3 to 10.3 months)
Population: The analyses were performed on the According-To-Protocol (ATP) cohort for efficacy, which included all evaluable for whom data concerning efficacy outcome measures were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK257049 Group | Number of Subjects Positive for P. Falciparum Parasitaemia | 7 Participants |
| Rabipur Group | Number of Subjects Positive for P. Falciparum Parasitaemia | 11 Participants |
Secondary
Number of Subjects With Alanine Aminotransferase (ALT) Values Outside Normal Ranges With Toxicity Grades
Definition for toxicity grading for ALT were: Normal ALT = ≤ 60 international units per liter (IU/L); Grade 1 ALT = 1.1 to 2.5 x Upper Limit of Normal (ULN); Grade 2 ALT = 2.6 to 5.0 x ULN.
Time frame: At Day 0, Month 3 and at Cross-sectional Visit (took place between 7 and 13 months post Dose 1, mean: 10 months, standard deviation: 1.29)
Population: The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| GSK257049 Group | Number of Subjects With Alanine Aminotransferase (ALT) Values Outside Normal Ranges With Toxicity Grades | At Day 0 | Normal | 446 Participants |
| GSK257049 Group | Number of Subjects With Alanine Aminotransferase (ALT) Values Outside Normal Ranges With Toxicity Grades | At Day 0 | Grade 1 | 1 Participants |
| GSK257049 Group | Number of Subjects With Alanine Aminotransferase (ALT) Values Outside Normal Ranges With Toxicity Grades | At Day 0 | Grade 2 | 0 Participants |
| GSK257049 Group | Number of Subjects With Alanine Aminotransferase (ALT) Values Outside Normal Ranges With Toxicity Grades | At Day 0 | Missing | 0 Participants |
| GSK257049 Group | Number of Subjects With Alanine Aminotransferase (ALT) Values Outside Normal Ranges With Toxicity Grades | At Month 3 | Normal | 413 Participants |
| GSK257049 Group | Number of Subjects With Alanine Aminotransferase (ALT) Values Outside Normal Ranges With Toxicity Grades | At Month 3 | Grade 1 | 1 Participants |
| GSK257049 Group | Number of Subjects With Alanine Aminotransferase (ALT) Values Outside Normal Ranges With Toxicity Grades | At Month 3 | Grade 2 | 0 Participants |
| GSK257049 Group | Number of Subjects With Alanine Aminotransferase (ALT) Values Outside Normal Ranges With Toxicity Grades | At Month 3 | Missing | 33 Participants |
| GSK257049 Group | Number of Subjects With Alanine Aminotransferase (ALT) Values Outside Normal Ranges With Toxicity Grades | At Cross-sectional Visit | Normal | 393 Participants |
| GSK257049 Group | Number of Subjects With Alanine Aminotransferase (ALT) Values Outside Normal Ranges With Toxicity Grades | At Cross-sectional Visit | Grade 1 | 5 Participants |
| GSK257049 Group | Number of Subjects With Alanine Aminotransferase (ALT) Values Outside Normal Ranges With Toxicity Grades | At Cross-sectional Visit | Grade 2 | 0 Participants |
| GSK257049 Group | Number of Subjects With Alanine Aminotransferase (ALT) Values Outside Normal Ranges With Toxicity Grades | At Cross-sectional Visit | Missing | 49 Participants |
| Rabipur Group | Number of Subjects With Alanine Aminotransferase (ALT) Values Outside Normal Ranges With Toxicity Grades | At Cross-sectional Visit | Grade 2 | 1 Participants |
| Rabipur Group | Number of Subjects With Alanine Aminotransferase (ALT) Values Outside Normal Ranges With Toxicity Grades | At Day 0 | Normal | 447 Participants |
| Rabipur Group | Number of Subjects With Alanine Aminotransferase (ALT) Values Outside Normal Ranges With Toxicity Grades | At Month 3 | Grade 2 | 1 Participants |
| Rabipur Group | Number of Subjects With Alanine Aminotransferase (ALT) Values Outside Normal Ranges With Toxicity Grades | At Day 0 | Grade 1 | 0 Participants |
| Rabipur Group | Number of Subjects With Alanine Aminotransferase (ALT) Values Outside Normal Ranges With Toxicity Grades | At Cross-sectional Visit | Grade 1 | 8 Participants |
| Rabipur Group | Number of Subjects With Alanine Aminotransferase (ALT) Values Outside Normal Ranges With Toxicity Grades | At Day 0 | Grade 2 | 0 Participants |
| Rabipur Group | Number of Subjects With Alanine Aminotransferase (ALT) Values Outside Normal Ranges With Toxicity Grades | At Month 3 | Missing | 24 Participants |
| Rabipur Group | Number of Subjects With Alanine Aminotransferase (ALT) Values Outside Normal Ranges With Toxicity Grades | At Day 0 | Missing | 0 Participants |
| Rabipur Group | Number of Subjects With Alanine Aminotransferase (ALT) Values Outside Normal Ranges With Toxicity Grades | At Cross-sectional Visit | Missing | 41 Participants |
| Rabipur Group | Number of Subjects With Alanine Aminotransferase (ALT) Values Outside Normal Ranges With Toxicity Grades | At Month 3 | Normal | 420 Participants |
| Rabipur Group | Number of Subjects With Alanine Aminotransferase (ALT) Values Outside Normal Ranges With Toxicity Grades | At Cross-sectional Visit | Normal | 397 Participants |
| Rabipur Group | Number of Subjects With Alanine Aminotransferase (ALT) Values Outside Normal Ranges With Toxicity Grades | At Month 3 | Grade 1 | 2 Participants |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 swelling = swelling spreading beyond 20 millimeters (mm) of injection site.
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Population: The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had their symptom sheets filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK257049 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 3 | 76 Participants |
| GSK257049 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Swelling 3 Pain, Across doses | 3 Participants |
| GSK257049 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 51 Participants |
| GSK257049 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 0 Participants |
| GSK257049 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Swelling Pain, Dose 1 | 20 Participants |
| GSK257049 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Swelling 3 Pain, Dose 1 | 0 Participants |
| GSK257049 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 45 Participants |
| GSK257049 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 0 Participants |
| GSK257049 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Swelling Pain, Dose 2 | 6 Participants |
| GSK257049 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Swelling 3 Pain, Dose 2 | 1 Participants |
| GSK257049 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 3 | 0 Participants |
| GSK257049 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Swelling Pain, Dose 3 | 8 Participants |
| GSK257049 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Swelling 3 Pain, Dose 3 | 2 Participants |
| GSK257049 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 143 Participants |
| GSK257049 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 0 Participants |
| GSK257049 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Swelling Pain, Across doses | 30 Participants |
| Rabipur Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Swelling 3 Pain, Across doses | 0 Participants |
| Rabipur Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Swelling 3 Pain, Dose 2 | 0 Participants |
| Rabipur Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 3 | 80 Participants |
| Rabipur Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 39 Participants |
| Rabipur Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 130 Participants |
| Rabipur Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 0 Participants |
| Rabipur Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 3 | 0 Participants |
| Rabipur Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Swelling Pain, Dose 1 | 12 Participants |
| Rabipur Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Swelling Pain, Across doses | 13 Participants |
| Rabipur Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Swelling 3 Pain, Dose 1 | 0 Participants |
| Rabipur Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Swelling Pain, Dose 3 | 1 Participants |
| Rabipur Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 38 Participants |
| Rabipur Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 0 Participants |
| Rabipur Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 0 Participants |
| Rabipur Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Swelling 3 Pain, Dose 3 | 0 Participants |
| Rabipur Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Swelling Pain, Dose 2 | 3 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were drowsiness, fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever higher than (\>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Population: The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had their symptom sheets filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 1 | 49 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 3 | 1 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 2 | 3 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 3 | 32 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 1 | 0 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 3 | 17 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 2 | 51 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 3 | 0 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 1 | 0 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 3 | 13 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 2 | 16 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 3 | 6 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 1 | 14 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 3 | 0 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 2 | 0 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 3 | 3 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 1 | 1 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Across Doses | 66 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 2 | 14 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Across Doses | 0 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 2 | 22 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Across Doses | 55 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 2 | 24 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Across Doses | 125 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 1 | 17 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Across Doses | 5 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 2 | 0 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Across Doses | 111 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 2 | 0 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Across Doses | 45 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 2 | 12 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Across Doses | 0 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 1 | 26 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Across Doses | 33 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 3 | 15 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Across Doses | 54 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 2 | 22 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Across Doses | 0 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 3 | 0 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Across Doses | 28 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 1 | 34 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 1 | 44 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 3 | 15 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 1 | 0 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 2 | 56 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 1 | 32 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 3 | 38 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 1 | 55 Participants |
| Rabipur Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 3 | 2 Participants |
| Rabipur Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 1 | 2 Participants |
| Rabipur Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 1 | 133 Participants |
| Rabipur Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 1 | 12 Participants |
| Rabipur Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 1 | 0 Participants |
| Rabipur Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 1 | 8 Participants |
| Rabipur Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 1 | 28 Participants |
| Rabipur Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 1 | 1 Participants |
| Rabipur Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 1 | 9 Participants |
| Rabipur Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 2 | 25 Participants |
| Rabipur Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 2 | 1 Participants |
| Rabipur Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 2 | 23 Participants |
| Rabipur Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 2 | 159 Participants |
| Rabipur Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 2 | 8 Participants |
| Rabipur Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 2 | 156 Participants |
| Rabipur Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 2 | 7 Participants |
| Rabipur Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 2 | 0 Participants |
| Rabipur Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 2 | 7 Participants |
| Rabipur Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 2 | 13 Participants |
| Rabipur Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 2 | 1 Participants |
| Rabipur Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 2 | 7 Participants |
| Rabipur Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 3 | 11 Participants |
| Rabipur Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 3 | 0 Participants |
| Rabipur Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 3 | 10 Participants |
| Rabipur Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 3 | 112 Participants |
| Rabipur Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 3 | 2 Participants |
| Rabipur Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 3 | 107 Participants |
| Rabipur Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 3 | 2 Participants |
| Rabipur Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 3 | 0 Participants |
| Rabipur Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 3 | 1 Participants |
| Rabipur Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 1 | 138 Participants |
| Rabipur Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 3 | 0 Participants |
| Rabipur Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 3 | 0 Participants |
| Rabipur Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Across Doses | 59 Participants |
| Rabipur Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Across Doses | 1 Participants |
| Rabipur Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Across Doses | 56 Participants |
| Rabipur Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Across Doses | 268 Participants |
| Rabipur Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Across Doses | 12 Participants |
| Rabipur Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Across Doses | 262 Participants |
| Rabipur Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Across Doses | 19 Participants |
| Rabipur Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Across Doses | 0 Participants |
| Rabipur Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Across Doses | 14 Participants |
| Rabipur Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Across Doses | 40 Participants |
| Rabipur Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Across Doses | 2 Participants |
| Rabipur Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Across Doses | 14 Participants |
| Rabipur Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 1 | 28 Participants |
| Rabipur Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 1 | 0 Participants |
| Rabipur Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 1 | 27 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: Within the 30-day (Days 0-29) post-vaccination follow-up period
Population: The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK257049 Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 349 Participants |
| Rabipur Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 332 Participants |
Secondary
Number of Subjects With Creatinine Values Outside Normal Ranges With Toxicity Grades
Definition for toxicity grading for creatinine were: Normal Creatinine = ≤ 60 micromols per liter (μmol/L); Grade 1 Creatinine = 1.1 to 1.5 x ULN; Grade 2 Creatinine = 1.6 to 3.0 x ULN.
Time frame: At Day 0, Month 3 and at Cross-sectional Visit (took place between 7 and 13 months post Dose 1, mean: 10 months, standard deviation: 1.29)
Population: The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| GSK257049 Group | Number of Subjects With Creatinine Values Outside Normal Ranges With Toxicity Grades | At Day 0 | Normal | 447 Participants |
| GSK257049 Group | Number of Subjects With Creatinine Values Outside Normal Ranges With Toxicity Grades | At Day 0 | Grade 1 | 0 Participants |
| GSK257049 Group | Number of Subjects With Creatinine Values Outside Normal Ranges With Toxicity Grades | At Day 0 | Grade 2 | 0 Participants |
| GSK257049 Group | Number of Subjects With Creatinine Values Outside Normal Ranges With Toxicity Grades | At Day 0 | Missing | 0 Participants |
| GSK257049 Group | Number of Subjects With Creatinine Values Outside Normal Ranges With Toxicity Grades | At Month 3 | Normal | 415 Participants |
| GSK257049 Group | Number of Subjects With Creatinine Values Outside Normal Ranges With Toxicity Grades | At Month 3 | Grade 1 | 0 Participants |
| GSK257049 Group | Number of Subjects With Creatinine Values Outside Normal Ranges With Toxicity Grades | At Month 3 | Grade 2 | 0 Participants |
| GSK257049 Group | Number of Subjects With Creatinine Values Outside Normal Ranges With Toxicity Grades | At Month 3 | Missing | 32 Participants |
| GSK257049 Group | Number of Subjects With Creatinine Values Outside Normal Ranges With Toxicity Grades | At Cross-sectional Visit | Normal | 397 Participants |
| GSK257049 Group | Number of Subjects With Creatinine Values Outside Normal Ranges With Toxicity Grades | At Cross-sectional Visit | Grade 1 | 1 Participants |
| GSK257049 Group | Number of Subjects With Creatinine Values Outside Normal Ranges With Toxicity Grades | At Cross-sectional Visit | Grade 2 | 0 Participants |
| GSK257049 Group | Number of Subjects With Creatinine Values Outside Normal Ranges With Toxicity Grades | At Cross-sectional Visit | Missing | 49 Participants |
| Rabipur Group | Number of Subjects With Creatinine Values Outside Normal Ranges With Toxicity Grades | At Cross-sectional Visit | Grade 2 | 1 Participants |
| Rabipur Group | Number of Subjects With Creatinine Values Outside Normal Ranges With Toxicity Grades | At Day 0 | Normal | 447 Participants |
| Rabipur Group | Number of Subjects With Creatinine Values Outside Normal Ranges With Toxicity Grades | At Month 3 | Grade 2 | 0 Participants |
| Rabipur Group | Number of Subjects With Creatinine Values Outside Normal Ranges With Toxicity Grades | At Day 0 | Grade 1 | 0 Participants |
| Rabipur Group | Number of Subjects With Creatinine Values Outside Normal Ranges With Toxicity Grades | At Cross-sectional Visit | Grade 1 | 0 Participants |
| Rabipur Group | Number of Subjects With Creatinine Values Outside Normal Ranges With Toxicity Grades | At Day 0 | Grade 2 | 0 Participants |
| Rabipur Group | Number of Subjects With Creatinine Values Outside Normal Ranges With Toxicity Grades | At Month 3 | Missing | 25 Participants |
| Rabipur Group | Number of Subjects With Creatinine Values Outside Normal Ranges With Toxicity Grades | At Day 0 | Missing | 0 Participants |
| Rabipur Group | Number of Subjects With Creatinine Values Outside Normal Ranges With Toxicity Grades | At Cross-sectional Visit | Missing | 41 Participants |
| Rabipur Group | Number of Subjects With Creatinine Values Outside Normal Ranges With Toxicity Grades | At Month 3 | Normal | 422 Participants |
| Rabipur Group | Number of Subjects With Creatinine Values Outside Normal Ranges With Toxicity Grades | At Cross-sectional Visit | Normal | 405 Participants |
| Rabipur Group | Number of Subjects With Creatinine Values Outside Normal Ranges With Toxicity Grades | At Month 3 | Grade 1 | 0 Participants |
Secondary
Number of Subjects With Hemoglobin Values Outside Normal Ranges With Toxicity Grades
Definitions for toxicity grading for hemoglobin were: Normal Hemoglobin = equal to or above (≥) 8.0 g/dL; Grade 1 Hemoglobin = under (\<) 8.0 g/dL and above (\>) 6.0 g/dL.; Grade 2 Hemoglobin = under (\<) 6.0 g/dL.
Time frame: At Day 0, Month 3 and at Cross-sectional Visit (took place between 7 and 13 months post Dose 1, mean: 10 months, standard deviation: 1.29)
Population: The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| GSK257049 Group | Number of Subjects With Hemoglobin Values Outside Normal Ranges With Toxicity Grades | At Day 0 | Normal | 445 Participants |
| GSK257049 Group | Number of Subjects With Hemoglobin Values Outside Normal Ranges With Toxicity Grades | At Day 0 | Grade 1 | 1 Participants |
| GSK257049 Group | Number of Subjects With Hemoglobin Values Outside Normal Ranges With Toxicity Grades | At Day 0 | Grade 2 | 1 Participants |
| GSK257049 Group | Number of Subjects With Hemoglobin Values Outside Normal Ranges With Toxicity Grades | At Day 0 | Missing | 0 Participants |
| GSK257049 Group | Number of Subjects With Hemoglobin Values Outside Normal Ranges With Toxicity Grades | At Month 3 | Normal | 410 Participants |
| GSK257049 Group | Number of Subjects With Hemoglobin Values Outside Normal Ranges With Toxicity Grades | At Month 3 | Grade 1 | 7 Participants |
| GSK257049 Group | Number of Subjects With Hemoglobin Values Outside Normal Ranges With Toxicity Grades | At Month 3 | Grade 2 | 0 Participants |
| GSK257049 Group | Number of Subjects With Hemoglobin Values Outside Normal Ranges With Toxicity Grades | At Month 3 | Missing | 30 Participants |
| GSK257049 Group | Number of Subjects With Hemoglobin Values Outside Normal Ranges With Toxicity Grades | At Cross-sectional Visit | Normal | 391 Participants |
| GSK257049 Group | Number of Subjects With Hemoglobin Values Outside Normal Ranges With Toxicity Grades | At Cross-sectional Visit | Grade 1 | 6 Participants |
| GSK257049 Group | Number of Subjects With Hemoglobin Values Outside Normal Ranges With Toxicity Grades | At Cross-sectional Visit | Grade 2 | 0 Participants |
| GSK257049 Group | Number of Subjects With Hemoglobin Values Outside Normal Ranges With Toxicity Grades | At Cross-sectional Visit | Missing | 50 Participants |
| Rabipur Group | Number of Subjects With Hemoglobin Values Outside Normal Ranges With Toxicity Grades | At Cross-sectional Visit | Grade 2 | 0 Participants |
| Rabipur Group | Number of Subjects With Hemoglobin Values Outside Normal Ranges With Toxicity Grades | At Day 0 | Normal | 446 Participants |
| Rabipur Group | Number of Subjects With Hemoglobin Values Outside Normal Ranges With Toxicity Grades | At Month 3 | Grade 2 | 0 Participants |
| Rabipur Group | Number of Subjects With Hemoglobin Values Outside Normal Ranges With Toxicity Grades | At Day 0 | Grade 1 | 1 Participants |
| Rabipur Group | Number of Subjects With Hemoglobin Values Outside Normal Ranges With Toxicity Grades | At Cross-sectional Visit | Grade 1 | 8 Participants |
| Rabipur Group | Number of Subjects With Hemoglobin Values Outside Normal Ranges With Toxicity Grades | At Day 0 | Grade 2 | 0 Participants |
| Rabipur Group | Number of Subjects With Hemoglobin Values Outside Normal Ranges With Toxicity Grades | At Month 3 | Missing | 24 Participants |
| Rabipur Group | Number of Subjects With Hemoglobin Values Outside Normal Ranges With Toxicity Grades | At Day 0 | Missing | 0 Participants |
| Rabipur Group | Number of Subjects With Hemoglobin Values Outside Normal Ranges With Toxicity Grades | At Cross-sectional Visit | Missing | 42 Participants |
| Rabipur Group | Number of Subjects With Hemoglobin Values Outside Normal Ranges With Toxicity Grades | At Month 3 | Normal | 413 Participants |
| Rabipur Group | Number of Subjects With Hemoglobin Values Outside Normal Ranges With Toxicity Grades | At Cross-sectional Visit | Normal | 397 Participants |
| Rabipur Group | Number of Subjects With Hemoglobin Values Outside Normal Ranges With Toxicity Grades | At Month 3 | Grade 1 | 10 Participants |
Secondary
Number of Subjects With Platelet Values Outside Normal Ranges With Toxicity Grades
Definitions for toxicity grading for platelets were: Normal Platelets = ≥ 75 x 10\^3 cells/μL; Grade 1 Platelets = 50 to 74 x 10\^3 /μL; Grade 2 Platelets = 25 to 49 x 10\^3 /μL; Grade 3 Platelets = \< 25 x 10\^3 /μL.
Time frame: At Day 0, Month 3 and at Cross-sectional Visit (took place between 7 and 13 months post Dose 1, mean: 10 months, standard deviation: 1.29)
Population: The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| GSK257049 Group | Number of Subjects With Platelet Values Outside Normal Ranges With Toxicity Grades | At Day 0 | Missing | 1 Participants |
| GSK257049 Group | Number of Subjects With Platelet Values Outside Normal Ranges With Toxicity Grades | At Month 3 | Grade 3 | 0 Participants |
| GSK257049 Group | Number of Subjects With Platelet Values Outside Normal Ranges With Toxicity Grades | At Day 0 | Grade 1 | 1 Participants |
| GSK257049 Group | Number of Subjects With Platelet Values Outside Normal Ranges With Toxicity Grades | At Month 3 | Missing | 30 Participants |
| GSK257049 Group | Number of Subjects With Platelet Values Outside Normal Ranges With Toxicity Grades | At Month 3 | Normal | 414 Participants |
| GSK257049 Group | Number of Subjects With Platelet Values Outside Normal Ranges With Toxicity Grades | At Cross-sectional Visit | Normal | 386 Participants |
| GSK257049 Group | Number of Subjects With Platelet Values Outside Normal Ranges With Toxicity Grades | At Day 0 | Grade 3 | 0 Participants |
| GSK257049 Group | Number of Subjects With Platelet Values Outside Normal Ranges With Toxicity Grades | At Cross-sectional Visit | Grade 1 | 4 Participants |
| GSK257049 Group | Number of Subjects With Platelet Values Outside Normal Ranges With Toxicity Grades | At Month 3 | Grade 1 | 1 Participants |
| GSK257049 Group | Number of Subjects With Platelet Values Outside Normal Ranges With Toxicity Grades | At Cross-sectional Visit | Grade 2 | 1 Participants |
| GSK257049 Group | Number of Subjects With Platelet Values Outside Normal Ranges With Toxicity Grades | At Day 0 | Grade 2 | 0 Participants |
| GSK257049 Group | Number of Subjects With Platelet Values Outside Normal Ranges With Toxicity Grades | At Cross-sectional Visit | Grade 3 | 0 Participants |
| GSK257049 Group | Number of Subjects With Platelet Values Outside Normal Ranges With Toxicity Grades | At Month 3 | Grade 2 | 2 Participants |
| GSK257049 Group | Number of Subjects With Platelet Values Outside Normal Ranges With Toxicity Grades | At Cross-sectional Visit | Missing | 56 Participants |
| GSK257049 Group | Number of Subjects With Platelet Values Outside Normal Ranges With Toxicity Grades | At Day 0 | Normal | 445 Participants |
| Rabipur Group | Number of Subjects With Platelet Values Outside Normal Ranges With Toxicity Grades | At Cross-sectional Visit | Missing | 50 Participants |
| Rabipur Group | Number of Subjects With Platelet Values Outside Normal Ranges With Toxicity Grades | At Day 0 | Normal | 447 Participants |
| Rabipur Group | Number of Subjects With Platelet Values Outside Normal Ranges With Toxicity Grades | At Day 0 | Grade 1 | 0 Participants |
| Rabipur Group | Number of Subjects With Platelet Values Outside Normal Ranges With Toxicity Grades | At Day 0 | Grade 2 | 0 Participants |
| Rabipur Group | Number of Subjects With Platelet Values Outside Normal Ranges With Toxicity Grades | At Day 0 | Grade 3 | 0 Participants |
| Rabipur Group | Number of Subjects With Platelet Values Outside Normal Ranges With Toxicity Grades | At Day 0 | Missing | 0 Participants |
| Rabipur Group | Number of Subjects With Platelet Values Outside Normal Ranges With Toxicity Grades | At Month 3 | Normal | 417 Participants |
| Rabipur Group | Number of Subjects With Platelet Values Outside Normal Ranges With Toxicity Grades | At Month 3 | Grade 1 | 0 Participants |
| Rabipur Group | Number of Subjects With Platelet Values Outside Normal Ranges With Toxicity Grades | At Month 3 | Grade 2 | 4 Participants |
| Rabipur Group | Number of Subjects With Platelet Values Outside Normal Ranges With Toxicity Grades | At Month 3 | Grade 3 | 1 Participants |
| Rabipur Group | Number of Subjects With Platelet Values Outside Normal Ranges With Toxicity Grades | At Month 3 | Missing | 25 Participants |
| Rabipur Group | Number of Subjects With Platelet Values Outside Normal Ranges With Toxicity Grades | At Cross-sectional Visit | Normal | 396 Participants |
| Rabipur Group | Number of Subjects With Platelet Values Outside Normal Ranges With Toxicity Grades | At Cross-sectional Visit | Grade 1 | 1 Participants |
| Rabipur Group | Number of Subjects With Platelet Values Outside Normal Ranges With Toxicity Grades | At Cross-sectional Visit | Grade 2 | 0 Participants |
| Rabipur Group | Number of Subjects With Platelet Values Outside Normal Ranges With Toxicity Grades | At Cross-sectional Visit | Grade 3 | 0 Participants |
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: Throughout the study period (Day 0 - Month 14)
Population: The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK257049 Group | Number of Subjects With Serious Adverse Events (SAEs) | 51 Participants |
| Rabipur Group | Number of Subjects With Serious Adverse Events (SAEs) | 88 Participants |
Secondary
Number of Subjects With White Blood Cell (WBC) Values Outside Normal Ranges With Toxicity Grades
Definitions for toxicity grading for WBC were: Normal WBC = ≥ 4.0 x 10\^3 cells per microliters (cells/μL) or \< 17 x 10\^3 cells /μL; Grade 1 WBC = 2.5 to 4.0 x 10\^3 cells/μL.
Time frame: At Day 0, Month 3 and at Cross-sectional Visit (took place between 7 and 13 months post Dose 1, mean: 10 months, standard deviation: 1.29)
Population: The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| GSK257049 Group | Number of Subjects With White Blood Cell (WBC) Values Outside Normal Ranges With Toxicity Grades | At Day 0 | Grade 1 | 0 Participants |
| GSK257049 Group | Number of Subjects With White Blood Cell (WBC) Values Outside Normal Ranges With Toxicity Grades | At Month 3 | Missing | 31 Participants |
| GSK257049 Group | Number of Subjects With White Blood Cell (WBC) Values Outside Normal Ranges With Toxicity Grades | At Month 3 | Normal | 416 Participants |
| GSK257049 Group | Number of Subjects With White Blood Cell (WBC) Values Outside Normal Ranges With Toxicity Grades | At Cross-sectional Visit | Normal | 395 Participants |
| GSK257049 Group | Number of Subjects With White Blood Cell (WBC) Values Outside Normal Ranges With Toxicity Grades | At Day 0 | Missing | 0 Participants |
| GSK257049 Group | Number of Subjects With White Blood Cell (WBC) Values Outside Normal Ranges With Toxicity Grades | At Cross-sectional Visit | Grade 1 | 0 Participants |
| GSK257049 Group | Number of Subjects With White Blood Cell (WBC) Values Outside Normal Ranges With Toxicity Grades | At Month 3 | Grade 1 | 0 Participants |
| GSK257049 Group | Number of Subjects With White Blood Cell (WBC) Values Outside Normal Ranges With Toxicity Grades | At Cross-sectional Visit | Missing | 52 Participants |
| GSK257049 Group | Number of Subjects With White Blood Cell (WBC) Values Outside Normal Ranges With Toxicity Grades | At Day 0 | Normal | 447 Participants |
| Rabipur Group | Number of Subjects With White Blood Cell (WBC) Values Outside Normal Ranges With Toxicity Grades | At Cross-sectional Visit | Missing | 42 Participants |
| Rabipur Group | Number of Subjects With White Blood Cell (WBC) Values Outside Normal Ranges With Toxicity Grades | At Day 0 | Normal | 447 Participants |
| Rabipur Group | Number of Subjects With White Blood Cell (WBC) Values Outside Normal Ranges With Toxicity Grades | At Day 0 | Grade 1 | 0 Participants |
| Rabipur Group | Number of Subjects With White Blood Cell (WBC) Values Outside Normal Ranges With Toxicity Grades | At Day 0 | Missing | 0 Participants |
| Rabipur Group | Number of Subjects With White Blood Cell (WBC) Values Outside Normal Ranges With Toxicity Grades | At Month 3 | Normal | 422 Participants |
| Rabipur Group | Number of Subjects With White Blood Cell (WBC) Values Outside Normal Ranges With Toxicity Grades | At Month 3 | Grade 1 | 1 Participants |
| Rabipur Group | Number of Subjects With White Blood Cell (WBC) Values Outside Normal Ranges With Toxicity Grades | At Month 3 | Missing | 24 Participants |
| Rabipur Group | Number of Subjects With White Blood Cell (WBC) Values Outside Normal Ranges With Toxicity Grades | At Cross-sectional Visit | Normal | 405 Participants |
| Rabipur Group | Number of Subjects With White Blood Cell (WBC) Values Outside Normal Ranges With Toxicity Grades | At Cross-sectional Visit | Grade 1 | 0 Participants |