Malaria
Conditions
Keywords
Infants, Efficacy, Children, Malaria, Plasmodium falciparum, Safety, Surveillance, Immunogenicity, RTS,S/AS01E, Africa
Brief summary
The purpose of this study is to conduct long-term surveillance for efficacy, safety and immunogenicity of the GSK Biologicals RTS,S/AS01E candidate Plasmodium falciparum malaria vaccine in infants and children in Africa following a primary vaccination series (NCT00866619). No new subjects will be enrolled in this extension study.
Interventions
PROCEDUREBlood sampling
Annual blood sampling (Year 1, Year 2 and Year 3) during the present study.
BIOLOGICALMalaria Vaccine 257049 (MALARIA-055 PRI)
Administered intramuscularly into the left deltoid, during the MALARIA-055 study (NCT00866619).
BIOLOGICALMeningococcal C Conjugate Vaccine (MALARIA-055 PRI)
Administered intramuscularly into the left deltoid, during the MALARIA-055 study (NCT00866619).
BIOLOGICALCell-culture rabies vaccine (MALARIA-055 PRI)
Administered intramuscularly into the left deltoid, during the MALARIA-055 study (NCT00866619).
BIOLOGICALTritanrixHepB/Hib (MALARIA-055 PRI)
Administered intramuscularly into the left deltoid, during the MALARIA-055 study (NCT00866619).
BIOLOGICALPolio Sabin Oral Polio Vaccine (GSK) (MALARIA-055 PRI)
Administered orally, during the MALARIA-055 study (NCT00866619).
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
42 Months to 9 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects' parent(s)/ Legally Acceptable Representative (LARs) who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * Subjects who were enrolled and who received at least one vaccine dose in the primary study MALARIA-055 PRI NCT00866619 and who did not withdraw consent (except those who moved away from the area) during the primary study MALARIA-055 PRI NCT00866619. * Written informed consent obtained from the parent(s)/LAR(s) of the subject.
Exclusion criteria
* Child in care. * Use of any investigational or non-registered product or planned use during the study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Severe Malaria Meeting Case Definition 1 | From Year 0 to Year 3 (Starting January 2014 and ending December 2016) | Case definition 1 for severe malaria was defined as an episode of malaria with positive Plasmodium falciparum asexual parasitemia (within -1 to +3 days of admission) and with one or more marker of disease severity: Prostration, respiratory distress, Blantyre score equal to or less than (≤) 2, seizures 2 or more, hypoglycemia below (\<) 2.2 millimoles per liter (mmol/L), acidosis BE ≤ -10.0 mmol/L, lactate ≥ 5.0 mmol/L or anemia \< 5.0 grams per deciliter (g/dL). The incidence of severe malaria for case definition 1 is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years at risk (T). |
| Incidence of Severe Malaria Meeting Case Definition 2. | From Year 0 to Year 3 (Starting January 2014 and ending December 2016) | Case definition 2 for severe malaria was defined as an episode of malaria with positive Plasmodium falciparum asexual parasitemia (within -1 to +3 days of admission) and with one or more marker of disease severity: Prostration, respiratory distress, Blantyre score equal to or less than (≤) 2, seizures 2 or more, hypoglycemia below (\<) 2.2 millimoles per liter (mmol/L), acidosis BE ≤ -10.0 mmol/L, lactate ≥ 5.0 mmol/L or anemia \< 5.0 grams per deciliter (g/dL) or SAE report including preferred terms (Malaria, Plasmodium falciparum infection or Cerebral malaria) within -1 to +3 days of admission. The incidence of severe malaria for case definition 2 is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years at risk (T). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Malaria Hospitalization Meeting Case Definition 2. | From Year 0 to Year 3 (Starting January 2014 and ending December 2016) | Malaria hospitalization, case definition 2, was defined as a hospitalization for which, in the judgment of the principal investigator, Plasmodium falciparum infection was the sole or a major contributing factor to the presentation. |
| Number of Subjects With Prevalent Parasitemia | At Years 1, 2 and 3 | Prevalent parasitemia (PP) was defined as a documented Plasmodium falciparum asexual parasite density greater than (\>) 0 parasites/µL, identified at an annual visit. |
| Number of Subjects With Prevalent Severe Anemia (Level of Hemoglobin <5g/dL) | At Years 1, 2 and 3 | Prevalent severe anemia (PSA) was defined as a documented hemoglobin lower than (\<) 5.0 grams per deciliter (g/dL), identified at an annual visit. |
| Number of Subjects With Prevalent Moderate Anemia (Level of Hemoglobin <8g/dL) | At Years 1, 2 and 3 | Prevalent moderate anemia (PMA) was defined as a documented hemoglobin \< 8.0 g/dL, identified at an annual visit. |
| Incidence of Severe Malaria Meeting Case Definition 1. | From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076) | Case definition 1 for severe malaria was defined as an episode of malaria with positive Plasmodium falciparum asexual parasitemia (within -1 to +3 days of admission) and with one or more marker of disease severity: Prostration, respiratory distress, Blantyre score equal to or less than (≤) 2, seizures 2 or more, hypoglycemia below (\<) 2.2 millimoles per liter (mmol/L), acidosis BE ≤ -10.0 mmol/L, lactate ≥ 5.0 mmol/L or anemia \< 5.0 grams per deciliter (g/dL). The incidence of severe malaria for case definition 1 is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years at risk (T). |
| Incidence of Severe Malaria Meeting Case Definition 2. | From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076) | Case definition 2 for severe malaria was defined as an episode of malaria with positive Plasmodium falciparum asexual parasitemia (within -1 to +3 days of admission) and with one or more marker of disease severity: Prostration, respiratory distress, Blantyre score equal to or less than (≤) 2, seizures 2 or more, hypoglycemia below (\<) 2.2 millimoles per liter (mmol/L), acidosis BE ≤ -10.0 mmol/L, lactate ≥ 5.0 mmol/L or anemia \< 5.0 grams per deciliter (g/dL) or SAE report including preferred terms (Malaria, Plasmodium falciparum infection or Cerebral malaria) within -1 to +3 days of admission. The incidence of severe malaria for case definition 2 is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years at risk (T). |
| Number of Subjects With Cerebral Malaria Meeting Both Case Definitions. | From Year 0 to Year 3 (Starting January 2014 and ending December 2016) | Cerebral malaria was defined as a positive P. falciparum asexual parasitemia (within -1 to +3 days of admission), accompanied either by the presence of a marker of disease severity (a Blantyre score ≤ 2) or a SAE report with 'cerebral malaria' as preferred term. |
| Incidence of Clinical Malaria Meeting Case Definition | From Year 0 to Year 3 (Starting January 2014 and ending December 2016) | Clinical malaria was defined as an episode of malaria with positive Plasmodium falciparum asexual parasitemia, accompanied by the presence of fever (axillary temperature ≥ 37.5°C ) at the time of presentation or history of fever within 24 hours of presentation and occurring in a child who was unwell and brought for treatment to a healthcare facility. The incidence of clinical malaria for case definition 1 is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years a t risk (T). Due to late protocol approvals and retrospective data collection the sites did not collect the data according to protocol and as such the case definition cannot be applied. For the final analysis, specific case definitions based on available data were developed. |
| Number of Subjects With Fatal Malaria Meeting Case Definition 2. | From Year 0 to Year 3 (Starting January 2014 and ending December 2016) | Fatal malaria, case definition 2, was defined as a SAE report with preferred terms 'malaria', 'plasmodium falciparum infection', 'cerebral malaria' associated with a fatal outcome. |
| Number of Subjects With Cerebral Malaria | From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076). | Cerebral malaria was defined as a positive P. falciparum asexual parasitemia (within -1 to +3 days of admission), accompanied either by the presence of a marker of disease severity (a Blantyre score ≤ 2) or a SAE report with 'cerebral malaria' as preferred term. |
| Number of Subjects Reporting Any, Related, Malaria and Fatal Serious Adverse Events (SAEs) | From Year 0 to Year 3 (Starting January 2014 and ending December 2016) | Malaria SAEs were defined as SAEs coded by MedDRA preferred term level as 'malaria', 'Plasmodium falciparum infection' or 'cerebral malaria. A serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization or resulted in disability/incapacity. SAEs disclosed in this outcome are any SAEs , fatal SAEs, those that were related to vaccine administration in the primary study MALARIA-055 PRI (110021) and malaria hospitalization. |
| Number of Subjects Reporting Any Potential Immune-mediated Disorders (pIMDs) SAEs | From Year 0 to Year 3 (Starting January 2014 and ending December 2016) | Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Regardless of it being considered an AE or an SAE, it should have been reported per the SAE reporting rules. |
| Number of Subjects With Meningitis SAEs | From Year 0 to Year 3 (Starting January 2014 and ending December 2016) | For the further evaluation of the safety signal of meningitis all the cases occurring during the study were reported as SAE. Meningitis is defined as an SAE coded at lowest level terms code, coded by MedDRA preferred term level as: 'meningitis', 'meningitis haemophilus', 'meningitis meningococcal', 'meningitis salmonella', 'meningitis pneumococcal', 'meningitis staphylococcal', 'meningitis tuberculous', 'meningitis herpes', 'meningitis candida', 'meningitis enterococcal', 'meningitis enteroviral', 'meningitis neonatal', 'meningitis toxoplasmal', 'meningitis mumps', 'meningitis cryptococcal', 'meningitis histoplasma', 'meningitis trypanosomal', 'Neurosyphilis', 'meningitis leptospiral', 'meningitis listeria', 'meningitis in sarcoidosis' (code in preferred term 'cerebral sarcoidosis'), 'meningitis bacterial', 'meningitis viral', 'meningitis aseptic', 'meningitis fungal'. |
| Antibody Concentrations Against Against Plasmodium Falciparum Circumsporozoite (Anti-CS) | At screening, 1 month post Dose 3 (Month 3), 18 months post Dose 3 (Month 20), 1 month post Dose 4 (Month 21), 12 months post Dose 4 (Month 32) (of Malaria-055) and at Years 1, 2 and 3 (of Malaria-076) | Antibody concentrations were assessed by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean titers (GMTs). Seropositivity anti-CS antibody cut-off was 0.5 EU/mL for Malaria-055 time points and 1.9 EU/mL for Malaria-076 time points. |
| Number of Subjects With Fatal Malaria Meeting Case Definition 1. | From Year 0 to Year 3 (Starting January 2014 and ending December 2016) | Fatal malaria, case definition 1, was defined as a SAE report with preferred terms 'malaria', 'plasmodium falciparum infection', 'cerebral malaria' with confirmed positive Plasmodium falciparum asexual parasitemia associated with a fatal outcome (excludes planned admissions for medical investigation/care or elective surgery and trauma). |
| Number of Subjects With Malaria Hospitalization Meeting Case Definition 1. | From Year 0 to Year 3 (Starting January 2014 and ending December 2016) | Malaria hospitalization, case definition 1, was defined as a medical hospitalization with confirmed positive Plasmodium falciparum asexual parasitemia (excludes planned admissions for medical investigation/care or elective surgery and trauma). |
Countries
Burkina Faso, Kenya, Tanzania
Participant flow
Recruitment details
The randomization that was performed in the primary study NCT00866619 was kept for this extension, in which subjects from 3 sites were enrolled. Subjects remained in the same groups as the ones of the primary study.
Participants by arm
| Arm | Count |
|---|---|
| GSK257049 Group Male or female infants (between and including 6 to 12 weeks of age)/children (between and including 5 to 17 months of age) received 3 doses of GSK257049 malaria vaccine (co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, for the infants subgroup) on a 0-1-2-month schedule, and a booster dose of GSK257049 malaria vaccine (co-administered with Polio Sabin, for the infants subgroup) at Month 20 during the primary study MALARIA-055 PRI (NCT00866619). Vaccines were administered intramuscularly: in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB/Hib vaccine); orally: Polio Sabin vaccine. No vaccination was administered during this study. | 1,046 |
| GSK257049 Comparator Group Male or female infants (between and including 6 to 12 weeks of age)/children (between and including 5 to 17 months of age) received 3 doses of GSK257049 malaria vaccine (co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, for the infants subgroup) on 0-1-2-month schedule, and a booster dose of Menjugate vaccine (co-administered with Polio Sabin, for the infants subgroup) at Month 20 during the primary study MALARIA-055 PRI (NCT00866619). Vaccines were administered intramuscularly: in the anterolateral left thigh (GSK257049 vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine); orally: Polio Sabin vaccine. No vaccination was administered during this study. | 1,010 |
| VeroRab/Menjugate Comparator Group Male or female infants (between and including 6 to 12 weeks of age)/children (between and including 5 to 17 months of age) received 3 doses of VeroRab vaccine (children subgroup) or Menjugate vaccine (co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, for the infants subgroup) on 0-1-2-month schedule, and a booster dose of Menjugate vaccine (co-administered with Polio Sabin, for the infants subgroup) at Month 20 during the primary study MALARIA-055 PRI (NCT00866619). Vaccines were administered intramuscularly: left deltoid (VeroRab vaccine and Menjugate vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine); orally: Polio Sabin vaccine. No vaccination was administered during this study. | 1,028 |
| Total | 3,084 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Eligibility Criteria Not Fulfilled | 2 | 1 | 2 |
| Overall Study | Lost to Follow-up | 3 | 9 | 1 |
| Overall Study | Migrated/Moved From Study Area | 41 | 60 | 51 |
| Overall Study | Other | 1 | 2 | 4 |
| Overall Study | Serious Adverse Event | 0 | 5 | 2 |
| Overall Study | Withdrawal by Subject | 4 | 9 | 7 |
Baseline characteristics
| Characteristic | GSK257049 Group | GSK257049 Comparator Group | VeroRab/Menjugate Comparator Group | Total |
|---|---|---|---|---|
| Age, Continuous | 5.25 Years STANDARD_DEVIATION 0.99 | 5.23 Years STANDARD_DEVIATION 0.99 | 5.26 Years STANDARD_DEVIATION 0.97 | 5.25 Years STANDARD_DEVIATION 0.98 |
| Race/Ethnicity, Customized African Heritage/African American | 1046 Participants | 1010 Participants | 1028 Participants | 3084 Participants |
| Sex: Female, Male Female | 517 Participants | 480 Participants | 515 Participants | 1512 Participants |
| Sex: Female, Male Male | 529 Participants | 530 Participants | 513 Participants | 1572 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 5 / 1,051 | 10 / 1,015 | 7 / 1,033 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 39 / 1,051 | 43 / 1,015 | 52 / 1,033 |
Outcome results
Primary
Incidence of Severe Malaria Meeting Case Definition 1
Case definition 1 for severe malaria was defined as an episode of malaria with positive Plasmodium falciparum asexual parasitemia (within -1 to +3 days of admission) and with one or more marker of disease severity: Prostration, respiratory distress, Blantyre score equal to or less than (≤) 2, seizures 2 or more, hypoglycemia below (\<) 2.2 millimoles per liter (mmol/L), acidosis BE ≤ -10.0 mmol/L, lactate ≥ 5.0 mmol/L or anemia \< 5.0 grams per deciliter (g/dL). The incidence of severe malaria for case definition 1 is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years at risk (T).
Time frame: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)
Population: The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding study vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK257049 [5-17M] Group | Incidence of Severe Malaria Meeting Case Definition 1 | 0.001 events per person-year |
| GSK257049 Comparator [5-17M] Group | Incidence of Severe Malaria Meeting Case Definition 1 | 0.002 events per person-year |
| VeroRab Comparator [5-17M] Group | Incidence of Severe Malaria Meeting Case Definition 1 | 0.002 events per person-year |
| GSK257049 [6-12W] Group | Incidence of Severe Malaria Meeting Case Definition 1 | 0.004 events per person-year |
| GSK257049 Comparator [6-12W] Group | Incidence of Severe Malaria Meeting Case Definition 1 | 0.003 events per person-year |
| Menjugate Comparator [6-12W] Group | Incidence of Severe Malaria Meeting Case Definition 1 | 0.005 events per person-year |
Comparison: Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).p-value: 0.223595% CI: [-130, 97.14]Negative binomial regression
Comparison: Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).p-value: 0.897295% CI: [-339, 72.64]Negative binomial regression
Comparison: Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).p-value: 0.533395% CI: [-119, 78]Negative binomial regression
Comparison: Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).p-value: 0.352395% CI: [-90.9, 83.69]Negative binomial regression
Primary
Incidence of Severe Malaria Meeting Case Definition 2.
Case definition 2 for severe malaria was defined as an episode of malaria with positive Plasmodium falciparum asexual parasitemia (within -1 to +3 days of admission) and with one or more marker of disease severity: Prostration, respiratory distress, Blantyre score equal to or less than (≤) 2, seizures 2 or more, hypoglycemia below (\<) 2.2 millimoles per liter (mmol/L), acidosis BE ≤ -10.0 mmol/L, lactate ≥ 5.0 mmol/L or anemia \< 5.0 grams per deciliter (g/dL) or SAE report including preferred terms (Malaria, Plasmodium falciparum infection or Cerebral malaria) within -1 to +3 days of admission. The incidence of severe malaria for case definition 2 is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years at risk (T).
Time frame: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)
Population: The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK257049 [5-17M] Group | Incidence of Severe Malaria Meeting Case Definition 2. | 0.004 events per person-year |
| GSK257049 Comparator [5-17M] Group | Incidence of Severe Malaria Meeting Case Definition 2. | 0.007 events per person-year |
| VeroRab Comparator [5-17M] Group | Incidence of Severe Malaria Meeting Case Definition 2. | 0.009 events per person-year |
| GSK257049 [6-12W] Group | Incidence of Severe Malaria Meeting Case Definition 2. | 0.007 events per person-year |
| GSK257049 Comparator [6-12W] Group | Incidence of Severe Malaria Meeting Case Definition 2. | 0.007 events per person-year |
| Menjugate Comparator [6-12W] Group | Incidence of Severe Malaria Meeting Case Definition 2. | 0.011 events per person-year |
Comparison: Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).p-value: 0.09395% CI: [-13.7, 81.13]Negative binomial regression
Comparison: Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).p-value: 0.503595% CI: [-67.1, 64.82]Negative binomial regression
Comparison: Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).p-value: 0.350495% CI: [-53.1, 69.87]Negative binomial regression
Comparison: Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).p-value: 0.270495% CI: [-44.4, 73.01]Negative binomial regression
Secondary
Antibody Concentrations Against Against Plasmodium Falciparum Circumsporozoite (Anti-CS)
Antibody concentrations were assessed by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean titers (GMTs). Seropositivity anti-CS antibody cut-off was 0.5 EU/mL for Malaria-055 time points and 1.9 EU/mL for Malaria-076 time points.
Time frame: At screening, 1 month post Dose 3 (Month 3), 18 months post Dose 3 (Month 20), 1 month post Dose 4 (Month 21), 12 months post Dose 4 (Month 32) (of Malaria-055) and at Years 1, 2 and 3 (of Malaria-076)
Population: The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK257049 [5-17M] Group | Antibody Concentrations Against Against Plasmodium Falciparum Circumsporozoite (Anti-CS) | At Month 3 of Malaria-055 | 671.8 EU/mL |
| GSK257049 [5-17M] Group | Antibody Concentrations Against Against Plasmodium Falciparum Circumsporozoite (Anti-CS) | At Year 1 of Malaria-076 | 20.5 EU/mL |
| GSK257049 [5-17M] Group | Antibody Concentrations Against Against Plasmodium Falciparum Circumsporozoite (Anti-CS) | At Month 20 of Malaria-055 | 38.0 EU/mL |
| GSK257049 [5-17M] Group | Antibody Concentrations Against Against Plasmodium Falciparum Circumsporozoite (Anti-CS) | At Year 3 of Malaria-076 | 11.2 EU/mL |
| GSK257049 [5-17M] Group | Antibody Concentrations Against Against Plasmodium Falciparum Circumsporozoite (Anti-CS) | At Month 21 of Malaria-055 | 368.6 EU/mL |
| GSK257049 [5-17M] Group | Antibody Concentrations Against Against Plasmodium Falciparum Circumsporozoite (Anti-CS) | At Year 2 of Malaria-076 | 14.9 EU/mL |
| GSK257049 [5-17M] Group | Antibody Concentrations Against Against Plasmodium Falciparum Circumsporozoite (Anti-CS) | At Month 32 of Malaria-055 | 54.7 EU/mL |
| GSK257049 Comparator [5-17M] Group | Antibody Concentrations Against Against Plasmodium Falciparum Circumsporozoite (Anti-CS) | At Month 20 of Malaria-055 | 40.3 EU/mL |
| GSK257049 Comparator [5-17M] Group | Antibody Concentrations Against Against Plasmodium Falciparum Circumsporozoite (Anti-CS) | At Month 32 of Malaria-055 | 21.1 EU/mL |
| GSK257049 Comparator [5-17M] Group | Antibody Concentrations Against Against Plasmodium Falciparum Circumsporozoite (Anti-CS) | At Month 21 of Malaria-055 | 38.8 EU/mL |
| GSK257049 Comparator [5-17M] Group | Antibody Concentrations Against Against Plasmodium Falciparum Circumsporozoite (Anti-CS) | At Year 1 of Malaria-076 | 13.6 EU/mL |
| GSK257049 Comparator [5-17M] Group | Antibody Concentrations Against Against Plasmodium Falciparum Circumsporozoite (Anti-CS) | At Month 3 of Malaria-055 | 599.3 EU/mL |
| GSK257049 Comparator [5-17M] Group | Antibody Concentrations Against Against Plasmodium Falciparum Circumsporozoite (Anti-CS) | At Year 3 of Malaria-076 | 5.0 EU/mL |
| GSK257049 Comparator [5-17M] Group | Antibody Concentrations Against Against Plasmodium Falciparum Circumsporozoite (Anti-CS) | At Year 2 of Malaria-076 | 6.8 EU/mL |
| VeroRab Comparator [5-17M] Group | Antibody Concentrations Against Against Plasmodium Falciparum Circumsporozoite (Anti-CS) | At Month 21 of Malaria-055 | 0.3 EU/mL |
| VeroRab Comparator [5-17M] Group | Antibody Concentrations Against Against Plasmodium Falciparum Circumsporozoite (Anti-CS) | At Month 20 of Malaria-055 | 0.3 EU/mL |
| VeroRab Comparator [5-17M] Group | Antibody Concentrations Against Against Plasmodium Falciparum Circumsporozoite (Anti-CS) | At Month 3 of Malaria-055 | 0.3 EU/mL |
| VeroRab Comparator [5-17M] Group | Antibody Concentrations Against Against Plasmodium Falciparum Circumsporozoite (Anti-CS) | At Year 1 of Malaria-076 | 1.3 EU/mL |
| VeroRab Comparator [5-17M] Group | Antibody Concentrations Against Against Plasmodium Falciparum Circumsporozoite (Anti-CS) | At Year 2 of Malaria-076 | 1.2 EU/mL |
| VeroRab Comparator [5-17M] Group | Antibody Concentrations Against Against Plasmodium Falciparum Circumsporozoite (Anti-CS) | At Month 32 of Malaria-055 | 0.3 EU/mL |
| VeroRab Comparator [5-17M] Group | Antibody Concentrations Against Against Plasmodium Falciparum Circumsporozoite (Anti-CS) | At Year 3 of Malaria-076 | 1.2 EU/mL |
| GSK257049 [6-12W] Group | Antibody Concentrations Against Against Plasmodium Falciparum Circumsporozoite (Anti-CS) | At Month 32 of Malaria-055 | 11.7 EU/mL |
| GSK257049 [6-12W] Group | Antibody Concentrations Against Against Plasmodium Falciparum Circumsporozoite (Anti-CS) | At Month 3 of Malaria-055 | 152.9 EU/mL |
| GSK257049 [6-12W] Group | Antibody Concentrations Against Against Plasmodium Falciparum Circumsporozoite (Anti-CS) | At Month 20 of Malaria-055 | 4.2 EU/mL |
| GSK257049 [6-12W] Group | Antibody Concentrations Against Against Plasmodium Falciparum Circumsporozoite (Anti-CS) | At Month 21 of Malaria-055 | 149.3 EU/mL |
| GSK257049 [6-12W] Group | Antibody Concentrations Against Against Plasmodium Falciparum Circumsporozoite (Anti-CS) | At Year 1 of Malaria-076 | 5.9 EU/mL |
| GSK257049 [6-12W] Group | Antibody Concentrations Against Against Plasmodium Falciparum Circumsporozoite (Anti-CS) | At Year 2 of Malaria-076 | 5.4 EU/mL |
| GSK257049 [6-12W] Group | Antibody Concentrations Against Against Plasmodium Falciparum Circumsporozoite (Anti-CS) | At Year 3 of Malaria-076 | 3.9 EU/mL |
| GSK257049 Comparator [6-12W] Group | Antibody Concentrations Against Against Plasmodium Falciparum Circumsporozoite (Anti-CS) | At Month 21 of Malaria-055 | 5.3 EU/mL |
| GSK257049 Comparator [6-12W] Group | Antibody Concentrations Against Against Plasmodium Falciparum Circumsporozoite (Anti-CS) | At Month 20 of Malaria-055 | 5.5 EU/mL |
| GSK257049 Comparator [6-12W] Group | Antibody Concentrations Against Against Plasmodium Falciparum Circumsporozoite (Anti-CS) | At Year 3 of Malaria-076 | 2.2 EU/mL |
| GSK257049 Comparator [6-12W] Group | Antibody Concentrations Against Against Plasmodium Falciparum Circumsporozoite (Anti-CS) | At Month 3 of Malaria-055 | 169.0 EU/mL |
| GSK257049 Comparator [6-12W] Group | Antibody Concentrations Against Against Plasmodium Falciparum Circumsporozoite (Anti-CS) | At Year 2 of Malaria-076 | 2.4 EU/mL |
| GSK257049 Comparator [6-12W] Group | Antibody Concentrations Against Against Plasmodium Falciparum Circumsporozoite (Anti-CS) | At Month 32 of Malaria-055 | 3.6 EU/mL |
| GSK257049 Comparator [6-12W] Group | Antibody Concentrations Against Against Plasmodium Falciparum Circumsporozoite (Anti-CS) | At Year 1 of Malaria-076 | 2.5 EU/mL |
| Menjugate Comparator [6-12W] Group | Antibody Concentrations Against Against Plasmodium Falciparum Circumsporozoite (Anti-CS) | At Year 3 of Malaria-076 | 1.2 EU/mL |
| Menjugate Comparator [6-12W] Group | Antibody Concentrations Against Against Plasmodium Falciparum Circumsporozoite (Anti-CS) | At Year 1 of Malaria-076 | 1.4 EU/mL |
| Menjugate Comparator [6-12W] Group | Antibody Concentrations Against Against Plasmodium Falciparum Circumsporozoite (Anti-CS) | At Month 21 of Malaria-055 | 0.3 EU/mL |
| Menjugate Comparator [6-12W] Group | Antibody Concentrations Against Against Plasmodium Falciparum Circumsporozoite (Anti-CS) | At Month 20 of Malaria-055 | 0.3 EU/mL |
| Menjugate Comparator [6-12W] Group | Antibody Concentrations Against Against Plasmodium Falciparum Circumsporozoite (Anti-CS) | At Year 2 of Malaria-076 | 1.2 EU/mL |
| Menjugate Comparator [6-12W] Group | Antibody Concentrations Against Against Plasmodium Falciparum Circumsporozoite (Anti-CS) | At Month 3 of Malaria-055 | 0.3 EU/mL |
| Menjugate Comparator [6-12W] Group | Antibody Concentrations Against Against Plasmodium Falciparum Circumsporozoite (Anti-CS) | At Month 32 of Malaria-055 | 0.4 EU/mL |
Secondary
Incidence of Clinical Malaria Meeting Case Definition
Clinical malaria was defined as an episode of malaria with positive Plasmodium falciparum asexual parasitemia, accompanied by the presence of fever (axillary temperature ≥ 37.5°C ) at the time of presentation or history of fever within 24 hours of presentation and occurring in a child who was unwell and brought for treatment to a healthcare facility. The incidence of clinical malaria for case definition 1 is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years a t risk (T). Due to late protocol approvals and retrospective data collection the sites did not collect the data according to protocol and as such the case definition cannot be applied. For the final analysis, specific case definitions based on available data were developed.
Time frame: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)
Population: The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK257049 [5-17M] Group | Incidence of Clinical Malaria Meeting Case Definition | 1.079 events per person-year |
| GSK257049 Comparator [5-17M] Group | Incidence of Clinical Malaria Meeting Case Definition | 1.108 events per person-year |
| VeroRab Comparator [5-17M] Group | Incidence of Clinical Malaria Meeting Case Definition | 1.016 events per person-year |
| GSK257049 [6-12W] Group | Incidence of Clinical Malaria Meeting Case Definition | 1.632 events per person-year |
| GSK257049 Comparator [6-12W] Group | Incidence of Clinical Malaria Meeting Case Definition | 1.563 events per person-year |
| Menjugate Comparator [6-12W] Group | Incidence of Clinical Malaria Meeting Case Definition | 1.686 events per person-year |
Comparison: Vaccine efficacy (VE)/ incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).p-value: 0.443495% CI: [-20, 7.69]Negative binomial regression
Comparison: Vaccine efficacy (VE)/incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).p-value: 0.263495% CI: [-23.9, 5.7]Negative binomial regression
Comparison: Vaccine efficacy (VE)/ incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).p-value: 0.927895% CI: [-13.7, 13.13]Negative binomial regression
Comparison: Vaccine efficacy (VE)/ incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).p-value: 0.418995% CI: [-8.12, 17.09]Negative binomial regression
Secondary
Incidence of Clinical Malaria Meeting Case Definition
Clinical malaria was defined as an episode of malaria with positive Plasmodium falciparum asexual parasitemia, accompanied by the presence of fever (axillary temperature ≥ 37.5°C) at the time of presentation or history of fever within 24 hours of presentation and occurring in a child who was unwell and brought for treatment to a healthcare facility. The incidence of clinical malaria for case definition 1 is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years at risk (T). Due to late protocol approvals and retrospective data collection the sites did not collect the data according to protocol and as such the case definition cannot be applied. For the final analysis, specific case definitions based on available data were developed.
Time frame: From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076)
Population: The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received Dose 1 of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment on subjects from both studies.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK257049 [5-17M] Group | Incidence of Clinical Malaria Meeting Case Definition | 1.277 events per subject-year |
| GSK257049 Comparator [5-17M] Group | Incidence of Clinical Malaria Meeting Case Definition | 1.348 events per subject-year |
| VeroRab Comparator [5-17M] Group | Incidence of Clinical Malaria Meeting Case Definition | 1.555 events per subject-year |
| GSK257049 [6-12W] Group | Incidence of Clinical Malaria Meeting Case Definition | 1.662 events per subject-year |
| GSK257049 Comparator [6-12W] Group | Incidence of Clinical Malaria Meeting Case Definition | 1.723 events per subject-year |
| Menjugate Comparator [6-12W] Group | Incidence of Clinical Malaria Meeting Case Definition | 1.921 events per subject-year |
Comparison: Vaccine efficacy (VE)/incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).p-value: <0.000195% CI: [15.93, 30.71]Negative binomial regression
Comparison: Vaccine efficacy (VE)/incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).p-value: <0.000195% CI: [10.81, 26.71]Negative binomial regression
Comparison: Vaccine efficacy (VE)/incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).p-value: 0.000995% CI: [6.72, 23.54]Negative binomial regression
Comparison: Vaccine efficacy (VE)/incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).p-value: 0.005695% CI: [4.05, 21.39]Negative binomial regression
Secondary
Incidence of Severe Malaria Meeting Case Definition 1.
Case definition 1 for severe malaria was defined as an episode of malaria with positive Plasmodium falciparum asexual parasitemia (within -1 to +3 days of admission) and with one or more marker of disease severity: Prostration, respiratory distress, Blantyre score equal to or less than (≤) 2, seizures 2 or more, hypoglycemia below (\<) 2.2 millimoles per liter (mmol/L), acidosis BE ≤ -10.0 mmol/L, lactate ≥ 5.0 mmol/L or anemia \< 5.0 grams per deciliter (g/dL). The incidence of severe malaria for case definition 1 is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years at risk (T).
Time frame: From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076)
Population: The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received Dose 1 of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment on subjects from both studies.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK257049 [5-17M] Group | Incidence of Severe Malaria Meeting Case Definition 1. | 0.009 events per person-year |
| GSK257049 Comparator [5-17M] Group | Incidence of Severe Malaria Meeting Case Definition 1. | 0.016 events per person-year |
| VeroRab Comparator [5-17M] Group | Incidence of Severe Malaria Meeting Case Definition 1. | 0.015 events per person-year |
| GSK257049 [6-12W] Group | Incidence of Severe Malaria Meeting Case Definition 1. | 0.014 events per person-year |
| GSK257049 Comparator [6-12W] Group | Incidence of Severe Malaria Meeting Case Definition 1. | 0.013 events per person-year |
| Menjugate Comparator [6-12W] Group | Incidence of Severe Malaria Meeting Case Definition 1. | 0.02 events per person-year |
Comparison: Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).p-value: 0.007795% CI: [12.84, 59.39]Negative binomial regression
Comparison: Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).p-value: 0.792295% CI: [-45.3, 24.8]Negative binomial regression
Comparison: Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).p-value: 0.080295% CI: [-4.22, 51.67]Negative binomial regression
Comparison: Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).p-value: 0.038795% CI: [2.13, 55.32]Negative binomial regression
Secondary
Incidence of Severe Malaria Meeting Case Definition 2.
Case definition 2 for severe malaria was defined as an episode of malaria with positive Plasmodium falciparum asexual parasitemia (within -1 to +3 days of admission) and with one or more marker of disease severity: Prostration, respiratory distress, Blantyre score equal to or less than (≤) 2, seizures 2 or more, hypoglycemia below (\<) 2.2 millimoles per liter (mmol/L), acidosis BE ≤ -10.0 mmol/L, lactate ≥ 5.0 mmol/L or anemia \< 5.0 grams per deciliter (g/dL) or SAE report including preferred terms (Malaria, Plasmodium falciparum infection or Cerebral malaria) within -1 to +3 days of admission. The incidence of severe malaria for case definition 2 is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years at risk (T).
Time frame: From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076)
Population: The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received Dose 1 of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment on subjects from both studies.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK257049 [5-17M] Group | Incidence of Severe Malaria Meeting Case Definition 2. | 0.015 events per person-year |
| GSK257049 Comparator [5-17M] Group | Incidence of Severe Malaria Meeting Case Definition 2. | 0.021 events per person-year |
| VeroRab Comparator [5-17M] Group | Incidence of Severe Malaria Meeting Case Definition 2. | 0.023 events per person-year |
| GSK257049 [6-12W] Group | Incidence of Severe Malaria Meeting Case Definition 2. | 0.019 events per person-year |
| GSK257049 Comparator [6-12W] Group | Incidence of Severe Malaria Meeting Case Definition 2. | 0.019 events per person-year |
| Menjugate Comparator [6-12W] Group | Incidence of Severe Malaria Meeting Case Definition 2. | 0.028 events per person-year |
Comparison: Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).p-value: 0.002895% CI: [14.6, 53.07]Negative binomial regression
Comparison: Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).p-value: 0.44395% CI: [-18.1, 31.64]Negative binomial regression
Comparison: Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).p-value: 0.024595% CI: [4.67, 50.04]Negative binomial regression
Comparison: Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).p-value: 0.012295% CI: [8.74, 52.61]Negative binomial regression
Secondary
Number of Subjects Reporting Any Potential Immune-mediated Disorders (pIMDs) SAEs
Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Regardless of it being considered an AE or an SAE, it should have been reported per the SAE reporting rules.
Time frame: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)
Population: The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received Dose 1 of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK257049 [5-17M] Group | Number of Subjects Reporting Any Potential Immune-mediated Disorders (pIMDs) SAEs | 0 Participants |
| GSK257049 Comparator [5-17M] Group | Number of Subjects Reporting Any Potential Immune-mediated Disorders (pIMDs) SAEs | 0 Participants |
| VeroRab Comparator [5-17M] Group | Number of Subjects Reporting Any Potential Immune-mediated Disorders (pIMDs) SAEs | 0 Participants |
| GSK257049 [6-12W] Group | Number of Subjects Reporting Any Potential Immune-mediated Disorders (pIMDs) SAEs | 0 Participants |
| GSK257049 Comparator [6-12W] Group | Number of Subjects Reporting Any Potential Immune-mediated Disorders (pIMDs) SAEs | 0 Participants |
| Menjugate Comparator [6-12W] Group | Number of Subjects Reporting Any Potential Immune-mediated Disorders (pIMDs) SAEs | 0 Participants |
Secondary
Number of Subjects Reporting Any, Related, Malaria and Fatal Serious Adverse Events (SAEs)
Malaria SAEs were defined as SAEs coded by MedDRA preferred term level as 'malaria', 'Plasmodium falciparum infection' or 'cerebral malaria. A serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization or resulted in disability/incapacity. SAEs disclosed in this outcome are any SAEs , fatal SAEs, those that were related to vaccine administration in the primary study MALARIA-055 PRI (110021) and malaria hospitalization.
Time frame: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)
Population: The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK257049 [5-17M] Group | Number of Subjects Reporting Any, Related, Malaria and Fatal Serious Adverse Events (SAEs) | Any SAE(s) | 20 Participants |
| GSK257049 [5-17M] Group | Number of Subjects Reporting Any, Related, Malaria and Fatal Serious Adverse Events (SAEs) | Related SAE(s) | 0 Participants |
| GSK257049 [5-17M] Group | Number of Subjects Reporting Any, Related, Malaria and Fatal Serious Adverse Events (SAEs) | Malaria SAE(s) | 19 Participants |
| GSK257049 [5-17M] Group | Number of Subjects Reporting Any, Related, Malaria and Fatal Serious Adverse Events (SAEs) | Fatal SAE(s) | 2 Participants |
| GSK257049 Comparator [5-17M] Group | Number of Subjects Reporting Any, Related, Malaria and Fatal Serious Adverse Events (SAEs) | Malaria SAE(s) | 20 Participants |
| GSK257049 Comparator [5-17M] Group | Number of Subjects Reporting Any, Related, Malaria and Fatal Serious Adverse Events (SAEs) | Any SAE(s) | 25 Participants |
| GSK257049 Comparator [5-17M] Group | Number of Subjects Reporting Any, Related, Malaria and Fatal Serious Adverse Events (SAEs) | Related SAE(s) | 0 Participants |
| GSK257049 Comparator [5-17M] Group | Number of Subjects Reporting Any, Related, Malaria and Fatal Serious Adverse Events (SAEs) | Fatal SAE(s) | 7 Participants |
| VeroRab Comparator [5-17M] Group | Number of Subjects Reporting Any, Related, Malaria and Fatal Serious Adverse Events (SAEs) | Related SAE(s) | 0 Participants |
| VeroRab Comparator [5-17M] Group | Number of Subjects Reporting Any, Related, Malaria and Fatal Serious Adverse Events (SAEs) | Malaria SAE(s) | 24 Participants |
| VeroRab Comparator [5-17M] Group | Number of Subjects Reporting Any, Related, Malaria and Fatal Serious Adverse Events (SAEs) | Any SAE(s) | 27 Participants |
| VeroRab Comparator [5-17M] Group | Number of Subjects Reporting Any, Related, Malaria and Fatal Serious Adverse Events (SAEs) | Fatal SAE(s) | 5 Participants |
| GSK257049 [6-12W] Group | Number of Subjects Reporting Any, Related, Malaria and Fatal Serious Adverse Events (SAEs) | Any SAE(s) | 19 Participants |
| GSK257049 [6-12W] Group | Number of Subjects Reporting Any, Related, Malaria and Fatal Serious Adverse Events (SAEs) | Related SAE(s) | 0 Participants |
| GSK257049 [6-12W] Group | Number of Subjects Reporting Any, Related, Malaria and Fatal Serious Adverse Events (SAEs) | Malaria SAE(s) | 17 Participants |
| GSK257049 [6-12W] Group | Number of Subjects Reporting Any, Related, Malaria and Fatal Serious Adverse Events (SAEs) | Fatal SAE(s) | 3 Participants |
| GSK257049 Comparator [6-12W] Group | Number of Subjects Reporting Any, Related, Malaria and Fatal Serious Adverse Events (SAEs) | Malaria SAE(s) | 16 Participants |
| GSK257049 Comparator [6-12W] Group | Number of Subjects Reporting Any, Related, Malaria and Fatal Serious Adverse Events (SAEs) | Any SAE(s) | 18 Participants |
| GSK257049 Comparator [6-12W] Group | Number of Subjects Reporting Any, Related, Malaria and Fatal Serious Adverse Events (SAEs) | Related SAE(s) | 0 Participants |
| GSK257049 Comparator [6-12W] Group | Number of Subjects Reporting Any, Related, Malaria and Fatal Serious Adverse Events (SAEs) | Fatal SAE(s) | 3 Participants |
| Menjugate Comparator [6-12W] Group | Number of Subjects Reporting Any, Related, Malaria and Fatal Serious Adverse Events (SAEs) | Fatal SAE(s) | 2 Participants |
| Menjugate Comparator [6-12W] Group | Number of Subjects Reporting Any, Related, Malaria and Fatal Serious Adverse Events (SAEs) | Malaria SAE(s) | 24 Participants |
| Menjugate Comparator [6-12W] Group | Number of Subjects Reporting Any, Related, Malaria and Fatal Serious Adverse Events (SAEs) | Any SAE(s) | 25 Participants |
| Menjugate Comparator [6-12W] Group | Number of Subjects Reporting Any, Related, Malaria and Fatal Serious Adverse Events (SAEs) | Related SAE(s) | 0 Participants |
Secondary
Number of Subjects With Cerebral Malaria
Cerebral malaria was defined as a positive P. falciparum asexual parasitemia (within -1 to +3 days of admission), accompanied either by the presence of a marker of disease severity (a Blantyre score ≤ 2) or a SAE report with 'cerebral malaria' as preferred term.
Time frame: From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).
Population: The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received Dose 1 of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment on subjects from both studies.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK257049 [5-17M] Group | Number of Subjects With Cerebral Malaria | 4 Participants |
| GSK257049 Comparator [5-17M] Group | Number of Subjects With Cerebral Malaria | 10 Participants |
| VeroRab Comparator [5-17M] Group | Number of Subjects With Cerebral Malaria | 2 Participants |
| GSK257049 [6-12W] Group | Number of Subjects With Cerebral Malaria | 3 Participants |
| GSK257049 Comparator [6-12W] Group | Number of Subjects With Cerebral Malaria | 2 Participants |
| Menjugate Comparator [6-12W] Group | Number of Subjects With Cerebral Malaria | 0 Participants |
Comparison: Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).p-value: 0.686995% CI: [-2098, 71.5]Two-sided Fisher Exact test
Comparison: Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).p-value: 0.021395% CI: [-4650, -7.8]Two-sided Fisher Exact test
Secondary
Number of Subjects With Cerebral Malaria Meeting Both Case Definitions.
Cerebral malaria was defined as a positive P. falciparum asexual parasitemia (within -1 to +3 days of admission), accompanied either by the presence of a marker of disease severity (a Blantyre score ≤ 2) or a SAE report with 'cerebral malaria' as preferred term.
Time frame: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)
Population: The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK257049 [5-17M] Group | Number of Subjects With Cerebral Malaria Meeting Both Case Definitions. | 0 Participants |
| GSK257049 Comparator [5-17M] Group | Number of Subjects With Cerebral Malaria Meeting Both Case Definitions. | 2 Participants |
| VeroRab Comparator [5-17M] Group | Number of Subjects With Cerebral Malaria Meeting Both Case Definitions. | 0 Participants |
| GSK257049 [6-12W] Group | Number of Subjects With Cerebral Malaria Meeting Both Case Definitions. | 1 Participants |
| GSK257049 Comparator [6-12W] Group | Number of Subjects With Cerebral Malaria Meeting Both Case Definitions. | 0 Participants |
| Menjugate Comparator [6-12W] Group | Number of Subjects With Cerebral Malaria Meeting Both Case Definitions. | 0 Participants |
Secondary
Number of Subjects With Fatal Malaria Meeting Case Definition 1.
Fatal malaria, case definition 1, was defined as a SAE report with preferred terms 'malaria', 'plasmodium falciparum infection', 'cerebral malaria' with confirmed positive Plasmodium falciparum asexual parasitemia associated with a fatal outcome (excludes planned admissions for medical investigation/care or elective surgery and trauma).
Time frame: From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).
Population: The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received Dose 1 of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment on subjects from both studies.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK257049 [5-17M] Group | Number of Subjects With Fatal Malaria Meeting Case Definition 1. | 2 Participants |
| GSK257049 Comparator [5-17M] Group | Number of Subjects With Fatal Malaria Meeting Case Definition 1. | 4 Participants |
| VeroRab Comparator [5-17M] Group | Number of Subjects With Fatal Malaria Meeting Case Definition 1. | 1 Participants |
| GSK257049 [6-12W] Group | Number of Subjects With Fatal Malaria Meeting Case Definition 1. | 1 Participants |
| GSK257049 Comparator [6-12W] Group | Number of Subjects With Fatal Malaria Meeting Case Definition 1. | 2 Participants |
| Menjugate Comparator [6-12W] Group | Number of Subjects With Fatal Malaria Meeting Case Definition 1. | 0 Participants |
Comparison: Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).p-value: 195% CI: [-12000, 89.6]Two-sided Fisher Exact test
Comparison: Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).p-value: 0.215495% CI: [-20000, 59.9]Two-sided Fisher Exact test
Secondary
Number of Subjects With Fatal Malaria Meeting Case Definition 1.
Fatal malaria, case definition 1, was defined as a SAE report with preferred terms 'malaria', 'plasmodium falciparum infection', 'cerebral malaria' with confirmed positive Plasmodium falciparum asexual parasitemia associated with a fatal outcome (excludes planned admissions for medical investigation/care or elective surgery and trauma).
Time frame: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)
Population: The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK257049 [5-17M] Group | Number of Subjects With Fatal Malaria Meeting Case Definition 1. | 1 Participants |
| GSK257049 Comparator [5-17M] Group | Number of Subjects With Fatal Malaria Meeting Case Definition 1. | 2 Participants |
| VeroRab Comparator [5-17M] Group | Number of Subjects With Fatal Malaria Meeting Case Definition 1. | 0 Participants |
| GSK257049 [6-12W] Group | Number of Subjects With Fatal Malaria Meeting Case Definition 1. | 0 Participants |
| GSK257049 Comparator [6-12W] Group | Number of Subjects With Fatal Malaria Meeting Case Definition 1. | 0 Participants |
| Menjugate Comparator [6-12W] Group | Number of Subjects With Fatal Malaria Meeting Case Definition 1. | 0 Participants |
Secondary
Number of Subjects With Fatal Malaria Meeting Case Definition 2.
Fatal malaria, case definition 2, was defined as a SAE report with preferred terms 'malaria', 'plasmodium falciparum infection', 'cerebral malaria' associated with a fatal outcome.
Time frame: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)
Population: The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK257049 [5-17M] Group | Number of Subjects With Fatal Malaria Meeting Case Definition 2. | 1 Participants |
| GSK257049 Comparator [5-17M] Group | Number of Subjects With Fatal Malaria Meeting Case Definition 2. | 2 Participants |
| VeroRab Comparator [5-17M] Group | Number of Subjects With Fatal Malaria Meeting Case Definition 2. | 2 Participants |
| GSK257049 [6-12W] Group | Number of Subjects With Fatal Malaria Meeting Case Definition 2. | 3 Participants |
| GSK257049 Comparator [6-12W] Group | Number of Subjects With Fatal Malaria Meeting Case Definition 2. | 1 Participants |
| Menjugate Comparator [6-12W] Group | Number of Subjects With Fatal Malaria Meeting Case Definition 2. | 1 Participants |
Comparison: Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group) over the entire follow-up period (from Year 0 to Year 3).p-value: 0.624495% CI: [-859, 99.2]Two-sided Fisher Exact test
Comparison: Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group) over the entire follow-up period (from Year 0 to Year 3).p-value: 195% CI: [-1358, 92.3]Two-sided Fisher Exact test
Comparison: Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group) over the entire follow-up period (from Year 0 to Year 3).p-value: 0.624495% CI: [-15000, 76.8]Two-sided Fisher Exact test
Comparison: Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group) over the entire follow-up period (from Year 0 to Year 3).p-value: 195% CI: [-7509, 98.8]Two-sided Fisher Exact test
Secondary
Number of Subjects With Fatal Malaria Meeting Case Definition 2.
Fatal malaria, case definition 2, was defined as a SAE report with preferred terms 'malaria', 'plasmodium falciparum infection', 'cerebral malaria' associated with a fatal outcome.
Time frame: From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).
Population: The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received Dose 1 of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment on subjects from both studies.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK257049 [5-17M] Group | Number of Subjects With Fatal Malaria Meeting Case Definition 2. | 5 Participants |
| GSK257049 Comparator [5-17M] Group | Number of Subjects With Fatal Malaria Meeting Case Definition 2. | 7 Participants |
| VeroRab Comparator [5-17M] Group | Number of Subjects With Fatal Malaria Meeting Case Definition 2. | 4 Participants |
| GSK257049 [6-12W] Group | Number of Subjects With Fatal Malaria Meeting Case Definition 2. | 4 Participants |
| GSK257049 Comparator [6-12W] Group | Number of Subjects With Fatal Malaria Meeting Case Definition 2. | 6 Participants |
| Menjugate Comparator [6-12W] Group | Number of Subjects With Fatal Malaria Meeting Case Definition 2. | 1 Participants |
Comparison: Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).p-value: 195% CI: [-526, 73.3]Two-sided Fisher Exact test
Comparison: Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).p-value: 0.383495% CI: [-725, 55]Two-sided Fisher Exact test
Comparison: Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).p-value: 0.37495% CI: [-19000, 60.7]Two-sided Fisher Exact test
Comparison: Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).p-value: 0.12495% CI: [-27000, 27.4]Two-sided Fisher Exact test
Secondary
Number of Subjects With Malaria Hospitalization Meeting Case Definition 1.
Malaria hospitalization, case definition 1, was defined as a medical hospitalization with confirmed positive Plasmodium falciparum asexual parasitemia (excludes planned admissions for medical investigation/care or elective surgery and trauma).
Time frame: From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076)
Population: The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received Dose 1 of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment on subjects from both studies.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK257049 [5-17M] Group | Number of Subjects With Malaria Hospitalization Meeting Case Definition 1. | 61 Participants |
| GSK257049 Comparator [5-17M] Group | Number of Subjects With Malaria Hospitalization Meeting Case Definition 1. | 82 Participants |
| VeroRab Comparator [5-17M] Group | Number of Subjects With Malaria Hospitalization Meeting Case Definition 1. | 94 Participants |
| GSK257049 [6-12W] Group | Number of Subjects With Malaria Hospitalization Meeting Case Definition 1. | 52 Participants |
| GSK257049 Comparator [6-12W] Group | Number of Subjects With Malaria Hospitalization Meeting Case Definition 1. | 60 Participants |
| Menjugate Comparator [6-12W] Group | Number of Subjects With Malaria Hospitalization Meeting Case Definition 1. | 73 Participants |
Comparison: Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).p-value: 0.005395% CI: [10, 54]Two-sided Fisher Exact test
Comparison: Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group), Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).p-value: 0.425595% CI: [-20, 35.2]Two-sided Fisher Exact test
Comparison: Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).p-value: 0.047995% CI: [-2.4, 51.4]Two-sided Fisher Exact test
Comparison: Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).p-value: 0.234695% CI: [-16.9, 42.8]Two-sided Fisher Exact test
Secondary
Number of Subjects With Malaria Hospitalization Meeting Case Definition 1.
Malaria hospitalization, case definition 1, was defined as a medical hospitalization with confirmed positive Plasmodium falciparum asexual parasitemia (excludes planned admissions for medical investigation/care or elective surgery and trauma).
Time frame: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)
Population: The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK257049 [5-17M] Group | Number of Subjects With Malaria Hospitalization Meeting Case Definition 1. | 7 Participants |
| GSK257049 Comparator [5-17M] Group | Number of Subjects With Malaria Hospitalization Meeting Case Definition 1. | 11 Participants |
| VeroRab Comparator [5-17M] Group | Number of Subjects With Malaria Hospitalization Meeting Case Definition 1. | 14 Participants |
| GSK257049 [6-12W] Group | Number of Subjects With Malaria Hospitalization Meeting Case Definition 1. | 10 Participants |
| GSK257049 Comparator [6-12W] Group | Number of Subjects With Malaria Hospitalization Meeting Case Definition 1. | 10 Participants |
| Menjugate Comparator [6-12W] Group | Number of Subjects With Malaria Hospitalization Meeting Case Definition 1. | 13 Participants |
Comparison: Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group) over the entire follow-up period (from Year 0 to Year 3).p-value: 0.130295% CI: [-32.2, 82.9]Two-sided Fisher Exact test
Comparison: Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group) over the entire follow-up period (from Year 0 to Year 3).p-value: 0.689795% CI: [-96.9, 65.9]Two-sided Fisher Exact test
Comparison: Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group) over the entire follow-up period (from Year 0 to Year 3).p-value: 0.529995% CI: [-82.9, 70.9]Two-sided Fisher Exact test
Comparison: Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group) over the entire follow-up period (from Year 0 to Year 3).p-value: 0.530795% CI: [-84.1, 70.7]Two-sided Fisher Exact test
Secondary
Number of Subjects With Malaria Hospitalization Meeting Case Definition 2.
Malaria hospitalization, case definition 2, was defined as a hospitalization for which, in the judgment of the principal investigator, Plasmodium falciparum infection was the sole or a major contributing factor to the presentation.
Time frame: From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).
Population: The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received Dose 1 of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment on subjects from both studies.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK257049 [5-17M] Group | Number of Subjects With Malaria Hospitalization Meeting Case Definition 2. | 60 Participants |
| GSK257049 Comparator [5-17M] Group | Number of Subjects With Malaria Hospitalization Meeting Case Definition 2. | 79 Participants |
| VeroRab Comparator [5-17M] Group | Number of Subjects With Malaria Hospitalization Meeting Case Definition 2. | 93 Participants |
| GSK257049 [6-12W] Group | Number of Subjects With Malaria Hospitalization Meeting Case Definition 2. | 54 Participants |
| GSK257049 Comparator [6-12W] Group | Number of Subjects With Malaria Hospitalization Meeting Case Definition 2. | 60 Participants |
| Menjugate Comparator [6-12W] Group | Number of Subjects With Malaria Hospitalization Meeting Case Definition 2. | 75 Participants |
Comparison: Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).p-value: 0.005195% CI: [10.3, 54.4]Two-sided Fisher Exact test
Comparison: Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).p-value: 0.33495% CI: [-17.3, 37.1]Two-sided Fisher Exact test
Comparison: Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Meenjugate Comparator \[6-12W\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).p-value: 0.051195% CI: [-2.9, 50.5]Two-sided Fisher Exact test
Comparison: Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Meenjugate Comparator \[6-12W\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).p-value: 0.172995% CI: [-13.5, 44.2]Two-sided Fisher Exact test
Secondary
Number of Subjects With Malaria Hospitalization Meeting Case Definition 2.
Malaria hospitalization, case definition 2, was defined as a hospitalization for which, in the judgment of the principal investigator, Plasmodium falciparum infection was the sole or a major contributing factor to the presentation.
Time frame: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)
Population: The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK257049 [5-17M] Group | Number of Subjects With Malaria Hospitalization Meeting Case Definition 2. | 7 Participants |
| GSK257049 Comparator [5-17M] Group | Number of Subjects With Malaria Hospitalization Meeting Case Definition 2. | 8 Participants |
| VeroRab Comparator [5-17M] Group | Number of Subjects With Malaria Hospitalization Meeting Case Definition 2. | 13 Participants |
| GSK257049 [6-12W] Group | Number of Subjects With Malaria Hospitalization Meeting Case Definition 2. | 10 Participants |
| GSK257049 Comparator [6-12W] Group | Number of Subjects With Malaria Hospitalization Meeting Case Definition 2. | 9 Participants |
| Menjugate Comparator [6-12W] Group | Number of Subjects With Malaria Hospitalization Meeting Case Definition 2. | 14 Participants |
Comparison: Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group) over the entire follow-up period (from Year 0 to Year 3).p-value: 0.185395% CI: [-45, 81.8]Two-sided Fisher Exact test
Comparison: Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group) over the entire follow-up period (from Year 0 to Year 3).p-value: 0.382895% CI: [-69.3, 76.6]Two-sided Fisher Exact test
Comparison: Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group) over the entire follow-up period (from Year 0 to Year 3).p-value: 0.411295% CI: [-66.5, 72.7]Two-sided Fisher Exact test
Comparison: Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group) over the entire follow-up period (from Year 0 to Year 3).p-value: 0.412195% CI: [-67.6, 72.5]Two-sided Fisher Exact test
Secondary
Number of Subjects With Meningitis SAEs
For the further evaluation of the safety signal of meningitis all the cases occurring during the study were reported as SAE. Meningitis is defined as an SAE coded at lowest level terms code, coded by MedDRA preferred term level as: 'meningitis', 'meningitis haemophilus', 'meningitis meningococcal', 'meningitis salmonella', 'meningitis pneumococcal', 'meningitis staphylococcal', 'meningitis tuberculous', 'meningitis herpes', 'meningitis candida', 'meningitis enterococcal', 'meningitis enteroviral', 'meningitis neonatal', 'meningitis toxoplasmal', 'meningitis mumps', 'meningitis cryptococcal', 'meningitis histoplasma', 'meningitis trypanosomal', 'Neurosyphilis', 'meningitis leptospiral', 'meningitis listeria', 'meningitis in sarcoidosis' (code in preferred term 'cerebral sarcoidosis'), 'meningitis bacterial', 'meningitis viral', 'meningitis aseptic', 'meningitis fungal'.
Time frame: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)
Population: The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK257049 [5-17M] Group | Number of Subjects With Meningitis SAEs | Meningitis | 0 Participants |
| GSK257049 [5-17M] Group | Number of Subjects With Meningitis SAEs | Meningitis meningococcal | 0 Participants |
| GSK257049 [5-17M] Group | Number of Subjects With Meningitis SAEs | Meningitis bacterial | 0 Participants |
| GSK257049 Comparator [5-17M] Group | Number of Subjects With Meningitis SAEs | Meningitis | 0 Participants |
| GSK257049 Comparator [5-17M] Group | Number of Subjects With Meningitis SAEs | Meningitis meningococcal | 0 Participants |
| GSK257049 Comparator [5-17M] Group | Number of Subjects With Meningitis SAEs | Meningitis bacterial | 0 Participants |
| VeroRab Comparator [5-17M] Group | Number of Subjects With Meningitis SAEs | Meningitis | 0 Participants |
| VeroRab Comparator [5-17M] Group | Number of Subjects With Meningitis SAEs | Meningitis meningococcal | 1 Participants |
| VeroRab Comparator [5-17M] Group | Number of Subjects With Meningitis SAEs | Meningitis bacterial | 0 Participants |
| GSK257049 [6-12W] Group | Number of Subjects With Meningitis SAEs | Meningitis | 1 Participants |
| GSK257049 [6-12W] Group | Number of Subjects With Meningitis SAEs | Meningitis meningococcal | 1 Participants |
| GSK257049 [6-12W] Group | Number of Subjects With Meningitis SAEs | Meningitis bacterial | 0 Participants |
| GSK257049 Comparator [6-12W] Group | Number of Subjects With Meningitis SAEs | Meningitis | 0 Participants |
| GSK257049 Comparator [6-12W] Group | Number of Subjects With Meningitis SAEs | Meningitis meningococcal | 0 Participants |
| GSK257049 Comparator [6-12W] Group | Number of Subjects With Meningitis SAEs | Meningitis bacterial | 0 Participants |
| Menjugate Comparator [6-12W] Group | Number of Subjects With Meningitis SAEs | Meningitis meningococcal | 0 Participants |
| Menjugate Comparator [6-12W] Group | Number of Subjects With Meningitis SAEs | Meningitis bacterial | 1 Participants |
| Menjugate Comparator [6-12W] Group | Number of Subjects With Meningitis SAEs | Meningitis | 1 Participants |
Secondary
Number of Subjects With Prevalent Moderate Anemia (Level of Hemoglobin <8g/dL)
Prevalent moderate anemia (PMA) was defined as a documented hemoglobin \< 8.0 g/dL, identified at an annual visit.
Time frame: At Years 1, 2 and 3
Population: The analysis was performed on the modified ITT population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study, with available results at the specified time-points. The analyses on the modified ITT population were performed per treatment assignment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK257049 [5-17M] Group | Number of Subjects With Prevalent Moderate Anemia (Level of Hemoglobin <8g/dL) | Prevalent moderate anemia, Year 2 | 7 Participants |
| GSK257049 [5-17M] Group | Number of Subjects With Prevalent Moderate Anemia (Level of Hemoglobin <8g/dL) | Prevalent moderate anemia, Year 1 | 7 Participants |
| GSK257049 [5-17M] Group | Number of Subjects With Prevalent Moderate Anemia (Level of Hemoglobin <8g/dL) | Prevalent moderate anemia, Year 3 | 4 Participants |
| GSK257049 Comparator [5-17M] Group | Number of Subjects With Prevalent Moderate Anemia (Level of Hemoglobin <8g/dL) | Prevalent moderate anemia, Year 2 | 10 Participants |
| GSK257049 Comparator [5-17M] Group | Number of Subjects With Prevalent Moderate Anemia (Level of Hemoglobin <8g/dL) | Prevalent moderate anemia, Year 1 | 9 Participants |
| GSK257049 Comparator [5-17M] Group | Number of Subjects With Prevalent Moderate Anemia (Level of Hemoglobin <8g/dL) | Prevalent moderate anemia, Year 3 | 4 Participants |
| VeroRab Comparator [5-17M] Group | Number of Subjects With Prevalent Moderate Anemia (Level of Hemoglobin <8g/dL) | Prevalent moderate anemia, Year 2 | 11 Participants |
| VeroRab Comparator [5-17M] Group | Number of Subjects With Prevalent Moderate Anemia (Level of Hemoglobin <8g/dL) | Prevalent moderate anemia, Year 1 | 2 Participants |
| VeroRab Comparator [5-17M] Group | Number of Subjects With Prevalent Moderate Anemia (Level of Hemoglobin <8g/dL) | Prevalent moderate anemia, Year 3 | 7 Participants |
| GSK257049 [6-12W] Group | Number of Subjects With Prevalent Moderate Anemia (Level of Hemoglobin <8g/dL) | Prevalent moderate anemia, Year 2 | 18 Participants |
| GSK257049 [6-12W] Group | Number of Subjects With Prevalent Moderate Anemia (Level of Hemoglobin <8g/dL) | Prevalent moderate anemia, Year 1 | 16 Participants |
| GSK257049 [6-12W] Group | Number of Subjects With Prevalent Moderate Anemia (Level of Hemoglobin <8g/dL) | Prevalent moderate anemia, Year 3 | 10 Participants |
| GSK257049 Comparator [6-12W] Group | Number of Subjects With Prevalent Moderate Anemia (Level of Hemoglobin <8g/dL) | Prevalent moderate anemia, Year 2 | 15 Participants |
| GSK257049 Comparator [6-12W] Group | Number of Subjects With Prevalent Moderate Anemia (Level of Hemoglobin <8g/dL) | Prevalent moderate anemia, Year 1 | 6 Participants |
| GSK257049 Comparator [6-12W] Group | Number of Subjects With Prevalent Moderate Anemia (Level of Hemoglobin <8g/dL) | Prevalent moderate anemia, Year 3 | 6 Participants |
| Menjugate Comparator [6-12W] Group | Number of Subjects With Prevalent Moderate Anemia (Level of Hemoglobin <8g/dL) | Prevalent moderate anemia, Year 1 | 11 Participants |
| Menjugate Comparator [6-12W] Group | Number of Subjects With Prevalent Moderate Anemia (Level of Hemoglobin <8g/dL) | Prevalent moderate anemia, Year 3 | 8 Participants |
| Menjugate Comparator [6-12W] Group | Number of Subjects With Prevalent Moderate Anemia (Level of Hemoglobin <8g/dL) | Prevalent moderate anemia, Year 2 | 8 Participants |
Comparison: Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).p-value: 0.102595% CI: [-3399, 32.5]Two-sided Fisher Exact test
Comparison: Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).p-value: 0.028495% CI: [-4642, -3.2]Two-sided Fisher Exact test
Comparison: Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).p-value: 0.354395% CI: [-78.8, 79.2]Two-sided Fisher Exact test
Comparison: Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).p-value: 195% CI: [-151, 63.2]Two-sided Fisher Exact test
Comparison: Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).p-value: 0.380995% CI: [-120, 88]Two-sided Fisher Exact test
Comparison: Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).p-value: 0.54995% CI: [-140, 86.9]Two-sided Fisher Exact test
Comparison: Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).p-value: 0.323995% CI: [-249, 36.2]Two-sided Fisher Exact test
Comparison: Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).p-value: 0.218495% CI: [-54.5, 84.1]Two-sided Fisher Exact test
Comparison: Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).p-value: 0.072495% CI: [-476, 10.3]Two-sided Fisher Exact test
Comparison: Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).p-value: 0.205595% CI: [-393, 27.9]Two-sided Fisher Exact test
Comparison: Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).p-value: 0.813895% CI: [-245, 57.9]Two-sided Fisher Exact test
Comparison: Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).p-value: 0.788795% CI: [-148, 78.4]Two-sided Fisher Exact test
Secondary
Number of Subjects With Prevalent Parasitemia
Prevalent parasitemia (PP) was defined as a documented Plasmodium falciparum asexual parasite density greater than (\>) 0 parasites/µL, identified at an annual visit.
Time frame: At Years 1, 2 and 3
Population: The analysis was performed on the modified ITT population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study, with available results at the specified time-points. The analyses on the modified ITT population were performed per treatment assignment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK257049 [5-17M] Group | Number of Subjects With Prevalent Parasitemia | Prevalent parasitemia, Year 2 | 132 Participants |
| GSK257049 [5-17M] Group | Number of Subjects With Prevalent Parasitemia | Prevalent parasitemia, Year 1 | 52 Participants |
| GSK257049 [5-17M] Group | Number of Subjects With Prevalent Parasitemia | Prevalent parasitemia, Year 3 | 135 Participants |
| GSK257049 Comparator [5-17M] Group | Number of Subjects With Prevalent Parasitemia | Prevalent parasitemia, Year 2 | 127 Participants |
| GSK257049 Comparator [5-17M] Group | Number of Subjects With Prevalent Parasitemia | Prevalent parasitemia, Year 1 | 46 Participants |
| GSK257049 Comparator [5-17M] Group | Number of Subjects With Prevalent Parasitemia | Prevalent parasitemia, Year 3 | 148 Participants |
| VeroRab Comparator [5-17M] Group | Number of Subjects With Prevalent Parasitemia | Prevalent parasitemia, Year 2 | 156 Participants |
| VeroRab Comparator [5-17M] Group | Number of Subjects With Prevalent Parasitemia | Prevalent parasitemia, Year 1 | 89 Participants |
| VeroRab Comparator [5-17M] Group | Number of Subjects With Prevalent Parasitemia | Prevalent parasitemia, Year 3 | 158 Participants |
| GSK257049 [6-12W] Group | Number of Subjects With Prevalent Parasitemia | Prevalent parasitemia, Year 2 | 116 Participants |
| GSK257049 [6-12W] Group | Number of Subjects With Prevalent Parasitemia | Prevalent parasitemia, Year 1 | 48 Participants |
| GSK257049 [6-12W] Group | Number of Subjects With Prevalent Parasitemia | Prevalent parasitemia, Year 3 | 106 Participants |
| GSK257049 Comparator [6-12W] Group | Number of Subjects With Prevalent Parasitemia | Prevalent parasitemia, Year 2 | 133 Participants |
| GSK257049 Comparator [6-12W] Group | Number of Subjects With Prevalent Parasitemia | Prevalent parasitemia, Year 1 | 65 Participants |
| GSK257049 Comparator [6-12W] Group | Number of Subjects With Prevalent Parasitemia | Prevalent parasitemia, Year 3 | 105 Participants |
| Menjugate Comparator [6-12W] Group | Number of Subjects With Prevalent Parasitemia | Prevalent parasitemia, Year 1 | 61 Participants |
| Menjugate Comparator [6-12W] Group | Number of Subjects With Prevalent Parasitemia | Prevalent parasitemia, Year 3 | 99 Participants |
| Menjugate Comparator [6-12W] Group | Number of Subjects With Prevalent Parasitemia | Prevalent parasitemia, Year 2 | 123 Participants |
Comparison: Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).p-value: <0.000195% CI: [15.7, 58.8]Two-sided Fisher Exact test
Comparison: Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).p-value: <0.000195% CI: [17.4, 60.8]Two-sided Fisher Exact test
Comparison: Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).p-value: 0.088395% CI: [-6.6, 33.9]Two-sided Fisher Exact test
Comparison: Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).p-value: 0.188995% CI: [-10.7, 31.7]Two-sided Fisher Exact test
Comparison: Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).p-value: 0.07795% CI: [-5.9, 34]Two-sided Fisher Exact test
Comparison: Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).p-value: 195% CI: [-25.8, 20.7]Two-sided Fisher Exact test
Comparison: Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).p-value: 0.162495% CI: [-17.5, 46.9]Two-sided Fisher Exact test
Comparison: Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).p-value: 0.911295% CI: [-47.6, 29]Two-sided Fisher Exact test
Comparison: Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).p-value: 0.402395% CI: [-18, 30.1]Two-sided Fisher Exact test
Comparison: Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).p-value: 0.709195% CI: [-34.5, 18.9]Two-sided Fisher Exact test
Comparison: Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).p-value: 0.936195% CI: [-34.7, 23.6]Two-sided Fisher Exact test
Comparison: Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).p-value: 0.62895% CI: [-42, 19.6]Two-sided Fisher Exact test
Secondary
Number of Subjects With Prevalent Severe Anemia (Level of Hemoglobin <5g/dL)
Prevalent severe anemia (PSA) was defined as a documented hemoglobin lower than (\<) 5.0 grams per deciliter (g/dL), identified at an annual visit.
Time frame: At Years 1, 2 and 3
Population: The analysis was performed on the modified ITT population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study, with available results at the specified time-points. The analyses on the modified ITT population were performed per treatment assignment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK257049 [5-17M] Group | Number of Subjects With Prevalent Severe Anemia (Level of Hemoglobin <5g/dL) | Prevalent severe anemia, Year 2 | 0 Participants |
| GSK257049 [5-17M] Group | Number of Subjects With Prevalent Severe Anemia (Level of Hemoglobin <5g/dL) | Prevalent severe anemia, Year 3 | 0 Participants |
| GSK257049 [5-17M] Group | Number of Subjects With Prevalent Severe Anemia (Level of Hemoglobin <5g/dL) | Prevalent severe anemia, Year 1 | 0 Participants |
| GSK257049 Comparator [5-17M] Group | Number of Subjects With Prevalent Severe Anemia (Level of Hemoglobin <5g/dL) | Prevalent severe anemia, Year 2 | 0 Participants |
| GSK257049 Comparator [5-17M] Group | Number of Subjects With Prevalent Severe Anemia (Level of Hemoglobin <5g/dL) | Prevalent severe anemia, Year 3 | 0 Participants |
| GSK257049 Comparator [5-17M] Group | Number of Subjects With Prevalent Severe Anemia (Level of Hemoglobin <5g/dL) | Prevalent severe anemia, Year 1 | 0 Participants |
| VeroRab Comparator [5-17M] Group | Number of Subjects With Prevalent Severe Anemia (Level of Hemoglobin <5g/dL) | Prevalent severe anemia, Year 3 | 0 Participants |
| VeroRab Comparator [5-17M] Group | Number of Subjects With Prevalent Severe Anemia (Level of Hemoglobin <5g/dL) | Prevalent severe anemia, Year 1 | 0 Participants |
| VeroRab Comparator [5-17M] Group | Number of Subjects With Prevalent Severe Anemia (Level of Hemoglobin <5g/dL) | Prevalent severe anemia, Year 2 | 1 Participants |
| GSK257049 [6-12W] Group | Number of Subjects With Prevalent Severe Anemia (Level of Hemoglobin <5g/dL) | Prevalent severe anemia, Year 1 | 0 Participants |
| GSK257049 [6-12W] Group | Number of Subjects With Prevalent Severe Anemia (Level of Hemoglobin <5g/dL) | Prevalent severe anemia, Year 2 | 0 Participants |
| GSK257049 [6-12W] Group | Number of Subjects With Prevalent Severe Anemia (Level of Hemoglobin <5g/dL) | Prevalent severe anemia, Year 3 | 0 Participants |
| GSK257049 Comparator [6-12W] Group | Number of Subjects With Prevalent Severe Anemia (Level of Hemoglobin <5g/dL) | Prevalent severe anemia, Year 3 | 1 Participants |
| GSK257049 Comparator [6-12W] Group | Number of Subjects With Prevalent Severe Anemia (Level of Hemoglobin <5g/dL) | Prevalent severe anemia, Year 1 | 0 Participants |
| GSK257049 Comparator [6-12W] Group | Number of Subjects With Prevalent Severe Anemia (Level of Hemoglobin <5g/dL) | Prevalent severe anemia, Year 2 | 1 Participants |
| Menjugate Comparator [6-12W] Group | Number of Subjects With Prevalent Severe Anemia (Level of Hemoglobin <5g/dL) | Prevalent severe anemia, Year 2 | 0 Participants |
| Menjugate Comparator [6-12W] Group | Number of Subjects With Prevalent Severe Anemia (Level of Hemoglobin <5g/dL) | Prevalent severe anemia, Year 1 | 0 Participants |
| Menjugate Comparator [6-12W] Group | Number of Subjects With Prevalent Severe Anemia (Level of Hemoglobin <5g/dL) | Prevalent severe anemia, Year 3 | 0 Participants |
Comparison: Vaccine efficacy (VE) against prevalent severe anemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).p-value: 0.498795% CI: [-3779, 100]Two-sided Fisher Exact test
Comparison: Vaccine efficacy (VE) against prevalent severe anemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).p-value: 195% CI: [-4051, 100]Two-sided Fisher Exact test