Malaria
Conditions
Keywords
Plasmodium falciparum, schedule, HIV, malaria vaccine, EPI, Africa
Brief summary
The purpose of this study is to assess the safety and immunogenicity of the candidate malaria vaccine in HIV-infected infants and children
Detailed description
This protocol posting has been updated due to protocol Amendment 2.
Interventions
All infants enrolled to group A will receive 3 doses of the experimental vaccine. The vaccine will be administered intramuscularly.
BIOLOGICALHuman Diploid Cell Vaccine (HDCV) or Purified Vero Cell Rabies Vaccine (PVRV, Verorab) (Aventis Pasteur);
To ensure consistent vaccine availability, three cell culture rabies vaccines from two manufacturers may be sourced for this trial (Aventis-Pasteur and Novartis). It will be ensured that an individual child will receive all 3 doses of cell culture rabies vaccine from the same product. The vaccine will be administered intramuscularly
BIOLOGICALPurified Chick Embryo Cell Culture (PCEC) Rabies Vaccine (Rabipur or equivalent) (Novartis).
To ensure consistent vaccine availability, three cell culture rabies vaccines from two manufacturers may be sourced for this trial (Aventis-Pasteur and Novartis). It will be ensured that an individual child will receive all 3 doses of cell culture rabies vaccine from the same product. The vaccine will be administered intramuscularly.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 17 Months
Healthy volunteers
No
Inclusion criteria
All subjects must satisfy ALL the following criteria at study entry: * A male or female infant or child between and including 6 weeks to 17 months of age, at the time of first vaccination. * Signed or thumb-printed informed consent obtained from the parent(s)/LAR(s) of the infant or child. Where parents/LARs are illiterate, the consent form will be countersigned by a witness. * Subjects who the investigator believes that their parents/LARs can and will comply with the requirements of the protocol should be enrolled in the study. * Subjects who are known to be HIV-infected (documented positive DNA PCR), whether taking HIV antiretroviral treatment (ART) or not. * Subjects who are born following a normal gestation period.
Exclusion criteria
The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study: * Acute disease at the time of enrolment. However, the presence of an illness listed as Grade I or Grade II (WHO pediatric AIDS clinical staging) will not of itself constitute an exclusion criterion. Enrolment should be deferred if axillary temperature is \>=37.5°C. * Grade III or Grade IV abnormality on screening laboratory blood sample. * Grade III or IV AIDS at the time of enrolment (WHO pediatric AIDS clinical staging). * Major congenital defects. * Planned administration/administration of a vaccine not foreseen by the study protocol prior to or within 7 days of study vaccine. * Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine 30 days preceding Dose°1 of study vaccine, or planned use during the study period. * Previous participation in any other malaria vaccine trial. * Simultaneous participation in another clinical trial including administration of experimental treatment. * Same sex twins. * History of allergic reactions (significant IgE-mediated events) or anaphylaxis to previous immunizations. * History of allergic disease or reactions likely to be exacerbated by any component of the study vaccine. * Child in care.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Serious Adverse Events (SAEs) | During the entire study period (from 30 days before Dose 1 up to Month 14) | SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | During the 7-day post-vaccination period following each dose and across doses: Day 1 through Day 7, Month 1 through Month 1 + 7 days (Day 37), Month 2 through Month 2 + 7 days (Day 67) | Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 irritability/fussiness = crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as causally related to the study vaccination. |
| Number of Subjects With Any Unsolicited Adverse Events (AEs) | During the 30-day post-vaccination period (up to Day 90) | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. |
| Number of Subjects With Non-malaria Related SAEs | During the entire study period (from 30 days before vaccine Dose 1 up to Month 14) | SAEs (excluding malaria, cerebral malaria and P. falciparum parasitemia) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
| Anti-circumsporozoite Protein of P. Falciparum (Anti-CS) Antibody Concentrations | Prior to vaccination (PRE) and one month post Dose 3 (Month 3) | Anti-CS antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL). The reference seropositivity cut-off value was equal to or above (≥) 0.5 EL.U/mL. |
| Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Titers | Prior to vaccination (PRE) and one month post Dose 3 (Month 3) | Anti-HBs antibody titers are presented as geometric mean titers (GMTs), expressed in milliinternational units per milliliter (mIU/mL). |
| Anti-CS Antibody Concentrations | 12 months post Dose 3 (Month 14) | Anti-CS antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL). The reference seropositivity cut-off value was equal to or above (≥) 0.5 EL.U/mL. |
| Anti-HBs Antibody Titers | 12 months post Dose 3 (Month 14) | Anti-HBs antibody titers are presented as geometric mean titers (GMTs), expressed in mIU/mL. |
| Number of Episodes With Clinical Malaria Disease According to Primary Case Definition | From Day 0 to Month 14 | Primary case definition for clinical malaria: P. falciparum asexual parasitemia \> 2500 parasites/μL and presence of fever (axillary temperature ≥ 37.5°C) at the time of presentation and occurring in a child who was unwell and brought for treatment to a healthcare facility. |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | During the 7-day post-vaccination period following each dose and across doses: Day 1 through Day 7, Month 1 through Month 1 + 7 days (Day 37), Month 2 through Month 2 + 7 days (Day 67) | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond (\>) 20 millimeters (mm) of injection site. |
| Number of Subjects Affected by Prevalent Parasitemia and Prevalent Moderate Anemia | 12 months post Dose 3 (Month 14) | The number of subjects affected by prevalent asexual P. falciparum parasitemia and prevalent moderate anemia. Moderate anemia = hemoglobin \< 8 g/dL. |
| Asexual P. Falciparum Parasitemia Density | 12 months post Dose 3 (Month 14) | The number of subjects with a positive blood slide for asexual P. falciparum. |
| Prevalent Hemoglobin Level | 12 months post Dose 3 (Month 14) | The prevalent hemoglobin level in subjects with a positive blood slide is reported as grams per deciliter (g/dl). |
| HIV Viral Load | At baseline (PRE) and at one month (Month 3), 6 months (Month 8) and 12 months (Month 14) post Dose 3 | The HIV viral load is reported. Detectable HIV viral load: 400 or more copies/mL. |
| Percentage of CD4+ Cells | At baseline (PRE) and at one month (Month 3), 6 months (Month 8) and 12 months (Month 14) post Dose 3 | The percentage of CD4+ cells is reported. |
| CD4+ Absolute Cell Counts | At baseline (PRE) and at 1 month (Month 3), 6 months (Month 8) and 12 months (Month 14) post Dose 3 | The CD4+ absolute cell counts are reported. |
| World Health Organization (WHO) HIV Clinical Classification Progression | At baseline (PRE), at study months 1 (Month 1) and 2 (Month 2) and at 1 month (Month 3), 6 months (Month 8) and 12 months (Month 14) post Dose 3 | Clinical staging was done at each time point according to the WHO HIV/AIDS clinical staging system. Clinical stages included: * Stage 1 (asymptomatic or have persistent generalized lymphadenopathy), * Stage 2 (mildly symptomatic stage - presenting with unexplained weight loss of less than 10 percent of total body weight, recurrent respiratory infections or dermatological conditions), * Stage 3 (moderately symptomatic stage - presenting with weight loss of greater than 10 percent of total body weight, prolonged unexplained diarrhea or pulmonary tuberculosis, severe systemic bacterial infections or mucocutaneous conditions), * Stage 4 (severely symptomatic stage which includes all of the AIDS-defining illnesses) Additional categories included deceased and missing. |
| Growth Parameters: Weight, Age/Length and Middle Upper Arm Circumference for Age Z-score | At baseline (PRE), at Month 3 and at study end (Month 14) | The following growth parameters: weight, age/length and middle upper arm circumference for age z-score are reported. |
| Number of Episodes With Severe Malaria According to Primary Case Definition | From Day 0 to Month 14 | The number of episodes of severe malaria of primary case definition within and outside risk period. Primary case definition for severe malaria: P. falciparum \> 2500 parasites per μL and with one or more marker of disease severity and without a diagnosis of co-morbidity. |
Countries
Kenya
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GSK257049 Group Male and female infants and children between and including 6 weeks to 17 months of age, known to be HIV-infected, who received a 3-dose course of GSK257049 vaccine administered via intramuscular injection, for infants aged less than (\<) 5 months, in the left anterolateral thigh and, for infants/children aged 5 months or more (≥ 5 months), in the left deltoid, at Days 0, 30 and 60. | 99 |
| Verorab Group Male and female infants and children between and including 6 weeks to 17 months of age, known to be HIV-infected, who received a 3-dose course of Verorab™ vaccine administered via intramuscular injection, for infants aged less than (\<) 5 months, in the left anterolateral thigh and, for infants/children aged 5 months or more (≥ 5 months), in the left deltoid, at Days 0, 30 and 60. | 101 |
| Total | 200 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Failure to comply with study procedures | 0 | 1 |
| Overall Study | Lost to Follow-up | 2 | 0 |
| Overall Study | Migrated/moved from study area | 3 | 6 |
| Overall Study | Refusal | 1 | 0 |
| Overall Study | Serious Adverse Event | 5 | 4 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | GSK257049 Group | Verorab Group | Total |
|---|---|---|---|
| Age, Continuous | 10.1 Months STANDARD_DEVIATION 4.99 | 9.5 Months STANDARD_DEVIATION 4.63 | 9.80 Months STANDARD_DEVIATION 4.81 |
| Race/Ethnicity, Customized African heritage/African American | 99 Participants | 101 Participants | 200 Participants |
| Sex: Female, Male Female | 57 Participants | 45 Participants | 102 Participants |
| Sex: Female, Male Male | 42 Participants | 56 Participants | 98 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 5 / 99 | 4 / 101 |
| other Total, other adverse events | 98 / 99 | 99 / 101 |
| serious Total, serious adverse events | 41 / 99 | 37 / 101 |
Outcome results
Primary
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: During the entire study period (from 30 days before Dose 1 up to Month 14)
Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK257049 Group | Number of Subjects With Serious Adverse Events (SAEs) | Any SAE(s) | 41 Participants |
| GSK257049 Group | Number of Subjects With Serious Adverse Events (SAEs) | Any SAE(s) excluding Malaria | 41 Participants |
| Verorab Group | Number of Subjects With Serious Adverse Events (SAEs) | Any SAE(s) | 37 Participants |
| Verorab Group | Number of Subjects With Serious Adverse Events (SAEs) | Any SAE(s) excluding Malaria | 37 Participants |
Secondary
Anti-circumsporozoite Protein of P. Falciparum (Anti-CS) Antibody Concentrations
Anti-CS antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL). The reference seropositivity cut-off value was equal to or above (≥) 0.5 EL.U/mL.
Time frame: Prior to vaccination (PRE) and one month post Dose 3 (Month 3)
Population: The analysis was performed on the ATP population for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK257049 Group | Anti-circumsporozoite Protein of P. Falciparum (Anti-CS) Antibody Concentrations | Anti-CS, PRE | 0.3 EL.U/mL |
| GSK257049 Group | Anti-circumsporozoite Protein of P. Falciparum (Anti-CS) Antibody Concentrations | Anti-CS, Month 3 | 329.2 EL.U/mL |
| Verorab Group | Anti-circumsporozoite Protein of P. Falciparum (Anti-CS) Antibody Concentrations | Anti-CS, PRE | 0.3 EL.U/mL |
| Verorab Group | Anti-circumsporozoite Protein of P. Falciparum (Anti-CS) Antibody Concentrations | Anti-CS, Month 3 | 0.3 EL.U/mL |
Secondary
Anti-CS Antibody Concentrations
Anti-CS antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL). The reference seropositivity cut-off value was equal to or above (≥) 0.5 EL.U/mL.
Time frame: 12 months post Dose 3 (Month 14)
Population: The analysis was performed on the ATP population for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK257049 Group | Anti-CS Antibody Concentrations | 18.4 EL.U/mL |
| Verorab Group | Anti-CS Antibody Concentrations | 0.3 EL.U/mL |
Secondary
Anti-HBs Antibody Titers
Anti-HBs antibody titers are presented as geometric mean titers (GMTs), expressed in mIU/mL.
Time frame: 12 months post Dose 3 (Month 14)
Population: The analysis was performed on the ATP population for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK257049 Group | Anti-HBs Antibody Titers | 2294.8 mIU/mL |
| Verorab Group | Anti-HBs Antibody Titers | 11.8 mIU/mL |
Secondary
Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Titers
Anti-HBs antibody titers are presented as geometric mean titers (GMTs), expressed in milliinternational units per milliliter (mIU/mL).
Time frame: Prior to vaccination (PRE) and one month post Dose 3 (Month 3)
Population: The analysis was performed on the ATP population for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK257049 Group | Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Titers | Anti-HBs, PRE | 24.1 mIU/mL |
| GSK257049 Group | Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Titers | Anti-HBs, Month 3 | 13637.6 mIU/mL |
| Verorab Group | Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Titers | Anti-HBs, PRE | 19.2 mIU/mL |
| Verorab Group | Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Titers | Anti-HBs, Month 3 | 19.9 mIU/mL |
Secondary
Asexual P. Falciparum Parasitemia Density
The number of subjects with a positive blood slide for asexual P. falciparum.
Time frame: 12 months post Dose 3 (Month 14)
Population: The analysis was performed on children affected by prevalent parasitemia from the ATP population for efficacy, which included subjects in the Total Vaccinated cohort who received all vaccinations according to protocol procedures within specified intervals that contribute time at risk in the follow-up period starting 14 days post Dose 3.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK257049 Group | Asexual P. Falciparum Parasitemia Density | 7 Participants |
| Verorab Group | Asexual P. Falciparum Parasitemia Density | 3 Participants |
Secondary
CD4+ Absolute Cell Counts
The CD4+ absolute cell counts are reported.
Time frame: At baseline (PRE) and at 1 month (Month 3), 6 months (Month 8) and 12 months (Month 14) post Dose 3
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK257049 Group | CD4+ Absolute Cell Counts | CD4+ absolute cell count, PRE | 2075.91 number of cells/μL | Standard Deviation 997.81 |
| GSK257049 Group | CD4+ Absolute Cell Counts | CD4+ absolute cell count, Month 3 | 2150.99 number of cells/μL | Standard Deviation 1054.12 |
| GSK257049 Group | CD4+ Absolute Cell Counts | CD4+ absolute cell count, Month 8 | 2261.71 number of cells/μL | Standard Deviation 1045.2 |
| GSK257049 Group | CD4+ Absolute Cell Counts | CD4+ absolute cell count, Month 14 | 1995.36 number of cells/μL | Standard Deviation 998.98 |
| Verorab Group | CD4+ Absolute Cell Counts | CD4+ absolute cell count, Month 14 | 2003.70 number of cells/μL | Standard Deviation 1027.09 |
| Verorab Group | CD4+ Absolute Cell Counts | CD4+ absolute cell count, PRE | 2086.46 number of cells/μL | Standard Deviation 1255.78 |
| Verorab Group | CD4+ Absolute Cell Counts | CD4+ absolute cell count, Month 8 | 2044.51 number of cells/μL | Standard Deviation 1014.05 |
| Verorab Group | CD4+ Absolute Cell Counts | CD4+ absolute cell count, Month 3 | 2173.04 number of cells/μL | Standard Deviation 912.96 |
Secondary
Growth Parameters: Weight, Age/Length and Middle Upper Arm Circumference for Age Z-score
The following growth parameters: weight, age/length and middle upper arm circumference for age z-score are reported.
Time frame: At baseline (PRE), at Month 3 and at study end (Month 14)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK257049 Group | Growth Parameters: Weight, Age/Length and Middle Upper Arm Circumference for Age Z-score | Weight for age z-score, PRE | -1.38 age z-score | Standard Deviation 1.13 |
| GSK257049 Group | Growth Parameters: Weight, Age/Length and Middle Upper Arm Circumference for Age Z-score | Mid upper arm circumference z-score, Month 3 | -0.39 age z-score | Standard Deviation 1.03 |
| GSK257049 Group | Growth Parameters: Weight, Age/Length and Middle Upper Arm Circumference for Age Z-score | Height for age z-score, Month 3 | -1.91 age z-score | Standard Deviation 1.14 |
| GSK257049 Group | Growth Parameters: Weight, Age/Length and Middle Upper Arm Circumference for Age Z-score | Height for age z-score, Month 14 | -1.74 age z-score | Standard Deviation 1.19 |
| GSK257049 Group | Growth Parameters: Weight, Age/Length and Middle Upper Arm Circumference for Age Z-score | Mid upper arm circumference z-score, PRE | -0.65 age z-score | Standard Deviation 1.13 |
| GSK257049 Group | Growth Parameters: Weight, Age/Length and Middle Upper Arm Circumference for Age Z-score | Weight for age z-score, Month 14 | -1.10 age z-score | Standard Deviation 1.14 |
| GSK257049 Group | Growth Parameters: Weight, Age/Length and Middle Upper Arm Circumference for Age Z-score | Weight for age z-score, Month 3 | -1.32 age z-score | Standard Deviation 1.1 |
| GSK257049 Group | Growth Parameters: Weight, Age/Length and Middle Upper Arm Circumference for Age Z-score | Mid upper arm circumference z-score, Month 14 | -0.29 age z-score | Standard Deviation 1.13 |
| GSK257049 Group | Growth Parameters: Weight, Age/Length and Middle Upper Arm Circumference for Age Z-score | Height for age z-score, PRE | -1.67 age z-score | Standard Deviation 1.2 |
| Verorab Group | Growth Parameters: Weight, Age/Length and Middle Upper Arm Circumference for Age Z-score | Mid upper arm circumference z-score, Month 14 | -0.51 age z-score | Standard Deviation 0.93 |
| Verorab Group | Growth Parameters: Weight, Age/Length and Middle Upper Arm Circumference for Age Z-score | Height for age z-score, PRE | -1.98 age z-score | Standard Deviation 1.37 |
| Verorab Group | Growth Parameters: Weight, Age/Length and Middle Upper Arm Circumference for Age Z-score | Weight for age z-score, PRE | -1.67 age z-score | Standard Deviation 1.19 |
| Verorab Group | Growth Parameters: Weight, Age/Length and Middle Upper Arm Circumference for Age Z-score | Mid upper arm circumference z-score, PRE | -0.90 age z-score | Standard Deviation 1.19 |
| Verorab Group | Growth Parameters: Weight, Age/Length and Middle Upper Arm Circumference for Age Z-score | Height for age z-score, Month 3 | -2.12 age z-score | Standard Deviation 1.16 |
| Verorab Group | Growth Parameters: Weight, Age/Length and Middle Upper Arm Circumference for Age Z-score | Weight for age z-score, Month 3 | -1.55 age z-score | Standard Deviation 1.09 |
| Verorab Group | Growth Parameters: Weight, Age/Length and Middle Upper Arm Circumference for Age Z-score | Mid upper arm circumference z-score, Month 3 | -0.65 age z-score | Standard Deviation 1.04 |
| Verorab Group | Growth Parameters: Weight, Age/Length and Middle Upper Arm Circumference for Age Z-score | Height for age z-score, Month 14 | -2.26 age z-score | Standard Deviation 1.18 |
| Verorab Group | Growth Parameters: Weight, Age/Length and Middle Upper Arm Circumference for Age Z-score | Weight for age z-score, Month 14 | -1.47 age z-score | Standard Deviation 1.02 |
Secondary
HIV Viral Load
The HIV viral load is reported. Detectable HIV viral load: 400 or more copies/mL.
Time frame: At baseline (PRE) and at one month (Month 3), 6 months (Month 8) and 12 months (Month 14) post Dose 3
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK257049 Group | HIV Viral Load | HIV viral load, PRE | 149000.00 copies/mL |
| GSK257049 Group | HIV Viral Load | HIV viral load, Month 3 | 3125.00 copies/mL |
| GSK257049 Group | HIV Viral Load | HIV viral load, Month 8 | 3790.00 copies/mL |
| GSK257049 Group | HIV Viral Load | HIV viral load, Month 14 | 947.00 copies/mL |
| Verorab Group | HIV Viral Load | HIV viral load, Month 14 | 400.00 copies/mL |
| Verorab Group | HIV Viral Load | HIV viral load, PRE | 157000.00 copies/mL |
| Verorab Group | HIV Viral Load | HIV viral load, Month 8 | 400.00 copies/mL |
| Verorab Group | HIV Viral Load | HIV viral load, Month 3 | 583.50 copies/mL |
Secondary
Number of Episodes With Clinical Malaria Disease According to Primary Case Definition
Primary case definition for clinical malaria: P. falciparum asexual parasitemia \> 2500 parasites/μL and presence of fever (axillary temperature ≥ 37.5°C) at the time of presentation and occurring in a child who was unwell and brought for treatment to a healthcare facility.
Time frame: From Day 0 to Month 14
Population: The analysis was performed on the ATP population for efficacy, which included all subjects included in the Total Vaccinated cohort who received all vaccinations according to protocol procedures within specified intervals that contribute time at risk in the follow-up period starting 14 days post Dose 3.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK257049 Group | Number of Episodes With Clinical Malaria Disease According to Primary Case Definition | 44 Episodes |
| Verorab Group | Number of Episodes With Clinical Malaria Disease According to Primary Case Definition | 76 Episodes |
Secondary
Number of Episodes With Severe Malaria According to Primary Case Definition
The number of episodes of severe malaria of primary case definition within and outside risk period. Primary case definition for severe malaria: P. falciparum \> 2500 parasites per μL and with one or more marker of disease severity and without a diagnosis of co-morbidity.
Time frame: From Day 0 to Month 14
Population: The analysis was performed on the ATP population for efficacy, which included all subjects included in the Total Vaccinated cohort who received all vaccinations according to protocol procedures within specified intervals that contribute time at risk in the follow-up period starting 14 days post Dose 3.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK257049 Group | Number of Episodes With Severe Malaria According to Primary Case Definition | Episodes outside risk period | 0 Episodes |
| GSK257049 Group | Number of Episodes With Severe Malaria According to Primary Case Definition | Episodes within risk period | 0 Episodes |
| Verorab Group | Number of Episodes With Severe Malaria According to Primary Case Definition | Episodes outside risk period | 0 Episodes |
| Verorab Group | Number of Episodes With Severe Malaria According to Primary Case Definition | Episodes within risk period | 6 Episodes |
Secondary
Number of Subjects Affected by Prevalent Parasitemia and Prevalent Moderate Anemia
The number of subjects affected by prevalent asexual P. falciparum parasitemia and prevalent moderate anemia. Moderate anemia = hemoglobin \< 8 g/dL.
Time frame: 12 months post Dose 3 (Month 14)
Population: The analysis was performed on the ATP population for efficacy, which included all subjects in the Total Vaccinated cohort who received all vaccinations according to protocol procedures within specified intervals that contribute time at risk in the follow-up period starting 14 days post Dose 3.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK257049 Group | Number of Subjects Affected by Prevalent Parasitemia and Prevalent Moderate Anemia | Prevalent parasitemia | 7 Participants |
| GSK257049 Group | Number of Subjects Affected by Prevalent Parasitemia and Prevalent Moderate Anemia | Prevalent moderate anemia | 5 Participants |
| Verorab Group | Number of Subjects Affected by Prevalent Parasitemia and Prevalent Moderate Anemia | Prevalent parasitemia | 3 Participants |
| Verorab Group | Number of Subjects Affected by Prevalent Parasitemia and Prevalent Moderate Anemia | Prevalent moderate anemia | 4 Participants |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond (\>) 20 millimeters (mm) of injection site.
Time frame: During the 7-day post-vaccination period following each dose and across doses: Day 1 through Day 7, Month 1 through Month 1 + 7 days (Day 37), Month 2 through Month 2 + 7 days (Day 67)
Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented, who had their symptom sheets filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK257049 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 15 Participants |
| GSK257049 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 0 Participants |
| GSK257049 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 6 Participants |
| GSK257049 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Participants |
| GSK257049 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 11 Participants |
| GSK257049 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| GSK257049 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 19 Participants |
| GSK257049 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 0 Participants |
| GSK257049 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 8 Participants |
| GSK257049 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 0 Participants |
| GSK257049 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 7 Participants |
| GSK257049 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Participants |
| GSK257049 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 3 | 18 Participants |
| GSK257049 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 3 | 1 Participants |
| GSK257049 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 3 | 6 Participants |
| GSK257049 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 3 | 0 Participants |
| GSK257049 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 3 | 13 Participants |
| GSK257049 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 3 | 1 Participants |
| GSK257049 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 33 Participants |
| GSK257049 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 1 Participants |
| GSK257049 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across doses | 14 Participants |
| GSK257049 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across doses | 0 Participants |
| GSK257049 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across doses | 26 Participants |
| GSK257049 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 1 Participants |
| Verorab Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across doses | 13 Participants |
| Verorab Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 7 Participants |
| Verorab Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 3 | 5 Participants |
| Verorab Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 0 Participants |
| Verorab Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 18 Participants |
| Verorab Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 3 Participants |
| Verorab Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 3 | 0 Participants |
| Verorab Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Participants |
| Verorab Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across doses | 0 Participants |
| Verorab Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 4 Participants |
| Verorab Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 3 | 2 Participants |
| Verorab Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| Verorab Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 0 Participants |
| Verorab Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 6 Participants |
| Verorab Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 3 | 0 Participants |
| Verorab Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 0 Participants |
| Verorab Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 0 Participants |
| Verorab Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 4 Participants |
| Verorab Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 3 | 4 Participants |
| Verorab Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 0 Participants |
| Verorab Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across doses | 9 Participants |
| Verorab Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 5 Participants |
| Verorab Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 3 | 0 Participants |
| Verorab Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 irritability/fussiness = crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as causally related to the study vaccination.
Time frame: During the 7-day post-vaccination period following each dose and across doses: Day 1 through Day 7, Month 1 through Month 1 + 7 days (Day 37), Month 2 through Month 2 + 7 days (Day 67)
Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented, who had their symptom sheets filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 2 | 10 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 1 | 3 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 1 | 0 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 1 | 21 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 1 | 9 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 1 | 0 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 1 | 14 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 1 | 3 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 1 | 0 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 1 | 31 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 1 | 11 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 1 | 4 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 1 | 9 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 2 | 5 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 2 | 0 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 2 | 22 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 2 | 14 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 2 | 0 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 2 | 18 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 2 | 8 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 2 | 0 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 2 | 34 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 2 | 16 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 2 | 2 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 3 | 13 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 3 | 6 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 3 | 0 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 3 | 30 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 3 | 19 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 3 | 0 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 3 | 19 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 3 | 8 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 3 | 0 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 3 | 55 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 3 | 28 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 3 | 6 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Across doses | 22 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Across doses | 11 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Across doses | 0 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Across doses | 46 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Across doses | 29 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Across doses | 0 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Across doses | 33 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Across doses | 17 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Across doses | 0 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Across doses | 74 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Across doses | 39 Participants |
| GSK257049 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Across doses | 10 Participants |
| Verorab Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Across doses | 9 Participants |
| Verorab Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 1 | 3 Participants |
| Verorab Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 3 | 6 Participants |
| Verorab Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 1 | 0 Participants |
| Verorab Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Across doses | 15 Participants |
| Verorab Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 1 | 0 Participants |
| Verorab Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 3 | 2 Participants |
| Verorab Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 1 | 12 Participants |
| Verorab Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Across doses | 22 Participants |
| Verorab Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 1 | 3 Participants |
| Verorab Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 3 | 0 Participants |
| Verorab Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 1 | 0 Participants |
| Verorab Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Across doses | 2 Participants |
| Verorab Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 1 | 7 Participants |
| Verorab Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 3 | 8 Participants |
| Verorab Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 1 | 0 Participants |
| Verorab Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Across doses | 46 Participants |
| Verorab Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 1 | 0 Participants |
| Verorab Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 3 | 2 Participants |
| Verorab Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 1 | 20 Participants |
| Verorab Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Across doses | 0 Participants |
| Verorab Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 1 | 4 Participants |
| Verorab Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 3 | 1 Participants |
| Verorab Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 1 | 2 Participants |
| Verorab Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Across doses | 2 Participants |
| Verorab Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 2 | 6 Participants |
| Verorab Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 3 | 9 Participants |
| Verorab Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 2 | 0 Participants |
| Verorab Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Across doses | 25 Participants |
| Verorab Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 2 | 0 Participants |
| Verorab Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 3 | 1 Participants |
| Verorab Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 2 | 12 Participants |
| Verorab Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Across doses | 6 Participants |
| Verorab Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 2 | 0 Participants |
| Verorab Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 3 | 0 Participants |
| Verorab Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 2 | 0 Participants |
| Verorab Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Across doses | 5 Participants |
| Verorab Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 2 | 10 Participants |
| Verorab Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 3 | 13 Participants |
| Verorab Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 2 | 1 Participants |
| Verorab Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Across doses | 0 Participants |
| Verorab Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 2 | 0 Participants |
| Verorab Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 3 | 2 Participants |
| Verorab Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 2 | 23 Participants |
| Verorab Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Across doses | 1 Participants |
| Verorab Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 2 | 3 Participants |
| Verorab Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 3 | 4 Participants |
| Verorab Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 2 | 0 Participants |
Secondary
Number of Subjects With Any Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Time frame: During the 30-day post-vaccination period (up to Day 90)
Population: The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK257049 Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 98 Participants |
| Verorab Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 100 Participants |
Secondary
Number of Subjects With Non-malaria Related SAEs
SAEs (excluding malaria, cerebral malaria and P. falciparum parasitemia) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: During the entire study period (from 30 days before vaccine Dose 1 up to Month 14)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK257049 Group | Number of Subjects With Non-malaria Related SAEs | 41 Participants |
| Verorab Group | Number of Subjects With Non-malaria Related SAEs | 37 Participants |
Secondary
Percentage of CD4+ Cells
The percentage of CD4+ cells is reported.
Time frame: At baseline (PRE) and at one month (Month 3), 6 months (Month 8) and 12 months (Month 14) post Dose 3
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK257049 Group | Percentage of CD4+ Cells | CD4+ percentage, PRE | 27.55 Percentage | Standard Deviation 8.48 |
| GSK257049 Group | Percentage of CD4+ Cells | CD4+ percentage, Month 3 | 29.70 Percentage | Standard Deviation 9.33 |
| GSK257049 Group | Percentage of CD4+ Cells | CD4+ percentage, Month 8 | 32.70 Percentage | Standard Deviation 9.7 |
| GSK257049 Group | Percentage of CD4+ Cells | CD4+ percentage, Month 14 | 32.80 Percentage | Standard Deviation 10.3 |
| Verorab Group | Percentage of CD4+ Cells | CD4+ percentage, Month 14 | 31.61 Percentage | Standard Deviation 9.56 |
| Verorab Group | Percentage of CD4+ Cells | CD4+ percentage, PRE | 26.52 Percentage | Standard Deviation 8.48 |
| Verorab Group | Percentage of CD4+ Cells | CD4+ percentage, Month 8 | 31.07 Percentage | Standard Deviation 9.25 |
| Verorab Group | Percentage of CD4+ Cells | CD4+ percentage, Month 3 | 29.92 Percentage | Standard Deviation 8.67 |
Secondary
Prevalent Hemoglobin Level
The prevalent hemoglobin level in subjects with a positive blood slide is reported as grams per deciliter (g/dl).
Time frame: 12 months post Dose 3 (Month 14)
Population: The analysis was performed on the ATP population for efficacy, which included all subjects in the Total Vaccinated cohort who received all vaccinations according to protocol procedures within specified intervals that contribute time at risk in the follow-up period starting 14 days post Dose 3.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GSK257049 Group | Prevalent Hemoglobin Level | 10.3 grams per deciliter | Standard Deviation 1.3 |
| Verorab Group | Prevalent Hemoglobin Level | 10.1 grams per deciliter | Standard Deviation 1.2 |
Secondary
World Health Organization (WHO) HIV Clinical Classification Progression
Clinical staging was done at each time point according to the WHO HIV/AIDS clinical staging system. Clinical stages included: * Stage 1 (asymptomatic or have persistent generalized lymphadenopathy), * Stage 2 (mildly symptomatic stage - presenting with unexplained weight loss of less than 10 percent of total body weight, recurrent respiratory infections or dermatological conditions), * Stage 3 (moderately symptomatic stage - presenting with weight loss of greater than 10 percent of total body weight, prolonged unexplained diarrhea or pulmonary tuberculosis, severe systemic bacterial infections or mucocutaneous conditions), * Stage 4 (severely symptomatic stage which includes all of the AIDS-defining illnesses) Additional categories included deceased and missing.
Time frame: At baseline (PRE), at study months 1 (Month 1) and 2 (Month 2) and at 1 month (Month 3), 6 months (Month 8) and 12 months (Month 14) post Dose 3
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK257049 Group | World Health Organization (WHO) HIV Clinical Classification Progression | Deceased, Month 1 | 2 Participants |
| GSK257049 Group | World Health Organization (WHO) HIV Clinical Classification Progression | Stage 2, Month 3 | 12 Participants |
| GSK257049 Group | World Health Organization (WHO) HIV Clinical Classification Progression | Stage 1, Month 1 | 75 Participants |
| GSK257049 Group | World Health Organization (WHO) HIV Clinical Classification Progression | Stage 3, Month 3 | 4 Participants |
| GSK257049 Group | World Health Organization (WHO) HIV Clinical Classification Progression | Missing, Month 1 | 1 Participants |
| GSK257049 Group | World Health Organization (WHO) HIV Clinical Classification Progression | Stage 4, Month 3 | 0 Participants |
| GSK257049 Group | World Health Organization (WHO) HIV Clinical Classification Progression | Stage 4, PRE | 0 Participants |
| GSK257049 Group | World Health Organization (WHO) HIV Clinical Classification Progression | Deceased, Month 3 | 2 Participants |
| GSK257049 Group | World Health Organization (WHO) HIV Clinical Classification Progression | Stage 1, Month 2 | 79 Participants |
| GSK257049 Group | World Health Organization (WHO) HIV Clinical Classification Progression | Missing, Month 3 | 5 Participants |
| GSK257049 Group | World Health Organization (WHO) HIV Clinical Classification Progression | Stage 2, Month 1 | 19 Participants |
| GSK257049 Group | World Health Organization (WHO) HIV Clinical Classification Progression | Stage 1, Month 8 | 74 Participants |
| GSK257049 Group | World Health Organization (WHO) HIV Clinical Classification Progression | Stage 2, Month 2 | 15 Participants |
| GSK257049 Group | World Health Organization (WHO) HIV Clinical Classification Progression | Stage 2, Month 8 | 12 Participants |
| GSK257049 Group | World Health Organization (WHO) HIV Clinical Classification Progression | Stage 3, PRE | 0 Participants |
| GSK257049 Group | World Health Organization (WHO) HIV Clinical Classification Progression | Stage 3, Month 8 | 0 Participants |
| GSK257049 Group | World Health Organization (WHO) HIV Clinical Classification Progression | Stage 3, Month 2 | 1 Participants |
| GSK257049 Group | World Health Organization (WHO) HIV Clinical Classification Progression | Stage 4, Month 8 | 0 Participants |
| GSK257049 Group | World Health Organization (WHO) HIV Clinical Classification Progression | Stage 3, Month 1 | 2 Participants |
| GSK257049 Group | World Health Organization (WHO) HIV Clinical Classification Progression | Deceased, Month 8 | 4 Participants |
| GSK257049 Group | World Health Organization (WHO) HIV Clinical Classification Progression | Stage 4, Month 2 | 0 Participants |
| GSK257049 Group | World Health Organization (WHO) HIV Clinical Classification Progression | Missing, Month 8 | 9 Participants |
| GSK257049 Group | World Health Organization (WHO) HIV Clinical Classification Progression | Deceased, PRE | 0 Participants |
| GSK257049 Group | World Health Organization (WHO) HIV Clinical Classification Progression | Stage 1, Month 12 | 74 Participants |
| GSK257049 Group | World Health Organization (WHO) HIV Clinical Classification Progression | Deceased, Month 2 | 2 Participants |
| GSK257049 Group | World Health Organization (WHO) HIV Clinical Classification Progression | Stage 2, Month 12 | 10 Participants |
| GSK257049 Group | World Health Organization (WHO) HIV Clinical Classification Progression | Stage 4, Month 1 | 0 Participants |
| GSK257049 Group | World Health Organization (WHO) HIV Clinical Classification Progression | Stage 3, Month 12 | 3 Participants |
| GSK257049 Group | World Health Organization (WHO) HIV Clinical Classification Progression | Missing, Month 2 | 2 Participants |
| GSK257049 Group | World Health Organization (WHO) HIV Clinical Classification Progression | Stage 4, Month 12 | 0 Participants |
| GSK257049 Group | World Health Organization (WHO) HIV Clinical Classification Progression | Stage 2, PRE | 18 Participants |
| GSK257049 Group | World Health Organization (WHO) HIV Clinical Classification Progression | Deceased, Month 12 | 5 Participants |
| GSK257049 Group | World Health Organization (WHO) HIV Clinical Classification Progression | Stage 1, Month 3 | 76 Participants |
| GSK257049 Group | World Health Organization (WHO) HIV Clinical Classification Progression | Missing, Month 12 | 7 Participants |
| GSK257049 Group | World Health Organization (WHO) HIV Clinical Classification Progression | Stage 1, PRE | 81 Participants |
| Verorab Group | World Health Organization (WHO) HIV Clinical Classification Progression | Missing, Month 12 | 7 Participants |
| Verorab Group | World Health Organization (WHO) HIV Clinical Classification Progression | Stage 1, PRE | 82 Participants |
| Verorab Group | World Health Organization (WHO) HIV Clinical Classification Progression | Stage 2, PRE | 19 Participants |
| Verorab Group | World Health Organization (WHO) HIV Clinical Classification Progression | Stage 3, PRE | 0 Participants |
| Verorab Group | World Health Organization (WHO) HIV Clinical Classification Progression | Stage 4, PRE | 0 Participants |
| Verorab Group | World Health Organization (WHO) HIV Clinical Classification Progression | Deceased, PRE | 0 Participants |
| Verorab Group | World Health Organization (WHO) HIV Clinical Classification Progression | Stage 1, Month 1 | 72 Participants |
| Verorab Group | World Health Organization (WHO) HIV Clinical Classification Progression | Stage 2, Month 1 | 27 Participants |
| Verorab Group | World Health Organization (WHO) HIV Clinical Classification Progression | Stage 3, Month 1 | 1 Participants |
| Verorab Group | World Health Organization (WHO) HIV Clinical Classification Progression | Stage 4, Month 1 | 0 Participants |
| Verorab Group | World Health Organization (WHO) HIV Clinical Classification Progression | Deceased, Month 1 | 1 Participants |
| Verorab Group | World Health Organization (WHO) HIV Clinical Classification Progression | Missing, Month 1 | 0 Participants |
| Verorab Group | World Health Organization (WHO) HIV Clinical Classification Progression | Stage 1, Month 2 | 77 Participants |
| Verorab Group | World Health Organization (WHO) HIV Clinical Classification Progression | Stage 2, Month 2 | 20 Participants |
| Verorab Group | World Health Organization (WHO) HIV Clinical Classification Progression | Stage 3, Month 2 | 2 Participants |
| Verorab Group | World Health Organization (WHO) HIV Clinical Classification Progression | Stage 4, Month 2 | 0 Participants |
| Verorab Group | World Health Organization (WHO) HIV Clinical Classification Progression | Deceased, Month 2 | 1 Participants |
| Verorab Group | World Health Organization (WHO) HIV Clinical Classification Progression | Missing, Month 2 | 1 Participants |
| Verorab Group | World Health Organization (WHO) HIV Clinical Classification Progression | Stage 1, Month 3 | 76 Participants |
| Verorab Group | World Health Organization (WHO) HIV Clinical Classification Progression | Stage 2, Month 3 | 19 Participants |
| Verorab Group | World Health Organization (WHO) HIV Clinical Classification Progression | Stage 3, Month 3 | 0 Participants |
| Verorab Group | World Health Organization (WHO) HIV Clinical Classification Progression | Stage 4, Month 3 | 0 Participants |
| Verorab Group | World Health Organization (WHO) HIV Clinical Classification Progression | Deceased, Month 3 | 2 Participants |
| Verorab Group | World Health Organization (WHO) HIV Clinical Classification Progression | Missing, Month 3 | 4 Participants |
| Verorab Group | World Health Organization (WHO) HIV Clinical Classification Progression | Stage 1, Month 8 | 72 Participants |
| Verorab Group | World Health Organization (WHO) HIV Clinical Classification Progression | Stage 2, Month 8 | 16 Participants |
| Verorab Group | World Health Organization (WHO) HIV Clinical Classification Progression | Stage 3, Month 8 | 3 Participants |
| Verorab Group | World Health Organization (WHO) HIV Clinical Classification Progression | Stage 4, Month 8 | 0 Participants |
| Verorab Group | World Health Organization (WHO) HIV Clinical Classification Progression | Deceased, Month 8 | 3 Participants |
| Verorab Group | World Health Organization (WHO) HIV Clinical Classification Progression | Missing, Month 8 | 7 Participants |
| Verorab Group | World Health Organization (WHO) HIV Clinical Classification Progression | Stage 1, Month 12 | 69 Participants |
| Verorab Group | World Health Organization (WHO) HIV Clinical Classification Progression | Stage 2, Month 12 | 18 Participants |
| Verorab Group | World Health Organization (WHO) HIV Clinical Classification Progression | Stage 3, Month 12 | 1 Participants |
| Verorab Group | World Health Organization (WHO) HIV Clinical Classification Progression | Stage 4, Month 12 | 2 Participants |
| Verorab Group | World Health Organization (WHO) HIV Clinical Classification Progression | Deceased, Month 12 | 4 Participants |