| 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. | The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | During the entire study period (from 30 days before Dose 1 up to Month 14) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
| | | Title | Denominators | Categories |
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| Any SAE(s) | | | | Any SAE(s) excluding Malaria | | |
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| 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. | 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. | Posted | | Count of Participants | | Participants | | 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) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Count of Participants | | Participants | | 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) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | Verorab Group |
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| 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. | The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | During the 30-day post-vaccination period (up to Day 90) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | During the entire study period (from 30 days before vaccine Dose 1 up to Month 14) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | The analysis was performed on the ATP population for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | | Geometric Mean | 95% Confidence Interval | EL.U/mL | | Prior to vaccination (PRE) and one month post Dose 3 (Month 3) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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). | The analysis was performed on the ATP population for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | | Geometric Mean | 95% Confidence Interval | mIU/mL | | Prior to vaccination (PRE) and one month post Dose 3 (Month 3) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | The analysis was performed on the ATP population for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | | Geometric Mean | 95% Confidence Interval | EL.U/mL | | 12 months post Dose 3 (Month 14) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| Secondary | Anti-HBs Antibody Titers | Anti-HBs antibody titers are presented as geometric mean titers (GMTs), expressed in mIU/mL. | The analysis was performed on the ATP population for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | | Geometric Mean | 95% Confidence Interval | mIU/mL | | 12 months post Dose 3 (Month 14) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Number | | Episodes | | From Day 0 to Month 14 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Number | | Episodes | | From Day 0 to Month 14 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Count of Participants | | Participants | | 12 months post Dose 3 (Month 14) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| Secondary | Asexual P. Falciparum Parasitemia Density | The number of subjects with a positive blood slide for asexual P. falciparum. | 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. | Posted | | Count of Participants | | Participants | | 12 months post Dose 3 (Month 14) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| Secondary | Prevalent Hemoglobin Level | The prevalent hemoglobin level in subjects with a positive blood slide is reported as grams per deciliter (g/dl). | 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. | Posted | | Mean | Standard Deviation | grams per deciliter | | 12 months post Dose 3 (Month 14) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| Secondary | HIV Viral Load | The HIV viral load is reported. Detectable HIV viral load: 400 or more copies/mL. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | | Median | Inter-Quartile Range | copies/mL | | At baseline (PRE) and at one month (Month 3), 6 months (Month 8) and 12 months (Month 14) post Dose 3 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| Secondary | Percentage of CD4+ Cells | The percentage of CD4+ cells is reported. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | | Mean | Standard Deviation | Percentage | | At baseline (PRE) and at one month (Month 3), 6 months (Month 8) and 12 months (Month 14) post Dose 3 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| Secondary | CD4+ Absolute Cell Counts | The CD4+ absolute cell counts are reported. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | | Mean | Standard Deviation | number of cells/μL | | At baseline (PRE) and at 1 month (Month 3), 6 months (Month 8) and 12 months (Month 14) post Dose 3 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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".
| The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | | Count of Participants | | Participants | | 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 | | | | ID | Title | Description |
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| OG000 | 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. | |
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| 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. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. | Posted | | Mean | Standard Deviation | age z-score | | At baseline (PRE), at Month 3 and at study end (Month 14) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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