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Also known as GSK257049, RTS
GSK Biological's Investigational Malaria Vaccine 257049 · 2 trials · 1 indication
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or may evolve into one of the outcomes listed above. "Any" is defined an incidence of a SAE regardless of intensity/severity.
Anti-CS antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean concentrations (GMCs) expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the endpoint was a GMC value greater than or equal to (≥) 0.5 EL.U/mL.
| Arm | Type | Description |
|---|---|---|
| Group A | EXPERIMENTAL | Infants enrolled to this group will receive 3 doses of the experimental vaccine. |
| Group B | ACTIVE_COMPARATOR | Infants enrolled to this group will receive 3 doses of the rabies comparator vaccine. |
| RTS,S Neo-10-14 Group | EXPERIMENTAL | Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder. |
| RTS,S Neo-10-26 Group | EXPERIMENTAL | Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanri xHepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder. |
| RTS,S 6-10-14 Group | EXPERIMENTAL | Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder. |
| RTS,S 6-10-26 Group | EXPERIMENTAL | Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder. |
| Engerix-B Neo/RTS,S 6-10-26 Group | EXPERIMENTAL | Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder. |
| RTS,S 10-14-26 Group | EXPERIMENTAL | Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder. |
| RTS,S 14-26-9M Group | EXPERIMENTAL | Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder. |
| Engerix-B Neo Group | ACTIVE_COMPARATOR | Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder. |
| Name | Type | Description |
|---|---|---|
| GSK Biological's Investigational Malaria Vaccine 257049 | BIOLOGICAL | All infants enrolled to group A will receive 3 doses of the experimental vaccine. The vaccine will be administered intramuscularly. |
| Human Diploid Cell Vaccine (HDCV) or Purified Vero Cell Rabies Vaccine (PVRV, Verorab) (Aventis Pasteur); | BIOLOGICAL | 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 |
| Purified Chick Embryo Cell Culture (PCEC) Rabies Vaccine (Rabipur or equivalent) (Novartis). | BIOLOGICAL | 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. |
| Engerix-B | BIOLOGICAL | 1 dose, intramuscular route: left antero-lateral thigh at birth (=\< 7 days of age) |
| Tritanrix HepB Hib | BIOLOGICAL | 3 doses, intramuscular route: right antero-lateral thigh at 6, 10 and 14 weeks of age |
| BCG | BIOLOGICAL | 1 dose, intradermal route, in shoulder at birth (=\< 7 days of age) |
| OPV | BIOLOGICAL | 4 doses, orally, at birth (=\< 7 days of age) and at 6, 10 and 14 weeks of age |
| Rouvax | BIOLOGICAL | 1 dose, intramuscular (IM) route, in left antero-lateral thigh, at 9 months of age |
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 infa...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GSK plc Sponsored ADR | GSK | 4 | PHASE3 | Tafenoquine, GSK3772701, Mosquirix, GSK4425689A |
| Novartis AG Sponsored ADR | NVS | 2 | PHASE2 | INE963, KAE609, KLU156 |
| 60 Degrees Pharmaceuticals, Inc. | SXTP | 1 | PHASE2 | Tafenoquine |
GSK Biological's Investigational Malaria Vaccine 257049 is a vaccine candidate being developed by GSK plc for the prevention of malaria. It is an investigational product, meaning it is still in clinical development and has not been approved for use. The vaccine has been studied in infants and children in African countries, including Malawi and Kenya.
GSK Biological's Investigational Malaria Vaccine 257049 is being developed for the prevention of malaria, an infectious disease. Clinical studies have evaluated the vaccine in infants and children, including HIV infected infants and children. The vaccine is intended to protect against malaria, though it remains investigational and is not yet approved for use.
GSK Biological's Investigational Malaria Vaccine 257049 is being developed by GSK plc, which trades under the ticker GSK. GSK Biologicals is the vaccine division associated with the program. The company has sponsored the clinical trials evaluating this malaria vaccine candidate in African infant and child populations.
GSK Biological's Investigational Malaria Vaccine 257049 is in Phase 3 development. One Phase 3 trial has been completed, and a Phase 2 trial has also been completed. The vaccine remains investigational and has not been approved. Both completed trials enrolled a combined total of 680 participants.
Two completed trials have evaluated GSK Biological's Investigational Malaria Vaccine 257049. NCT01231503 was a Phase 2 trial of 480 infants in Malawi testing seven schedules. NCT01148459 was a Phase 3 trial of 200 HIV infected infants and children in Kenya. Both trials assessed safety and immunogenicity, and both are now completed.
GSK Biological's Investigational Malaria Vaccine 257049 was studied in two completed randomized, double-blind, active-controlled trials. NCT01231503 enrolled 480 infants in Malawi, and NCT01148459 enrolled 200 HIV infected infants and children in Kenya. Both trials evaluated safety and immunogenicity, with a combined enrollment of 680 participants across the two studies.