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Also known as RTS, S vaccine
GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049 · 3 trials · 1 indication
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
| Arm | Type | Description |
|---|---|---|
| SB257049 F2 0-1 M Group | EXPERIMENTAL | Healthy infants between 5 and 17 months of age at the time of first vaccination received 2 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1-month schedule administered intramuscularly (IM) in the left deltoid muscle. |
| SB257049 F1 0-1 M Group | EXPERIMENTAL | Healthy infants between 5 and 17 months of age at the time of first vaccination received 2 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1-month schedule administered intramuscularly (IM) in the left deltoid muscle. |
| SB257049 F2 0-1-2 M Group | EXPERIMENTAL | Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle. |
| SB257049 F1 0-1-2 M Group | EXPERIMENTAL | Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle. |
| SB257049 F2 0-1-7 M Group | EXPERIMENTAL | Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1, 7-month schedule administered intramuscularly (IM) in the left deltoid muscle. |
| SB257049 F1 0-1-7 M Group | ACTIVE_COMPARATOR | Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1, 7-month schedule administered intramuscularly (IM) in the left deltoid muscle. |
| Rabipur 0-1-2 M Group | ACTIVE_COMPARATOR | Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle. |
| Group A | ACTIVE_COMPARATOR | - |
| Group B | EXPERIMENTAL | - |
| Cohort 1-RTS,S/AS02A <24M Group | EXPERIMENTAL | Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection. |
| Cohort 1-RTS,S/AS02A ≥24M Group | EXPERIMENTAL | Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection. |
| Cohort 2-RTS,S/AS02A <24M Group | EXPERIMENTAL | Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. |
| Cohort 2-RTS,S/AS02A ≥24M Group | EXPERIMENTAL | Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 of the NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. |
| Cohort 1-Prevnar-Hiberix <24M Group | ACTIVE_COMPARATOR | Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection. |
| Cohort 1-Engerix-B ≥24M Group | ACTIVE_COMPARATOR | Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection. |
| Cohort 2-Prevnar- Hiberix <24M Group | ACTIVE_COMPARATOR | Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. |
| Cohort 2-Engerix-B ≥24M Group | ACTIVE_COMPARATOR | Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. |
| Name | Type | Description |
|---|---|---|
| GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049 | BIOLOGICAL | 2 different formulations are tested. For each formulation, 3 different dosing schedules are tested |
| Rabipur | BIOLOGICAL | 3-dose intramuscular injection. |
| Engerix™-B | BIOLOGICAL | IM injection in the deltoid muscle |
| Hiberix® | BIOLOGICAL | IM injection in the deltoid muscle |
| Prevnar™ | BIOLOGICAL | IM injection in the deltoid muscle |
| sulfadoxine-pyrimethamine | DRUG | 1 dose orally per day for 3 days, 4 weeks prior to onset of surveillance |
| amodiaquine | DRUG | 1 dose orally per day for 3 days, 4 weeks prior to onset of surveillance |
Inclusion Criteria: * A male or female child between 5 months and 17 months of age at the time of first vaccination. * Written or oral, signed or thumb-printed and witnessed informed consent obtained from the parent(s)/guardian(s) of the child. * Subjects who the investigator believes that their pa...
| 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 |
It is an investigational vaccine developed by GSK plc (ticker GSK) against Plasmodium falciparum malaria. It is a preventive vaccine candidate studied in children in malaria-endemic regions of Africa. The vaccine has been evaluated in Phase 2 clinical trials and is not approved for use.
It is being studied for the prevention of malaria caused by Plasmodium falciparum. Clinical trials have enrolled children in Ghana, Mozambique, and Gabon, including infants as young as 5 months. The vaccine is investigational and has not been approved for any indication.
The vaccine is developed by GSK plc, which trades under the ticker GSK. GSK Biologicals is the company's vaccine division. The candidate is identified as GSK 257049 in its clinical program.
The vaccine is in Phase 2 development. Three Phase 2 trials have been completed, with no active trials ongoing. It is an investigational product and has not been approved by the FDA or any regulatory authority.
Three completed Phase 2 trials have evaluated the vaccine: NCT00360230 in Ghanaian children, NCT00323622, a two-year follow-up study in Mozambican children, and NCT00307021 in Gabonese children. Together these trials enrolled 2,457 participants. All were randomized, double-blind or observer-blind, and active-controlled.