Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Malaria Vaccine 257049 (MALARIA-055 PRI)
Malaria Vaccine 257049 · 2 trials · 1 indication
Case definition 1 for severe malaria was defined as an episode of malaria with positive Plasmodium falciparum asexual parasitemia (within -1 to +3 days of admission) and with one or more marker of disease severity: Prostration, respiratory distress, Blantyre score equal to or less than (≤) 2, seizures 2 or more, hypoglycemia below (\<) 2.2 millimoles per liter (mmol/L), acidosis BE ≤ -10.0 mmol/L, lactate ≥ 5.0 mmol/L or anemia \< 5.0 grams per deciliter (g/dL). The incidence of severe malaria for case definition 1 is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years at risk (T).
Case definition 2 for severe malaria was defined as an episode of malaria with positive Plasmodium falciparum asexual parasitemia (within -1 to +3 days of admission) and with one or more marker of disease severity: Prostration, respiratory distress, Blantyre score equal to or less than (≤) 2, seizures 2 or more, hypoglycemia below (\<) 2.2 millimoles per liter (mmol/L), acidosis BE ≤ -10.0 mmol/L, lactate ≥ 5.0 mmol/L or anemia \< 5.0 grams per deciliter (g/dL) or SAE report including preferred terms (Malaria, Plasmodium falciparum infection or Cerebral malaria) within -1 to +3 days of admission. The incidence of severe malaria for case definition 2 is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years at risk (T).
A CPFMI-PCD was defined as an episode of malaria for which P. falciparum asexual parasitemia was greater than (\>) 5000 parasites per microliter (µL) accompanied by the presence of fever \[axillary temperature greater than or equal to (≥) 37.5°C\] at the time of presentation AND occurring in a child who is unwell and brought for treatment to a healthcare facility OR a case of malaria meeting the primary case definition of severe malaria disease. The time to first or only CPFMI-PCD is expressed in terms of rate of first or only CPFMI (RfoCPFMI), that is person-year rate in each group (n/T). Analysis for this outcome was solely performed on subjects in the 5-17 months age category.
A CPFMI-PCD was defined as an episode of malaria for which P. falciparum asexual parasitemia \> 5000 parasites/µL was accompanied by the presence of fever (axillary temperature ≥ 37.5°C) at the time of presentation AND occurring in a child who is unwell and brought for treatment to a healthcare facility OR a case of malaria meeting the primary case definition of severe malaria disease. The time to first or only CPFMI-PCD is expressed in terms of rate of first or only CPFMI (RfoCPFMI), that is, person-year rate in each group (n/T). Analysis for this outcome was solely performed on subjects in the 6-12 weeks (6-12W) age category.
| Arm | Type | Description |
|---|---|---|
| GSK257049 Group | EXPERIMENTAL | Male or female infants (between and including 6 to 12 weeks of age)/children (between and including 5 to 17 months of age) received 3 doses of GSK257049 malaria vaccine (co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, for the infants subgroup) on a 0-1-2-month schedule, and a booster dose of GSK257049 malaria vaccine (co-administered with Polio Sabin, for the infants subgroup) at Month 20 during the primary study MALARIA-055 PRI (NCT00866619). Vaccines were administered intramuscularly: in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB/Hib vaccine); orally: Polio Sabin vaccine. No vaccination was administered during this study. |
| GSK257049 Comparator Group | ACTIVE_COMPARATOR | Male or female infants (between and including 6 to 12 weeks of age)/children (between and including 5 to 17 months of age) received 3 doses of GSK257049 malaria vaccine (co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, for the infants subgroup) on 0-1-2-month schedule, and a booster dose of Menjugate vaccine (co-administered with Polio Sabin, for the infants subgroup) at Month 20 during the primary study MALARIA-055 PRI (NCT00866619). Vaccines were administered intramuscularly: in the anterolateral left thigh (GSK257049 vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine); orally: Polio Sabin vaccine. No vaccination was administered during this study. |
| VeroRab/Menjugate Comparator Group | ACTIVE_COMPARATOR | Male or female infants (between and including 6 to 12 weeks of age)/children (between and including 5 to 17 months of age) received 3 doses of VeroRab vaccine (children subgroup) or Menjugate vaccine (co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, for the infants subgroup) on 0-1-2-month schedule, and a booster dose of Menjugate vaccine (co-administered with Polio Sabin, for the infants subgroup) at Month 20 during the primary study MALARIA-055 PRI (NCT00866619). Vaccines were administered intramuscularly: left deltoid (VeroRab vaccine and Menjugate vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine); orally: Polio Sabin vaccine. No vaccination was administered during this study. |
| GSK257049 [5-17M] Group | EXPERIMENTAL | Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine, according to a 0-1-2 Month schedule, followed by either a booster dose of the same GSK257049 vaccine or a dose of Menjugate vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid. |
| GSK257049 [6-12W] Group | EXPERIMENTAL | Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of the GSK257049 malaria vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by either a booster dose of the GSK257049 and Polio Sabin vaccines or a booster dose of Menjugate and Polio Sabin vaccines, at Month 20. All vaccines have been administered intramuscularly in the interolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which has been given orally. |
| VeroRab Comparator [5-17M] Group | ACTIVE_COMPARATOR | Male or female children between and including 5 to 17 months of age \[5-17M\], who received a 3-dose primary vaccination course of the VeroRab vaccine, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate vaccine, at Month 20. Both vaccines have been administered intramuscularly into the left deltoid. |
| Menjugate Comparator [6-12W] Group | EXPERIMENTAL | Male or female children between and including 6 to 12 weeks of age \[6-12W\], who received a 3-dose primary vaccination course of Menjugate vaccine co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, according to a 0-1-2 Month schedule, followed by a booster dose of Menjugate and Polio Sabin vaccines, at Month 12. All vaccines have been administered intramuscularly in the left thigh for children under 1 year and left deltoid for children above 1 year of age (Menjugate vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine), except for the Polio Sabin vaccine, which has been given orally. |
| Name | Type | Description |
|---|---|---|
| Blood sampling | PROCEDURE | Annual blood sampling (Year 1, Year 2 and Year 3) during the present study. |
| Malaria Vaccine 257049 (MALARIA-055 PRI) | BIOLOGICAL | Administered intramuscularly into the left deltoid, during the MALARIA-055 study (NCT00866619). |
| Meningococcal C Conjugate Vaccine (MALARIA-055 PRI) | BIOLOGICAL | Administered intramuscularly into the left deltoid, during the MALARIA-055 study (NCT00866619). |
| Cell-culture rabies vaccine (MALARIA-055 PRI) | BIOLOGICAL | Administered intramuscularly into the left deltoid, during the MALARIA-055 study (NCT00866619). |
| TritanrixHepB/Hib (MALARIA-055 PRI) | BIOLOGICAL | Administered intramuscularly into the left deltoid, during the MALARIA-055 study (NCT00866619). |
| Polio Sabin Oral Polio Vaccine (GSK) (MALARIA-055 PRI) | BIOLOGICAL | Administered orally, during the MALARIA-055 study (NCT00866619). |
| Malaria Vaccine 257049 | BIOLOGICAL | administered intramuscularly into the left deltoid. |
| Meningococcal C Conjugate Vaccine | BIOLOGICAL | administered intramuscularly into the left deltoid. |
| Cell-culture rabies vaccine | BIOLOGICAL | administered intramuscularly into the left deltoid. |
| TritanrixHepB/Hib | BIOLOGICAL | administered intramuscularly into the left deltoid. |
| Polio Sabin Oral Polio Vaccine (GSK) | BIOLOGICAL | administered orally. |
Inclusion Criteria: * Subjects' parent(s)/ Legally Acceptable Representative (LARs) who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * Subjects who were enrolled and who received at least one vaccine dose in the primary study MALARIA-055 PRI NCT008...
| 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 |
Malaria Vaccine 257049 is an investigational vaccine developed by GSK plc for the prevention of malaria. It is a Phase 3 candidate studied in infants and children in Africa. It is also known as Malaria Vaccine 257049 (MALARIA-055 PRI).
Malaria Vaccine 257049 is being developed for the prevention of malaria in infants and children. Its clinical program enrolled healthy volunteers in African countries including Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique and Tanzania.
Malaria Vaccine 257049 is developed by GSK plc, which trades under the ticker GSK. GSK Biologicals is the sponsor entity named in the clinical trial records for the candidate malaria vaccine.
Malaria Vaccine 257049 is in Phase 3 clinical development. It is an investigational vaccine and has been evaluated in two completed Phase 3 trials. It is not described as approved.
Malaria Vaccine 257049 has been studied in two completed Phase 3 trials: NCT00866619, which evaluated efficacy against malaria disease in infants and children in Africa with 15,459 participants, and NCT02207816, an extension study with 3,084 participants assessing long-term efficacy, safety and immunogenicity.
Yes. Malaria Vaccine 257049 is also known as Malaria Vaccine 257049 (MALARIA-055 PRI). The MALARIA-055 PRI designation refers to the same GSK candidate malaria vaccine program, and the extension trial NCT02207816 was conducted as a follow-on to study MALARIA-055 PRI.