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GSK1024850A · 1 trial · 1 indication
Antibodies have been assessed against the following vaccine pneumococcal serotypes: 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration greater than or equal to (≥) 0.05 micrograms per milliliter (µg/mL). Antibody concentrations below than (\<) 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.
Anti-PD antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 100 EL.U/mL. Antibody concentrations \< 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.
| Arm | Type | Description |
|---|---|---|
| Tritanrix-HepB/Hib+Polio Sabin <6S Group | EXPERIMENTAL | Children below (\<) 6 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8. |
| Tritanrix-HepB/Hib+Polio Sabin <6NS Group | ACTIVE_COMPARATOR | Healthy children, below (\<) 6 months of age at time of enrolment, who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8. |
| Synflorix 7-11S Group | EXPERIMENTAL | Children between 7-11 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3. |
| Synflorix 7-11NS Group | ACTIVE_COMPARATOR | Healthy children between 7-11 months of age at time of enrolment, who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3. |
| Synflorix 12-23S Group | EXPERIMENTAL | Children between 12-23 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2. |
| Synflorix 12-23NS Group | ACTIVE_COMPARATOR | Healthy children between 12-23 months of age at time of enrolment, who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2. |
| Name | Type | Description |
|---|---|---|
| GSK1024850A (Synflorix) | BIOLOGICAL | 2, 3 or 4 intramuscular injection |
| Tritanrix-HepB/Hib | BIOLOGICAL | Intramuscular injection, 4 doses |
| Polio Sabin | BIOLOGICAL | 4 oral doses |
Inclusion Criteria: * Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits). * A male or female between, and including: * 8 ...
GSK1024850A is an investigational monoclonal antibody being developed for the prevention of streptococcal infections. It is intended for use in children between 8 weeks and 2 years of age, as studied in a Phase 3 clinical trial conducted in Burkina Faso.
GSK1024850A is a monoclonal antibody, but its specific molecular target has not been disclosed. The drug is being studied for its potential to prevent infections caused by Streptococcus bacteria, which are the focus of the clinical development program.
GSK1024850A is being developed by GSK plc, a global biopharmaceutical company. GSK plc is listed on the stock exchange under the ticker symbol GSK.
GSK1024850A is in Phase 3 clinical development. It has completed one Phase 3 trial, and the drug remains investigational, meaning it has not been approved for use outside of clinical research settings.
GSK1024850A has been studied in one completed Phase 3 clinical trial with the identifier NCT01175083. This trial, titled 'Immunization of Children Between 8 Weeks and 2 Years of Age With GSK Pneumococcal Vaccine GSK1024850A,' enrolled 300 participants in Burkina Faso.