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Also known as GSK1024850A (Synflorix)
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 pneumococcal vaccine developed by GSK plc for the prevention of streptococcal infections. It is also known as Synflorix. The candidate has been studied in a Phase 3 trial in children, and it is designed for immunization against pneumococcal disease in pediatric populations.
GSK1024850A is being developed for immunization against streptococcal infections, specifically pneumococcal disease. Its Phase 3 trial enrolled children between 8 weeks and 2 years of age in Burkina Faso. The vaccine is intended for active immunization of young children against infections caused by Streptococcus pneumoniae.
GSK1024850A is developed by GSK plc, which trades under the ticker GSK. The company sponsored the Phase 3 study of the vaccine candidate in children. GSK is the sole developer listed for this pneumococcal vaccine asset.
GSK1024850A is in Phase 3 development. One Phase 3 trial has been completed, and no trials are currently active. The candidate is investigational and has not been established as approved for any indication based on the available development record.
GSK1024850A has been evaluated in one completed Phase 3 trial, NCT01175083, titled Immunization of Children Between 8 Weeks and 2 Years of Age With GSK Pneumococcal Vaccine GSK1024850A. The study enrolled 300 children in Burkina Faso, used an active-controlled design, and included healthy volunteers.
Yes, GSK1024850A is also known as Synflorix. Both names refer to the same pneumococcal vaccine candidate developed by GSK plc. Readers searching for either name will find the same Phase 3 asset for streptococcal infection prevention in children.