Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK Biologicals' Synflorix · 1 trial · 1 indication
Pneumococcal serotypes assessed were vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Seropositivity cut-off for the assay was an anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) concentrations greater than or equal to (≥) 0.05 microgram per milliliter (μg/mL).
Anti-PD antibody concentrations were expressed in enzyme-linked immunsorbent assay (ELISA) units per milliliter (EL.U/mL). Seropositivity cut-off for the assay was an anti-PD antibody concentrations ≥ 100 EL.U/mL.
| Arm | Type | Description |
|---|---|---|
| SYNFLORIX™ + ZILBRIX™ HIB + POLIO SABIN™ | EXPERIMENTAL | Subjects in this group received 3 doses of Synflorix™ vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to the same schedule. The Synflorix™ and Zilbrix™ Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin™ vaccine was administered orally. |
| ZILBRIX™ HIB + POLIO SABIN™ | EXPERIMENTAL | Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix™ Hib and Polio Sabin™ according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix™ Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin™ vaccine was administered orally. |
| Name | Type | Description |
|---|---|---|
| GSK Biologicals' Synflorix™ | BIOLOGICAL | 3 IM doses. |
| GSK Biologicals' Polio Sabin™ | BIOLOGICAL | 3 oral doses |
| GSK Biologicals' Zilbrix™ Hib | BIOLOGICAL | 3 IM doses. |
Inclusion Criteria: * Male or female subjects between, and including 6-10 weeks of age at the time of the first vaccination. * Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol should be enrolled in the study. * Wr...
Synflorix is a pneumococcal vaccine developed by GSK Biologicals for the prevention of infections caused by Streptococcus pneumoniae. It is intended for use in children, with a primary vaccination course studied in infants as young as 6 weeks of age. The vaccine is being investigated for its ability to protect against streptococcal infections.
Synflorix is developed by GSK Biologicals, a subsidiary of GSK plc, which trades on the London Stock Exchange under the ticker GSK. The vaccine is part of GSK's infectious disease portfolio and has been studied in a Phase 3 clinical trial for the prevention of streptococcal infections in children.
Synflorix is in Phase 3 clinical development. A Phase 3 trial, NCT00678301, has been completed, evaluating the primary vaccination course in children receiving the pneumococcal vaccine GSK 1024850A. The trial enrolled 365 participants and was conducted in Mali and Nigeria.
Synflorix has one completed Phase 3 clinical trial, NCT00678301, titled 'Primary Vaccination Course in Children Receiving the Pneumococcal Vaccine GSK 1024850A, Zilbrix™ Hib and Polio Sabin™'. The trial enrolled 365 children aged 6 weeks and older in Mali and Nigeria, and was a controlled, randomized study.
Synflorix is an investigational vaccine and has not been reported as FDA approved. It is currently in clinical development, with a completed Phase 3 trial. The vaccine is being studied for the prevention of streptococcal infections, but regulatory approval status has not been established based on available information.