Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as 10Pn
GSK Biologicals' Synflorix · 2 trials · 1 indication
Grade 3 adverse events are severe symptoms that prevent normal, everyday activities.
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 Group | EXPERIMENTAL | Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively. |
| Prevenar Group | ACTIVE_COMPARATOR | Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively. |
| 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™ (Pneumococcal vaccine GSK1024850A) | BIOLOGICAL | Intramuscular injection, administered as a single dose |
| Wyeth-Lederle's Prevenar™ | BIOLOGICAL | Intramuscular injection, administered as a single dose |
| GSK Biologicals' Hiberix™ | BIOLOGICAL | Intramuscular injection, administered as a single dose |
| 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: * A male or female between, and including, 12-18 months of age at the time of booster vaccination. * Subjects for whom the investigator believes that their parent(s)/ guardian(s) can and will comply with the requirements of the protocol. * Subjects who received three doses of pn...
GSK Biologicals' Synflorix is a pneumococcal vaccine developed by GSK plc for the prevention of streptococcal infections. It is a vaccine candidate studied in pediatric populations, including infants and young children. The program has completed Phase 3 clinical development across two trials with a combined enrollment of 815 participants.
GSK Biologicals' Synflorix is being studied for the prevention of Infections, Streptococcal, a category of pneumococcal disease. Its clinical trials enrolled healthy children, including infants from 6 weeks of age and children from 12 months of age, in South Korea, Mali, and Nigeria.
GSK Biologicals' Synflorix is developed by GSK plc, which trades under the ticker GSK. The vaccine is also referred to in company materials as Pneumococcal vaccine GSK1024850A, reflecting its internal development code.
GSK Biologicals' Synflorix is in Phase 3 development. Both of its recorded clinical trials are Phase 3 studies and both have completed, with no trials currently listed as active. The program enrolled 815 participants in total across randomized, active-controlled designs.
GSK Biologicals' Synflorix has been evaluated in two completed Phase 3 trials. NCT00911144 was a booster vaccination study in children primed with the same vaccine, run in South Korea with 450 participants. NCT00678301 studied a primary vaccination course in children in Mali and Nigeria with 365 participants.
Yes. GSK Biologicals' Synflorix is also known as Pneumococcal vaccine GSK1024850A, its internal GSK development designation. The two names refer to the same pneumococcal vaccine candidate, which is also written as GSK Biologicals' Synflorix.