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Wyeth-Lederle's Prevenar · 1 trial · 1 indication
Grade 3 adverse events are severe symptoms that prevent normal, everyday activities.
| 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. |
| 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 |
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...
Prevenar is an investigational pneumococcal vaccine being developed for the prevention of Streptococcal infections. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities. The vaccine is intended for use in children, as studied in a booster vaccination trial.
Prevenar is being developed by GSK plc, a global biopharma company listed on the London Stock Exchange under the ticker GSK. The drug is currently in Phase 3 clinical trials for the prevention of Streptococcal infections.
Prevenar is currently in Phase 3 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. One Phase 3 trial has been completed, involving 450 participants in South Korea.
Prevenar has one completed Phase 3 clinical trial registered under NCT00911144, titled "Booster Vaccination Study With a Pneumococcal Vaccine in Children Primed With the Same Vaccine." The trial enrolled 450 children aged 12 months and older in South Korea and was active-controlled.
Yes, Prevenar is the same drug as Wyeth-Lederle's Prevenar. The drug is now being developed by GSK plc, which acquired the asset. It is an investigational pneumococcal vaccine in Phase 3 development for Streptococcal infections.