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GSK Biologicals´ Pneumococcal Conjugate Vaccine · 1 trial · 2 indications
Fever was measured as rectal temperature. Assessment of occurrences of fever \> 39.0 °C was performed within 4-days (Day 0-3) after booster vaccination of Synflorix™ and Infanrix™-IPV/Hib vaccine.
| Arm | Type | Description |
|---|---|---|
| Preterm I Group | EXPERIMENTAL | Children born after a gestation period of 27-30 weeks |
| Preterm II Group | EXPERIMENTAL | Children born after a gestation period of 31-36 weeks |
| Full term Group | ACTIVE_COMPARATOR | Children born after a gestation period of more than 36 weeks |
| Name | Type | Description |
|---|---|---|
| GSK Biologicals´ Pneumococcal Conjugate Vaccine (GSK1024850A) | BIOLOGICAL | Single dose, intramuscular injection |
| Infanrix™-IPV/Hib | BIOLOGICAL | Single dose, intramuscular injection |
Inclusion Criteria: * Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study. * A male or female between, and including, 16-18 months of age at the time of the booster vaccination. * A male or fem...
GSK Biologicals' Pneumococcal Conjugate Vaccine is an investigational vaccine developed by GSK plc for streptococcal infections, specifically those caused by Streptococcus pneumoniae. It is a vaccine modality in Phase 3 clinical development. The candidate is also identified by the code GSK1024850A.
It is being developed for the prevention of streptococcal infections, including disease associated with Streptococcus pneumoniae. The clinical program has studied it as a booster dose in preterm born infants. It remains investigational and is not described as approved for any indication.
GSK Biologicals' Pneumococcal Conjugate Vaccine is developed by GSK plc, which trades under the ticker GSK. GSK Biologicals is the vaccine unit associated with the product name.
GSK Biologicals' Pneumococcal Conjugate Vaccine is in Phase 3 clinical development. One Phase 3 trial has been completed, and no trials are currently listed as active. The candidate is investigational and is not described as FDA approved.
The vaccine has been studied in trial NCT00609492, titled Evaluate Safety and Immunogenicity of a Booster Dose of Pneumococcal Conjugate Vaccine in Preterm Born Infants. This completed Phase 3 study enrolled 245 participants across Greece and Spain, with an active-controlled design and participants aged 16 months and older.
Yes. GSK1024850A is an alternative designation for GSK Biologicals' Pneumococcal Conjugate Vaccine. Both names refer to the same GSK plc vaccine candidate for streptococcal infections, so searches using either name point to the same Phase 3 asset.