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Pneumococcal conjugate vaccine GSK1024850A · 1 trial · 6 indications
Fever was measured as rectal temperature.
| Arm | Type | Description |
|---|---|---|
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | EXPERIMENTAL | Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany \& Poland and Infanrix™ IPV Hib in Spain) and Wyeth's Men-C conjugate vaccine (Meningitec™) at 11-18 months of age. |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | EXPERIMENTAL | Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany \& Poland and Infanrix™ IPV Hib in Spain) and Baxter's Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age. |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | EXPERIMENTAL | Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany \& Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age. |
| Prevenar™ + Menitorix™ | ACTIVE_COMPARATOR | Subjects receiving a booster dose of Wyeth's pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany \& Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age. |
| Name | Type | Description |
|---|---|---|
| Pneumococcal conjugate vaccine GSK1024850A | BIOLOGICAL | Intramuscular injection, 1 dose. |
| Prevenar | BIOLOGICAL | Intramuscular injection, 1 dose. |
| Infanrix hexa | BIOLOGICAL | Intramuscular injection, 1 dose. In Germany and Poland. |
| Infanrix IPV Hib | BIOLOGICAL | Intramuscular injection, 1 dose. In Spain. |
| Infanrix penta | BIOLOGICAL | Intramuscular injection, 1 dose. In Germany and Poland. |
| Infanrix IPV | BIOLOGICAL | Intramuscular injection, 1 dose. In Spain. |
| Meningitec | BIOLOGICAL | Intramuscular injection, 1 dose. |
| NeisVac-C | BIOLOGICAL | Intramuscular injection, 1 dose. |
| Menitorix | BIOLOGICAL | Intramuscular injection, 1 dose. |
Inclusion Criteria: * Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol. * A male or female between, and including, 11-18 months of age at the time of the booster vaccination. * A male or female who previously participated ...
Pneumococcal conjugate vaccine GSK 1024850A is an investigational vaccine being studied for the prevention of infections caused by Streptococcus pneumoniae, including pneumonia, invasive disease, and acute otitis media. It is also being evaluated in the context of Hepatitis B. The vaccine is intended for use in infants and young children, with clinical trials enrolling participants as young as 6 weeks of age.
Pneumococcal conjugate vaccine GSK 1024850A is being developed by GSK plc, a global biopharma company listed on the London Stock Exchange under the ticker GSK. GSK is conducting Phase 3 clinical trials to evaluate the vaccine's safety, immunogenicity, and efficacy against pneumococcal infections.
Pneumococcal conjugate vaccine GSK 1024850A is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. GSK has completed eight Phase 3 trials with a total enrollment of 67,416 participants, all of which are now completed.
Pneumococcal conjugate vaccine GSK 1024850A has been studied in eight completed Phase 3 trials. Key trials include NCT00344318, a safety and immunogenicity study in 806 participants; NCT00466947, the COMPAS study evaluating efficacy against pneumonia and acute otitis media in 23,802 participants; NCT00861380, an effectiveness study against invasive disease in 41,188 participants; and NCT00907777, a booster study in 52 children.
Pneumococcal conjugate vaccine GSK 1024850A is a 10-valent pneumococcal conjugate vaccine developed by GSK. While it is often referred to by its development code, the vaccine is commercially known as Synflorix. The clinical trials listed under GSK 1024850A evaluate this 10-valent formulation for protection against pneumococcal disease.