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GSK Biologicals´ Pneumococcal Conjugate Vaccine GSK1024850A · 1 trial · 1 indication
Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) were measured by 22F-inhibition Enzyme-Linked ImmunSorbent Assay (ELISA); presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off for the assay was greater than or equal to (≥) 0.05 μg/mL.
Anti-PD antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the assay was ≥ 100 EL.U/mL.
| Arm | Type | Description |
|---|---|---|
| Synflorix + Infanrix hexa Group | ACTIVE_COMPARATOR | Subjects received 3 doses of SynflorixTM vaccine co-administered with Infanrix hexaTM at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (SynflorixTM) or left (Infanrix hexaTM) thigh or deltoid. |
| Synflorix + Pediacel Group | EXPERIMENTAL | Subjects received 3 doses of SynflorixTM vaccine co-administered with PediacelTM at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (SynflorixTM) or left (PediacelTM) thigh or deltoid.thigh or deltoid. |
| Prevenar + Pediacel Group | ACTIVE_COMPARATOR | Subjects received 3 doses of PrevenarTM co-administered with PediacelTM vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (PrevenarTM) or left (PediacelTM) thigh or deltoid. |
| Name | Type | Description |
|---|---|---|
| GSK Biologicals´ Pneumococcal Conjugate Vaccine GSK1024850A (Synflorix™) | BIOLOGICAL | Intramuscular injection, 3 doses in the primary vaccination and 1 dose in the booster vaccination |
| Infanrix™ hexa. | BIOLOGICAL | Intramuscular injection, , 3 doses in the primary vaccination and 1 dose in the booster vaccination |
| Pediacel™ | BIOLOGICAL | Intramuscular injection, , 3 doses in the primary vaccination and 1 dose in the booster vaccination |
| Prevenar™ | BIOLOGICAL | Intramuscular injection, , 3 doses in the primary vaccination and 1 dose in the booster vaccination |
Inclusion Criteria: * Subjects who the investigator believes that their parents/guardian(s) can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study. * A male or female between, and including, 6-12 w...
GSK Biologicals' Pneumococcal Conjugate Vaccine GSK1024850A is an investigational vaccine developed by GSK plc for streptococcal infections. It is a vaccine candidate studied in a Phase 3 clinical trial in the Netherlands. The vaccine was evaluated in healthy infants from 6 weeks of age.
GSK Biologicals' Pneumococcal Conjugate Vaccine GSK1024850A is being studied for the prevention of streptococcal infections. Its Phase 3 trial enrolled 780 healthy infants in the Netherlands. The study examined co-administration of the pneumococcal conjugate vaccine with two different combination vaccine regimens.
GSK Biologicals' Pneumococcal Conjugate Vaccine GSK1024850A is developed by GSK plc, which trades under the ticker GSK. GSK Biologicals is the vaccine division associated with the product. The company sponsored the Phase 3 trial evaluating the vaccine candidate.
GSK Biologicals' Pneumococcal Conjugate Vaccine GSK1024850A is in Phase 3 development. One Phase 3 trial has been completed, and no trials are currently active. The completed study was randomized, active-controlled, and enrolled 780 participants.
GSK Biologicals' Pneumococcal Conjugate Vaccine GSK1024850A was studied in the completed Phase 3 trial NCT00652951, titled Co-administration of Pneumococcal Conjugate Vaccine With DTPa-IPV-Hib Versus Co-administration With DTPa-HBV-IPV/Hib. The trial enrolled 780 healthy infants aged 6 weeks and older in the Netherlands and was active-controlled and randomized.
Yes. GSK Biologicals' Pneumococcal Conjugate Vaccine GSK1024850A is also known as Synflorix. The two names refer to the same GSK plc pneumococcal conjugate vaccine candidate studied for streptococcal infections. Readers searching for Synflorix will find the same asset under the GSK1024850A designation.