Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK1024805A · 1 trial · 2 indications
A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Analysis was performed using the 22F-inhibition Enzyme-linked immunosorbent assay (ELISA), using 0.05 microgram per milliliter (µg/mL) as seropositivity cut off.
A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Analysis was performed using the 22F-inhibition Enzyme -linked immunosorbent assay (ELISA), using 0.05 μg/mL as seropositivity cut off.
A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Analysis was performed using the 22F-inhibition Enzyme-linked immunosorbent assay (ELISA), using 0.05 μg/mL as seropositivity cut off.
| Arm | Type | Description |
|---|---|---|
| Synflorix + Infanrix + Havrix and/or Varilrix Group | EXPERIMENTAL | This group consisted of subjects primed with Synflorix vaccine in the 10PN-PD-DIT-001 (1105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Synflorix vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose of Synflorix vaccine at 12-18 months of age co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix) and/or against varicella (a single dose of Varilrix). |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | ACTIVE_COMPARATOR | This group consisted of subjects vaccinated with Prevenar vaccine in the 10PN-PD-DIT-001 (105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose at 12-18 months of age of Prevenar vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 111347 study, subjects had received at Month 48 (4 years post Dose 1 in study 105553) one dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix). |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | EXPERIMENTAL | This group consisted of subjects vaccinated with Prevenar and Synflorix vaccines in the 10PN-PD-DIT-001 (105553) and 10PN-PD-DIT-007 (107046) studies. In 105553 study, subjects had been primed with 3 doses Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In the 107046 study, subjects had received at 12-18 months of age a booster dose of Synflorix vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects had received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix). |
| Unprimed Group | EXPERIMENTAL | This group consisted of subjects between, and including, 64-68 months of age at the time of additional vaccination (primed subjects) or dose 1 (unprimed subjects), and for whom the investigator believed that their parents/guardians could and would comply with the requirements of the protocol. Subjects were not previously vaccinated with any pneumococcal vaccine and received 2 doses of Synflorix vaccine at 64-68 and 66-70 months of age (at Day 0 and Month 2). The Unprimed Group was added only in Year 4 of the study. |
| Name | Type | Description |
|---|---|---|
| GSK1024805A | BIOLOGICAL | No vaccination in this trial |
| Prevenar | BIOLOGICAL | No vaccination in this trial |
| Infanrix hexa | BIOLOGICAL | No vaccination in this trial |
| Havrix | BIOLOGICAL | No vaccination in this trial |
| Varilrix | BIOLOGICAL | No vaccination in this trial |
Inclusion Criteria: * Male or female between, and including, 28-30 months of age at the time of first blood sampling. * Subjects who previously participated in the 105553 and 107046 studies and who received a full four dose regimen of pneumococcal conjugate vaccine during the primary and booster st...
GSK1024805A is a monoclonal antibody being developed for streptococcal infections, specifically related to Streptococcus pneumoniae. It is currently in Phase 3 clinical development as an investigational therapy. The drug is being studied in the context of pneumococcal conjugate vaccine antibody persistence in children.
GSK1024805A is developed by GSK plc, a global biopharmaceutical company. GSK plc is publicly traded under the ticker symbol GSK on major stock exchanges. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational monoclonal antibody for streptococcal infections.
GSK1024805A is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, with a total enrollment of 524 participants. The study was conducted in Poland and focused on children aged 28 months and older.
GSK1024805A has one completed Phase 3 clinical trial registered as NCT00624819. The trial, titled 'Assessment of Antibody Persistence in Children Previously Vaccinated With Pneumococcal Conjugate Vaccine,' enrolled 524 participants in Poland. The study was active-controlled and included healthy volunteers, with a minimum age of 28 months.
GSK1024805A is a monoclonal antibody designed to target streptococcal infections, specifically Streptococcus pneumoniae. Monoclonal antibodies work by binding to specific targets to neutralize pathogens or modulate immune responses. However, the specific molecular target of GSK1024805A has not been disclosed in available information.