Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as GSK Biologicals' GSK2340274A (two different formulations)
GSK Biologicals' GSK2340274A · 1 trial · 1 indication
Seroconversion rate (SCR) was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titer below (\<) 10 and a post-vaccination reciprocal titre greater than or equal to (≥) 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus. The Flu strain assessed was A/California/7/2009 (H1N1)v-like virus (Flu A/CAL/7/09), following the Committee for Medicinal Products for Human Use (CHMP) and the Center for Biologics Evaluation and Research (CBER) guidance. The CBER criterion was fulfilled if the lower 95% confidence interval (CI) for SCR was (\>) 40%. The CHMP criterion was fulfilled if the point estimate for SCR was \> 40%.
A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance. The CBER criterion was fulfilled if the lower limit of the 95% CI for seroprotection (SPR) was \> 70%. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was \> 70%.
GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance. The CHMP criterion was fulfilled if the point estimate for GMFR was \> 2.5.
| Arm | Type | Description |
|---|---|---|
| AREPANRIX 1/2 GROUP | EXPERIMENTAL | Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm. |
| PANDEMRIX 1/2 GROUP | EXPERIMENTAL | Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm. |
| AREPANRIX GROUP | EXPERIMENTAL | Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm. |
| Name | Type | Description |
|---|---|---|
| GSK Biologicals' GSK2340274A (two different formulations) | BIOLOGICAL | Intramuscular injection |
| GSK Biologicals' - GSK2340272A | BIOLOGICAL | Intramuscular injection |
Inclusion Criteria: * Male or pre-menarchal female children 3 to \< 10 years of age at the time of the study vaccination. "Less than 10 years of age" implies inclusion of children who have not reached their 10th birthday as of Day 0, the day of the study vaccine dose under this protocol. * Written ...
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GSK Biologicals' GSK2340274A is an investigational monoclonal antibody developed by GSK plc for influenza. It was studied as a candidate H1N1 influenza vaccine in children. It is not an approved product and remains in clinical development, with Phase 2 testing completed.
GSK Biologicals' GSK2340274A was developed for influenza, specifically as a candidate H1N1 influenza vaccine. Its Phase 2 trial evaluated safety and immune response in children 3 to less than 10 years old. It is investigational and has not been approved for use.
GSK Biologicals' GSK2340274A is developed by GSK plc, which trades under the ticker GSK. GSK Biologicals is the vaccines unit associated with the asset. The candidate was studied as an H1N1 influenza vaccine in pediatric participants.
GSK Biologicals' GSK2340274A is in Phase 2 development. Its only listed trial, NCT01161160, is a completed Phase 2 study, and no trials are currently active. The asset is investigational and has not been approved for any indication.
GSK Biologicals' GSK2340274A was studied in one completed Phase 2 trial, NCT01161160, titled Safety and Immune Response of Candidate H1N1 Influenza Vaccines GSK2340274A and GSK234072A in Children 3 to Less Than 10 Years Old. It enrolled 209 participants in the Philippines and Thailand.
No. GSK Biologicals' GSK2340274A and GSK234072A are two different formulations evaluated in the same Phase 2 trial, NCT01161160. That study compared the safety and immune response of both candidate H1N1 influenza vaccines in children aged 3 to less than 10 years.