Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Quadrivalent influenza GSK2282512A vaccine · 1 trial · 1 indication
A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (\<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2), Flu B/Hubei-Wujiagang/158/09 (Yamagata) and Flu B/Bri/60/08 (Victoria). This outcome concerns solely subjects in the GSK2282512A Group.
Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain was defined as pain that prevented normal everyday activities. Grade 3 swelling was greater than 100 millimeters (mm) i.e. \>100mm.
Solicited general symptoms assessed were drowsiness, irritability/fussiness and loss of appetite. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 irritability/fussiness was defined as crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite was defined as not eating at all. Grade 3 drowsiness was defined as drowsiness that prevented normal activity.
Any fever was defined as any fever ≥38.0 degrees Celsius (°C) irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 fever was defined as fever ≥39.0 °C.
| Arm | Type | Description |
|---|---|---|
| GSK2282512A Group | EXPERIMENTAL | Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine. Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects \< 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age). |
| Fluarix Group | ACTIVE_COMPARATOR | Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine. Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects \< 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age). |
| Name | Type | Description |
|---|---|---|
| Quadrivalent influenza GSK2282512A vaccine | BIOLOGICAL | 1 or 2 doses administered intramuscularly (IM) in deltoid muscle or anterolateral thigh on Day 0 (primed subjects) and on Day 0 and Day 28 (unprimed subjects) respectively. |
| Fluarix | BIOLOGICAL | 1 or 2 doses administered IM in deltoid muscle or anterolateral thigh, on Day 0 (primed subjects) and on Day 0 and Day 28 (unprimed subjects) respectively. |
Inclusion Criteria: * Subject's parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * A male or female between, and including, 6 and 35 months of age at the time of the first vaccination. * Wri...
Quadrivalent influenza GSK2282512A vaccine is an investigational vaccine being developed for the prevention of influenza. It is designed to be administered to children aged 6 to 35 months. The vaccine is currently in Phase 3 clinical development and is not yet approved by regulatory authorities.
Quadrivalent influenza GSK2282512A vaccine is being developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the vaccine's immunogenicity and safety in the pediatric population.
Quadrivalent influenza GSK2282512A vaccine is in Phase 3 clinical development. It is an investigational vaccine, meaning it has not yet received regulatory approval. The Phase 3 trial has been completed, and the vaccine is being studied for use in children aged 6 to 35 months.
Quadrivalent influenza GSK2282512A vaccine has been studied in one completed Phase 3 clinical trial with the identifier NCT01711736. This randomized, double-blind, active-controlled study evaluated the immunogenicity and safety of the vaccine in 606 children aged 6 to 35 months across Canada, the Dominican Republic, and Honduras.
Yes, Quadrivalent influenza GSK2282512A vaccine is the same as GSK2282512A. The vaccine is referred to by both names in clinical trial documentation. It is being developed by GSK plc for the prevention of influenza in young children.