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...
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|---|---|---|---|---|
| GSK plc Sponsored ADR | GSK | 3 | PHASE3 | mRNA Seasonal Flu vaccine, Flu/COVID-19 mRNA combination vaccine |
| Sinovac Biotech Ltd. | SVA | 1 | PHASE3 | Quadrivalent influenza vaccine (split virion), inactivated |
| Moderna, Inc. | MRNA | 2 | PHASE3 | mRNA-1018-H5, mRNA-1010, Fluarix Trivalent |
| Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | CDTX | 1 | PHASE3 | CD388 |
| Traws Pharma, Inc. | TRAW | 2 | PHASE2 | TRX-100 |
| Sanofi SA Sponsored ADR | SNY | 4 | PHASE1 | H5N8 pandemic influenza vaccine (adjuvanted) |
| Hoffmann-La Roche | RHHBY | 2 | PHASE3 | Baloxavir Marboxil |
| AstraZeneca PLC | AZN | 1 | PHASE1 | AZD4117, AZD5315 |
The quadrivalent influenza GSK2282512A vaccine is an investigational vaccine developed by GSK plc for the prevention of influenza. It is designed to protect against four influenza virus strains, which is what quadrivalent means. It is a vaccine candidate in the infectious disease therapeutic area and has been studied in young children.
It is being developed for the prevention of influenza, a contagious respiratory illness caused by influenza viruses. The vaccine targets four influenza strains rather than the three covered by traditional trivalent vaccines. Its clinical program studied administration in children 6 to 35 months of age to assess immune response and safety.
GSK plc, which trades under the ticker GSK, is the developer of the quadrivalent influenza GSK2282512A vaccine. The company sponsored the clinical study of the candidate in children. GSK is a global pharmaceutical and vaccines company.
The quadrivalent influenza GSK2282512A vaccine has been studied in Phase 3 clinical development. It is an investigational vaccine and is not described as approved. The Phase 3 trial evaluating it has been completed.
The quadrivalent influenza GSK2282512A vaccine was evaluated in one Phase 3 trial, NCT01711736, titled a study of immunogenicity and safety of GSK Biologicals' quadrivalent influenza vaccine GSK2282512A in children 6 to 35 months of age. The trial enrolled 606 participants, was randomized, double blind, and active controlled, and was conducted in Canada, the Dominican Republic, and Honduras. It is completed.
A total of 606 participants were enrolled in the clinical trial of the quadrivalent influenza GSK2282512A vaccine. The study was a randomized, double blind, active controlled Phase 3 trial in healthy children aged 6 to 35 months. It was conducted across sites in Canada, the Dominican Republic, and Honduras.