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GSK Biologicals' investigational vaccine GSK2340274A · 1 trial · 1 indication
The influenza virus presence was confirmed by quantitative reverse transcription polymerase chain reaction assay (RT-qPCR).
| Arm | Type | Description |
|---|---|---|
| Arepanrix 2D 6M-3Y Group | EXPERIMENTAL | Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. |
| Arepanrix 2D 3Y-10Y Group | EXPERIMENTAL | Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm). |
| Arepanrix 1D 6M-3Y Group | EXPERIMENTAL | Subjects, male and female, aged 6 months (M) to 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. |
| Arepanrix 1D 3Y-10Y Group | EXPERIMENTAL | Subjects, male and female, aged 3 years (Y) to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm). |
| GSK2340273A 6M-3Y Group | EXPERIMENTAL | Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh. |
| GSK2340273A 3Y-10Y Group | EXPERIMENTAL | Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm). |
| Name | Type | Description |
|---|---|---|
| GSK Biologicals' investigational vaccine GSK2340274A (alternative formulations) | BIOLOGICAL | Intramuscular injection, one or two doses |
| GSK Biologicals' investigational vaccine GSK2340273A (alternative formulations) | BIOLOGICAL | Intramuscular injection, two doses |
| Placebo | BIOLOGICAL | Intramuscular injection, one dose |
Inclusion Criteria: * Male or female children 6 months to less than 10 years of age at the time of the first 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 first vaccine dose under this protocol. * Written info...
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| GSK plc Sponsored ADR | GSK | 3 | PHASE3 | mRNA Seasonal Flu vaccine, Flu/COVID-19 mRNA combination vaccine |
| 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 |
| Sinovac Biotech Ltd. | SVA | 1 | PHASE1 | Cell-based Trivalent Split Influenza Virus Vaccine, Egg-based Trivalent Split Influenza Virus Vaccine |
GSK Biologicals' investigational vaccine GSK2340274A is a vaccine candidate developed by GSK plc for the prevention of influenza. It is an investigational product, meaning it has not been approved by regulatory authorities and remains in clinical development. The vaccine was studied in a Phase 3 trial in children.
GSK Biologicals' investigational vaccine GSK2340274A is being developed for influenza. Its intended use is immunization against influenza virus infection. The clinical program evaluated the vaccine in children aged 6 months to less than 10 years, a population at risk for influenza and its complications.
GSK Biologicals' investigational vaccine GSK2340274A is made by GSK plc, which trades under the ticker GSK. GSK Biologicals is the vaccine division of GSK plc. The company is responsible for the development and clinical evaluation of this influenza vaccine candidate.
GSK Biologicals' investigational vaccine GSK2340274A is in Phase 3 clinical development. The Phase 3 trial has been completed. The vaccine is investigational and has not been approved for use. No active trials are currently listed for this candidate.
GSK Biologicals' investigational vaccine GSK2340274A was evaluated in a single Phase 3 trial, NCT01051661, titled Safety and Efficacy of H1N1 Vaccines in Children Aged 6 Months to Less Than 10 Years of Age. The trial enrolled 6,154 participants across Australia, Brazil, Colombia, Costa Rica, Mexico, the Philippines, Singapore, and Thailand.
GSK Biologicals' investigational vaccine GSK2340274A is also referred to as GSK Biologicals' investigational vaccine GSK2340274A (alternative formulations). These alternative formulations represent different versions of the same vaccine candidate. The Phase 3 trial NCT01051661 evaluated the vaccine in children aged 6 months to less than 10 years.