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GSK Biologicals' Influenza investigational vaccine GSK2340274A · 1 trial · 1 indication
Seroconversion defined as: - For initially seronegative subjects, antibody titre ≥ 1:40 after vaccination - For initially seropositive subjects, antibody titre after vaccination ≥ 4 fold the pre-vaccination antibody titre
A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.
Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0.
| Arm | Type | Description |
|---|---|---|
| AREPANRIX-ADJUVANTED F1 2D GROUP | EXPERIMENTAL | Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21. |
| AREPANRIX-ADJUVANTED F2 2D GROUP | EXPERIMENTAL | Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21. |
| AREPANRIX-ADJUVANTED F2 3D GROUP | EXPERIMENTAL | Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster). |
| AREPANRIX-UNADJUVANTED F2 2D GROUP | EXPERIMENTAL | Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21. |
| Name | Type | Description |
|---|---|---|
| GSK Biologicals' Influenza investigational vaccine GSK2340274A | BIOLOGICAL | One or two doses administered intramuscularly |
| GSK Biologicals' Influenza investigational vaccine GSK2340273A | BIOLOGICAL | Two doses intramuscularly |
| Placebo (saline) | BIOLOGICAL | One dose intramuscularly |
Inclusion Criteria: * Male or female children 10 to \< 18 years of age at the time of the first vaccination. "Less than 18 years of age" implies inclusion of adolescents who have not reached their 18th birthday as of Day 0, the day of the first vaccine dose under this protocol. * Written informed c...
Top 8 of 11 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| 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 |
GSK2340274A is an investigational influenza vaccine developed by GSK plc (ticker GSK). It is a Phase 2 candidate studied for influenza, including pandemic H1N1 influenza, in children aged 10 to less than 18 years. It is a vaccine modality and has not been approved; it remains an investigational product in clinical development.
GSK2340274A is being studied for the prevention of influenza, specifically pandemic influenza (H1N1). Its only recorded clinical trial enrolled healthy children aged 10 to less than 18 years in Estonia and Slovakia. The vaccine is investigational and is not an approved product for any indication.
GSK2340274A is developed by GSK plc, which trades under the ticker GSK. GSK Biologicals is the developer name associated with this influenza vaccine candidate. The company sponsored the Phase 2 study of the vaccine in children aged 10 to less than 18 years.
GSK2340274A is in Phase 2 development. It is an investigational influenza vaccine and is not approved. One Phase 2 trial has been completed, and no trials are currently active. The completed study was randomized, double blind, and controlled, enrolling 310 participants.
GSK2340274A has been studied in one clinical trial, NCT01035749, titled "Study of GSK Biologicals' Pandemic Influenza (H1N1) Candidate Vaccine in Children Aged 10 to Less Than 18 Years." That Phase 2 trial is completed, enrolled 310 participants, and was conducted in Estonia and Slovakia.
GSK2340274A is not approved. It is an investigational influenza vaccine in Phase 2 clinical development, and its single recorded trial, NCT01035749, has been completed. No regulatory approval has been granted for this candidate based on the development information available.