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Influenza Vaccine GSK1247446A · 2 trials · 2 indications
Assessed solicited local symptoms were ecchymosis, pain, redness and swelling at injection site. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal everyday activity. Grade 3 redness/swelling/ecchymosis = redness/swelling/ecchymosis spreading beyond 50 millimeters (mm) of the injection site. All solicited local symptoms assessed were considered by the investigator as related to study vaccination.
Assessed solicited general symptoms were arthralgia, fatigue, fever \[oral temperature equal to or above ≥ 37.5 degrees Celsius (°C)\], headache, myalgia, nausea and shivering. Any = incidence of a particular symptom regardless of grade intensity or relationship with the study vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0°C. Related = symptom considered by the investigator to have a causal relationship to study vaccination.
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented normal activity. Related = unsolicited AE assessed by the investigator as causally related to the study vaccination.
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related = SAE assessed by the investigator as causally related to the study vaccination.
Assessed solicited local symptoms were ecchymosis, pain, redness and swelling. Any = Incidence of a particular solicited local symptom regardless of intensity grade. Grade 3 pain = Pain that prevented normal everyday activity. Grade 3 redness/swelling/ecchymosis = Redness/swelling/ecchymosis above 50 millimeters (mm).
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = Any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = Unsolicited AE that prevented normal activity. Related = Unsolicited AE assessed by the investigator as causally related to the vaccination.
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE = Occurrence of any SAE regardless of intensity grade or relation to vaccination Related = SAE considered by the investigator to have a causal relationship to study vaccination.
| Arm | Type | Description |
|---|---|---|
| GSK1247446A Group | EXPERIMENTAL | Subjects aged between 18 and 60 years, having previously received one dose of the AS03-adjuvanted GSK1247446A vaccine in the primary study NCT00374842, received a single dose of GSK1247446A vaccine adjuvanted with a half dose of AS03 adjuvant at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from either the GSK1247446A Formulation 1 or GSK1247446A Formulation 2 groups in study NCT00374862. |
| Fluarix Group | ACTIVE_COMPARATOR | Subjects aged between 18 and 60 years, having previously received one dose of Fluarix™ vaccine during the primary study NCT00374842, received one dose of Fluarix™ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltiod region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862. |
| Name | Type | Description |
|---|---|---|
| Influenza Vaccine GSK1247446A | BIOLOGICAL | Single dose, Intramuscular injection |
| Fluarix™ | BIOLOGICAL | Single dose, Intramuscular injection |
| FluarixTM | BIOLOGICAL | Single dose, intramuscular injection |
Inclusion Criteria: * A male or female aged 18-60 years old at the time of vaccination, who previously participated in 108656 clinical trial. * Subjects who the investigator believes that they can and will comply with the requirements of the protocol. * Written informed consent obtained from the su...
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| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| 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 |
Influenza Vaccine GSK1247446A is an investigational vaccine candidate developed by GSK plc for the prevention of influenza. It is an adjuvanted influenza vaccine candidate that has been studied in Phase 2 clinical trials. It is not an approved product and remains in clinical development.
Influenza Vaccine GSK1247446A is being studied for use against influenza, including influenza in humans. Its clinical trials enrolled healthy adult volunteers, with one study focused on adults aged 60 years and older. It is an investigational candidate and has not been approved for use.
Influenza Vaccine GSK1247446A is developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical program studying this adjuvanted influenza vaccine candidate.
Influenza Vaccine GSK1247446A is in Phase 2 development. Both of its recorded clinical trials were Phase 2 studies, and both are now completed. The vaccine candidate is investigational and has not been approved.
Influenza Vaccine GSK1247446A has been studied in two completed Phase 2 trials. NCT00545025 evaluated revaccination with the vaccine in Belgium and enrolled 243 participants. NCT00385840 assessed the immunogenicity and safety of a second vaccination in Norway and enrolled 678 participants aged 60 years and older.
The two Phase 2 trials of Influenza Vaccine GSK1247446A were randomized, double-blind, and actively controlled, together enrolling 921 participants. One trial studied revaccination in adults aged 18 years and older in Belgium, and the other studied a second vaccination in adults aged 60 years and older in Norway.