Approval Probability
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Trivalent influenza vaccine GSK 138842A · 1 trial · 1 indication
Solicited local symptoms were pain, redness and swelling at the injection site. Any = occurrence of a symptom regardless of intensity.
Solicited general symptoms were arthralgia, fatigue, headache, muscle aches, shivering and temperature, assessed as oral temperature above or equal (≥) 38.0 degrees Celsius (°C). Any = occurrence of a symptom regardless of intensity or relationship to vaccination.
Medically-attended events (MAEs) refer to non-serious and serious events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits and hospitalization. Related MAE = MAE assessed by the investigator as related to the vaccination.
NOCDs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.
Unsolicited AEs cover any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any unsolicited AE = any unsolicited AE regardless of intensity or relationship to 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. Any SAE = any SAE regardless of intensity or relationship to vaccination.
Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.)
A seroprotected subject was defined as a vaccinated subject with a serum HI antibody titer ≥ 1:40, a level of HI antibody that has been viewed as correlating with protection against influenza. The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.)
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer \<1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.)
GMFR was defined as the geometric mean of the ratio of the post-vaccination inverse HI titer to the Day 0 inverse HI titer. The 3 influenza strains assessed were A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2) and B/Malaysia/2506/2004 (MALAY.)
| Arm | Type | Description |
|---|---|---|
| GSK 1388442A Group | EXPERIMENTAL | Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| Fluarix Group | ACTIVE_COMPARATOR | Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| Name | Type | Description |
|---|---|---|
| Trivalent influenza vaccine GSK 138842A | BIOLOGICAL | IM injection on Day 0 |
| Fluarix | BIOLOGICAL | IM injection on Day 0 |
Inclusion Criteria: * Subjects who the investigator believes can and will comply with the requirements of the protocol * A male or non-pregnant, non-lactating female between 18 and 49 years of age at the time of vaccination * Access to a telephone for scheduled follow-up telephone contacts * Abilit...
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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 |
Trivalent influenza vaccine GSK 138842A is an investigational vaccine developed by GSK plc for the prevention of influenza. It is designed to protect against three influenza virus strains and has been studied in a Phase 1 clinical trial. It is not yet approved for use.
Trivalent influenza vaccine GSK 138842A is being developed for the prevention of influenza, a contagious respiratory illness caused by influenza viruses. The vaccine is intended to stimulate an immune response against three influenza strains. It is currently investigational and not approved for any indication.
Trivalent influenza vaccine GSK 138842A is being developed by GSK plc, a global pharmaceutical company listed on the New York Stock Exchange under the ticker GSK. GSK is responsible for the research and clinical development of this vaccine candidate.
Trivalent influenza vaccine GSK 138842A is in Phase 1 clinical development. It has completed one Phase 1 trial and is not currently in active trials. The vaccine remains investigational and has not been approved by the FDA or any regulatory authority.
Trivalent influenza vaccine GSK 138842A has been evaluated in one completed Phase 1 clinical trial, NCT00693706. The trial enrolled 200 healthy adult volunteers in the United States and compared the vaccine with Fluarix. It was randomized, double-blind, and active-controlled.