Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Adjuvanted pandemic influenza candidate vaccine · 1 trial · 1 indication
Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling. Any = occurrence of symptom regardless of intensity grade. Grade 3 Pain = pain that prevented normal everyday activities Grade 3 ecchymosis/induration/redness/swelling = redness/swelling spreading beyond (\>) 50 millimeters (mm) in diameter
Assessed solicited general symptoms were arthralgia, fatigue, fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], headache, myalgia, shivering, sweating. Any = occurrence of symptom regardless of intensity grade and relationship to vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 Fever = fever higher than (\>) 39.0 °C. Related = symptom considered by the investigator to be casually related with the study vaccination.
Assessed solicited general symptoms were arthralgia, fatigue, fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], headache, myalgia, shivering, sweating. Any = occurrence of symptom regardless of intensity grade and relationship to vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 Fever = fever higher than (\>) 39.0 °C. Related = symptom considered by the investigator to be casually related with the study vaccination.
Assessed solicited general symptoms were arthralgia, fatigue, fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], headache, myalgia, shivering, sweating. Any = occurrence of symptom regardless of intensity grade and relationship to vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 Fever = fever higher than (\>) 39.0 °C. Related = symptom considered by the investigator to be casually related with the study vaccination.
An unsolicited AE covers 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 and 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 was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. Related symptoms were not available.
An unsolicited AE covers 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 and 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 was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. Related symptoms were not available.
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.
MSCs prompting emergency room or physician visits that were not related to common diseases or routine visits. Common diseases included upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
| Arm | Type | Description |
|---|---|---|
| GSK1562902A Group | EXPERIMENTAL | Male and female subjects aged 18 or over received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm. The group was further stratified by age for analyses. |
| Fluarix+Placebo Group | ACTIVE_COMPARATOR | Male and female subjects aged 18 or over received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm. The group was further stratified by age for analyses. |
| Name | Type | Description |
|---|---|---|
| Adjuvanted pandemic influenza candidate vaccine | BIOLOGICAL | 2 doses, intramuscular injection |
| Fluarix | BIOLOGICAL | One intramuscular injection |
| Placebo | BIOLOGICAL | One intramuscular injection |
Inclusion Criteria: * Subjects who the investigator believes that they can and will comply with the requirements of the protocol. * A male or female aged 18 years or above at the time of the first vaccination. * Written informed consent obtained from the subject. * Healthy subjects as established b...
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 |
| 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 |
It is an investigational vaccine developed by GSK plc for protection against pandemic influenza. It is an adjuvanted vaccine, meaning it includes an adjuvant to strengthen the immune response. It is in Phase 3 clinical development and is not yet approved.
The adjuvanted pandemic influenza candidate vaccine is being developed for the prevention of influenza caused by pandemic influenza strains. Its intended use is to protect adults aged 18 years and above against pandemic influenza.
The adjuvanted pandemic influenza candidate vaccine is being developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical program for this vaccine candidate.
The adjuvanted pandemic influenza candidate vaccine is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by the FDA. The Phase 3 trial has been completed.
The adjuvanted pandemic influenza candidate vaccine has been studied in one Phase 3 clinical trial, NCT00319098, titled "Study to Evaluate the Safety and Immunogenicity of a Pandemic Influenza Vaccine in Adults Aged 18 Years and Above." The trial enrolled 5,075 participants and has been completed.
The Phase 3 trial NCT00319098 was a randomized, double-blind, active-controlled study. It enrolled 5,075 healthy adult volunteers aged 18 years and above across Estonia, France, Germany, Netherlands, Russia, Spain, and Sweden. The trial evaluated the safety and immunogenicity of the vaccine.