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...
Adjuvanted pandemic influenza candidate vaccine is an investigational vaccine being studied for the prevention of influenza. It is designed to be used in adults aged 18 years and above. The vaccine is currently in Phase 3 clinical development, meaning it is still being tested and is not yet approved for public use.
Adjuvanted pandemic influenza candidate vaccine is being developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the vaccine's safety and immunogenicity in adults.
Adjuvanted pandemic influenza candidate vaccine is in Phase 3 clinical development. This is the final stage of testing before a potential regulatory submission. The vaccine is investigational and has not been approved by regulatory authorities. One Phase 3 trial has been completed, involving 5,075 participants.
Adjuvanted pandemic influenza candidate vaccine has been studied in one completed Phase 3 clinical trial, registered as NCT00319098. This trial evaluated the safety and immunogenicity of the vaccine in adults aged 18 years and above. The study was conducted across multiple countries, including Estonia, France, Germany, Netherlands, Russia, Spain, and Sweden.
Adjuvanted pandemic influenza candidate vaccine is not FDA approved. It is an investigational vaccine that has completed a Phase 3 clinical trial, but it remains in clinical development. The vaccine has not been submitted for or granted approval by the U.S. Food and Drug Administration or any other regulatory agency.