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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...
Influenza Vaccine GSK1247446A is an investigational vaccine being developed for the prevention of influenza. It is a monoclonal antibody modality, though it is studied as a vaccine candidate. The drug is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
Influenza Vaccine GSK1247446A is being developed by GSK plc, a global biopharmaceutical 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 healthy volunteers.
Influenza Vaccine GSK1247446A is in Phase 2 clinical development. It is an investigational vaccine and has not received regulatory approval. Two Phase 2 trials have been completed, involving a total of 921 participants, to assess the vaccine's safety and immune response.
Influenza Vaccine GSK1247446A has been studied in two completed Phase 2 clinical trials. The first trial, NCT00385840, enrolled 678 adults aged 60 years and older in Norway. The second trial, NCT00545025, enrolled 243 adults aged 18 years and older in Belgium. Both trials evaluated revaccination with the vaccine candidate.
Influenza Vaccine GSK1247446A is designed to stimulate the immune system to produce a protective response against influenza. As a vaccine candidate, it works by presenting influenza antigens to the immune system, prompting the body to generate antibodies that can recognize and neutralize the virus upon future exposure.