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GSK Biologicals' influenza vaccine GSK1557482A · 1 trial · 1 indication
Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported regardless of intensity grade. Grade 3 pain = Cried when limb was moved/spontaneously painful. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeters (mm). This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.
Symptoms assessed were drowsiness, irritability, loss of appetite and fever. Any was defined as occurrence of any general symptom regardless of their intensity grade or relationship to vaccination. Any fever = Axillary temperature ≥ 38.0 degrees Celsius (°C). Grade 3 fever = Axillary temperature ≥ 39.0°C. For other symptoms, grade 3 was defined as an adverse event which prevented normal everyday activities. Related = A general symptom assessed by the investigator as causally related to vaccination. This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.
Unsolicited AEs 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 = Occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 = Occurrence of any unsolicited AE that prevented normal, everyday activities. Related = Occurrence of an unsolicited AE assessed by the investigator to be causally related to study vaccination. This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.
MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. Analysis of intensity and relationship to vaccination of MAEs was not performed. This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.
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(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s) = Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination. This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.
| Arm | Type | Description |
|---|---|---|
| Fluviral F1 Group | EXPERIMENTAL | Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm. |
| Fluviral F2 Group | EXPERIMENTAL | Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm. |
| Vaxigrip Group | ACTIVE_COMPARATOR | Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm. |
| Name | Type | Description |
|---|---|---|
| GSK Biologicals' influenza vaccine GSK1557482A | BIOLOGICAL | one IM injection at Day 0 for primed subjects (defined as subjects who had a prior 2-dose priming influenza immunization) or two IM injections at Day 0 and approximately Day 28 for un-primed subjects (defined as subjects who have not previously received a complete 2-dose priming influenza immunization). |
| Vaxigrip | BIOLOGICAL | one IM injection at Day 0 for primed subjects (defined as subjects who had a prior 2-dose priming influenza immunization) or two IM injections at Day 0 and approximately Day 28 for un-primed subjects (defined as subjects who have not previously received a complete 2-dose priming influenza immunization). |
Inclusion Criteria: * A male or female child 6 months to \< 3 years of age at the time of the vaccination, regardless of previous administration of influenza vaccine in a previous season; * Subjects must be in good health established by medical history and physical examination before entering into ...
GSK1557482A is an investigational influenza vaccine being developed by GSK plc for the prevention of influenza. It is currently in Phase 2 clinical development and has been studied in children aged 6 months to 3 years.
GSK1557482A is a monoclonal antibody-based vaccine designed to target influenza. As a vaccine, it is intended to elicit an immune response against influenza viruses, though the specific antigen or molecular target has not been disclosed.
GSK1557482A is developed by GSK plc, a global biopharma company listed on the London Stock Exchange under the ticker GSK. The vaccine is being studied for use in influenza prevention.
GSK1557482A is in Phase 2 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. One Phase 2 trial has been completed.
GSK1557482A has been studied in one completed Phase 2 trial, NCT00778895, which enrolled 390 children aged 6 months to 3 years in Canada. The trial compared two dose levels of the experimental vaccine against a licensed influenza vaccine, Vaxigrip, as an active control.
No, GSK1557482A is an experimental influenza vaccine, while Vaxigrip is a licensed influenza vaccine used as the active control in the clinical trial. They are different products, and GSK1557482A is still under investigation.