Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Pumarix · 1 trial · 1 indication
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (\<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer on the specified day.
Titers are presented as geometric mean titers (GMTs).
A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any solicited local symptoms regardless of their intensity grade. Any redness and swelling were ≥ 20 millimeters (mm).
Assessed solicited general symptoms were fatigue, headache, joint pain at other location (joint pain), muscle aches, shivering, sweating and fever. Fever was defined as oral temperature (≥) 38 degrees Celsius (°C). Any = occurrence of any solicited general symptoms regardless of intensity grade or relationship to vaccination.
A MAE was defined as any unsolicited symptom that received medical attention such as hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. NOCDs included autoimmune diseases, diabetes mellitus.
An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with 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.
A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or resulted in a congenital anomaly/birth defect in the offspring of a study subject.
| Arm | Type | Description |
|---|---|---|
| Pumarix Formulation 1 Group | EXPERIMENTAL | Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one). |
| Pumarix Formulation 2 Group | EXPERIMENTAL | Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one). |
| Pumarix Formulation 3 Group | EXPERIMENTAL | Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one). |
| Pandemrix Formulation A Group | EXPERIMENTAL | Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one). |
| Pandemrix Formulation B Group | EXPERIMENTAL | Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one). |
| Pumarix Formulation 4 Group | EXPERIMENTAL | Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one). |
| Pumarix Formulation 5 Group | EXPERIMENTAL | Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one). |
| Name | Type | Description |
|---|---|---|
| Pumarix™ | BIOLOGICAL | Two doses administered intramuscularly (IM), the first in the deltoid region of the non-dominant arm and the second in the deltoid region of the dominant arm. |
| Pandemrix ™ | BIOLOGICAL | Two doses administered intramuscularly (IM), the first in the deltoid region of the non-dominant arm and the second in the deltoid region of the dominant arm. |
Inclusion Criteria: * Male and female adults 18 to 64 years of age at time of first vaccination, inclusive. * Good general health as assessed by medical history and physical examination. * Access to a consistent means of telephone contact * Written informed consent obtained from the subject. * Comp...
Pumarix is an investigational monoclonal antibody being developed for influenza, an infectious disease. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied for its safety and immune response in adults.
Pumarix is being developed by GSK plc, a pharmaceutical company traded on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the drug's safety and immunogenicity for influenza.
Pumarix is in Phase 1 clinical development. It is an investigational drug and has not received regulatory approval. One Phase 1 trial has been completed, and the drug is not currently in active clinical trials.
Pumarix has been studied in one completed Phase 1 clinical trial, NCT00510874, which evaluated the safety and immune response of two doses of the candidate influenza vaccine in adults. The trial enrolled 780 participants in the United States and Canada.
Yes, Pumarix is also known as GSK 1557484A. In clinical trial NCT00510874, the drug is referred to as the candidate influenza vaccine GSK 1557484A, which is being evaluated for its safety and immune response in adults.