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...
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Pumarix is being developed for the prevention of influenza. It is an investigational monoclonal antibody studied in adults 18 years and older. The clinical program has evaluated it in healthy volunteers, and it has not been approved for any use.
Pumarix is being developed by GSK plc, which trades under the ticker GSK. GSK sponsored the clinical study of the candidate in the United States and Canada.
Pumarix is in Phase 1 clinical development. One Phase 1 trial has been completed, and no trials are currently active. It is an investigational product and has not been approved by the FDA or any other regulatory agency.
Pumarix has been studied in one completed Phase 1 trial, NCT00510874, titled a study to evaluate the safety and immune response of two doses of candidate influenza vaccine GSK 1557484A in adults. The trial enrolled 780 participants in the United States and Canada.
The Phase 1 trial of Pumarix, NCT00510874, was a randomized, double-blind, controlled study. It enrolled 780 healthy adult volunteers aged 18 years and older of all sexes across sites in the United States and Canada. The study has been completed.
Yes. Pumarix and Pumarix™ refer to the same investigational monoclonal antibody being developed by GSK plc for influenza. The trademark symbol is simply a stylized form of the same product name.