Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Poliorix · 2 trials · 2 indications
A seroprotected subject was defined as a vaccinated subject with anti-polio types 1, 2 and 3 titers greater than or equal to (≥) 8 effective dose 50 (ED50).
Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the symptom irrespective of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimetres (mm) of injection site.
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever \[defined as axillary temperature equal to or above (≥) 37.1 degrees Celsius (°C)\]. Any = occurrence of symptom regardless of intensity grade of relationship to vaccination. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 irritability = crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = subject did not eat at all. Grade 3 fever = fever above (\>) 39.0°C. Related = symptom assessed by the investigator as related to 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 = occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
SAEs assessed included any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.
| Arm | Type | Description |
|---|---|---|
| Poliorix Group | EXPERIMENTAL | Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Poliorix™ (IPV) vaccine at 2, 3 and 4 months of age, administered intramuscularly into the anterolateral side of the right thigh. |
| Control Group | ACTIVE_COMPARATOR | Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Oral Poliomyelitis Vaccine (OPV) at 2, 3 and 4 months of age, according to the vaccination policy recommended in China. |
| IPV Group | EXPERIMENTAL | Healthy male or female subjects between, and including, 60 and 90 days of age at the time of the first vaccination, receive 3 doses of Poliorix at 2 (Study Day 0, Visit 1), 3 (Study Month 1, Visit 2) and 4 (Study Month 2, Visit 3) months of age, administered intramuscularly into the upper right side of the thigh. |
| Name | Type | Description |
|---|---|---|
| Poliorix™ | BIOLOGICAL | 3 doses, intramuscular administration |
| Oral Poliovirus vaccine | BIOLOGICAL | 3 doses, oral administration |
| Poliorix | BIOLOGICAL | All subjects receive three doses of Poliorix vaccine, administered intramuscularly into the upper right side of the thigh. |
Inclusion Criteria: * A male or female infant between, and including, 60 and 90 days of age at the time of the first vaccination. * Born after a gestation period of 36 to 42 weeks inclusive. * Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative (LAR) (s) ca...
Poliorix is an investigational vaccine being developed for the prevention of poliomyelitis, a viral infectious disease that can cause paralysis. It is currently in clinical development and has not been approved by regulatory authorities. The vaccine is being studied for use in infants, with clinical trials conducted in China.
Poliorix 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 for the prevention of poliomyelitis.
Poliorix is in Phase 3 clinical development. It has completed two clinical trials, including a Phase 1 study and a Phase 3 study, both of which have been completed. The vaccine remains investigational and is not yet approved for public use.
Poliorix has completed two clinical trials. NCT00937404 was a Phase 1 study evaluating safety and reactogenicity in 25 infants in China. NCT01021293 was a Phase 3 study assessing immunogenicity and safety in 1,101 infants in China. Both trials are completed, with a total enrollment of 1,126 participants.
Poliorix is not FDA approved. It is an investigational vaccine currently in clinical development, having completed Phase 1 and Phase 3 trials. The vaccine is being studied for the prevention of poliomyelitis, but regulatory approval has not been granted.