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 a vaccine developed for the prevention of poliomyelitis, a disease caused by poliovirus. It is an inactivated poliomyelitis vaccine studied in infants and young children, with clinical trials conducted in China. The studies enrolled healthy volunteers from 60 days of age, evaluating immune response and safety against polio.
Poliorix is developed by GSK plc, which trades under the ticker GSK. GlaxoSmithKline Biologicals, the company's vaccine division, conducted the clinical studies of Poliorix, including the Phase 3 immunogenicity and safety trial NCT01021293 and the Phase 1 safety study NCT00937404.
Poliorix has been studied in Phase 3 clinical development. Its Phase 3 trial, NCT01021293, was an active-controlled immunogenicity and safety study that enrolled 1,101 participants in China. A separate Phase 1 safety and reactogenicity study, NCT00937404, enrolled 25 infants. Both trials are listed as completed.
Poliorix has been evaluated in two completed clinical trials. NCT01021293 was a Phase 3 immunogenicity and safety study of the Poliorix vaccine with 1,101 participants in China. NCT00937404 was a Phase 1 study of the inactivated poliomyelitis vaccine assessing safety and reactogenicity in 25 infants, also in China.
Yes, Poliorix and Poliorix™ refer to the same vaccine developed by GSK plc for poliomyelitis. The trademark symbol is simply a notation of the product's registered brand name. Both names appear in reference to the same inactivated poliomyelitis vaccine studied in the Phase 3 and Phase 1 trials.