Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PoliorixTM · 2 trials · 1 indication
A seroprotected subject was defined as a vaccinated subject whose antibody titer is greater than or equal to (≥) 8 Effective Dose 50 (ED50). This outcome measure concerns subjects in the Poliorix Group only.
Antibody titers were summarized by geometric mean titers (GMTs) with their 95% confidence intervals (CIs). This outcome measure concerns subjects in the Poliorix Group only.
Antibody titers were summarized by geometric mean titers (GMTs) with their 95% CIs.
Assessed solicited local symptoms were pain, redness and swelling. Any = all reports of the specified symptom irrespective of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.
Assessed solicited general symptoms were temperature \[defined as axillary temperature equal to or above (≥) 37.1 degrees Celsius (°C)\], drowsiness, irritability and loss of appetite. Any = all reports of the specified symptom irrespective of intensity grade and 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 the vaccination.
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the 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. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
| Arm | Type | Description |
|---|---|---|
| Group A | EXPERIMENTAL | Subjects in this group will receive the GSK Biologicals' IPV vaccine at 18 months of age. Subjects will also receive a dose of DTPa/Hib (Infanrix+Hib) as part of the local standard of care. |
| Group B | ACTIVE_COMPARATOR | Subjects in this group will receive only a booster dose of GSK Biologicals' DTPa/Hib vaccine (Infanrix+Hib) as part of the local standard of care and will not be associated with any study endpoint. |
| POLIORIX GROUP | EXPERIMENTAL | Healthy male or female subjects between, and including, 18 and 24 months of age, received a single booster dose of Poliorix™ vaccine that was administrated into the upper right thigh by intramuscular injection (IM). |
| Name | Type | Description |
|---|---|---|
| PoliorixTM | BIOLOGICAL | Single dose, intramuscular administration |
| Infanrix+Hib | BIOLOGICAL | Single dose, intramuscular injection. Part of the local standard of care. No outcome measures associated. |
Inclusion Criteria: * Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol. * Subjects who received the complete three-dose primary vaccination course in study NCT01021293. * Healthy male or female...
Poliorix is a vaccine used for poliomyelitis, a viral infectious disease that can cause paralysis. It is being developed by GSK plc as an inactivated polio vaccine for toddlers. The vaccine is currently in Phase 3 clinical development and is not yet approved for use.
Poliorix is developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. The vaccine is being studied for the prevention of poliomyelitis in toddlers, with clinical trials conducted in China.
Poliorix is in Phase 3 clinical development. It is an investigational vaccine for poliomyelitis and has not yet received regulatory approval. Two Phase 3 trials have been completed, but the vaccine remains under study and is not available for public use.
Poliorix has been studied in two completed Phase 3 clinical trials. NCT00920439 assessed safety and reactogenicity in 26 toddlers, and NCT01323647 evaluated immunogenicity and safety of a booster dose in 957 toddlers. Both trials were conducted in China and enrolled healthy children aged 18 months and older.
Poliorix is an inactivated polio vaccine (IPV), which is a type of vaccine that uses inactivated poliovirus to trigger an immune response. It is being developed by GSK plc for the prevention of poliomyelitis. The clinical trials refer to it as Poliorix, and it is not known by other names.