Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01021293 | Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Poliorix™ Vaccine | PHASE3 | COMPLETED | 1,101 | — | — | Nov 28, 2009 | Jul 5, 2010 | Jan 21, 2020 | 1 | China |
| NCT00937404 | Safety and Reactogenicity of GSK Biologicals' Inactivated Poliomyelitis Vaccine (IPV) (Poliorix) in Infants | PHASE1 | COMPLETED | 25 | — | — | Aug 4, 2009 | Nov 13, 2009 | Dec 17, 2018 | 1 | China |
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...