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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01106092 | Study to Evaluate the Immunogenicity and Reactogenicity of a Booster Dose of GSK2036874A Vaccine in Healthy Toddlers | PHASE2 | COMPLETED | 312 | — | — | May 13, 2010 | Sep 2, 2010 | Oct 1, 2019 | 1 | Philippines |
Seroprotection was defined as anti-polio types 1, 2 and 3 antibody titres ≥ 8 effective dose (ED50), for 50% of vaccinated subjects.
Antibody titers were presented as geometric mean titers (GMTs).
| Arm | Type | Description |
|---|---|---|
| GSK2036874A GROUP 1 | EXPERIMENTAL | Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0. |
| GSK2036874A GROUP 2 | EXPERIMENTAL | Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0. |
| GSK2036874A GROUP 3 | EXPERIMENTAL | Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0. |
| ZILBRIX/HIB/POLIORIX GROUP | ACTIVE_COMPARATOR | Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively. |
| Name | Type | Description |
|---|---|---|
| GSK2036874A vaccine | BIOLOGICAL | Intramuscular, single dose |
| Zilbrix™/Hib vaccine | BIOLOGICAL | Intramuscular, single dose |
| Poliorix™ | BIOLOGICAL | Intramuscular, single dose |
Inclusion Criteria: * A male or female subject, between and including 12 and 24 months of age at the time of booster vaccination. * Subjects who have received three doses of polio vaccine as primary vaccination along with the routine vaccinations indicated during the first year of life. * Subjects ...