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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00871338 | Study to Evaluate GSK Biologicals' GSK2197870A Vaccine Given as Primary Course in Infants | PHASE2 | COMPLETED | 284 | — | — | Jun 24, 2009 | Dec 9, 2010 | Jun 6, 2018 | 5 | United Kingdom |
A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).
A seropositive subject was defined as a vaccinated subject who had rSBA-MenC ≥ 1:8.
| Arm | Type | Description |
|---|---|---|
| GSK2197870A Group | EXPERIMENTAL | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh. |
| Pediacel Group | ACTIVE_COMPARATOR | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh. |
| Name | Type | Description |
|---|---|---|
| GSK2197870A | BIOLOGICAL | 3 doses given at 2, 3 and 4 months of age |
| Prevenar™ | BIOLOGICAL | 3 co-administered doses, intramuscular into right thigh |
| Menitorix™ | BIOLOGICAL | 1 booster dose at 12 months of age |
| Pediacel™ | BIOLOGICAL | 3 doses given at 2, 3 and 4 months of age |
| Menjugate™ | BIOLOGICAL | 2 doses given at 3 and 4 months of age |
Inclusion Criteria: All subjects must satisfy the following criteria at study entry: * A male or female infant between, and including, 6 and 12 weeks of age at the time of the first vaccination. * Born after 36 to 42 weeks of gestation. * Subjects who the investigator believes that their parents/ ...