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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00911144 | Booster Vaccination Study With a Pneumococcal Vaccine in Children Primed With the Same Vaccine | PHASE3 | COMPLETED | 450 | — | — | Jun 11, 2009 | Jan 11, 2010 | Sep 20, 2018 | 14 | South Korea |
Grade 3 adverse events are severe symptoms that prevent normal, everyday activities.
| Arm | Type | Description |
|---|---|---|
| Synflorix Group | EXPERIMENTAL | Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively. |
| Prevenar Group | ACTIVE_COMPARATOR | Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively. |
| Name | Type | Description |
|---|---|---|
| GSK Biologicals' Synflorix™ (Pneumococcal vaccine GSK1024850A) | BIOLOGICAL | Intramuscular injection, administered as a single dose |
| Wyeth-Lederle's Prevenar™ | BIOLOGICAL | Intramuscular injection, administered as a single dose |
| GSK Biologicals' Hiberix™ | BIOLOGICAL | Intramuscular injection, administered as a single dose |
Inclusion Criteria: * A male or female between, and including, 12-18 months of age at the time of booster vaccination. * Subjects for whom the investigator believes that their parent(s)/ guardian(s) can and will comply with the requirements of the protocol. * Subjects who received three doses of pn...