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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00463437 | Pneumococcal Vaccine Booster Study in Healthy Children 11-18 Months Old Previously Primed With the Same Vaccines | PHASE3 | COMPLETED | 1,437 | — | — | Apr 25, 2007 | Jun 14, 2008 | Jan 2, 2020 | 63 | Germany, Poland +1 |
Fever was measured as rectal temperature.
| Arm | Type | Description |
|---|---|---|
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | EXPERIMENTAL | Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany \& Poland and Infanrix™ IPV Hib in Spain) and Wyeth's Men-C conjugate vaccine (Meningitec™) at 11-18 months of age. |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | EXPERIMENTAL | Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany \& Poland and Infanrix™ IPV Hib in Spain) and Baxter's Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age. |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | EXPERIMENTAL | Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany \& Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age. |
| Prevenar™ + Menitorix™ | ACTIVE_COMPARATOR | Subjects receiving a booster dose of Wyeth's pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany \& Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age. |
| Name | Type | Description |
|---|---|---|
| Pneumococcal conjugate vaccine GSK1024850A | BIOLOGICAL | Intramuscular injection, 1 dose. |
| Prevenar | BIOLOGICAL | Intramuscular injection, 1 dose. |
| Infanrix hexa | BIOLOGICAL | Intramuscular injection, 1 dose. In Germany and Poland. |
| Infanrix IPV Hib | BIOLOGICAL | Intramuscular injection, 1 dose. In Spain. |
| Infanrix penta | BIOLOGICAL | Intramuscular injection, 1 dose. In Germany and Poland. |
| Infanrix IPV | BIOLOGICAL | Intramuscular injection, 1 dose. In Spain. |
| Meningitec | BIOLOGICAL | Intramuscular injection, 1 dose. |
| NeisVac-C | BIOLOGICAL | Intramuscular injection, 1 dose. |
| Menitorix | BIOLOGICAL | Intramuscular injection, 1 dose. |
Inclusion Criteria: * Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol. * A male or female between, and including, 11-18 months of age at the time of the booster vaccination. * A male or female who previously participated ...