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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01061541 | Immunogenicity, Safety & Reactogenicity of GSK Vaccine Tritanrix™-HepB/Hib2.5 Compared to GSK Vaccine Tritanrix™-HepB/Hiberix™ | PHASE2 | COMPLETED | 192 | — | — | Aug 1, 2003 | Aug 1, 2004 | Sep 9, 2016 | 1 | Philippines |
| Arm | Type | Description |
|---|---|---|
| Group A | EXPERIMENTAL | - |
| Group B | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Tritanrix™-HepB low thio / | BIOLOGICAL | One dose as intramuscular injection at 6, 10 and 14 weeks of age. |
| Hib 2.5 | BIOLOGICAL | One dose as intramuscular injection at 6, 10 and 14 weeks of age. |
| Tritanrix™-HepB | BIOLOGICAL | One dose as intramuscular injection at 6, 10 and 14 weeks of age. |
| Hiberix™ | BIOLOGICAL | One dose as intramuscular injection at 6, 10 and 14 weeks of age. |
| Unconjugated Hib vaccine (plain PRP) | BIOLOGICAL | One dose as intramuscular injection at 10 months of age |
Inclusion Criteria: * Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study. * A male or female between, and including, 6 and 8 weeks of age at the time of the first vaccination. * Written inform...