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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00473668 | Non-inferiority of GSK Biologicals' DTPw-HBV/Hib Compared to Two Formulations of GSK Biologicals' DTPw-HBV/Hib | PHASE3 | COMPLETED | 300 | — | — | Jun 1, 2007 | Jan 30, 2008 | Aug 18, 2017 | 3 | India |
A seroprotected subject was defined as a subject with anti-PRP concentrations greater than or equal to (≥) 0.15 microgram per milliliter (µg/mL).
| Arm | Type | Description |
|---|---|---|
| TRITANRIX-HEPB/HIBERIX KFT. GROUP | EXPERIMENTAL | Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age. |
| TRITANRIX-HEPB/HIBERIX LD GROUP | ACTIVE_COMPARATOR | Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age. |
| TRITANRIX-HEPB/HIBERIX HD GROUP | ACTIVE_COMPARATOR | Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age. |
| Name | Type | Description |
|---|---|---|
| Zilbrix-Hib | BIOLOGICAL | Intramuscular injection, 1 dose |
| Tritanrix™-HepB/ Hiberix™ | 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 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...