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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01262924 | Study of Reduced-antigen-content Acellular Pertussis Vaccine and Diphtheria-Tetanus-Acellular Pertussis Vaccine | PHASE3 | COMPLETED | 116 | — | — | Oct 1, 1997 | Dec 1, 1998 | Dec 17, 2010 | - | — |
| Arm | Type | Description |
|---|---|---|
| Group A | EXPERIMENTAL | dTPa vaccine |
| Group B | EXPERIMENTAL | Pa vaccine |
| Group C | ACTIVE_COMPARATOR | Tedivax-Adult™/ Td-Rix™ |
| Name | Type | Description |
|---|---|---|
| GSK Biologicals' reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccine | BIOLOGICAL | Intramuscular, single dose |
| GSK Biologicals' reduced-antigen-content acellular pertussis vaccine | BIOLOGICAL | Intramuscular, single dose |
| Tedivax-Adult™/ Td-Rix™ | BIOLOGICAL | Intramuscular, single dose or 2 doses (in the annex phase) |
Inclusion Criteria: * A male or female aged ≥18 years at the time of vaccination * Free of obvious health problems as established by medical history and clinical examination before entering into the study * Written informed consent obtained from the subject * If the subject is female, she must be o...