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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02040636 | Study of Tetanus and Diphtheria Toxoids Adsorbed Combined With Component Pertussis Vaccine and Inactivated Poliomyelitis | PHASE2 | COMPLETED | 277 | — | — | Jan 1, 1999 | May 1, 2000 | Mar 25, 2015 | 1 | Canada |
Seroprotection defined as: Diphtheria levels ≥ 0.01 IU/mL and ≥ 0.1 IU/mL; Tetanus levels ≥ 0.01 EU/mL and ≥ 0.1 EU/mL.
Diphtheria antibodies assayed using enzyme-linked immunoassay; Tetanus antibodies were assessed using microneutralization assay
Solicited local injection site reactions: Redness, Swelling, and Tenderness. Solicited systemic reactions: Altered Appetite, Headache, General Malaise, Nausea, Vomiting and Muscle aches.
| Arm | Type | Description |
|---|---|---|
| Study Group 1 | EXPERIMENTAL | Participants randomized to receive Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis Vaccine and Inactivated Poliomyelitis Vaccine (TdcP-IPV) at month 0, Hepatitis B at months 1, 2 and 7. |
| Study Group 2 | ACTIVE_COMPARATOR | Participants randomized to receive Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis Vaccine and Inactivated Poliomyelitis Vaccine (TdcP-IPV) + Hepatitis B at month 0, Hepatitis B at months 1 and 6. |
| Name | Type | Description |
|---|---|---|
| Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis Vaccine and IPV | BIOLOGICAL | 0.5 mL, Intramuscular |
| Hepatitis B vaccine | BIOLOGICAL | 0.5 ml, Intramuscular |
Inclusion Criteria: * Age 11 years and \< 14 years of age. * Signed, witnessed and dated informed consent that is obtained prior to the first study intervention. * Judged to be in good health on the basis of reported medical history. * Plans to remain in the study area for the length of the trial. ...