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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01461980 | A Clinical Trial to Study the Safety, Tolerance and Immunogenic Response to MCV4, Tdap and Bivalent rLP2086 Vaccine When Given at the Same Time to Children Between the Ages of 10 Through 12 Years of Age | PHASE2 | COMPLETED | 2,648 | — | — | Sep 28, 2011 | May 8, 2014 | Dec 20, 2018 | 117 | United States |
| NCT01461993 | A Clinical Trial to Study the Safety, Tolerance and Immunogenic Response to Gardasil and Bivalent rLP2086 Vaccine When Given at the Same Time to Children Between the Ages of 11 and 17 | PHASE2 | COMPLETED | 2,499 | — | — | Sep 28, 2011 | Jul 6, 2013 | Dec 19, 2018 | 87 | United States |
Antibody GMCs of 2 antigens of diphtheria and tetanus toxoid were computed in International Units per milliliter (IU/mL) along with corresponding 2-sided 95 percent (%) confidence intervals (CIs). Here, 'number of participants analyzed' signifies participants with valid and determinate assay results for given antigen.
Antibody GMCs of 4 acellular pertussis antigens (pertussis toxoid, pertussis filamentous hemagglutinin, pertussis pertactin and pertussis fimbrial agglutinogens types 2+3) were computed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EU/mL) along with corresponding 2-sided 95% CIs.
Antibody GMTs of 4 MCV4 antigens (serogroup A, serogroup C, serogroup Y and serogroup W-135) were computed along with corresponding 2-sided 95% CIs.
Antibody hSBA GMTs of primary strain PMB80 \[A22\] and PMB2948 \[B24\] were computed along with corresponding 2-sided 95% CIs. hSBA titers from the 2 primary strains were logarithmically transformed for analysis. Here, 'number of participants analyzed' signifies evaluable immunogenicity population and 'N' signifies participants with valid and determinate assay results for given strain for each group, respectively.
| Arm | Type | Description |
|---|---|---|
| MCV4 + Tdap+ rLP2086 | ACTIVE_COMPARATOR | Group 1 - MCV4 + Tdap + rLP2086 |
| MCV4 + Tdap + saline | ACTIVE_COMPARATOR | Group 2, MCV4 + Tdap+ saline |
| Saline + saline + rLP2086 | PLACEBO_COMPARATOR | Group 3- rLP2086 + saline |
| Group 1 | ACTIVE_COMPARATOR | rLP2086 + Gardasil |
| Group 2 | PLACEBO_COMPARATOR | rLP2086 and saline |
| Group 3 | ACTIVE_COMPARATOR | Saline + Gardasil |
| Name | Type | Description |
|---|---|---|
| rLP2086 + MCV4 + Tdap | BIOLOGICAL | At visit 1, group 1 will receive MCV4 + Tdap vaccines concomitantly with an injection of rLP2086. At visits 3 and 5 (Months 2 and 6), group 1 will receive an injection of rLP2086. |
| MCV4 + Tdap + saline | BIOLOGICAL | At visit 1, group 2 will receive MCV4 + Tdap vaccines concomitantly with an injection of saline. At visits 3 and 5 (months 2 and 6), this group will receive a saline injection only. |
| rLP2086 + saline | BIOLOGICAL | At visit 1, group 3 will receive 2 injections of saline concomitantly with an injection of rLP2086. At visits 3 and 5 (Months 2 and 6), group 3 will receive an injection of rLP2086. Subjects randomized to this group will receive MCV4 and Tdap following their final visit blood draw (Visit 6). |
| rLP2086 and Gardasil | BIOLOGICAL | Gardasil vaccine and rLP2086 injection will be given to the subject concomitantly in Group 1 at Months 0, 2 and 6. |
| rLP2086 | BIOLOGICAL | Injections of rLP2086 and saline will be given to the subject concomitantly in Group 2 at Months 0, 2 and 6. |
| Gardasil | BIOLOGICAL | Injections of saline and Gardasil vaccine will be given to the subject concomitantly in Group 3 at Months 0, 2 and 6. |
Inclusion Criteria: * Evidence of a personally signed and dated informed consent document (ICD) indicating that the subject (and a legally authorized representative) has been informed of all pertinent aspects of the study. * Parent /legally authorized representative and subjects who are willing and...