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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01466387 | A Phase 3b, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of Select Travel Vaccines When Administered Concomitantly With MenACWY in Adults | PHASE3 | COMPLETED | 552 | — | — | Nov 1, 2011 | Apr 1, 2012 | Mar 11, 2014 | 5 | Czechia, Germany |
Assessment was made to demonstrate the non-inferiority of the geometric mean anti-typhoid Vi antibody concentrations, 28 days after the vaccination of typhoid Vi polysaccharide (TF) and yellow fever (YF) vaccines given concomitantly with MenACWY-CRM197 to typhoid Vi polysaccharide and yellow fever vaccines given alone in healthy adults aged ≥18 years to ≤60 years.
Assessment was made to demonstrate the non-inferiority of the geometric mean anti-yellow fever antibody titers, 28 days after the vaccination of typhoid Vi polysaccharide (TF) and yellow fever (YF) vaccines given concomitantly with MenACWY-CRM197 to typhoid Vi polysaccharide and yellow fever vaccines given alone in healthy adults aged ≥18 years to ≤60 years.
Assessment was made to demonstrate the non-inferiority of the geometric mean anti-Japanese encephalitis neutralizing antibody titers, 28 days after the vaccination of the second dose of Japanese Encephalitis vaccine and third dose of the rabies virus vaccine given concomitantly with MenACWY-CRM197 or alone in healthy adults aged ≥18 years to ≤60 years.
Assessment was made to demonstrate the non-inferiority of the geometric mean anti-rabies virus neutralizing antibody concentrations, 28 days after the vaccination of the second dose of Japanese encephalitis vaccine and third dose of rabies virus vaccine given concomitantly with MenACWY-CRM197 or alone in healthy adults aged ≥18 years to ≤60 years.
| Arm | Type | Description |
|---|---|---|
| TF+YF | ACTIVE_COMPARATOR | Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide and yellow fever vaccine. |
| TF + YF + MenACWY-CRM197 | ACTIVE_COMPARATOR | Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide, yellow fever and meningococcal ACWY conjugate vaccine. |
| JE + Rabies | ACTIVE_COMPARATOR | Subjects ≥18 years to ≤60 years of age who received two doses of Japanese encephalitis and three doses of Rabies vaccine. |
| JE + Rab + MenACWY-CRM197 | ACTIVE_COMPARATOR | Subjects ≥18 years to ≤60 years of age who received two doses of Japanese encephalitis and three doses of Rabies and one dose of meningococcal ACWY conjugate vaccine. |
| Rabies | ACTIVE_COMPARATOR | Subjects ≥18 years to ≤60 years of age who received three doses of Rabies vaccine. |
| MenACWY-CRM197 (Combined) | ACTIVE_COMPARATOR | Subjects ≥18 years to ≤60 years of age who received one dose of meningococcal ACWY conjugate vaccine. |
| Name | Type | Description |
|---|---|---|
| Typhoid Vi Polysaccharide Vaccine | BIOLOGICAL | One dose of typhoid Vi polysaccharide vaccine. |
| Yellow Fever Vaccine | BIOLOGICAL | One dose of yellow fever vaccine. |
| Japanese Encephalitis Vaccine | BIOLOGICAL | Two doses of Japanese Encephalitis Vaccine. |
| Rabies Vaccine | BIOLOGICAL | Three doses of Rabies vaccine. |
| MenACWY-CRM Vaccine | BIOLOGICAL | One dose of MenACWY-CRM vaccine. |
Inclusion Criteria: Female and male subjects who must be healthy and must be: 1. Between 18 and 60 years of age inclusive and who have given their written informed consent; 2. Available for all visits and telephone calls scheduled for the study; 3. In good health as determined by medical history, ...