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Yellow Fever Vaccine · 1 trial · 6 indications
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, ...
The Yellow Fever Vaccine is a vaccine studied for use against yellow fever, an infectious disease. In the clinical program described here, it was evaluated as one of several travel vaccines given at the same time as a meningococcal vaccine in healthy adults. The related study also covered conditions including meningococcal disease, typhoid, rabies, and Japanese encephalitis.
Novartis AG, which trades under the ticker NVS, is the developer associated with this Yellow Fever Vaccine program. The company sponsored the Phase 3b study that evaluated the vaccine alongside other travel vaccines and a meningococcal vaccine in adult volunteers.
The Yellow Fever Vaccine program is in Phase 3. One Phase 3b trial has been completed, and no trials are currently listed as active. The completed study enrolled 552 participants and was conducted in Czechia and Germany.
The Yellow Fever Vaccine was studied in NCT01466387, a Phase 3b, randomized, open-label trial. It evaluated the safety and immunogenicity of select travel vaccines when given together with MenACWY in adults. The trial enrolled 552 healthy volunteers aged 18 years and older and has been completed.
NCT01466387 was a Phase 3b, randomized, open-label study with an active control. It enrolled 552 healthy adult volunteers aged 18 years and older across sites in Czechia and Germany. The study assessed safety and immune response when travel vaccines, including the Yellow Fever Vaccine, were administered concomitantly with MenACWY.