Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Live attenuated Japanese encephalitis virus; Yellow fever virus · 1 trial · 2 indications
Neutralising antibody titer against homologous Japanese encephalitis (JE), yellow fever (YF), and other relevant wild type JE strains were determined using a 50% serum dilution plaque reduction neutralisation test. Seroconversion post-vaccination was defined as the appearance of neutralising antibody titer when not present at Day 0, or at least a four-fold rise in neutralising antibody titer between the pre-vaccination (Day 0) and the post-vaccination samples. The 30 Days post-JE seroconversion is: Day 30 for Group 1 (ChimeriVax™-JE then STAMARIL®) and Group 3 (Co-administration of ChimeriVax™-JE and STAMARIL, then Diluent); Day 60 for Group 2 (STAMARIL® then ChimeriVax™-JE) and Group 4 (Diluent then Co-administration of ChimeriVax™-JE and STAMARIL).
Neutralising antibody titer against yellow fever strains was determined using a 50% serum dilution plaque reduction neutralisation test. Seroconversion at a later post vaccination timepoint ws defined as the appearance of neutralising antibody titer when not present at Day 0, or at least a four-fold rise in neutralising antibody titre between the pre-injection Day 0 and later post vaccination samples. The Day 30 post-JE seroconversion is: Day 30 for Group 1 (ChimeriVax™-JE then STAMARIL®) and Group 3 (Co-administration of ChimeriVax™-JE and STAMARIL, then Diluent); Day 60 for Group 2 (STAMARIL® then ChimeriVax™-JE) and Group 4 (Diluent then Co-administration of ChimeriVax™-JE and STAMARIL).
Neutralising antibody titer against homologous JE, YF, and other relevant wild type JE strains was determined using a 50% serum dilution plaque reduction neutralisation test. Seroconversion at a later post vaccination timepoint was defined as the appearance of neutralising antibody titer when not present at Day 0, or at least a four-fold rise in neutralising antibody titer between the pre-injection Day 0 and post-vaccination samples.
Solicited Local Adverse Events: Injection Site Pain, Erythema, Swelling, Hemorrhage, Venipuncture site Hemorrhage. Solicited Systemic Adverse Events: Fatigue, Malaise, Pyrexia, Chills, Headache, Dizziness, Myalgia, Abdominal Pain, Diarrhea, Nausea, Pharyngolaryngeal Pain. All solicited local reactions associated with ChimeriVax™-JE are presented in Group 1, those associated with STAMARIL® in Group 2, those associated with co-administered vaccines in Group 3, and those associated with diluent in Group 4. The solicited systemic adverse events are reported according to the participants' randomized study groups.
| Arm | Type | Description |
|---|---|---|
| ChimeriVax™-JE then STAMARIL® | EXPERIMENTAL | Participants will receive ChimeriVax™-JE on Day 0 and STAMARIL® on Day 30 |
| STAMARIL® then ChimeriVax™-JE | EXPERIMENTAL | Participants will receive STAMARIL® on Day 0 and ChimeriVax™-JE on Day 30 |
| ChimeriVax™-JE and STAMARIL®, then Diluent | EXPERIMENTAL | Participants will receive ChimeriVax™-JE and STAMARIL® on Day 0 and diluent on Day 30. |
| Diluent then ChimeriVax™-JE and STAMARIL® | EXPERIMENTAL | Participants will receive Diluent on Day 0 and ChimeriVax™-JE and STAMARIL® on Day 30. |
| Name | Type | Description |
|---|---|---|
| Live attenuated Japanese encephalitis virus; Yellow fever virus | BIOLOGICAL | ChimeriVax™-JE, 0.5 mL, Subcutaneous on Day 0; STAMARIL®, 0.5 mL, Subcutaneous on Day 30. |
| Yellow fever virus; Live attenuated Japanese encephalitis virus | BIOLOGICAL | STAMARIL®, 0.5 mL Subcutaneous on Day 0; ChimeriVax™-JE, 0.5 mL Subcutaneous on Day 30. |
Inclusion Criteria : * All aspects of the protocol explained and written informed consent obtained from the participant. * Aged ≥ 18 to ≤ 55 years at Day 0. * In good general health, without significant medical history, physical examination findings, or clinically significant abnormal laboratory re...