Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IC51 has given in the parent study IC51-322 · 1 trial · 1 indication
Rate of subjects with PRNT50 titers of ≥ 1:10 at Month 12 after the first IC51 vaccination (in study IC51-322)
| Arm | Type | Description |
|---|---|---|
| No treatment | OTHER | subjects will be followed up on immunity (analysis of blood samples) and safety |
| Name | Type | Description |
|---|---|---|
| Blood draw | PROCEDURE | blood draw at Month 12, Month 24 and Month 36. |
| IC51 has given in the parent study IC51-322 | BIOLOGICAL | No more vaccinations in IC51-324 since this a study for long-term follow-up on safety and immunogenicity after vaccinations in parent study IC51-322. |
Inclusion Criteria: * Subjects who have received two vaccinations in study IC51 322. (2) Subjects who were enrolled as part of the immunogenicity subgroup of study IC51-322. * Male or female healthy subjects aged ≥ 9 months to \< 21 years at the time of enrolment into this study. * Written informed...
IC51 is being studied for Japanese Encephalitis, a viral infection of the brain. The Phase 3 study NCT01246479 followed pediatric participants in non-endemic countries after vaccination with the JEV IC51 product, tracking long term immunity and safety in children as young as 9 months.
IC51 is developed by Valneva SE, which trades under the ticker VALN. The company is the sponsor behind the Japanese Encephalitis vaccine program referenced in the Phase 3 follow-up study NCT01246479, conducted in the United States, Australia, and Germany.
IC51 is in Phase 3 development for Japanese Encephalitis. The single listed trial, NCT01246479, is a completed Phase 3 long term follow-up study that enrolled 23 pediatric participants. It is an investigational program and is not described as approved for this pediatric follow-up use.
IC51 has been evaluated in the Phase 3 study NCT01246479, titled a long term immunity and safety follow-up after vaccination with JEV IC51 in a pediatric population in non-endemic countries. The trial is completed, enrolled 23 participants, was uncontrolled, and included sites in the United States, Australia, and Germany.
Yes. IC51 is the same asset referenced as IXIARO and JESPECT in the Phase 3 study NCT01246479. Those names appear in the trial title for the Japanese Encephalitis vaccine, so searches for IXIARO or JESPECT point to the same Valneva program studied in that pediatric follow-up.
The Phase 3 study NCT01246479 enrolled 23 healthy pediatric volunteers of all sexes, with a minimum age of 9 months. Participants came from non-endemic countries, specifically the United States, Australia, and Germany, and the study was uncontrolled with no randomization or blinding.