Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IC51 Japanese Encephalitis · 1 trial · 1 indication
Rate of subjects with these types of AEs, comparison vs respective control vaccine stratified by age group: All study participants aged \< 1 year: IC51 0.25mL vs. Prevnar; All study participants aged 1 year and above: IC51 0.25 mL or =.5 mL vs. Havrix.
| Arm | Type | Description |
|---|---|---|
| IC51 0.5 mL | EXPERIMENTAL | Japanese Encephalitis Vaccine 6mcg im. at day 0 and day 28 |
| IC51 0.25 mL | EXPERIMENTAL | Japanese Encephalitis Vaccine 3mcg im. at day 0 and day 28 |
| Havrix 720 | ACTIVE_COMPARATOR | Havrix®720 0.5 ml im. at day 0 and month 7 |
| Prevnar | ACTIVE_COMPARATOR | Prevnar 0.5 ml im. at day 0 and day 56 and month 7 or 0.5 ml im. at day 0, day 28 and day56 and month 7-13 |
| Name | Type | Description |
|---|---|---|
| IC51 Japanese Encephalitis | BIOLOGICAL | 6 mcg or 3 mcg im. at day 0 and day 28 |
| Havrix®720 | BIOLOGICAL | 0.5 ml im. at day 0 and month 7 |
| Prevnar | BIOLOGICAL | 0.5 ml im. at day 0 and day 56 and month 7 |
Inclusion Criteria: * Male or female healthy children and adolescents aged \> 2 months to \< 18 years at the time of first vaccination. * Written informed consent by the subject's legal representative(s), according to local requirements, and written informed assent of the subject, if applicable. * ...
IC51 Japanese Encephalitis is an investigational vaccine being studied for the prevention of encephalitis caused by the Japanese encephalitis virus. It is being developed for use in pediatric populations, as evaluated in a Phase 3 clinical trial. The vaccine is intended to generate an immune response against the virus to protect against the disease.
IC51 Japanese Encephalitis is being developed by Valneva SE, a biopharmaceutical company. Valneva is listed on the stock exchange under the ticker symbol VALN. The company is conducting clinical development of this vaccine for the prevention of Japanese encephalitis.
IC51 Japanese Encephalitis is in Phase 3 clinical development. It has completed a Phase 3 trial, and it remains an investigational product. It is not yet approved by regulatory authorities, and further development and regulatory review would be required before it could be made available to the public.
IC51 Japanese Encephalitis has been studied in one completed Phase 3 clinical trial, registered as NCT01041573. This trial, titled 'Safety and Immunogenicity of the Japanese Encephalitis Vaccine IC51 (IXIARO®) in a Pediatric Population,' enrolled 1,869 participants in the Philippines. The study was active-controlled and included healthy volunteers aged 2 months and older.
Yes, IC51 Japanese Encephalitis is also known as IXIARO. The Phase 3 clinical trial NCT01041573 refers to the vaccine as 'IC51 (IXIARO®),' indicating that both names are used for the same product. This vaccine is being developed by Valneva SE for the prevention of Japanese encephalitis.