Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Japanese Encephalitis vaccine, Japanese Encephalitis purified inactivated vaccine
IC51 · 8 trials · 2 indications
Rate of subjects with serious adverse events (SAEs) and medically attended AEs up to Day 56 after the first vaccination.
Equivalence between batches with regards to GMT (Geometric Mean Titer) was postulated if all three pair-wise 95 % Confidence Intervals for GMT ratios were between 0.5 and 2.
Seroprotection rate (SPR) (anti-JEV neutralizing antibody titer ≥ 1:10) 24 months (M24) after the primary vaccination - imputed; Persistence of immunogenicity (SPR) at M24 defined as: * pos. (positive) (persistent): Subjects * with a non-missing, pos. seroconversion at D56 (Study IC51-304) and * without booster at M11 or M23 and * with non-missing, seroprotection (SP) pos. PRNT50 at M6 or M12 and * with non-missing, SP pos. PRNT50 at M24 * neg. (negative) (non-persistent): Subjects with * missing or neg. seroconversion at D56 (Study IC51-304) or * booster at M11 or at M23, or * non-missing, SP neg. PRNT50 at M6 or M12 or * missing PRNT50 at both M6 and M12 or * missing or SP neg. PRNT50 (serum dilution giving 50% reduction in plaques in a Plaque Reduction Neutralization Test) at M24
Seroconversion rate: percentage of subjects with \>= 1:10 anti-JEV neutralizing antibody titer
anti-JEV Neutralizing Antibodies were tabulated for IC51 groups only; for HAV GMTs (co-primary endpoint GMT for Hepatitis A Virus (HAV) Antibody at Day 28), please refer to "Outcome 2" within outcome measure section
SCR: anti-JEV neutralizing antibody titer ≥1:10
GMT: geometric mean of PRNT50
| Arm | Type | Description |
|---|---|---|
| >=2 months to <3 years | EXPERIMENTAL | IC51 0.25 ml, 2 i.m. vaccinations at Day 0 and 28 |
| >=3 to <12 years | EXPERIMENTAL | IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28 |
| >=12 to <18 years | EXPERIMENTAL | IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28 |
| IC51 (~12 months post filling) | ACTIVE_COMPARATOR | 6 mcg (\~12 months post filling) |
| IC51 (~18 months post filling) | ACTIVE_COMPARATOR | 6 mcg (\~18 months post filling) |
| IC51 (~24 months post filling) | ACTIVE_COMPARATOR | 6 mcg (\~24 months post filling) |
| A | ACTIVE_COMPARATOR | - |
| IC51 Group A | ACTIVE_COMPARATOR | IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches |
| IC51 Group B | ACTIVE_COMPARATOR | IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches |
| IC51 Group C | ACTIVE_COMPARATOR | IC51 (JE-PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches |
| IC51 | OTHER | In study IC51-305, subjects who had received IC51 in study IC51-304 were tested for seroconversion 6 months after the first vaccination. Subjects who had protective titers were again tested for persistence of immunity at 12 months after the first immunization,whereas subjects who had titers below the seroconversion threshold by Month 6 received a booster dose of 1x6 mcg IC51 at Month 11. Their immune response was also assessed at Month 12. Thereafter, subjects who had no protective titer by Month 12 received a booster dose of 1x6 mcg IC51 at Month 23, regardless of prior treatment; and neutralizing antibody titers were reassessed at Month 24. Subjects who had protective titers at month 12 did not receive a booster at Month 23, and their neutralizing antibody titer was also assessed at Month 24. |
| IC51 2 x 6 mcg | ACTIVE_COMPARATOR | 2 x 6 mcg (microgram) |
| IC51 1 x 12 mcg | ACTIVE_COMPARATOR | 1 x 12 mcg (microgram) |
| IC51 1 x 6 mcg | ACTIVE_COMPARATOR | 1 x 6 mcg (microgram) |
| IC51 and Placebo | ACTIVE_COMPARATOR | 6 mcg i.m. IC51 with 2 injections (day 0 and 28)and placebo 0.5 mL with 1 injection (day 0) |
| HAVRIX and placebo | ACTIVE_COMPARATOR | HAVRIX with 1 injection (day 0) and placebo 0.5 mL with 2 injections (day 0 and 28) |
| IC51 and HAVRIX | ACTIVE_COMPARATOR | IC51 6 mcg i.m. with 2 injections (day 0 and 28) and HAVRIX with 1 injection (day 0) |
| JE-VAX | ACTIVE_COMPARATOR | given s.c. on Day 0, 7 and 28 |
| Name | Type | Description |
|---|---|---|
| IC51 | BIOLOGICAL | 0.25 ml, 2 i.m. vaccinations at Day 0 and 28 |
| HAVRIX | BIOLOGICAL | - |
| Placebo | OTHER | - |
| JE-VAX | BIOLOGICAL | JE-VAX, 1mL s.c. injection, 3 vaccinations, days 0, 7 and 28 |
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 * Fem...
IC51 is a vaccine used for Japanese Encephalitis and Encephalitis. It is being developed by Valneva SE for the prevention of Japanese encephalitis, a viral infection that can cause inflammation of the brain. The vaccine is intended for use in both adult and pediatric populations.
IC51 is developed by Valneva SE, a biopharmaceutical company traded on the stock exchange under the ticker symbol VALN. Valneva is conducting clinical trials to evaluate the safety and immunogenicity of IC51 for the prevention of Japanese encephalitis.
IC51 is in Phase 3 clinical development. It is an investigational vaccine, meaning it has not yet received regulatory approval. The Phase 3 trials are designed to assess the vaccine's immunogenicity, safety, and the need for booster doses in various populations.
IC51 has been studied in several Phase 3 clinical trials, including NCT00595270, NCT00595790, NCT00596271, and NCT01047839. These trials evaluated long-term immunity, rapid immunization schedules, concomitant vaccination with HARVIX 1440, and use in pediatric populations across multiple countries.
Yes, IC51 is also known as IXIARO and JESPECT. The clinical trial NCT01047839 specifically refers to IC51 as IXIARO and JESPECT, indicating these are alternative names for the same vaccine product being developed by Valneva.