Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Japanese Encephalitis purified inactivated vaccine (IC51), IC51
Japanese Encephalitis purified inactivated vaccine · 10 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.
calculation based on safety population, numbers provide percentages of participants with Adverse Events (AEs)
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) |
| IC51 Batch A | ACTIVE_COMPARATOR | - |
| IC51 Batch B | ACTIVE_COMPARATOR | - |
| IC51 Batch C | ACTIVE_COMPARATOR | - |
| 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 |
| 1 | EXPERIMENTAL | IC51 |
| 2 | PLACEBO_COMPARATOR | Placebo |
| 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 |
| Japanese Encephalitis purified inactivated vaccine | BIOLOGICAL | IC51 6 mcg i.m. injection on Day 0 and Day 28 |
| Japanese Encephalitis purified inactivated vaccine (IC51) | BIOLOGICAL | IC51 (JE-PIV), 6 mcg, i.m. injection, 2 vaccinations, days 0 and 28 |
| Placebo | BIOLOGICAL | Placebo: Phosphate-buffered saline (PBS) solution containing 0.1% aluminum hydroxide as an adjuvant, 0.5 mL, i.m. injection, 2 injections, days 0 and 28 |
| HAVRIX | BIOLOGICAL | - |
| 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...
The Japanese Encephalitis purified inactivated vaccine is used to prevent Japanese Encephalitis, a viral infection of the brain. It is a vaccine developed by Valneva SE and is given to healthy adults to protect against the disease. It is also known by the designation IC51.
Valneva SE develops the Japanese Encephalitis purified inactivated vaccine. Valneva SE trades under the ticker VALN. The vaccine is also referred to as IC51 in clinical documentation.
The Japanese Encephalitis purified inactivated vaccine has completed Phase 3 clinical development. Two Phase 3 trials have been completed, and no trials are currently active. It is an investigational vaccine that has been studied in healthy adult volunteers.
Two completed Phase 3 trials studied the Japanese Encephalitis purified inactivated vaccine. NCT00605085 evaluated safety and tolerability in 2,675 participants. NCT00595465 compared three commercial batches of the vaccine in 389 participants in Austria and Germany. Both trials enrolled healthy adults aged 18 years and older.
Yes, IC51 is another name for the Japanese Encephalitis purified inactivated vaccine. Both names refer to the same vaccine developed by Valneva SE. The IC51 designation appears in the clinical trial titles for the two completed Phase 3 studies.
A total of 3,064 participants were enrolled across the two completed Phase 3 trials of the Japanese Encephalitis purified inactivated vaccine. Both studies were randomized, double-blind, and actively controlled, and they enrolled healthy adult volunteers.