Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00776230 | Immunogenicity of a Commercial Batch of JEV IC51 up to 24 Months Post Filling | PHASE3 | COMPLETED | 304 | — | — | Sep 1, 2008 | Jun 1, 2010 | May 4, 2016 | 3 | Austria, Germany |
| NCT00595309 | Effect of a Booster Dose of the Japanese Encephalitis Vaccine IC51 | PHASE3 | COMPLETED | 198 | — | — | Dec 1, 2007 | Oct 1, 2009 | May 16, 2014 | 3 | Austria, Germany |
| NCT00594958 | Comparison of Three Batches of the Japanese Encephalitis Vaccine IC51 | PHASE3 | COMPLETED | 639 | — | — | Sep 1, 2006 | Sep 1, 2007 | Mar 21, 2024 | - | — |
| NCT00595270 | Long Term Persistence and Effect of a Booster Dose of the Japanese Encephalitis Vaccine IC51 | PHASE3 | COMPLETED | 349 | — | — | Oct 1, 2005 | Apr 1, 2009 | Mar 7, 2014 | - | — |
| NCT00595790 | Rapid Immunization Study of the Japanese Encephalitis Vaccine IC51 | PHASE3 | COMPLETED | 374 | — | — | Sep 1, 2005 | Nov 1, 2007 | Apr 29, 2014 | - | — |
| NCT00596271 | Concomitant Vaccination With the Japanese Encephalitis Vaccine IC51 and HARVIX® 1440 | PHASE3 | COMPLETED | 192 | — | — | Sep 1, 2005 | Aug 1, 2008 | May 13, 2014 | - | — |
| NCT00604708 | Immunogenicity Study of the Japanese Encephalitis Vaccine IC51 | PHASE3 | COMPLETED | 867 | — | — | Sep 1, 2005 | Sep 1, 2006 | Mar 21, 2024 | - | — |
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 |
|---|---|---|
| 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 | 6 mcg im. at day 0 and day 28 |
| HAVRIX | BIOLOGICAL | - |
| Placebo | OTHER | - |
| JE-VAX | BIOLOGICAL | JE-VAX, 1mL s.c. injection, 3 vaccinations, days 0, 7 and 28 |
Inclusion Criteria: * Male and female healthy adults aged at least 18 years with written informed consent and either no childbearing potential or negative pregnancy test. Exclusion Criteria: * History of immunodeficiency or immunosuppressive therapy, known HIV infection, drug addiction including ...