Japanese Encephalitis
Conditions
Brief summary
The objective is to investigate the safety and tolerability of Japanese Encephalitis vaccine IC51 with an inactive control in healthy subjects aged \> or = 18 years
Interventions
BIOLOGICALJapanese Encephalitis purified inactivated vaccine (IC51)
IC51 (JE-PIV), 6 mcg, i.m. injection, 2 vaccinations, days 0 and 28
BIOLOGICALPlacebo
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
Sponsors
Valneva Austria GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* At least 18 years of age * Written informed consent obtained prior to study entry
Exclusion criteria
* Use of any other investigational or non-registered drug or vaccine in addition to the study vaccine during the study period or within 30 days preceding the first dose of study vaccine * History of any previous JE vaccination (e.g. JE-VAX®) * Immunodeficiency including post-organ-transplantation or immunosuppressive therapy * A family history of congenital or hereditary immunodeficiency * History of autoimmune disease * Any acute infections within 2 weeks prior to enrollment * Known or suspected HIV Infection * Pregnancy, lactation or unreliable contraception in female subjects
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability up to Day 56 | Day 56 | calculation based on safety population, numbers provide percentages of participants with Adverse Events (AEs) |
Secondary
| Measure | Time frame |
|---|---|
| Rates of Serious Adverse Events and Medically Attended Adverse Events | until Day 56 |
| Changes in Laboratory Parameters | until Day 56 |
| SCR and GMT of Subjects With Concomitant Vaccinations | until Day 56 |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IC51 IC51 | 1,993 |
| Placebo Placebo | 657 |
| Total | 2,650 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | administrative reasons | 18 | 8 |
| Overall Study | Adverse Event | 9 | 5 |
| Overall Study | Lost to Follow-up | 10 | 5 |
| Overall Study | Pregnancy | 2 | 0 |
| Overall Study | Protocol Violation | 3 | 2 |
| Overall Study | Withdrawal by Subject | 8 | 5 |
Baseline characteristics
| Characteristic | IC51 | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 33.9 years STANDARD_DEVIATION 13.3 | 33.4 years STANDARD_DEVIATION 13 | 33.8 years STANDARD_DEVIATION 13.2 |
| Region of Enrollment Australia | 294 participants | 100 participants | 394 participants |
| Region of Enrollment Europe | 1236 participants | 406 participants | 1642 participants |
| Region of Enrollment United States | 463 participants | 151 participants | 614 participants |
| Sex: Female, Male Female | 1088 Participants | 378 Participants | 1466 Participants |
| Sex: Female, Male Male | 905 Participants | 279 Participants | 1184 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 917 / 1,993 | 292 / 657 |
| serious Total, serious adverse events | 10 / 1,993 | 6 / 657 |
Outcome results
Primary
Safety and Tolerability up to Day 56
calculation based on safety population, numbers provide percentages of participants with Adverse Events (AEs)
Time frame: Day 56
Population: Safety Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IC51 | Safety and Tolerability up to Day 56 | 58.9 percentage of participants with AEs |
| Placebo | Safety and Tolerability up to Day 56 | 56.6 percentage of participants with AEs |
Secondary
Changes in Laboratory Parameters
Time frame: until Day 56
Secondary
Rates of Serious Adverse Events and Medically Attended Adverse Events
Time frame: until Day 56
Secondary
SCR and GMT of Subjects With Concomitant Vaccinations
Time frame: until Day 56