Japanese Encephalitis
Conditions
Brief summary
The objective is to demonstrate equivalence of three IC51 batches in terms of Geometric Mean Titers for anti-JEV neutralizing antibody.
Detailed description
This is a randomized, controlled, multi-center, double blind phase 3 study. The study population consists of male and female healthy subjects, aged at least 18 years. 624 subjects will be enrolled at approximately 6 sites in study centers in Austria and Germany.
Interventions
BIOLOGICALIC51
6 mcg, intramuscularly \[i.m.\], 0.5 mL
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
Main Inclusion Criteria: * Male and female subjects aged at least 18 years with written informed consent and either no childbearing potential or negative pregnancy test Main
Exclusion criteria
* History of immunodeficiency or immunosuppressive therapy, known HIV, drug addiction including alcohol dependence
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| GMT for Anti-JEV Neutralizing Antibody | day 56 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety | study duration | Safety laboratory parameters, rate of SAEs and medically attended AEs, systemic and local tolerability |
| SCR for Anti-JEC Neutralizing Antibody Titer | day 56 | — |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IC51 Group A 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 | 212 |
| IC51 Group B 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 | 213 |
| IC51 Group C 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 | 211 |
| Total | 636 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | administrative | 3 | 0 | 2 |
| Overall Study | Adverse Event | 4 | 1 | 2 |
| Overall Study | Lost to Follow-up | 5 | 0 | 3 |
| Overall Study | Pregnancy | 0 | 2 | 0 |
| Overall Study | Protocol Violation | 1 | 0 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 1 |
Baseline characteristics
| Characteristic | IC51 Group A | IC51 Group B | IC51 Group C | Total |
|---|---|---|---|---|
| Age, Continuous | 31.7 years STANDARD_DEVIATION 10.8 | 31.3 years STANDARD_DEVIATION 11 | 30.7 years STANDARD_DEVIATION 10.3 | 31.3 years STANDARD_DEVIATION 10.7 |
| Region of Enrollment Europe | 212 participants | 213 participants | 211 participants | 636 participants |
| Sex: Female, Male Female | 108 Participants | 123 Participants | 119 Participants | 350 Participants |
| Sex: Female, Male Male | 104 Participants | 90 Participants | 92 Participants | 286 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 102 / 212 | 124 / 213 | 114 / 211 |
| serious Total, serious adverse events | 3 / 212 | 2 / 213 | 5 / 211 |
Outcome results
Primary
GMT for Anti-JEV Neutralizing Antibody
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.
Time frame: day 56
Population: Per Protocol Population (observed values)
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| IC51 Group A | GMT for Anti-JEV Neutralizing Antibody | 160.71 GMT |
| IC51 Group B | GMT for Anti-JEV Neutralizing Antibody | 272.24 GMT |
| IC51 Group C | GMT for Anti-JEV Neutralizing Antibody | 127.56 GMT |
Secondary
Safety
Safety laboratory parameters, rate of SAEs and medically attended AEs, systemic and local tolerability
Time frame: study duration
Secondary
SCR for Anti-JEC Neutralizing Antibody Titer
Time frame: day 56