Phase 3
N=2,675
Safety and Tolerability of the Japanese Encephalitis Vaccine IC51
Japanese Encephalitis
Bottom Line
View on ClinicalTrials.gov: NCT00605085 ↗Enrolled (actual)
2,675
Serious AEs
0.6%
Results posted
Nov 2012
Primary outcome: Primary: Safety and Tolerability up to Day 56 — 58.9; 56.6 percentage of participants with AEs
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Japanese Encephalitis purified inactivated vaccine (IC51) (Biological); Placebo (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Valneva Austria GmbH
- Primary completion
- —
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety and Tolerability up to Day 56 |
58.9; 56.6 | — |
| SECONDARY Rates of Serious Adverse Events and Medically Attended Adverse Events |
— | — |
| SECONDARY Changes in Laboratory Parameters |
— | — |
| SECONDARY SCR and GMT of Subjects With Concomitant Vaccinations |
— | — |
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
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00605085). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.