Phase 3
N=374
Rapid Immunization Study of the Japanese Encephalitis Vaccine IC51
Japanese Encephalitis
Bottom Line
View on ClinicalTrials.gov: NCT00595790 ↗Enrolled (actual)
374
Serious AEs
0.3%
Results posted
Mar 2014
Primary outcome: Primary: SCR (Seroconversion Rate) at Day 56 — 41.2; 97.3; 25.6 percentage of participants — p=>0.99
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- IC51 (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Valneva Austria GmbH
- Primary completion
- Feb 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY SCR (Seroconversion Rate) at Day 56 |
41.2; 97.3; 25.6 | >0.99 |
| SECONDARY SCR at Day 10, 28 and 35 |
— | — |
| SECONDARY GMT at Day 10, 28, 35 and 56 |
— | — |
| SECONDARY Safety |
— | — |
Summary
The study investigates a rapid immunization regime of the Japanese Encephalitis vaccine IC51 (JE-PIV) 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
- History of clinical manifestation of any flavivirus infection
- History of vaccination against Japanese encephalitis (JE), Yellow fever and Dengue fever (an anti-JEV neutralizing antibody titer >= 1:10 at baseline is acceptable for inclusion, these subjects will be part of the safety population, but will not be analyzed for immunogenicity in the per-protocol analysis)
- 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
- Immunodeficiency including post-organ-transplantation or immunosuppressive therapy
- A family history of congenital or hereditary immunodeficiency
- History of autoimmune disease
- Any acute infections within 4 weeks prior to enrollment
- Infection with HIV, Hepatitis B or Hepatitis C
- Pregnancy, lactation or unreliable contraception in female subjects
Data sourced from ClinicalTrials.gov (NCT00595790). 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.