Phase 3
Completed N=867
Immunogenicity Study of the Japanese Encephalitis Vaccine IC51
Source: ClinicalTrials.gov NCT00604708 ↗Enrolled (actual)
867
Serious AEs
0.1%
Results posted
Nov 2012
Primary outcomePrimary: SCR (Seroconversion Rate)of IC51 Compared to JE-VAX at Day 56 — 96.4; 93.6 percentage of participants
Summary
The objective is to demonstrate the non-inferiority of the Japanese Encephalitis vaccine IC51 compared to JE-VAX in healthy subjects aged > or = 18 years
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY SCR (Seroconversion Rate)of IC51 Compared to JE-VAX at Day 56 |
96.4; 93.6 | — |
| PRIMARY GMT (Geometric Mean Titer) of IC51 Compared to JE-VAX at Day 56 |
243.6; 102 | — |
| SECONDARY Safety and Adverse Events |
— | — |
| SECONDARY Immunogenicity at Day 28 |
— | — |
| SECONDARY Immunogenicity at Day 56 for North America vs. Europe |
— | — |
| SECONDARY Immunogenicity at Day 56 for Subjects Older vs. Younger Than 50 Years of Age |
— | — |
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 (NCT00604708). 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. Informational only — not medical advice.