Phase 3
Completed N=349
Long Term Persistence and Effect of a Booster Dose of the Japanese Encephalitis Vaccine IC51
Source: ClinicalTrials.gov NCT00595270 ↗Enrolled (actual)
349
Serious AEs
3.2%
Results posted
Mar 2014
Primary outcomePrimary: Long Term Immunogenicity of IC51 Vaccine 24 Months After the Primary Vaccination — 56; 7; 5 percentage of participants
Summary
The study investigates the long term persistence the Japanese encephalitis vaccine IC51 and the need of a booster dose
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Long Term Immunogenicity of IC51 Vaccine 24 Months After the Primary Vaccination |
56; 7; 5 | — |
| SECONDARY SPR 24 Months After the Primary Vaccination (Observed) |
— | — |
| SECONDARY Persistent and Actual SPR 6, 12 and 24 Months After Primary Vaccination |
— | — |
| SECONDARY Persistent and Actual GMT 6, 12 and 24 Months After Primary Vaccination |
— | — |
| SECONDARY SCR 1 Month After the Booster Doses |
— | — |
| SECONDARY GMT 1month After Booster Doses |
— | — |
| SECONDARY Safety Profile of IC51 |
— | — |
Eligibility Criteria
Inclusion Criteria
- At least 18 years of age
- Written informed consent obtained prior to study entry
- Subjects correctly included in and having completed study IC51-304 according to the protocol.
Exclusion Criteria
- Use of any other investigational or non-registered drug or vaccine in addition to the study vaccine during the study period
- Immunodeficiency including post-organ-transplantation or immunosuppressive therapy
- Pregnancy, lactation or unreliable contraception in female subjects
Data sourced from ClinicalTrials.gov (NCT00595270). 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.