Phase 3 Completed N=374 Randomized Single-blind Prevention

Rapid Immunization Study of the Japanese Encephalitis Vaccine IC51

Japanese Encephalitis

Source: ClinicalTrials.gov NCT00595790 ↗

Enrolled (actual)

374

Serious AEs

0.3%

Results posted

Mar 2014

Primary outcomePrimary: SCR (Seroconversion Rate) at Day 56 — 41.2; 97.3; 25.6 percentage of participants — p=>0.99

Summary

The study investigates a rapid immunization regime of the Japanese Encephalitis vaccine IC51 (JE-PIV) in healthy subjects aged > or = 18 years

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	—	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.