Phase 3 Completed N=2,675 Randomized Double-blind Prevention

Safety and Tolerability of the Japanese Encephalitis Vaccine IC51

Japanese Encephalitis

Source: ClinicalTrials.gov NCT00605085 ↗

Enrolled (actual)

2,675

Serious AEs

0.6%

Results posted

Nov 2012

Primary outcomePrimary: Safety and Tolerability up to Day 56 — 58.9; 56.6 percentage of participants with AEs

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

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	—	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.