Safety and Tolerability Study of the JE Vaccine IC51

Safety and Tolerability of the Japanese Encephalitis Vaccine IC51(JE-PIV).

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000680662

Enrollment

600

Registered

2005-10-21

Start date

2006-10-12

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

A double-blind, randomized controlled Phase III study to investigate the safety and the tolerability of the JE vaccine IC51.The duration of the treatment including a follow-up period is 56 days.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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- 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.

Outcome results