Safety and Tolerability of the Japanese Encephalitis Vaccine IC51

Japanese Encephalitis Clinical Trial

Official title:

Safety and Tolerability of the Japanese Encephalitis Vaccine IC51. Double Blind, Randomized, Placebo Controlled Phase 3 Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00605085
• Other study ID #: IC51-302
• Status: Completed
• Phase: Phase 3
• Start date: October 2005
• Est. completion date: November 2006

Study information

• Verified date: March 2024
• Source: Valneva Austria GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2675
• Est. completion date: November 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Encephalitis
• Encephalitis, Japanese
• Japanese Encephalitis

Intervention

Biological:
• Japanese Encephalitis purified inactivated vaccine (IC51)
IC51 (JE-PIV), 6 mcg, i.m. injection, 2 vaccinations, days 0 and 28
• Placebo
Placebo: Phosphate-buffered saline (PBS) solution containing 0.1% aluminum hydroxide as an adjuvant, 0.5 mL, i.m. injection, 2 injections, days 0 and 28

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Valneva Austria GmbH

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability up to Day 56	calculation based on safety population, numbers provide percentages of participants with Adverse Events (AEs)	Day 56
Secondary	Rates of Serious Adverse Events and Medically Attended Adverse Events		until Day 56
Secondary	Changes in Laboratory Parameters		until Day 56
Secondary	SCR and GMT of Subjects With Concomitant Vaccinations		until Day 56