Rapid Immunization Study of the Japanese Encephalitis Vaccine IC51

Japanese Encephalitis Clinical Trial

Official title:

Phase 3 Study to Compare a Rapid Immunization Regime With the Standard Regime of IC51 as Vaccine for Japanese Encephalitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00595790
• Other study ID #: IC51-304
• Status: Completed
• Phase: Phase 3
• First received: January 4, 2008
• Last updated: April 9, 2014
• Start date: September 2005
• Est. completion date: November 2007

Study information

• Verified date: April 2014
• Source: Valneva Austria GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

This is a multicenter, observer blinded, controlled, randomized phase 3 study. The study population consists of healthy male and female volunteers, aged at least 18 years.

Approximately 375 volunteers will be enrolled at approximately 2 to 3 sites.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 374
• Est. completion date: November 2007
• Est. primary completion date: February 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• 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:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Encephalitis
• Encephalitis, Japanese
• Japanese Encephalitis

Intervention

Biological:
• IC51

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Valneva Austria GmbH

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SCR (Seroconversion Rate) at Day 56	Seroconversion rate: percentage of subjects with >= 1:10 anti-JEV neutralizing antibody titer	day 56	No
Secondary	SCR at Day 10, 28 and 35		Day 10, 28 and 35	No
Secondary	GMT at Day 10, 28, 35 and 56		Day 10, 28, 35 and 56	No
Secondary	Safety	AEs, Local and systemic tolerability, Safety laboratory parameters	Study duration	Yes