Immunogenicity of a Commercial Batch of JEV IC51 up to 24 Months Post Filling

Japanese Encephalitis Clinical Trial

Official title:

Immunogenicity of a Commercial Batch of the Japanese Encephalitis Vaccine IC51 up to Twenty-four Months Post Filling. An Open-label, Multicenter, Phase 3 Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00776230
• Other study ID #: IC51-314
• Status: Completed
• Phase: Phase 3
• First received: October 20, 2008
• Last updated: May 5, 2014
• Start date: September 2008
• Est. completion date: June 2010

Study information

• Verified date: May 2014
• Source: Valneva Austria GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-InstitutAustria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial Summary

The objective is to assess immunogenicity of a commercial IC51 batch at 3 different time points post filling (12, 18, 24 months) in terms of Geometric Mean Titers (GMT) for anti-JEV neutralizing antibodies at Day 56 after the first vaccination.

Description:

Open‐label, multicenter, phase 3 study assessing immunogenicity at various time points throughout the shelf‐life of a commercial batch of IC51 (Batch IC51/07F/008) The study population consists of male and female healthy subjects, aged at least 18 years.

The study will be performed at 3 study centers in Germany and Austria. Three sequential cohorts, each containing 100 subjects, will be enrolled into the study at approximately 12, 18 and 24 months after filling of the commercial batch IC51/07F/008 of IC51

Recruitment information / eligibility

• Status: Completed
• Enrollment: 304
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male and female healthy adults aged at least 18 years with written informed consent and either no childbearing potential or negative pregnancy test.

Exclusion Criteria:

• History of immunodeficiency or immunosuppressive therapy, known HIV infection, drug addiction including alcohol dependence, prior vaccination against JE

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Encephalitis
• Encephalitis, Japanese
• Japanese Encephalitis

Intervention

Biological:
• IC51
6 mcg im. at day 0 and day 28

Locations

Country	Name	City	State
Austria	Zentrum für Reisemedizin	Vienna
Germany	Berliner Zentrum Reise- und Tropenmedizin	Berlin
Germany	Universitätsklinikum Rostock	Rostock

Sponsors (1)

Lead Sponsor	Collaborator
Valneva Austria GmbH

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary: 1. Geometric Mean Titers (GMT) at Day 56		see above	No
Secondary	Secondary: 1. Seroconversion Rate 2. GMTs Day 28, Month 6 and Month 12 3. Treatment Emergent Adverse Events 4. Systemic and Local Tolerability		see above	Yes