NCT00776230

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
304

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2008

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 21, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
3.6 years until next milestone

Results Posted

Study results publicly available

January 23, 2014

Completed
Last Updated

May 4, 2016

Status Verified

March 1, 2016

Enrollment Period

1.7 years

First QC Date

October 20, 2008

Results QC Date

December 5, 2013

Last Update Submit

March 29, 2016

Conditions

Japanese Encephalitis

Outcome Measures

Primary Outcomes (1)

  • Primary: 1. Geometric Mean Titers (GMT) at Day 56

    56 days post 1st vaccination

Secondary Outcomes (1)

  • 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

Study Arms (3)

IC51 (~12 months post filling)

ACTIVE COMPARATOR

6 mcg (\~12 months post filling)

Biological: IC51

IC51 (~18 months post filling)

ACTIVE COMPARATOR

6 mcg (\~18 months post filling)

Biological: IC51

IC51 (~24 months post filling)

ACTIVE COMPARATOR

6 mcg (\~24 months post filling)

Biological: IC51

Interventions

IC51BIOLOGICAL

6 mcg im. at day 0 and day 28

Also known as: Japanese Encephalitis vaccine
IC51 (~12 months post filling)IC51 (~18 months post filling)IC51 (~24 months post filling)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Zentrum für Reisemedizin

Vienna, Vienna, 1090, Austria

Location

Universitätsklinikum Rostock

Rostock, Rostock, 18057, Germany

Location

Berliner Zentrum Reise- und Tropenmedizin

Berlin, State of Berlin, 10117, Germany

Location

MeSH Terms

Conditions

Encephalitis, Japanese

Interventions

Japanese Encephalitis Vaccines

Condition Hierarchy (Ancestors)

Encephalitis, ArbovirusEncephalitis, ViralCentral Nervous System Viral DiseasesCentral Nervous System InfectionsInfectionsInfectious EncephalitisArbovirus InfectionsVector Borne DiseasesMosquito-Borne DiseasesVirus DiseasesRNA Virus InfectionsFlavivirus InfectionsFlaviviridae InfectionsEncephalitisBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeuroinflammatory Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Results Point of Contact

Title
Katrin Dubischar-Kastner
Organization
Valneva Austria GmbH
info@valneva.com
+43120620

Study Officials

  • Evelyn Hatzenbichler

    Valneva Austria GmbH

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2008

First Posted

October 21, 2008

Study Start

September 1, 2008

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

May 4, 2016

Results First Posted

January 23, 2014

Record last verified: 2016-03

Locations

DE(2)AU(1)