NCT00595465

Brief Summary

The objective is to demonstrate equivalence of three commercial IC51 batches in terms of geometric mean titers for anti-JEV neutralizing antibody

Trial Health

90
On Track

Trial Health Score

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

Enrollment
389

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Dec 2007

Shorter than P25 for phase_3

Geographic Reach
2 countries

4 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

December 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 4, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 16, 2008

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
4.5 years until next milestone

Results Posted

Study results publicly available

November 20, 2012

Completed
Last Updated

May 16, 2014

Status Verified

May 1, 2014

Enrollment Period

2 months

First QC Date

January 4, 2008

Results QC Date

June 1, 2012

Last Update Submit

May 5, 2014

Conditions

Japanese Encephalitis

Outcome Measures

Primary Outcomes (1)

  • Geometric Mean Titer (GMT) for Anti-JEV Neutralizing Antibody

    Day 56

Secondary Outcomes (2)

  • Seroconversion Rate

    Day 56

  • Safety and Adverse Events

    Day 56

Study Arms (3)

IC51 Batch A

ACTIVE COMPARATOR
Biological: Japanese Encephalitis purified inactivated vaccine

IC51 Batch B

ACTIVE COMPARATOR
Biological: Japanese Encephalitis purified inactivated vaccine

IC51 Batch C

ACTIVE COMPARATOR
Biological: Japanese Encephalitis purified inactivated vaccine

Interventions

Japanese Encephalitis purified inactivated vaccineBIOLOGICAL

IC51 6 mcg i.m. injection on Day 0 and Day 28

IC51 Batch AIC51 Batch BIC51 Batch C

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 Human Immunodeficiency Virus (HIV); OR
  • Drug addiction including alcohol dependence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Medizinische Universität Wien, Universitätsklinik für Klinische Pharmakologie

Vienna, 1090, Austria

Location

Berliner Zentrum Reise- und Tropenmedizin

Berlin, 10117, Germany

Location

Klinikum der Universität München, Abteilung für Infektions- und Tropenmedizin

Munich, 80802, Germany

Location

Klinik und Poliklinik für Innere Medizin der Universität Rostock

Rostock, 18057, Germany

Location

MeSH Terms

Conditions

Encephalitis, Japanese

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

Results Point of Contact

Title
Senior Manager Clinical Research
Organization
Intercell AG
kdubischar-kastner@intercell.com
+43 1 206 20

Study Officials

  • Nicole Haas

    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
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2008

First Posted

January 16, 2008

Study Start

December 1, 2007

Primary Completion

February 1, 2008

Study Completion

June 1, 2008

Last Updated

May 16, 2014

Results First Posted

November 20, 2012

Record last verified: 2014-05

Locations

DE(3)AU(1)