Longterm Immunogenicity of the Japanese Encephalitis Vaccine IC51

NCT00596102 | Completed Results

• 1 other identifier: IC51-303
• Study Type: observational
• Target: 3,258
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study investigates the long term safety and immunogenicity of the Japanese Encephalitis vaccine IC51 up to month 60.

Conditions

Japanese Encephalitis

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects With Seroconversion Rate (SCR) ≥ 1:10 Anti-JEV Neutralizing Antibody Titer (PRNT)

  first vaccination refers to 1st vaccine administration in studies IC51-301 or IC51-302

  24 months after the first vaccination

Secondary Outcomes (3)

• Percentage of Subjects With Seroconversion Rate (SCR) ≥ 1:10 Anti-JEV Neutralizing Antibody Titer (PRNT)

  6, 12, 36, 48 and 60 months after 1st vaccination

• Geometric Mean Titers

  6, 12, 36, 48 and 60 months

• Adverse Events

  6, 12, 24, 36, 48 and 60 months after 1st vaccination

Interventions

Japanese Encephalitis purified inactivated vaccine BIOLOGICAL

Japanese Encephalitis purified inactivated vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Approximately 3,300 subjects having completed IC51, JE-VAX or placebo treatment in studies IC51-301 or IC51-302 will take part in the safety follow up, up to month 6 after 1st vaccination in the study IC51-301 (NCT00604708) or IC51-302 (NCT00605085). Only \~160 subjects, who have been treated with IC51 will take part in the immunogenicity and long-term analysis up to month 60.

You may qualify if:

• Healthy subjects at least 18 years of age
• Written informed consent obtained prior to study entry
• Subjects correctly included and having completed clinical studies IC51-301 (NCT00604708) and IC51-302 (NCT00605085) with at least one vaccination

You may not qualify if:

• Inability or unwillingness to provide informed consent and to abide the requirements of the study

Sponsors & Collaborators

• Valneva Austria GmbH: lead

Related Publications (1)

• Taucher C, Kollaritsch H, Dubischar KL. Persistence of the immune response after vaccination with the Japanese encephalitis vaccine, IXIARO(R) in healthy adults: A five year follow-up study. Vaccine. 2019 May 1;37(19):2529-2531. doi: 10.1016/j.vaccine.2019.03.030. Epub 2019 Apr 5.

  PMID: 30962094 DERIVED

MeSH Terms

Conditions

Encephalitis, Japanese

Condition Hierarchy (Ancestors)

Encephalitis, Arbovirus; Encephalitis, Viral; Central Nervous System Viral Diseases; Central Nervous System Infections; Infections; Infectious Encephalitis; Arbovirus Infections; Vector Borne Diseases; Mosquito-Borne Diseases; Virus Diseases; RNA Virus Infections; Flavivirus Infections; Flaviviridae Infections; Encephalitis; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases

Results Point of Contact

• Title: Katrin Dubischar-Kastner
• Organization: Valneva Austria GmbH

info@valneva.com

+43 1 20620

Study Officials

• Evelyn Hatzenbichler, Ph.D.

  Valneva Austria GmbH

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2008
• First Posted: January 16, 2008
• Study Start: October 1, 2005
• Primary Completion: March 1, 2011
• Last Updated: July 30, 2014
• Results First Posted: July 30, 2014

Record last verified: 2014-06