Open-label, Randomized Study in a Pediatric Population in a JEV (Japanese Encephalitis Virus)-Endemic Country

NCT01296360 | Completed Phase 3 Results

• 1 other identifier: IC51-325
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 3

Brief Summary

This is a randomized, open-label Phase 3 study including children aged \>9 months to \<17 years and 7 months who have been vaccinated with IXIARO in study IC51-323.

Conditions

Japanese Encephalitis

Keywords

immune response; IC51-325; Japanese Encephalitis; Intercell AG

Outcome Measures

Primary Outcomes (1)

• SCRs (Seroconversion Rate) as Defined by Percentage of Subjects With Plaque Reduction Neutralization Test Titers of>1:10 at 1 Month After the Booster Dose

  1 month post booster

Secondary Outcomes (8)

• Rate of Subjects Achieving a >4-fold Increase in JEV (Japanese Encephalitis Virus) Neutralizing Antibody Titers at 1 Month After the Booster Dose

  1 month

• GMTs (Geometric Mean Titre) for JEV Neutralizing Antibodies Measured Using a Validated PRNT (Plaque Reduction Neutralization Test) at 1 Month After the Booster Dose

  1 month

• GMTs and Rate of Subjects With a PRNT Titer of >1:10 at Months 12, 24 and 36 After First IXIARO Vaccination in IC51-323 With and Without Booster Vaccination

  36 months

• Rate of Subjects With SAEs (Serious Adverse Events) Following Immunization and Medically Attended AEs (Adverse Events) up to Months 12, 24 and 36 After the First IXIARO Vaccination in IC51 323 With and Without Booster Vaccination. Severity, Duration and

  36 months

• Rate of Subjects With Unsolicited AEs (Adverse Events) up to Months 12, 24 and 36 After the First IXIARO Vaccination in IC51 323 With and Without Booster Vaccination. Severity, Duration and Relationship to Vaccinations.

  36 months

Study Arms (2)

>14 months to <2 years

ACTIVE COMPARATOR

IXIARO 0.25 ml i.m. (milliliter, intramuscular)

Biological: IXIARO

>3 years - <18 years

ACTIVE COMPARATOR

IXIARO 0.5 ml i.m (milliliter, intramuscular)

Biological: IXIARO

Interventions

IXIARO BIOLOGICAL

0.25 ml i.m. (milliliter, intramuscular)

>14 months to <2 years

Eligibility Criteria

• Age: 9 Months - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children and adolescents who have completed study IC51-323 and received both IXIARO vaccinations according to protocol.
• Children who have received the dose confirmed for their age group.
• Male or female healthy children and adolescents aged ≥9 months to \<17 years and 7 months at the time of enrolment into this study.
• Written informed consent by the subject's legal representative(s), according to local requirements, and written informed assent of the subject, if applicable.
• Female subjects: either no childbearing potential or negative pregnancy test (pregnancy test to be performed in female subjects after onset of menarche) at Visits 1, 2 and 2a as stipulated by the protocol. For females after menarche willingness to practice a reliable method of contraception

You may not qualify if:

• Vaccination against JE virus (JEV) (except within study IC51-323 and IC51 325), Yellow fever, West Nile virus and Dengue fever at any time prior to or planned during the study.
• History of or clinical manifestation of any Flavivirus disease during IC51-323 or IC51 325.
• Participation in another study with an investigational drug during IC51 323 or IC51 325.
• Planned active or passive immunization within 2 weeks before and 1 week after the IXIARO booster.
• History of or development of an autoimmune disease during study IC51-323 or IC51 325.
• Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying medications started during IC51-323 or IC51 325. (For corticosteroids, this would mean prednisone or equivalent at \>0.05 mg/kg/day; topical and inhaled steroids are allowed).
• Acute febrile infection at Visit 2 (only for the Booster Group).
• Pregnancy (positive pregnancy test at Visit 1 and Visit 2), lactation or unreliable contraception in female subjects after onset of menarche.
• Hypersensitivity reactions to IXIARO or adverse events in study IC51-323 requiring withdrawal from further vaccination or anaphylaxis or severe cases of atopy requiring emergency treatment or hospital admission during IC51-323 or IC51 325.
• History of urticaria after hymenoptera envenomation, drugs, physical or other provocations or of idiopathic cause during IC51-323 or IC51 325.
• Known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) (measurement of Hepatitis B surface antigen \[HBsAg\] titers) or hepatitis C virus (HCV).
• Illicit drug use and/or current drug or alcohol addiction.
• Inability or unwillingness by the legal representative(s) and/or the subject (where applicable) to provide informed consent/assent and to abide by the requirements of the study.
• Persons who have been committed to an institution (by a court or by an authority).

Sponsors & Collaborators

• Valneva Austria GmbH: lead

Study Sites (3)

Research Institute for Tropical Medicine - Clinical Research Division

City of Muntinlupa, Alabang, 1781, Philippines

Location

Research Institute for Tropical Medicine

City of Muntinlupa, Alabang, 1781, Philippines

Location

UP-Philippine General Hospital

Manila, Manila, 1000, Philippines

Location

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: Senior Manager Clinical Research
• Organization: Valneva Austria GmbH

katrin.dubischar-kastner@valneva.com

+43 1 206 20

Study Officials

• Vera Kadlecek, Mag.

  Valneva Austria GmbH

  STUDY CHAIR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2010
• First Posted: February 15, 2011
• Study Start: December 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: October 1, 2013
• Last Updated: December 19, 2014
• Results First Posted: December 19, 2014

Record last verified: 2014-12

Locations

PH (3)