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Immunogenicity and Safety of the Japanese Encephalitis Vaccine IC51 (IXIARO®, JESPECT®) in a Pediatric Population in Non-endemic Countries

Primary Purpose

Encephalitis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
IC51
IC51
IC51
Sponsored by
Valneva Austria GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Encephalitis focused on measuring Pediatric, Japanese Encephalitis Vaccine, non-endemic countries, to assess immunogenicity of purified inactivated Japanese Encephalitis (JE) vaccine IC51

Eligibility Criteria

2 Months - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Male or female healthy children and adolescents aged >=2 months to <18 years at the time of first vaccination
  • 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. For females after menarche willingness to practice a reliable method of contraception.
  • The subject is planning to travel to an area where JE is endemic after completion of the vaccination schedule. Exposure to JE should be avoided until 1 week after the second IC51 dose and subjects should return from travel to JE endemic areas before the Month 7 visit. The planned travel to JE endemic areas should not interfere with the study visits and can take place between Visit 2 + 7 days to Month 7.

Exclusion Criteria:

  • Clinical manifestation or history of any Flavivirus disease
  • Vaccination against JE (except within this protocol), Yellow fever, West Nile virus and Dengue at any time prior or during the study
  • History of immunodeficiency or immunosuppressive therapy
  • Known HIV, HBV or HCV infection
  • History of hypersensitivity reactions to other vaccines
  • Acute febrile infection at each visit during which the subject receives a vaccination
  • Active or passive immunization within 1 week before and 1 week after each IC51 vaccination.

Sites / Locations

  • Tampa Clinical Research Inc.
  • Passport Health
  • Boston Medical Center
  • Bronx Lebanon Hospital Center
  • Dr. Deb - The Travel Doctor
  • Travel Doctor - TMVC Australia
  • Danske Laegers Forsknings Center
  • Berliner Zentrum für Reise- und Tropenmedizin
  • Universitätsklinikum Hamburg-Eppendorf
  • City Akuten Wasa Vaccination

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

>=2 months to <3 years

>=3 to <12 years

>=12 to <18 years

Arm Description

IC51 0.25 ml, 2 i.m. vaccinations at Day 0 and 28

IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28

IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28

Outcomes

Primary Outcome Measures

Rate of Subjects With Serious Adverse Events (SAEs) and Medically Attended AEs up to Day 56 After the First Vaccination
Rate of subjects with serious adverse events (SAEs) and medically attended AEs up to Day 56 after the first vaccination.

Secondary Outcome Measures

Rate of Subjects With Serious Adverse Events (SAEs) and Medically Attended AEs up to Month 7 After the First Vaccination
Rate of Subjects With Solicited Local and Systemic aEs Assessed With a Subject Diary for 7 Consecutive Days After Each Vaccination
Rate of Subjects With Unsolicited AEs up to Day 56 and up to Month 7 After the First Vaccination
Rate of Subjects With Abnormal Laboratory Parameters up to Day 56 and up to Month 7 After the First Vaccination
Laboratory parameters were assessed at the Day 28, Day 56 and Month 7 visit. Endpoint reflects abnormal laboratory parameters assessed as clinically significant by the investigator.
SCRs as Defined as Percentage of Subjects With JEV Neutralizing Antibody Titers of PRNT 50 >= 1:10 at Day 56 and Month 7, Measured Using a Validated Plaque Reduction Neutralization Test (PRNT)
GMTs for JEV Neutralizing Antibodies Measured Using a Validated PRNT at Day 56 and Month 7
SCRs at Day 56 and Month 7 Stratified According to Dose Groups and Age Groups
GMTs at Day 56 and Month 7 Stratified According to Age Groups

Full Information

First Posted
January 12, 2010
Last Updated
June 29, 2020
Sponsor
Valneva Austria GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT01047839
Brief Title
Immunogenicity and Safety of the Japanese Encephalitis Vaccine IC51 (IXIARO®, JESPECT®) in a Pediatric Population in Non-endemic Countries
Official Title
Immunogenicity and Safety of the Japanese Encephalitis Vaccine IC51 (IXIARO®, JESPECT®) in a Pediatric Population in Non-endemic Countries. Uncontrolled, Open-label Phase 3 Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Valneva Austria GmbH

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective is to assess the safety profile of IC51 in a pediatric population from regions where JEV is not endemic

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Encephalitis
Keywords
Pediatric, Japanese Encephalitis Vaccine, non-endemic countries, to assess immunogenicity of purified inactivated Japanese Encephalitis (JE) vaccine IC51

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
>=2 months to <3 years
Arm Type
Experimental
Arm Description
IC51 0.25 ml, 2 i.m. vaccinations at Day 0 and 28
Arm Title
>=3 to <12 years
Arm Type
Experimental
Arm Description
IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
Arm Title
>=12 to <18 years
Arm Type
Experimental
Arm Description
IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
Intervention Type
Biological
Intervention Name(s)
IC51
Intervention Description
0.25 ml, 2 i.m. vaccinations at Day 0 and 28
Intervention Type
Biological
Intervention Name(s)
IC51
Intervention Description
0.5 ml, 2 i.m. vaccinations at Day 0 and 28
Intervention Type
Biological
Intervention Name(s)
IC51
Intervention Description
0.5 ml, 2 i.m. vaccinations at Day 0 and 28
Primary Outcome Measure Information:
Title
Rate of Subjects With Serious Adverse Events (SAEs) and Medically Attended AEs up to Day 56 After the First Vaccination
Description
Rate of subjects with serious adverse events (SAEs) and medically attended AEs up to Day 56 after the first vaccination.
Time Frame
until Day 56
Secondary Outcome Measure Information:
Title
Rate of Subjects With Serious Adverse Events (SAEs) and Medically Attended AEs up to Month 7 After the First Vaccination
Time Frame
up to Month 7
Title
Rate of Subjects With Solicited Local and Systemic aEs Assessed With a Subject Diary for 7 Consecutive Days After Each Vaccination
Time Frame
7 days
Title
Rate of Subjects With Unsolicited AEs up to Day 56 and up to Month 7 After the First Vaccination
Time Frame
up to Day 56 and upt to Month 7
Title
Rate of Subjects With Abnormal Laboratory Parameters up to Day 56 and up to Month 7 After the First Vaccination
Description
Laboratory parameters were assessed at the Day 28, Day 56 and Month 7 visit. Endpoint reflects abnormal laboratory parameters assessed as clinically significant by the investigator.
Time Frame
up to Month 7
Title
SCRs as Defined as Percentage of Subjects With JEV Neutralizing Antibody Titers of PRNT 50 >= 1:10 at Day 56 and Month 7, Measured Using a Validated Plaque Reduction Neutralization Test (PRNT)
Time Frame
at Day 56 and Month 7
Title
GMTs for JEV Neutralizing Antibodies Measured Using a Validated PRNT at Day 56 and Month 7
Time Frame
at Day 56 and Month 7
Title
SCRs at Day 56 and Month 7 Stratified According to Dose Groups and Age Groups
Time Frame
at Day 56 and Month 7
Title
GMTs at Day 56 and Month 7 Stratified According to Age Groups
Time Frame
at Day 56 and Month 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male or female healthy children and adolescents aged >=2 months to <18 years at the time of first vaccination 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. For females after menarche willingness to practice a reliable method of contraception. The subject is planning to travel to an area where JE is endemic after completion of the vaccination schedule. Exposure to JE should be avoided until 1 week after the second IC51 dose and subjects should return from travel to JE endemic areas before the Month 7 visit. The planned travel to JE endemic areas should not interfere with the study visits and can take place between Visit 2 + 7 days to Month 7. Exclusion Criteria: Clinical manifestation or history of any Flavivirus disease Vaccination against JE (except within this protocol), Yellow fever, West Nile virus and Dengue at any time prior or during the study History of immunodeficiency or immunosuppressive therapy Known HIV, HBV or HCV infection History of hypersensitivity reactions to other vaccines Acute febrile infection at each visit during which the subject receives a vaccination Active or passive immunization within 1 week before and 1 week after each IC51 vaccination.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Ayad, Dr.
Organizational Affiliation
Valneva Austria GmbH
Official's Role
Study Chair
Facility Information:
Facility Name
Tampa Clinical Research Inc.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33624
Country
United States
Facility Name
Passport Health
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21230
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Bronx Lebanon Hospital Center
City
New York
State/Province
New York
ZIP/Postal Code
10457
Country
United States
Facility Name
Dr. Deb - The Travel Doctor
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4001
Country
Australia
Facility Name
Travel Doctor - TMVC Australia
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Facility Name
Danske Laegers Forsknings Center
City
Soborg
ZIP/Postal Code
2860
Country
Denmark
Facility Name
Berliner Zentrum für Reise- und Tropenmedizin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Universitätsklinikum Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
City Akuten Wasa Vaccination
City
Stockholm
ZIP/Postal Code
11136
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

Immunogenicity and Safety of the Japanese Encephalitis Vaccine IC51 (IXIARO®, JESPECT®) in a Pediatric Population in Non-endemic Countries

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