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

Purpose

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

Condition	Intervention	Phase
Encephalitis	Biological: IC51	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
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

Resource links provided by NLM:

MedlinePlus related topics: Encephalitis

Genetic and Rare Diseases Information Center resources: Japanese Encephalitis

U.S. FDA Resources

Further study details as provided by Valneva Austria GmbH:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]
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 [ Time Frame: up to Month 7 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
Rate of Subjects With Abnormal Laboratory Parameters up to Day 56 and up to Month 7 After the First Vaccination [ Time Frame: up to Day 56 and up to Month 7 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
GMTs for JEV Neutralizing Antibodies Measured Using a Validated PRNT at Day 56 and Month 7 [ Time Frame: at Day 56 and Month 7 ] [ Designated as safety issue: Yes ]
SCRs and GMTs at Day 56 and Month 7 Stratified According to Dose Groups and Age Groups [ Time Frame: at Day 56 and Month 7 ] [ Designated as safety issue: Yes ]


Enrollment:	100
Study Start Date:	January 2010
Study Completion Date:	August 2013
Primary Completion Date:	August 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: >=2 months to <3 years IC51 0.25 ml, 2 i.m. vaccinations at Day 0 and 28	Biological: IC51 0.25 ml, 2 i.m. vaccinations at Day 0 and 28
Experimental: >=3 to <12 years IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28	Biological: IC51 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
Experimental: >=12 to <18 years IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28	Biological: IC51 0.5 ml, 2 i.m. vaccinations at Day 0 and 28

Eligibility


Ages Eligible for Study:	2 Months to 17 Years (Child)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01047839

Locations


United States, Florida
Tampa Clinical Research Inc.
Tampa, Florida, United States, 33624
United States, Maryland
Passport Health
Baltimore, Maryland, United States, 21230
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
United States, New York
Bronx Lebanon Hospital Center
New York, New York, United States, 10457
Australia, Queensland
Dr. Deb - The Travel Doctor
Brisbane, Queensland, Australia, 4001
Australia, Victoria
Travel Doctor - TMVC Australia
Melbourne, Victoria, Australia, 3000
Denmark
Danske Laegers Forsknings Center
Soborg, Denmark, 2860
Germany
Berliner Zentrum für Reise- und Tropenmedizin
Berlin, Germany, 10117
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Sweden
City Akuten Wasa Vaccination
Stockholm, Sweden, 11136

Sponsors and Collaborators

Valneva Austria GmbH

Investigators


Study Chair:	Andrea Ayad, Dr.	Valneva Austria GmbH

More Information


Responsible Party:	Valneva Austria GmbH
ClinicalTrials.gov Identifier:	NCT01047839 History of Changes
Other Study ID Numbers:	IC51-322
Study First Received:	January 12, 2010
Results First Received:	September 25, 2014
Last Updated:	December 10, 2014
Health Authority:	United States: Food and Drug Administration

Keywords provided by Valneva Austria GmbH:


Pediatric Japanese Encephalitis Vaccine non-endemic countries to assess immunogenicity of purified inactivated Japanese Encephalitis (JE) vaccine IC51

Additional relevant MeSH terms:


Encephalitis Encephalitis, Japanese Brain Diseases Central Nervous System Diseases Nervous System Diseases Encephalitis, Arbovirus Arbovirus Infections Virus Diseases Encephalitis, Viral	Central Nervous System Viral Diseases RNA Virus Infections Flavivirus Infections Flaviviridae Infections Infectious Encephalitis Central Nervous System Infections Vaccines Immunologic Factors Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 27, 2016