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

U.S. FDA Resources

Further study details as provided by Intercell AG:

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 ]

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 gropus and age groups [ Time Frame: at Day 56 and Month 7 ] [ Designated as safety issue: Yes ]

Enrollment:	100
Study Start Date:	January 2010
Estimated Study Completion Date:	March 2014
Estimated Primary Completion Date:	March 2014 (Final data collection date for primary outcome measure)

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

Eligibility

Ages Eligible for Study:	2 Months to 17 Years
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

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
Bronx, New York, United States
United States, North Carolina
Passport Health Triad
Winston, Salem, North Carolina, United States, 27103
Australia, Queensland
Dr. Deb - The Travel Doctor
Brisbane, Queensland, Australia, 4001
Travel Doctor - TMVC Brisbane
Brisbane, Queensland, Australia, 4000
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

Intercell AG

Investigators

Study Director:

Andrea Ayad

Intercell AG

More Information

No publications provided

Responsible Party:	Intercell AG
ClinicalTrials.gov Identifier:	NCT01047839 History of Changes
Other Study ID Numbers:	IC51-322
Study First Received:	January 12, 2010
Last Updated:	February 1, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Intercell AG:

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
Encephalitis, Arbovirus
Encephalitis, Viral
Central Nervous System Viral Diseases
Virus Diseases
Brain Diseases

Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Infections
Arbovirus Infections
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on May 16, 2013