Open-label, Randomized Study in a Pediatric Population in a JEV(Japanese Encephalitis Vaccine)-Endemic Country - Full Text View

Purpose

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.

Condition	Intervention	Phase
Japanese Encephalitis	Biological: IXIARO	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Long-Term Immunity and Safety With or Without a Booster Dose Following Primary Vaccination With the Japanese Encephalitis Vaccine IC51 (IXIARO®) in a Pediatric Population in a JEV-Endemic Country. Open-Label, Randomized, 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:

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 [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Rate of subjects achieving a >4-fold increase in JEV neutralizing antibody titers at 1 month after the booster dose [ Time Frame: 1 month ] [ Designated as safety issue: No ]
GMTs (Geometric Mean Titre) for JEV neutralizing antibodies measured using a validated PRNT (Plaque Reduction Neutralization Test) at 1 month after the booster dose [ Time Frame: 1 month ] [ Designated as safety issue: No ]
GMTs and reate 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 [ Time Frame: 36 months ] [ Designated as safety issue: No ]
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 [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
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. [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
Rate of subjects with SAEs and medically attended AEs within 1 month following the booster dose. Severity, duration and relationship to vaccinations. [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
Rate of subjects with unsolicited AEs within 1 month following the booster dose. Severity, duration and relationship to vaccinations. [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
Rate of subjects with solicited AEs for up to 7 days following the booster dose. Severity and duration. [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	300
Study Start Date:	December 2010
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: >14 months to <2 years IXIARO 0.25 ml i.m. (mililitre, intramuscular)	Biological: IXIARO 0.25 ml i.m. (mililitre, intramuscular)
Active Comparator: >3 years - <18 years IXIARO 0.5 ml i.m (mililitre, intramuscular)	Biological: IXIARO 0.5 ml i.m. (mililitre, intramuscular)

Detailed Description:

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 the previous study IC51-323.

Eligibility

Ages Eligible for Study:	9 Months to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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 any immunodeficiency including post-organ-transplantation after inclusion into IC51-323 or IC51 325.
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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01296360

Locations

Philippines
Research Institute for Tropical Medicine
Muntinlupa City, Alabang, Philippines, 1781
Research Institute for Tropical Medicine - Clinical Research Division
Muntinlupa City, Alabang, Philippines, 1781
UP-Philippine General Hospital
Manila, Philippines, 1000

Sponsors and Collaborators

Intercell AG

Investigators

Study Chair:

Vera Kadlecek, Mag.

Intercell AG

More Information

No publications provided

Responsible Party:	Intercell AG
ClinicalTrials.gov Identifier:	NCT01296360 History of Changes
Other Study ID Numbers:	IC51-325
Study First Received:	December 28, 2010
Last Updated:	November 9, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Intercell AG:

immune response
IC51-325
Japanece Encephalitis
Intercell AG

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 23, 2013