This is a Study to Assess the Safety and Immunogenicity of Ixiaro® (IC51) in an Elderly Population

NCT01158599 | Completed Phase 4

• 1 other identifier: IC51-315
• Study Type: interventional
• Target: 200
• Locations: 2 countries
• Sites: 5

Brief Summary

This is an open-label, uncontrolled phase 4 study to assess the safety and immunogenicity of the Japanese encephalitis (JE) vaccine Ixiaro® (IC51) in an elderly population.

Conditions

Japanese Encephalitis

Keywords

Japanese Encephalitis; Vaccination; Ixiaro; elderly population

Outcome Measures

Primary Outcomes (1)

• Rate of subjects with serious adverse events (SAEs) and medically attended adverse events (AEs) during the vaccination period and until Day 70 after the first vaccination

  until day 70

Secondary Outcomes (6)

• Rate of subjects with SAEs and medically attended AEs during the vaccination period and up to 6 months after the second vaccination

  up to 6 months

• Rate of subjects with unsolicited AEs up to Day 70 after the first vaccination

  up to Day 70

• Rate of subjects with unsolicited AEs up to six months after the second vaccination

  up to 6 months

• Rate of subjects with abnormal safety laboratory parameters (hematology, clinical chemistry, urinalysis) up to Day 70 after the first vaccination

  up to Day 70

• Rate of subjects with solicited local and solicited systemic AEs assessed with a subject diary for 7 consecutive days after each vaccination

  7 consecutive days after each vaccination

Study Arms (1)

IXIARO 0,5 ml

OTHER

IXIARO®, 0.5 ml (6 µg), intramuscular (i.m.) injection, two vaccinations, Days 0 and 28

Biological: IXIARO®

Interventions

IXIARO® BIOLOGICAL

IXIARO®, 0.5 ml (6 µg), intramuscular (i.m.) injection, two vaccinations, Days 0 and 28

IXIARO 0,5 ml

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Male or female subjects ≥ 65 years of age at the time of 1st vaccination of good general health status including subjects with pharmacologically controlled conditions like hypercholesterolemia, hypertension, cardiovascular disease or non insulin-dependent diabetes mellitus
• Weight: ≥ 45.5 kg and ≤ 150 kg at Visit 0 (Screening Visit)
• White blood cells ≥2,500/mm3 and \<11,000/mm3 at Visit 0
• Absolute neutrophil count within normal limits at Visit 0
• Platelets within normal limits at Visit 0
• Written informed consent obtained from the subject prior to any study related procedures

You may not qualify if:

• History of clinical manifestation of any flavivirus infection (Yellow Fever, Dengue Fever, JE, Tick Borne Encephalitis (TBE) and West Nile Fever/Neuroinvasive Disease)
• Vaccination against JE (including study participation in any previous or current IC51/IXIARO® clinical study), Yellow fever, Dengue Fever or West Nile Fever at any time prior or during the study
• Vaccination against TBE within 30 days prior to first IXIARO® vaccination at Visit 1 (Day 0) and until Visit 3 (Day 70)
• Use of any other investigational or non-registered medicinal product within 30 days prior to IXIARO® vaccination at Visit 1 (Day 0) and throughout the entire study period
• Immunodeficiency including status post-organ-transplantation or immuno-suppressive therapy, and a family history of congenital or hereditary immunodeficiency
• Infection with the human immunodeficiency virus (HIV, a negative test result within 30 days before screening is acceptable), Hepatitis B virus (HBV, Hepatitis B surface antigen \[HBsAg\]) or Hepatitis C virus (HCV)
• Administration of chronic (defined as longer than 14 days) immunosuppressants or other immune-modifying drugs within 30 days prior to IXIARO® vaccination at Visit 1 (Day 0) and during the study until Visit 3 (Day 70). (For corticosteroids this means prednisone or equivalent \>= 0.05 mg/kg/day; topical and inhaled steroids are allowed).
• Periodic steroid injections, e.g., intra-articular, are not allowed within 30 days prior to first IXIARO® vaccination at Visit 1 (Day 0) and until Visit 3 (Day 70)
• History of autoimmune disease, including Type I Diabetes mellitus. Subjects with vitiligo or thyroid disease taking thyroid hormone replacement are not excluded.
• Acute febrile infections or exacerbation of chronic infection on the day of IXIARO® vaccination (Day 0 and Day 28)
• Skin cancer in the past six months. If treatment for skin cancer was successfully completed more than six months ago and the malignancy is considered to be cured, the subject may be enrolled. Subjects with history of skin cancer must not be vaccinated at the previous site of the malignancy.
• Any other malignancy in the past 5 years. If treatment for cancer was successfully completed more than 5 years ago and the malignancy is considered to be cured, the subject may be enrolled.
• Clinically significant hematological, renal, hepatic, pulmonary, central nervous, cardiovascular or gastrointestinal disorders, which are not adequately controlled by medical treatment within the last 12 weeks before IXIARO® vaccination at Visit 1 (Day 0) as judged by the site's Principal Investigator
• Clinically significant mental disorder not adequately controlled by medical treatment
• History of Guillain-Barré-Syndrome (GBS).

Sponsors & Collaborators

• Valneva Austria GmbH: lead

Study Sites (5)

Institut für Spezifische Prophylaxe und Tropenmedizin

Vienna, Vienna, 1090, Austria

Location

Medical University of Vienna - Klinische Pharmakologie

Vienna, Vienna, 1090, Austria

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Hamburg, 20359, Germany

Location

Universitätsklinikum Rostock

Rostock, Rostock, 18057, Germany

Location

Berliner Centrum Reise- und Tropenmedizin

Berlin, State of Berlin, 10117, Germany

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2010
• First Posted: July 8, 2010
• Study Start: June 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: October 1, 2011
• Last Updated: March 23, 2012

Record last verified: 2012-03

Locations

AU (2); DE (3)