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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Valneva Austria GmbH
ClinicalTrials.gov Identifier:
NCT01158599
First received: July 7, 2010
Last updated: March 22, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Japanese Encephalitis
Biological: IXIARO®
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Valneva Austria GmbH:

Primary Outcome Measures:
  • 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 [ Time Frame: until day 70 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Rate of subjects with SAEs and medically attended AEs during the vaccination period and up to 6 months after the second vaccination [ Time Frame: up to 6 months ] [ Designated as safety issue: Yes ]
  • Rate of subjects with unsolicited AEs up to Day 70 after the first vaccination [ Time Frame: up to Day 70 ] [ Designated as safety issue: Yes ]
  • Rate of subjects with unsolicited AEs up to six months after the second vaccination [ Time Frame: up to 6 months ] [ Designated as safety issue: Yes ]
  • Rate of subjects with abnormal safety laboratory parameters (hematology, clinical chemistry, urinalysis) up to Day 70 after the first vaccination [ Time Frame: up to Day 70 ] [ Designated as safety issue: Yes ]
  • Rate of subjects with solicited local and solicited systemic AEs assessed with a subject diary for 7 consecutive days after each vaccination [ Time Frame: 7 consecutive days after each vaccination ] [ Designated as safety issue: Yes ]
  • GMTs and SCRs for JEV neutralizing antibodies determined by PRNT at Day 70 [ Time Frame: Day 70 ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: June 2010
Study Completion Date: October 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
IXIARO 0,5 ml
IXIARO®, 0.5 ml (6 µg), intramuscular (i.m.) injection, two vaccinations, Days 0 and 28
Biological: IXIARO®
IXIARO®, 0.5 ml (6 µg), intramuscular (i.m.) injection, two vaccinations, Days 0 and 28

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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).
  • History of severe hypersensitivity reactions, in particular to a component of the IXIARO® vaccine (e.g. protamine sulfate), anaphylaxis or severe cases of atopy requiring emergency treatment or hospital admission
  • History of urticaria after hymenoptera envenomation, drugs, physical or other provocations, or of idiopathic cause
  • Drug addiction within 6 months prior to Visit 0 and throughout the entire study period (including alcohol dependence, i.e. more than approximately 60 g alcohol per day, or conditions which might interfere with the study conduct)
  • Inability or unwillingness to avoid more than the usual intake of alcohol (> 60 g alcohol/day) during the 48 hours after each vaccination
  • Any condition which might interfere with study objectives or would limit the subject's ability to complete the study in the opinion of the investigator
  • Persons who are committed to an institution (by virtue of an order issued either by the judicial or the administrative authorities) will not participate in the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01158599

Locations
Austria
Medical University of Vienna - Klinische Pharmakologie
Vienna, Austria, 1090
Institut für Spezifische Prophylaxe und Tropenmedizin
Vienna, Austria, 1090
Germany
Berliner Centrum Reise- und Tropenmedizin
Berlin, Germany, 10117
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20359
Universitätsklinikum Rostock
Rostock, Germany, 18057
Sponsors and Collaborators
Valneva Austria GmbH
  More Information

No publications provided

Responsible Party: Valneva Austria GmbH
ClinicalTrials.gov Identifier: NCT01158599     History of Changes
Other Study ID Numbers: IC51-315
Study First Received: July 7, 2010
Last Updated: March 22, 2012
Health Authority: Germany: Paul-Ehrlich-Institut
Austria: Agency for Health and Food Safety

Keywords provided by Valneva Austria GmbH:
Japanese Encephalitis
Vaccination
Ixiaro
elderly population

Additional relevant MeSH terms:
Encephalitis
Encephalitis, Japanese
Central Nervous System Viral Diseases
Virus Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Infections
Encephalitis, Arbovirus
Arbovirus Infections
Encephalitis, Viral
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on April 15, 2014