Japanese EncephalitisPhase 4NCT01158599
This is a Study to Assess the Safety and Immunogenicity of Ixiaro® (IC51) in an Elderly Population
A Phase 4 study testing IXIARO® in people with Japanese Encephalitis, run by Valneva Austria GmbH at 5 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Japanese Encephalitis
- What is being tested?
- IXIARO®
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Jun 2010to Oct 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Germany3 sites
Berliner Centrum Reise- und Tropenmedizin
Berlin, State of Berlin, 10117
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, 20359
Universitätsklinikum Rostock
Rostock, Rostock, 18057
Austria2 sites
Institut für Spezifische Prophylaxe und Tropenmedizin
Vienna, State of Vienna, 1090
Medical University of Vienna - Klinische Pharmakologie
Vienna, State of Vienna, 1090
About this study
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
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
- Being tested
- IXIARO®
- Keywords
- Japanese Encephalitis, Vaccination, Ixiaro, elderly population
- Medical subject headings
- Encephalitis, Japanese
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IXIARO®Biological
IXIARO®, 0.5 ml (6 µg), intramuscular (i.m.) injection, two vaccinations, Days 0 and 28
| Study group | Role | What they receive |
|---|---|---|
| IXIARO 0,5 ml | Other | IXIARO®, 0.5 ml (6 µg), intramuscular (i.m.) injection, two vaccinations, Days 0 and 28 Receives: Biological: IXIARO® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: up to 6 months
Rate of subjects with unsolicited AEs up to Day 70 after the first vaccination
Measured: up to Day 70
Rate of subjects with unsolicited AEs up to six months after the second vaccination
Measured: up to 6 months
Rate of subjects with abnormal safety laboratory parameters (hematology, clinical chemistry, urinalysis) up to Day 70 after the first vaccination
Measured: 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
Measured: 7 consecutive days after each vaccination
GMTs and SCRs for JEV neutralizing antibodies determined by PRNT at Day 70
Measured: Day 70
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2010 (estimated)
- Study startJun 2010
- Primary completionJun 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Japanese EncephalitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valneva Austria GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01158599
- Sponsor's protocol ID
- IC51-315
- Status last verified
- Mar 2012
- First submitted
- 7 Jul 2010
- Last updated
- 23 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01158599
- Acronym / sponsor ID
- IC51-315
- Conditions
- Japanese Encephalitis
- Keywords
- Japanese Encephalitis, Vaccination, Ixiaro, elderly population
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Valneva Austria GmbHIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 8 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IXIARO 0,5 ml | Other | Biological: IXIARO®IXIARO®, 0.5 ml (6 µg), intramuscular (i.m.) injection, two vaccinations, Days 0 and 28 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IXIARO®IXIARO®, 0.5 ml (6 µg), intramuscular (i.m.) injection, two vaccinations, Days 0 and 28 | Biological | IXIARO 0,5 ml |
Primary outcome
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
6 secondary outcomes
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
Rate of subjects with unsolicited AEs up to Day 70 after the first vaccination
Time frame: up to Day 70
Rate of subjects with unsolicited AEs up to six months after the second vaccination
Time frame: up to 6 months
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
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
GMTs and SCRs for JEV neutralizing antibodies determined by PRNT at Day 70
Time frame: Day 70
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing IXIARO® in people with Japanese Encephalitis, run by Valneva Austria GmbH at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2012.