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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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14 March 2016 |
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Main ID: |
NCT02293317 |
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Date of registration:
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09/11/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Phase II Study to Assess Safety & Immunogenicity of Multimeric-001 Influenza Vaccine, Followed by TIV
BVX006 |
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Scientific title:
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A Phase II, Randomized, Placebo-Controlled, Double-Blind Study to Assess the Safety and Immunogenicity of Multimeric-001 Influenza Vaccine, Followed by a Seasonal Trivalent Influenza Vaccine (TIV) |
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Date of first enrolment:
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November 2014 |
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Target sample size:
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37 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02293317 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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Phase:
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Phase 2
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Countries of recruitment
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Israel
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Contacts
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Name:
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Tamar Ben Yedidia, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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BiondVax Pharmaceuticals |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Males and females between =50 - =65 years old at the time expected for the first
injection.
2. Eligible to receive the standard seasonal influenza vaccine according to the ministry
of health guidelines.
3. Subjects who provide written informed consent to participate in the study.
4. Subjects able to adhere to the visit schedule and protocol requirements and are
available to complete the study.
5. Pre-menopausal female subjects must have a negative serum pregnancy test at screening
and be willing and able to use a medically acceptable method of birth control or
declare that they are abstaining from sexual intercourse, from the screening visit
through the study termination visit or be surgically sterile (bilateral tubal
ligation, bilateral oophorectomy, or hysterectomy).
6. Postmenopausal women, defined as women with menstruation cessation for 12 consecutive
months prior to signing of the informed consent form.
7. Subjects must agree to use an acceptable contraceptive method the full term of the
study period (including follow up).
Exclusion Criteria:
1. Subjects who are likely, in the opinion of the investigator, to confound the results
of the study or may be exposed to additional risks by participation in the study,
based on medical history, vital signs, ECG, physical examination and safety lab
tests.
2. Subjects with known Guillain Barré Syndrome in the past.
3. Subjects who have been immunized with anti-influenza vaccine or infected by influenza
virus (based on the assessment of the investigator) within eight months prior to
first vaccination.
4. Known hypersensitivity associated with previous influenza vaccination.
5. Use of an influenza antiviral medication within 4 weeks of first vaccination.
6. Known allergy to egg protein
7. Known hypersensitivity and/or allergy to any drug or vaccine.
8. Persons deficient in producing antibodies, whether due to genetic defect,
immunodeficiency disease, or immunosuppressive therapy.
9. History of any bleeding disorder or subjects with thrombocytopenia (since bleeding
may occur following an intramuscular administration to these subjects).
10. Positive serology for Human immunodeficiency virus (HIV) , Hepatitis C Virus (HCV)
antibody or HBsAg.
11. Any acute medical situation (e.g. acute infection, ongoing flu symptoms) with or
without fever within 48 hours of vaccination, which is considered significant by the
Investigator.
12. Pregnant or currently lactating women.
13. Subjects who participated in another interventional clinical study within 30 days
prior to first dose.
14. Subjects who are non-cooperative or unwilling to sign consent form.
Age minimum:
50 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Influenza
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Intervention(s)
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Other: Saline
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Biological: M-001
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Drug: TIV
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Primary Outcome(s)
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Number of participants with adverse events in treatment vs control group
[Time Frame: 3 months (from first visit to termination visit for each subject)]
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Secondary Outcome(s)
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Immunity induced by priming and boosting, measured by HAI (Hemagglutination Inhibition)
[Time Frame: Day 84 (21 days after TIV injection)]
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Number of participants with cell mediated immune response in treatment vs control group
[Time Frame: Day 63 (21 days after immunization with M-001)]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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