Status:
COMPLETED
A Study to Assess the Safety and Immunogenicity of M-001 Influenza Vaccine as a Primer to TIV in Elderly Volunteers
Lead Sponsor:
BiondVax Pharmaceuticals ltd.
Conditions:
Influenza
Healthy
Eligibility:
All Genders
65+ years
Phase:
PHASE2
Brief Summary
"Multimeric-001" (M-001) has been recently developed, containing conserved, common linear influenza epitopes that activate both cellular and humoral arms of the immune system against a wide variety of...
Detailed Description
This was a two-center, randomized, placebo-controlled study. 120 subjects were randomized 1:1:1:1 into four groups to receive either two sequential non-adjuvanted or a single non-adjuvanted or a singl...
Eligibility Criteria
Inclusion
- Males and females at the age of at least 65 years old
- Eligible to receive the standard seasonal influenza vaccine according to the MOH guidelines.
- Subjects who provide written informed consent to participate in the study.
- Subjects able to adhere to the visit schedule and protocol requirements and are available to complete the study.
- Haematology, chemistry and urinalysis values with no clinical significance or do not reflect a medical condition which, according to the physician's judgment, might confound the results of the study or pose additional risk to the subject by participation in the study.
- Male subjects must agree to use a condom during the full term of the study period (including follow up) if female partner is not using an acceptable contraceptive method.
- Subjects who are seronegative to at least one of the strains included in the seasonal vaccine against influenza for 2011- 2012
Exclusion
- Known history of significant medical disorder which, in the investigator's judgment, might confound the results of the study or pose additional risk to the subject by participation in the study.
- Subjects with known Guillain Barré Syndrome in the past.
- Subjects who have been immunized with anti-influenza vaccine or infected by influenza virus within eight months prior to the screening visit.
- Known hypersensitivity associated with previous influenza vaccination.
- Use of an influenza antiviral medication within 4 weeks of vaccination.
- Known hypersensitivity and/or allergy to any drug or vaccine.
- Known hypersensitivity to egg proteins (eggs or egg products), chicken proteins, or any of the components of the commercial vaccine (e.g., formaldehyde, and octoxinol 9 (Triton X-100) and neomycin).
- Persons deficient in producing antibodies, whether due to genetic defect, immunodeficiency disease, or immunosuppressive therapy.
- History of any bleeding disorder or subjects with thrombocytopenia (since bleeding may occur following an intramuscular administration to these subjects).
- Any clinically significant abnormality upon physical examination or in the clinical laboratory tests at screening visit which, according to the physician's judgment, might confound the results of the study or pose additional risk to the subject by participation in the study.
- Positive serology for HIV, HCV antibody or HBsAg.
- 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.
- Subjects who participated in another interventional clinical study within 30 days prior to first dose
- Subjects who are non-cooperative or unwilling to sign consent form.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01419925
Start Date
August 1 2011
End Date
January 1 2012
Last Update
May 13 2014
Active Locations (1)
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1
Hadassah medical center
Jerusalem, Israel