Status:
COMPLETED
A Double-Dose Safety Study of An Influenza Vaccine (Multimeric-001)
Lead Sponsor:
BiondVax Pharmaceuticals ltd.
Conditions:
Healthy
Eligibility:
All Genders
18-49 years
Phase:
PHASE1
PHASE2
Brief Summary
A phase I/II, randomized, single-blind, placebo-controlled escalating double-dose safety study of an intramuscular universal influenza vaccine (Multimeric-001) injected to healthy volunteers.
Eligibility Criteria
Inclusion
- Healthy males and females between 18 and 55 years (inclusive) of age.
- Non-smoking (by declaration) for a period of at least 6 months.
- Subjects able to adhere to the visit schedule and protocol requirements and be available to complete the study.
- Haematology and Chemistry values within normal ranges or with no clinical significance
- Subjects who provide written informed consent to participate in the study
Exclusion
- Known history of significant medical disorder, which in the investigator's judgment contraindicates administration of the study medications.
- Ongoing flu symptoms or influenza
- Any clinically significant abnormality upon physical examination or in the clinical laboratory test at screening visit.
- Treatment with immune immunosuppressant drugs or other immune enhancing drugs.
- Subjects who have been immunized with anti-influenza vaccine or infected by influenza virus within one year prior to the screening visit.
- Administration of any vaccine 30 days before the screening visit.
- Known history of drug or alcohol abuse.
- Known history of HIV, hepatitis C or B virus (HCV or HBV)
- Subjects with known Guillain Barré Syndrome in the past
- 2 or more hospitalization within the last year prior to screening visit
- Increased liver enzymes 2.5 times above the upper reference level
- Known hypersensitivity and/or allergy to any drugs
- Any acute medical situation (e.g. acute infection) within 48 hours of study start, which is considered of significance by the Principal Investigator.
- Subjects who participated in another clinical study within 30 days prior to study entry
- Subjects who are non-cooperative or unwilling to sign consent form.
- Pregnant or lactating women at entry to study and those that are unwilling to agree to continue precautions for two months after completion of the study
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00877448
Start Date
June 1 2009
End Date
November 1 2009
Last Update
March 7 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Tasmc Crc
Tel Aviv, Israel