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OpenTrials
Completed

NCT Number: NCT00877448

A Double-Dose Safety Study of An Influenza Vaccine (Multimeric-001)

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.

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Key information

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Tasmc Crc

Tel Aviv, Israel

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Adjuvanted Multimeric-001 250 Mcg

Biological

Multimeric-001 250 mcg

Biological

Phosphate Buffered saline

Biological

Adjuvanted PBS

Biological

Adjuvanted Multimeric-001 500 Mcg

Biological

Multimeric-001 500 mcg

Biological

Multimeric-001 125 Mcg

Biological

Primary outcomes

  1. Adverse Events

    Time frame: day 0 until day 42 (termination visit)

    Number of adverse events per cohort

  2. Treatment-related Adverse Events

    Time frame: Day 0 until day 42 (termination visit)

    Number of treatment-related adverse events per cohort

Sponsors and collaborators

Lead sponsor

BiondVax Pharmaceuticals ltd.

Industry

Registry information

Official study title

A Phase I/II, Randomized, Single-Blind, Placebo-Controlled Escalating Double-Dose Safety Study of an Intramuscular Influenza Vaccine (Multimeric-001) Injected to Healthy Volunteers

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Apr 7, 2009
Registry last updated
Mar 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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