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Phase 2 Completed N=63 Randomized Single-blind Prevention

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

Healthy
Source: ClinicalTrials.gov NCT00877448 ↗
Enrolled (actual)
63
Serious AEs
0.0%
Results posted
Mar 2013
Primary outcomePrimary: Adverse Events — 46; 28; 29; 36 number of reported events

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Adverse Events
46; 28; 29; 36; 42; 20
PRIMARY
Treatment-related Adverse Events
8; 11; 3; 17; 3; 9

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00877448). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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