A clinical study to generate a set of data characterising clinical events, physiological responses, and innate and adaptive immune responses following a single intramuscular immunisation with FluadTM seasonal influenza vaccine or saline as placebo control in healthy adults.

Ghent University Hospital0 sitesAugust 26, 2014

DrugsFluad

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: Ghent University Hospital
Status: Active, not recruiting
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 26, 2014

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Ghent University Hospital

Eligibility Criteria

Inclusion Criteria

•Healthy male or female subjects aged 18\-45 years inclusive.
•Male: Female ratio \- Screening will ensure that no more than 2/3 of the population should be of either male or female
•The subject is, in the opinion of the investigator:
•1\.Healthy based on medical history and clinical exam, with no active disease process that could interfere with the study endpoints.
•2\.Has a body Mass Index \=18 and \=30
•3\.Is able to read and understand the Informed Consent Form (ICF), and understand study procedures.
•4\.The subject has signed the ICF.
•5\.The subject is available for follow\-up for the duration of the study.
•6\.The subject agrees to abstain from donating blood during their participation in the study, or longer if necessary.
•7\.If the subject is a heterosexually active female, she is willing to use an effective method of contraception with partner (oral contraceptive pill; intrauterine device; injectable or implanted contraceptive; condoms incorporating spermicide if using these; physiological or anatomical sterility) from 30 days prior to, and 3 months after, vaccination. Willing to undergo urine pregnancy tests prior to vaccination at screening and final follow up.

Exclusion Criteria

•1\.Pregnant or lactating at any point during the study from screening to final follow up.
•2\.Hypersensitivity to the active components of FLUAD, any of the excipients, eggs, chicken proteins, kanamycin and neomycin sulphate, formaldehyde, and cetyltrimetholammonium bromide or those who have had a previous life\-threatening reaction to previous influenza vaccinations.
•3\.Presence of primary or acquired immunodeficiency states with a total lymphocyte count less than 1,200 per mm3 or presenting other evidence of lack of cellular immune competence e.g. leukaemias, lymphomas, blood dyscrasias, or patients receiving immunosuppressive therapy (including regular use of oral or parenteral corticosteroids).
•4\.Use of any immune suppressing or immunomodulating drugs within 6 months of Visit 1\.
•5\.Regular use of non\-steroidal anti\-inflammatory drugs (oral or parenteral route) within 6 months of Visit 1 considered by the study physician as likely to interfere with immune responses.
•6\.Current intake of excessive amounts of alcohol and/or caffeine (as evaluated by the investigator) and not willing to adapt this use during the study period.
•7\.Currently performing extreme physical activities (as evaluated by the investigator) and not willing to adapt this use during the study period.
•8\.Receipt of a vaccine within 30 days of visit 1, or requirement to receive another vaccine within the study period.
•9\.Vaccination with the 2014/2015 seasonal influenza vaccine and/or any other seasonal influenza vaccine within the last 6 months before the first study visit.
•10\.Presence of an acute severe febrile illness at time of immunisation.