Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Intercell USA, Inc.
With
Department of Health and Human Services
Age
18–49
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Healthy adult males or females 18-49 years of age (inclusive)
Signed Informed Consent
Women who are not post-menopausal or surgically sterile must have a negative serum or urine pregnancy test at screening and within 24 hours of each vaccination with understanding (through Informed Consent process) to not become pregnant and to employ an effective form of birth control for the duration of the study. Acceptable forms of birth control are: abstinence, hormonal contraceptives (oral, injectable, implant, patch, ring), double-barrier contraceptives (condom or diaphragm, with spermicide), and IUD
You may not be if
Laboratory abnormalities \[as determined by the Toxicity Grading Scale (grade 1 4)\] at laboratory screening
Abnormalities at physical examination \[as determined by the Toxicity Grading Scale (grade 1-4)\]
Known allergies to any component of the vaccine
Known egg protein allergy
Known allergies to adhesives
Known disturbance of coagulation
Participated in research involving investigational product within 45 days before planned date of first vaccination
Donated or received blood or blood products such as plasma within the past 45 days
Received any licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to planned date of first vaccination
Ever received investigational enterotoxigenic E. coli, LT, or LT (R192G) or NasalFlu, Berna Biotech, Ltd
Ever received cholera toxin or vaccine (e.g. Orochol™, Dukoral™)
History of travelers' diarrhea in the last two years
History of abdominal surgery (excluding C-section, hysterectomy, cosmetic surgery, liposuction, appendectomy, cholecystectomy, ventral hernia repair, and other surgeries not pertaining to gastrointestinal problems) or history of, or recent acute gastrointestinal illness
Previous vaccination with a pandemic candidate vaccine or previous proven contact with A/H5N1 wild type virus (contact with an individual with laboratory-confirmed A/H5N1 infection or contact with an animal which died as a result of A/H5N1 infection)
Recent or regular use of oral, topical or injected steroid medications within 45 days prior to first vaccination
Use of immunosuppressive systemic steroid medications including inhaled steroids within three months prior to first vaccination
Comorbid conditions or treatments that are immunosuppressive, including cancer, diabetes, end-stage renal disease, as determined by the Investigator
Positive serology for HIV-1, HIV-2, HBsAg, or HCV
History of severe atopy
Medical history of acute or chronic skin disease at vaccination area(s)
Active skin allergy
Signs of acute skin infection, sunburn or skin abnormalities at the vaccination area(s) including fungal infections, severe acne, or active contact dermatitis, or a history of keloid formation
Hirsute (significant amount of hair) at vaccination area(s)
Artificial tanning (UV radiation) over the duration of the study including the screening period
Visible tattoos or marks (tattoos/scars) at the vaccination area(s) that would prevent appropriate dermatologic monitoring of the vaccination site(s)
Fever greater than or equal to 38.0°C (100.4°F) at the time of planned vaccination
Suspicion of or recent history of (within one year of planned vaccination) alcohol or substance abuse
Women who are pregnant or breastfeeding
Acute illness at screening or at baseline
Ever had a serious reaction to prior influenza vaccination
Developed a neurological disorder (such as Guillain Barré syndrome) in the six weeks following a previous influenza vaccination
Medical history of achlorhydria
Employee of the investigational site
History of employment in bird or poultry industries or considerable exposure to birds (e.g. poultry or bird veterinarians, bird breeders, poultry butchers and/or cullers, etc.)
Clareo Health | A/H5N1 Dose Ranging Study With Adjuvant Patch
