Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2025-12-25 @ 2:39 AM
NCT ID:
NCT01353534
Eligibility Criteria:
Inclusion Criteria:
* 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 at all in-clinic visits with understanding to not become pregnant over the duration of the study.
Exclusion Criteria:
* Clinically significant laboratory abnormalities at screening
* abnormalities at physical examination
* known allergies to any component of the A/H5N1 antigen
* known egg protein allergy
* known allergies to adhesives
* known coagulation disorders
* use of any anticoagulant medication within 30 days prior to vaccination or planned usage during the study period
* participated in research involving investigational product within 30 days before planned date of vaccination or planned participation during study period
* donated or received blood or blood products such as plasma within the three months before planned date of vaccination or planned donation or use during the study period
* received or planned receipt of seasonal influenza vaccine during the study period
* received any licensed vaccines within 2 weeks (inactivated vaccines) or 4 weeks (live vaccines) prior to planned date of vaccination
* planned receipt of any licensed vaccine during the first 42 days on study
* previous or planned vaccination with any vaccine containing an oil in water emulsion adjuvant
* previous or planned vaccination with pandemic vaccine against A/H5N1 or previous proven contact with A/H5N1 wild type virus
* ever received investigational enterotoxigenic E. coli LT, or LT (R192G) or NasalFlu, Berna Biotech, Ltd. Ever received cholera toxin or vaccine
* Recent or regular use of oral, topical or injected steroid medications within 30 days prior to vaccination or planned use during the study period.
* Use of immunosuppressive systemic steroid medications including inhaled steroids within three months prior to vaccination or planned use during the study period
* Comorbid conditions or treatments that are immunosuppressive, including cancer, diabetes, and 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
* active skin allergy
* signs of acute skin infection, sunburn or skin abnormalities at the vaccination area including fungal infections, severe acne, active contact dermatitis, or a history of keloid formation
* hirsute at vaccination area
* artificial tanning over the duration of the study including the screening period
* visible tattoos or marks at the vaccination area that would prevent appropriate dermatologic monitoring of the vaccination site
* fever greater than or equal to 38.0°C at the time of planned vaccination
* suspicion of or recent history of alcohol or substance abuse
* women who are pregnant or breastfeeding
* acute illness at screening or at the time of planned vaccination
* ever had a serious reaction to prior influenza vaccination
* developed a neurological disorder following a previous influenza vaccination or have any acute and evolving neurological disorder
* employee of the investigational site or sponsor
* history of employment in bird or poultry industries or considerable exposure to birds
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
49 Years
Study:
NCT01353534
Study Brief:
Protocol Section:
NCT01353534