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:
2025-12-24 @ 5:36 PM
Ignite Modification Date:
2025-12-24 @ 5:36 PM
NCT ID:
NCT01147068
Eligibility Criteria:
Inclusion Criteria:
* Male or female aged 18-49 years.
* Give written informed consent to participate.
* Healthy, as determined by medical history, physical examination, vital signs, and clinical safety laboratory evaluation
* Females should fulfill one of the following criteria:
* At least one year post-menopausal;
* Surgically sterile;
* Will use oral, implantable, transdermal or injectable contraceptives for 30 days prior to first vaccination and until 28 days after the booster vaccination; or
* Willing to use another reliable form of contraception approved by the Investigator (e.g., intrauterine device (IUD), female condom, diaphragm with spermicide, cervical cap, use of condom by the sexual partner or a sterile sexual partner) for 30 days prior to first vaccination and until 28 days after the booster vaccination.
* Women of childbearing potential must have a negative urine pregnancy test within 24 hours preceding receipt of first and booster vaccinations
* Comprehension of the study requirements, expressed availability for the required study period, and ability to attend scheduled visits.
Exclusion Criteria:
* Persons under 18 years old or 50 years or older
* Persons with chronic illnesses such as cancer, diabetes, liver or kidney disease
* Persons taking medications or treatments that may adversely affect the immune system
* Persons with known allergy to eggs or other vaccine or adjuvant components
* Person currently pregnant, nursing mothers or planning a pregnancy within one month of vaccination
* Persons who have had a prior serious reaction to any influenza vaccine
* Persons with a known history of Guillain-Barré Syndrome
* Persons with a history of anaphylactic-type reaction to injected vaccines
* Persons with a history of drug or chemical abuse in the year preceding the study
* Persons who previously received an H5N1 influenza vaccine or who plan to receive an H5N1 influenza vaccine while participating in the study
* Persons who received a seasonal influenza vaccine six months prior to enrollment (may delay enrollment)
* Persons who received any other vaccine within one week prior to enrollment (may delay enrollment)
* Persons who have had a respiratory illness or illness with fever within three days of study enrollment (may delay enrollment)
* Persons currently participating in another research study involving any study medications (investigational drugs or vaccines).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
49 Years
Study:
NCT01147068
Study Brief:
Protocol Section:
NCT01147068