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 @ 5:05 AM
Ignite Modification Date:
2025-12-25 @ 5:05 AM
NCT ID:
NCT00617318
Eligibility Criteria:
Inclusion Criteria:
Subjects must meet all of the inclusion criteria in order to be eligible to participate in the study:
* Subject must be able to read and sign Informed Consent Form (ICF).
* Subject must be male or female \> 21 and \< 49 years of age at the time the ICF is signed.
* Subject must have made a personal decision NOT to receive influenza vaccine this season.
Exclusion Criteria:
A subject meeting any of the exclusion criteria at baseline will be excluded from study participation:
* Subject who has a known allergy to pomegranate and POM products. Subject who has an intercurrent infection and fever during the week before the investigational product administration is to begin.
Subject who has experienced acute respiratory tract infection, otitis media, bronchitis or sinusitis, or who had been treated with an antiviral drug, systemic steroids, or immunosuppressants within two weeks of the Screening/Randomization Visit.
Subject who has uncontrolled chronic medical disorders (e.g., subjects with evidence of evolving hepatic or renal failure, congestive heart failure Killip Class IV, or any terminal disease).
* Subject who reports HIV infection.
* Subject who abuses alcohol or other drugs of abuse.
* Subject who has clinical evidence of current malignancy.
* Female subject with positive pregnancy test, or who is sexually active and not using adequate contraception regularly, or who is a nursing mother.
* Subject who has taken other experimental products within one month prior to study entry.
* Subject who has any medical condition that may interfere with study protocol adherence.
* Subject has any disorder (excluding illiteracy or visual impairment) that compromises the ability of the subject to give written informed consent and/or to comply with study procedures.
* Subject who in the opinion of the study investigator has a risk of non-compliance with study procedures, or cannot read, understand or complete study related materials.
* Subject who has a foreseeable inability to complete the scheduled follow-ups.
* Subject who meets one or more of the criteria for influenza immunization according to the current CDC List of Priority Groups for Vaccination.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
49 Years
Study:
NCT00617318
Study Brief:
Protocol Section:
NCT00617318