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 @ 6:40 PM
Ignite Modification Date:
2025-12-24 @ 6:40 PM
NCT ID:
NCT01344057
Eligibility Criteria:
Key Inclusion Criteria:
* Males and females volunteers of 65 years of age or older, mentally competent, willing and able to give written informed consent prior to study entry.
* Individuals able to comply with all the study requirements.
* Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.
* Written informed consent must be obtained for all the subjects before enrollment into the study after the nature of the study has been explained.
Key Exclusion Criteria:
* Individuals with any serious chronic or acute disease.
* Individuals with history of any anaphylactic reaction and/or serious allergic reaction following a vaccination.
* Individuals with known or suspected impairment/alteration of immune function.
* Individuals with known or suspected history of drug or alcohol abuse.
* Individuals with a bleeding diathesis or conditions associated with prolonged bleeding time that in the investigator's opinion would interfere with the safety of the subject.
* Individuals within the past 6 months, they have: had any seasonal or pandemic laboratory confirmed influenza disease; received any seasonal or pandemic influenza vaccine.
* Individuals with any acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the last 7 days.
* Individuals that have experienced fever (i.e., axillary temperature ≥38°C) within the last 3 days of intended study vaccination.
* Individuals participating in any clinical trial with another investigational product 4 weeks prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study.
* Individuals who received any other vaccines within 4 weeks prior to enrollment in this study or who are planning to receive any vaccine within 4 weeks from the study vaccines.
* Individuals who are part of study personnel or close family members conducting this study.
* BMI \> 35 kg/m2.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT01344057
Study Brief:
Protocol Section:
NCT01344057