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 @ 3:53 AM
Ignite Modification Date:
2025-12-25 @ 3:53 AM
NCT ID:
NCT02557802
Eligibility Criteria:
Inclusion Criteria:
1. Healthy male or female participants aged 18-55 years inclusive at visit
2. Available for follow-up for the duration of the study.
3. If fertile female, willing to undergo urine pregnancy tests prior to immunisations.
4. Able to read and understand the Informed Consent Form (ICF), and understand study procedures and has signed the ICF.
5. Has not received any influenza vaccine in the 2015/16 influenza season.
Exclusion Criteria:
1. Any contraindication to receiving the study vaccines as detailed in the Summary of Product Characteristics.
2. Clinically significant medical condition that would interfere with study endpoints as determined by the study physician at screening.
3. Use of immunosuppressive/immunomodulating drugs orally or parenterally within 6 months of visit 1 or during the study follow-up period. Topical, inhaled and intranasal preparations are not excluded.
4. Currently participating in another clinical study with an investigational or non-investigational drug or device, or has participated in another clinical study within the 3 months preceding Visit 1.
5. Any condition that, in the investigator's opinion, compromises the participant's ability to meet protocol requirements or to complete the study.
6. Unable to read and speak English to a fluency level adequate for the full comprehension of procedures required in participation and consent.
7. Positive pregnancy test on the day of immunisation.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT02557802
Study Brief:
Protocol Section:
NCT02557802