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:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07455318
Eligibility Criteria:
Inclusion Criteria:
1. ≥ 18 to ≤ 60 years of age at time of inclusion
2. Willingness to provide written informed consent
3. Having received PrEP with a 21IM, 2²ID or 1²ID regimen at least 5 years before starting the study. For 21IM and 2²ID interval of 5 days to 56 days between the 2 visits is allowed.
Exclusion Criteria:
1. Known allergy to one of the components of the vaccine.
2. Subjects, who received immunomodulating therapy within the last 3 months (12 weeks).
Note: See Section 6.3 for detailed guidance on immunomodulating therapies.
3. Planned vaccination with any inactivated vaccine within 2 weeks before or after vaccination in the study or with any live attenuated vaccine within 1 month before or after each vaccination in the study.
4. Ongoing pregnancy or active child wish at the time of booster vaccination (D0).
5. Any other PrEP rabies vaccine schedule/vaccination than mentioned in the inclusion criteria.
6. Previous rabies (s)PEP
7. Inability or unwillingness to comply with study procedures, including protocol-defined visits, assessments, or interventions.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT07455318
Study Brief:
Protocol Section:
NCT07455318