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:
2025-12-26 @ 2:40 PM
Ignite Modification Date:
2025-12-26 @ 2:40 PM
NCT ID:
NCT05074706
Eligibility Criteria:
Inclusion Criteria:
* Signed and dated EC-approved informed consent
* Hematological disease defined according to World Health Organization (WHO) criteria
* Female or male, 18 years of age or older
* ECOG performance status 0-3
* Willingness and ability to comply with routine clinical practice and study procedures
* Regular vaccination against SARS-CoV-2 according to Italian Haematological Society (SIE) guidelines/recommendations (Version 2.0, 20 April, 2021).
* Routine blood test planned between 30 and 60 days after administration of the second vaccine dose according to regular hematological follow up.
* Routine blood test planned no later than 9 months after the completion of the vaccination series (only in case of absence of circulation specific antibodies).
Exclusion Criteria:
* Preventive vaccination against SARS-CoV-2 not administered according to Italian Haematological Society (SIE) guidelines/recommendations (Version 2.0, 20 April, 2021)
* Evidence of previous infection with the SARS-Cov-2 virus.
* Routine blood test not planned between 30 and 60 days after administration of the second vaccine dose.
* Routine blood test not planned within 9 months after the completion of the vaccination series (only in case of absence of circulation specific antibodies).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05074706
Study Brief:
Protocol Section:
NCT05074706