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 @ 10:35 PM
Ignite Modification Date:
2025-12-24 @ 10:35 PM
NCT ID:
NCT04460235
Eligibility Criteria:
Inclusion Criteria:
* Patient ≥ 18 year-old.
* AND medical follow-up in hematology unit
* AND had received a first course of chemotherapy for diffuse large B cell lymphoma or for follicular lymphoma
* Life expectancy \> 6 months.
* Negative pregnancy test.
* Having signed the consent form.
* Having an health insurance.
Exclusion Criteria:
* Receiving monoclonal antibodies or biotherapies altering the immune response, other than anti-CD20 antibodies in the chemotherapy protocol.
* Uncontrolled bacterial, viral or fungal infection less than 7 days.
* Previous vaccination with PCV13 or PPV23 (unless PCV13 was administered in childhood. The last injection must be performed at least five years ago).
* Preexisting condition that altered the immune response: splenectomy, HIV, primary or secondary immune deficiency, nephrotic syndrome, sickle cell anemia, autoimmune disorder, solid organ transplantation, immunosuppressive drugs or biotherapy not included in the chemotherapy.
* Patient who already received chemotherapy for malignancy in the previous 2 years before the inclusion.
* Major blood clotting disorders preventing intramuscular injection.
* Medical history of anaphylactic reaction to vaccination.
* Known allergy to one of the vaccine components.
* Involvement to another vaccine biomedical research.
* Protected person.
* Pregnant women or women of childbearing age without appropriate contraceptive measures.
* Perfusion of polyvalent immunoglobulins during follow-up.
* Participants with hypersensitivity to aluminum phosphate, phenol or CRM197 protein, protein derived from Corynebacterium diphtheria.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04460235
Study Brief:
Protocol Section:
NCT04460235