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Compares treatment options for Vaccine
Official title Clinical Trial Assessing the Immunogenicity of an Anti-pneumococcal Vaccination Strategy (PCV13+PPV23 Versus PREVENAR20) in Adult Patients Treated for a Lymphoma
ClinicalTrials.gov ID: NCT04460235
What this study is testing
What is Prevenar 13 + Pneumovax 23?
Prevenar 13 + Pneumovax 23 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for vaccine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The French Public Health Council recommended pneumococcal vaccination combined strategy for all immunocompromised patients in 2012. This strategy consisted in conjugated 13-valent pneumococcal (PCV13) injection followed 2 months later by polysaccharide 23-valent (PPV23) vaccine injection.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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...
- Patient who already received chemotherapy for malignancy in the previous 2 years before the inclusion.
- Major blood clotting disorders preventing intramuscular injection.
See the full eligibility 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Angers, France
- Bordeaux, France
- Limoges, France
- Nantes, France
- Périgueux, France
- Poitiers, France
- Tours, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Angers, France; Bordeaux, France; Limoges, France; Nantes, France; Périgueux, France; Poitiers, France and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.