Clinical trial · Interventional
Pneumococcal Vaccine in Untreated CLL Patients
A Randomized Phase III Trial to Determine Whether Conjugated Pneumococcal Vaccine Can Improve the Immune Responsiveness Compared to Polyclonal Pneumococcal Vaccine in Patients With Untreated Chronic Lymphocytic Leukemia
NCT01892618CI-TRIAL-00020557completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of the study is to determine whether patients with chronic lymphocytic leukaemia (CLL) will benefit from vaccination with a 13-valent conjugated pneumococcal vaccine, Prevenar13, compared with a conventional 23-valent capsular polysaccharide vaccine in terms of immune response.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pneumovax | Drug | — | UNRESOLVED |
| Prevenar 13 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Pneumovax
- description
- Pneumovax, 1x 0.5 ml injection
- interventionNames
- Drug: Pneumovax
- type
- EXPERIMENTAL
- label
- Prevenar 13
- description
- Prevenar 13, 1x 0.5 ml injection
- interventionNames
- Drug: Prevenar 13
Primary outcomes (1)
- measure
- Immune response to Pneumovax compared to immune response to Prevenar
- timeFrame
- 1 month post vaccination
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Untreated CLL patients all Rai stages (0 to IV), as early as possible after diagnosis, always before any therapy with monoclonal antibodies and/or chemotherapy Exclusion Criteria: * Immunosuppressive therapy planned to start within 1 month * Other malignancies * Corticosteroids or other immunosuppressive drugs * Previous allergic reaction to any vaccination in the past * Neutropenia (PMNs \< 500 cells/mm3)
References
Publications (1)
- DERIVEDZorger AM, Hirsch C, Baumann M, Feldmann M, Brockelmann PJ, Mellinghoff S, Monsef I, Skoetz N, Kreuzberger N. Vaccines for preventing infections in adults with haematological malignancies. Cochrane Database Syst Rev. 2025 May 21;5(5):CD015530. doi: 10.1002/14651858.CD015530.pub2. PMID 40396505