Pneumococcal Vaccine in Untreated CLL Patients

K

Karolinska University Hospital

Status and phase

Completed
Phase 3

Conditions

Chronic Lymphocytic Leukemia

Treatments

Drug: Pneumovax
Drug: Prevenar 13

Study type

Interventional

Funder types

Other

Identifiers

NCT01892618
2009-012642-22

Details and patient eligibility

About

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.

Enrollment

134 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

134 participants in 2 patient groups

Pneumovax
Active Comparator group
Description:
Pneumovax, 1x 0.5 ml injection
Treatment:
Drug: Pneumovax
Prevenar 13
Experimental group
Description:
Prevenar 13, 1x 0.5 ml injection
Treatment:
Drug: Prevenar 13

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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