Pneumococcal Vaccine in Untreated CLL Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2015-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Lymphocytic Leukemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pneumovax

Pneumovax, 1x 0.5 ml injection

Group Type ACTIVE_COMPARATOR

Pneumovax

Intervention Type DRUG

23-valent pneumococcal polysaccharide vaccine

Prevenar 13

Prevenar 13, 1x 0.5 ml injection

Group Type EXPERIMENTAL

Prevenar 13

Intervention Type DRUG

13-valent pneumococcal conjugated vaccine

Interventions

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Prevenar 13

13-valent pneumococcal conjugated vaccine

Intervention Type DRUG

Pneumovax

23-valent pneumococcal polysaccharide vaccine

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No