NCT01892618

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2013

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 4, 2013

Completed
28 days until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 15, 2016

Status Verified

January 1, 2016

Enrollment Period

2.3 years

First QC Date

June 12, 2013

Last Update Submit

January 14, 2016

Conditions

Chronic Lymphocytic Leukemia

Outcome Measures

Primary Outcomes (1)

  • Immune response to Pneumovax compared to immune response to Prevenar

    1 month post vaccination

Secondary Outcomes (3)

  • Serotype-specific immunoglobulin G (IgG) antibody levels

    1 and 6 months post vaccination

  • Levels of opsonophagocytic antibodies (OPA)

    6 months post vaccination

  • Serotype-specific IgG antibody levels by ELISA, geometric mean concentrations (GMCs)between arms

    1 and 6 months post vaccination

Study Arms (2)

Pneumovax

ACTIVE COMPARATOR

Pneumovax, 1x 0.5 ml injection

Drug: Pneumovax

Prevenar 13

EXPERIMENTAL

Prevenar 13, 1x 0.5 ml injection

Drug: Prevenar 13

Interventions

Prevenar 13DRUG

13-valent pneumococcal conjugated vaccine

Prevenar 13
PneumovaxDRUG

23-valent pneumococcal polysaccharide vaccine

Pneumovax

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University Hospital

Stockholm, Stockholm County, 14186, Sweden

Location

Related Publications (1)

  • Zorger 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: 40396505DERIVED

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

13-valent pneumococcal vaccinePneumococcal Vaccines

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Streptococcal VaccinesBacterial VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Eva Kimby, Professor

    Karolinska University Hospital, SE-141 86 Stockholm, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 12, 2013

First Posted

July 4, 2013

Study Start

August 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

January 15, 2016

Record last verified: 2016-01

Locations

SE(1)