Pneumococcal Vaccine in Untreated CLL Patients | NCT01892618

Studies
Pneumococcal Vaccine in Untreated CLL Patients

NCT01892618

Sponsor

Karolinska University Hospital

Status

Completed

Last Update Posted

Jan 15, 2016Estimated

Enrollment

134Actual

Phase

Phase 3

Conditions

Chronic Lymphocytic Leukemia

Interventions

Prevenar 13
Pneumovax

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2013

Primary Completion Date

Dec 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Jun 12, 2013

First Submission Date that Met QC Criteria

Jul 1, 2013

First Posted Date

Jul 4, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 14, 2016

Last Update Posted Date

Jan 15, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

134Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Prevenar 13	Drug	13-valent pneumococcal conjugated vaccine	Prevenar 13

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Immune response to Pneumovax compared to immune response to Prevenar		1 month post vaccination

Secondary Outcomes

Measure	Description	Time Frame
Serotype-specific immunoglobulin G (IgG) antibody levels	Immune response to Pneumovax vs. Prevenar13	1 and 6 months post vaccination
Levels of opsonophagocytic antibodies (OPA)	Immune response

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eva Kimby, Professor	Karolinska University Hospital, SE-141 86 Stockholm, Sweden	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Karolinska University Hospital		Stockholm	Stockholm County	14186	Sweden

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40396505	Derived	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.

ID	Term
D015448	Leukemia, B-Cell
D007945	Leukemia, Lymphoid
D007938	Leukemia
D009370	Neoplasms by Histologic Type

ID	Term
C538862	13-valent pneumococcal vaccine
D022242	Pneumococcal Vaccines

ID	Term
D022541	Streptococcal Vaccines
D001428	Bacterial Vaccines
D014612	Vaccines
D001688	Biological Products