NCT01892618

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 134 (actual)
• Sponsor: Karolinska University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Lymphocytic Leukemia

Interventions

Type	Name	Description
DRUG	Prevenar 13	13-valent pneumococcal conjugated vaccine
DRUG	Pneumovax	23-valent pneumococcal polysaccharide vaccine

Timeline

• Start date: 2013-08-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2013-07-04
• Last updated: 2016-01-15

Locations

1 site across 1 country: Sweden