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Reactogenicity, Immunogenicity of Trivalent Influenza Vaccine With Recombinant Interferon Alpha Among Chronic Lymphocytic Leukemia

NCT00962715 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2012-08-03

No results posted yet for this study

Summary

The goal of this clinical study is to learn if Pegasys (pegylated interferon) or Roferon (interferon) can make the Trivalent Inactivated Influenza vaccine (TIV) more effective in increasing the body's immune reaction against the flu virus in patients with Chronic Lymphocytic Leukemia (CLL).

Conditions

Interventions

BIOLOGICAL

Influenza Vaccine Trivalent Inactivated (TIV)

15 μg (0.5 ml) through needle into arm muscle on Days 1 and 28.

DRUG

Pegylated interferon (PEGrIFN-α, Pegasys)

180 μg (0.5 ml) before receiving TIV, through a needle under the skin.

DRUG

Interferon (IFNα, Roferon-A)

3 million units (0.5 ml) before receiving TIV, through a needle under the skin.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Amar Safdar, MD · UT MD Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00962715 on ClinicalTrials.gov