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Evaluation of Influenza H1N1 Vaccine in Adults With Lymphoid Malignancies on Chemotherapy

NCT01016548 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2010-06-04

No results posted yet for this study

Summary

The purpose of this study is to determine whether adults with hematologic malignancies on active systemic therapy or shortly after bone marrow transplantation need one or two doses of adjuvanted vaccine to achieve best possible rates of protection. An additional research question is whether baseline biomarkers of the cellular and humoral immune systems are associated with an antibody response to vaccination.

Conditions

Interventions

BIOLOGICAL

AS03-adjuvanted H1N1 pandemic influenza vaccine

One dose constitutes 0.5mL of suspended vaccine via the intramuscular route.

Sponsors & Collaborators

  • Princess Margaret Hospital, Canada

    collaborator OTHER

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • John Kuruvilla, MD · Princess Margaret Hospital, Canada

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2010-03-31
Completion
2010-06-30

Countries

  • Canada

Study Locations

More Related Trials

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 NCT01016548 on ClinicalTrials.gov