CompletedPhase 3

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

Canada42 participantsStarted 2009-11

Plain-language 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.

Who can participate

Age range20 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male or female, ages 20-65 * Diagnosis of lymphoproliferative disorder * One of the following types of systemic treatment: active chemo/immunotherapy at enrollment or completed within the last 3 months, OR auto/allo stem cell transplant recipient within the past 12 months * Able to provide consent and comply with trial requirements Exclusion Criteria: * Systemic hypersensitivity to hen's eggs, thimerosal, gentamicin * History of life-threatening reaction to prior influenza vaccination * Thrombocytopenia or bleeding disorder contraindicating IM injection * Pregnancy * Laboratory-confirmed infection with H1N1(2009) * IVIG infusion within the last three months

What they're measuring

Seroconversion rates.

Timeframe: Day 0, 21, 42

Trial details

NCT IDNCT01016548

SponsorUniversity Health Network, Toronto

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-03

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