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 range

20 Years – 65 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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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