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Influenza Vaccination Response in Patients With Non-Hematological Malignancies

18 Years
Open (Enrolling)

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Trial Information

Influenza Vaccination Response in Patients With Non-Hematological Malignancies

Inclusion Criteria:

- Patients must have biopsy-confirmed non-hematological malignancy

- Patients must be scheduled to receive cytotoxic chemotherapy (adjuvant or metastatic
setting), excluding immunotherapy

- Patients must be of age >=18 years.

- Patients must have an absolute lymphocyte count >= 1,000/mcL immediately prior to
influenza vaccination

- Ability of the patient (or legally authorized representative if applicable) to
understand and the willingness to sign a written informed consent document

Exclusion Criteria:

- Patients who have already received the influenza vaccine during the season in which
they are considered for eligibility will be excluded

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to the influenza vaccine or egg allergies

- Previous history of Guillian-Barre syndrome within the previous 6 weeks to influenza

- Patients must not be receiving chronic steroid therapy, defined as >= 14 days, unless
used as part of a chemotherapy regimen

- Patients must not be on any other agents that can suppress the immune system

- Planned concurrent therapy with radiation

- Uncontrolled illness at time of enrollment or influenza vaccination including, but
not limited to, ongoing or active febrile illness

- Psychiatric illness/social situations that would limit compliance with study

- Known immunosuppression eg. history of organ transplantation or known human
immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy
are ineligible because they may not be able to mount an appropriate immune response

- History of influenza-like illness, defined as a temperature > 37.8 degree C with
cough or sore throat starting October 1, 2011 throughout the duration of the study

- Patient may not be scheduled to receive chemotherapy on a weekly basis.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Optimal timing of seasonal influenza vaccination with regard to chemotherapy administration schedule.

Outcome Description:

We will assess co-primary endpoints of serologic response to the H3N2 and H1N1 strains in the 2011-2012 and 2012-2013 seasonal influenza vaccine.

Outcome Time Frame:

4 weeks from the influenza vaccine

Safety Issue:


Principal Investigator

Saiama Waqar, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine


United States: Institutional Review Board

Study ID:




Start Date:

September 2011

Completion Date:

December 2014

Related Keywords:

  • Neoplasms
  • Neoplasms
  • Influenza, Human



Washington University School of MedicineSaint Louis, Missouri  63110