Suspended
Influenza Vaccination Response in Patients With Non-Hematological Malignancies
What is being tested
trivalent influenza vaccine
+ trivalent influenza vaccine
Biological
Who is being recruted
Neoplasms
Over 18 Years
+16 Eligibility Criteria
How is the trial designed
Supportive Care Study
Phase 1
Interventional
Study Start: September 2011
Summary
Principal SponsorWashington University School of Medicine
Last updated: August 31, 2018
Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 2011
Actual date on which the first participant was enrolled.This clinical trial studies the best time to administer the influenza vaccine to patients with non-hematologic malignancies receiving chemotherapy. Giving the vaccine at different times relative to chemotherapy may affect how well it works to help the body build an immune response and prevent influenza in these patients.
Principal SponsorWashington University School of Medicine
Last updated: August 31, 2018
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
21 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Supportive Care Study
These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Neoplasms
Criteria
5 inclusion criteria required to participate
Ability of the patient (or legally authorized representative if applicable) to understand and the willingness to sign a written informed consent document
Patients must be of age >= 18 years
Patients must be scheduled to receive cytotoxic chemotherapy (adjuvant or metastatic setting), excluding immunotherapy
Patients must have an absolute lymphocyte count >= 1,000/mcL immediately prior to influenza vaccination
Show More Criteria
11 exclusion criteria prevent from participating
History of allergic reactions attributed to compounds of similar chemical or biologic composition to the influenza vaccine or egg allergies
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
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
Patient may not be scheduled to receive chemotherapy on a weekly basis
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalInfluenza vaccination on the first day of chemotherapy
Group II
ExperimentalInfluenza vaccination 1 week (+/- 1 day) prior to chemotherapy
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Washington University School of Medicine
St Louis, United StatesOpen Washington University School of Medicine in Google MapsSuspendedOne Study Center