Response to Influenza Vaccine in Patients With Non-Hemato... | NCT01695733

Studies
Response to Influenza Vaccine in Patients With Non-Hematologic Malignancies Receiving Chemotherapy

NCT01695733

Sponsor

Washington University School of Medicine

Status

Terminated

Last Update Posted

Aug 31, 2018Actual

Enrollment

21Actual

Phase

Phase 1

Conditions

Neoplasms

Interventions

trivalent influenza vaccine

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

no longer had funding to continue

Expanded Access Info

Start Date

Sep 2011

Primary Completion Date

Sep 2013Actual

Completion Date

Sep 2013Actual

First Submitted Date

Sep 26, 2012

First Submission Date that Met QC Criteria

Sep 26, 2012

First Posted Date

Sep 28, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 29, 2018

Last Update Posted Date

Aug 31, 2018Actual

Name	Class
National Cancer Institute (NCI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

21Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Schedule A	Experimental	Influenza vaccination on the first day of chemotherapy	Biological: trivalent influenza vaccine
Schedule B	Experimental	Influenza vaccination 1 week (+/- 1 day) prior to chemotherapy	Biological: trivalent influenza vaccine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
trivalent influenza vaccine	Biological		Schedule A Schedule B	Flushield, Fluvirin, Fluzone, Influenza Vaccine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Optimal timing of seasonal influenza vaccination with regard to chemotherapy administration schedule.	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.	4 weeks from the influenza vaccine

Secondary Outcomes

Measure	Description	Time Frame
Report the presence of post-vaccination adverse events		4 weeks from the influenza vaccine

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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 vaccination
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 requirements
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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D014765	Viral Vaccines
D014612	Vaccines
D001688	Biological Products
D045424	Complex Mixtures