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Trivalent Influenza Vaccine in Preventing Flu in Patients With Central Nervous System Tumors

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT01474174
First received: October 21, 2011
Last updated: September 17, 2014
Last verified: September 2014

October 21, 2011
September 17, 2014
September 2011
July 2012   (final data collection date for primary outcome measure)
Efficacy of influenza vaccination in patients with central nervous system tumors as defined by a four-fold increase in HI titers from the pre-vaccination baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Seroconversion rate will be defined as the percentage of patients with at least a four-fold increase in HI antibodies between baseline and follow up. Seroprotection rate will be defined as the percentage of patients with a serum HI antibody of at least 1:40. The relationship between seroconversion and various clinical variables including therapy status (active vs longterm follow-up), glucorticoid dose and immune function will be measured. Seroconversion and seroprotection rate comparisons will be made to publish normative data for the general population.
Same as current
Complete list of historical versions of study NCT01474174 on ClinicalTrials.gov Archive Site
  • Efficacy of influenza vaccination in patients with central nervous system tumors as defined by a serum post-vaccination HI titer of at least 1:40 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Relationship between a variety of clinical factors and seroconversion following influenza vaccination [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Relationship between serologic markers of immune function and response to vaccination [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Trivalent Influenza Vaccine in Preventing Flu in Patients With Central Nervous System Tumors
A Pilot Study of Influenza Vaccine Efficacy in Patients With Central Nervous System Tumors

This pilot clinical trial studies trivalent influenza vaccine in preventing flu in patients with central nervous system (CNS) tumors. Flu vaccine may help the body build an effective immune response and help prevent flu in patients who are receiving chemotherapy for CNS tumors

PRIMARY OBJECTIVES:

I. The primary objective of this pilot study is to assess the efficacy of influenza vaccination in patients with central nervous system tumors as defined by a four-fold increase in hemagglutinin inhibition (HI) titers from the pre-vaccination baseline.

SECONDARY OBJECTIVES:

I. A secondary objective of this pilot study is to assess the efficacy of influenza vaccination in patients with central nervous system tumors as defined by a serum post-vaccination HI titer of at least 1:40.

II. The secondary objectives of this pilot study include an assessment of the relationship between a variety of clinical factors and seroconversion following influenza vaccination.

III. Subgroup analyses will include an investigation of seroconversion and treatment (actively receiving chemotherapy, radiation therapy or both), disease status (active treatment vs long term followup), and use and dose of glucocorticoids.

TERTIARY OBJECTIVES:

I. An additional area of interest which will be further explored in this pilot study is an assessment of the relationship between serologic markers of immune function and response to vaccination.

OUTLINE:

Patients receive trivalent influenza vaccine intramuscularly (IM) on day 0.

After completion of study treatment, patients are followed up at 14 days, 21 days, and 3 and/or 6 months.

Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

patients with primary central nervous system turmors

Central Nervous System Neoplasm
  • Biological: trivalent influenza vaccine
    Given IM
    Other Names:
    • FluMist
    • Flushield
    • Fluvirin
    • Fluzone
    • Influenza Vaccine
  • Other: laboratory biomarker analysis
    Correlative studies
Supportive care (vaccine therapy)
Patients receive trivalent influenza vaccine IM on day 0.
Interventions:
  • Biological: trivalent influenza vaccine
  • Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
38
Not Provided
July 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients must have a clinical diagnosis of a primary central nervous system tumor
  • Patients must be eligible to receive the influenza vaccine
  • Patients must be able to provide written informed consent

Exclusion Criteria:

  • Patients unable to receive the influenza vaccine due to history of allergy to egg proteins, allergy to influenza vaccine component, acute febrile illness at the time of proposed vaccine administration, history of clinically or virologically confirmed influenza infection in the previous 6 months, contraindication to intramuscular injections, Guillan-Barré syndrome, or other contraindication to the vaccine
  • Patients who have received the 2011-2012 annual influenza vaccine prior to being considered for enrollment on this study
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01474174
CCCWFU 98411, NCI-2011-03033
No
Comprehensive Cancer Center of Wake Forest University
Comprehensive Cancer Center of Wake Forest University
National Cancer Institute (NCI)
Principal Investigator: Glenn Lesser Wake Forest School of Medicine
Comprehensive Cancer Center of Wake Forest University
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP