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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01215981
Other study ID # 2010NTLS050
Secondary ID MT2010-08R1007M8
Status Terminated
Phase N/A
First received October 5, 2010
Last updated December 3, 2017
Start date September 2010
Est. completion date June 2011

Study information

Verified date December 2017
Source Masonic Cancer Center, University of Minnesota
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Study Design:

This is a randomized, single center study to evaluate immune responses to the seasonal influenza vaccine in allogeneic hematopoietic stem cell transplant (HSCT) recipients who receive one vaccine or two vaccine doses one month apart. In addition, a cohort of healthy adult volunteers will be recruited as controls to confirm immune response to a single influenza vaccine.


Recruitment information / eligibility

Status Terminated
Enrollment 68
Est. completion date June 2011
Est. primary completion date June 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Months and older
Eligibility Inclusion Criteria:

- Patient Population

- HSCT recipients who are greater than 60 days post transplant.

- Age 6 months and older who are greater than 60 days post post allogeneic hematopoietic cell transplant

- Show neutrophil recovery, platelet count > 50,000/mm3 (may be transfused), no known disease relapse

- No history of previous allergic reaction to influenza vaccine, known egg allergy or Guillan-Barre Syndrome

- No flu vaccine in previous 4 months, no Campath in previous 6 months, no intravenous immune globulin (IVIG) in previous 3 months

- Controls:

- Age 18 to 50 years

- No history of previous allergic reaction to influenza vaccine, known egg allergy or Guillan-Barre Syndrome

- No flu vaccine in previous 4 months

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Influenza vaccine
One dose of inactivated hemagglutinins of influenza A (H1N1, H3N2) and influenza B
Influenza vaccine
Two doses of inactivated hemagglutinins of influenza A (H1N1, H3N2) and influenza B

Locations

Country Name City State
United States Masonic Cancer Center, University of Minnesota Minneapolis Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Masonic Cancer Center, University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Subjects With T-Cell Based Immune Response to Vaccine The primary endpoint of this study is to measure the response to the vaccine with laboratory studies including viral specific T cell immune responses. Response is defined as 4 times above the background after a filter plate was developed. Response is listed as a number of subjects (evaluable) that successfully responded. 8 Weeks After Vaccination
Secondary Number of Subjects With H3 Based Immune Response to Vaccine The secondary endpoint of this study is to measure the response to the vaccine with laboratory studies including viral specific H3 immune responses (IFN-y Elispot). Response is defined as 4 fold increase in H3N1. Response is listed as a number of subjects (evaluable) that successfully responded. 8 Weeks After Vaccination
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