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Randomized, Double Blind, Comparison of Standard Dose Trivalent Inactivated Influenza Vaccine Versus High Dose Trivalent Inactivated Influenza Vaccine in Pediatric Patients With Acute Lymphoblastic Leukemia


Phase 1
3 Years
17 Years
Open (Enrolling by invite only)
Both
Pediatric Patients With Acute Lymphoblastic Leukemia

Thank you

Trial Information

Randomized, Double Blind, Comparison of Standard Dose Trivalent Inactivated Influenza Vaccine Versus High Dose Trivalent Inactivated Influenza Vaccine in Pediatric Patients With Acute Lymphoblastic Leukemia


Inclusion Criteria:



- Pediatric patients with standard or high risk Acute Lymphoblastic Leukemia.

- Must be in 1st complete remission.

- Must be 4 weeks into maintenance therapy.

- 17 years of age, inclusive.

- Available for duration of study.

Exclusion Criteria:

- History of hypersensitivity to previous influenza vaccination or hypersensitivity to
eggs/egg protein.

- History of Guillain-Barre syndrome.

- Evidence of relapsed disease.

- Have any condition that would, in the opinion of the site investigator, place them at
an unacceptable risk of injury or render them unable to meet the requirements of the
protocol.

- Have any condition that the investigator believes may interfere with successful
completion of the study.

- History of receiving 2010 - 2011 influenza vaccine.

- Pregnant female.

- History of proven influenza disease after September 1, 2010.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

To compare safety profile of high dose trivalent inactivated influenza vaccine to standard dose trivalent inactivated influenza vaccine in pediatric Acute Lymphoblastic Leukemia subjects

Outcome Time Frame:

About 6 months after last dose of vaccine

Safety Issue:

Yes

Principal Investigator

Natasha Halasa, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Vanderbilt Universtiy Medical Center

Authority:

United States: Food and Drug Administration

Study ID:

VICC PED 1067

NCT ID:

NCT01216332

Start Date:

October 2010

Completion Date:

April 2012

Related Keywords:

  • Pediatric Patients With Acute Lymphoblastic Leukemia
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

Name

Location

Monroe Carell Jr. Children's Hospital at VanderbiltNashville, Tennessee  37232