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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Vanderbilt University
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Systemic Reaction
Study Overview
Brief Summary
This is a phase I safety and immunogenicity trial comparing high-dose (HD)trivalent inactivated influenza vaccine (TIV) to standard dose (SD) TIV in pediatric patients with Acute Lymphoblastic Leukemia.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 3 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
High-Dose trivalent inactivated influenza vaccine
0.5 mL of high-dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine.
Intervention: High-dose trivalent inactivated influenza vaccine (Drug)
Standard dose trivalent inactivated influenza vaccine
0.5 mL standard dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine
Intervention: Standard dose trivalent inactivated influenza vaccine (Drug)
Outcomes
Primary Outcomes
Systemic Reaction
Time Frame: From baseline to 7 days after each vaccination
Number of participants with systemic reactions after each vaccination
Local Reactions After Each Vaccination
Time Frame: From baseline to 7 days after each vaccination
Number of participants with local reactions after each vaccination
Secondary Outcomes
- Immunogenicity: Geometric Mean Titers Post-vaccine in Study Participants(About 6 months after last dose of vaccine.)
- Immunogenicity: Number of Participants With a Post-titer Greater Than or Equal to a Fourfold Titer Rise(About 6 months after last dose of vaccine.)
- Immunogenicity:Number of Participants With a Pre-titer ≥1:40(About 6 months after last dose of vaccine.)
- Immunogenicity: The Geometric Mean Titers Pre-vaccine in Study Participants(baseline)
- Immunogenicity: Number of Participants With a Post-titer ≥1:40(About 6 months after last dose of vaccine.)
Investigators
Natasha Halasa
Assistant Professor
Vanderbilt University