Standard Versus High-Dose Trivalent Inactivated Flu Vaccine in Pediatric Acute Lymphoblastic Leukemia Patients

NCT01216332 | Completed Phase 1 Results DMC

• 1 other identifier: VICC PED 1067
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Patients With Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (2)

• Local Reactions After Each Vaccination

  Number of participants with local reactions after each vaccination

  From baseline to 7 days after each vaccination

• Systemic Reaction

  Number of participants with systemic reactions after each vaccination

  From baseline to 7 days after each vaccination

Secondary Outcomes (5)

• 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: Number of Participants With a Post-titer ≥1:40

  About 6 months after last dose of vaccine.

• Immunogenicity: The Geometric Mean Titers Pre-vaccine in Study Participants

  baseline

• Immunogenicity: Geometric Mean Titers Post-vaccine in Study Participants

  About 6 months after last dose of vaccine.

Study Arms (2)

High-Dose trivalent inactivated influenza vaccine

EXPERIMENTAL

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.

Drug: High-dose trivalent inactivated influenza vaccine

Standard dose trivalent inactivated influenza vaccine

ACTIVE COMPARATOR

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

Drug: Standard dose trivalent inactivated influenza vaccine

Interventions

High-dose trivalent inactivated influenza vaccine DRUG

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.

High-Dose trivalent inactivated influenza vaccine

Standard dose trivalent inactivated influenza vaccine DRUG

0.5 mL standard dose trivalent inactivated influenza vaccine

Standard dose trivalent inactivated influenza vaccine

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Pediatric patients with standard or high risk Acute Lymphoblastic Leukemia.
• Must be in 1st complete remission.
• Must be 4 weeks into maintenance therapy.
• years of age, inclusive.
• Available for duration of study.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Monroe Carell Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee, 37232, United States

Location

Results Point of Contact

• Title: Dr. Natasha Halasa
• Organization: Vanderbilt

natasha.halasa@vanderbilt.edu

6153223346

Study Officials

• Natasha Halasa, M.D.

  Vanderbilt Universtiy Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 5, 2010
• First Posted: October 7, 2010
• Study Start: October 1, 2010
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: May 3, 2019
• Results First Posted: May 3, 2019

Record last verified: 2019-04

Locations

US (1)