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Completed

NCT Number: NCT01216332

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

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.

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Key information

Conditions

Pediatric Patients With Acute Lymphoblastic Leukemia

Age range

3 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Monroe Carell Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee, 37232, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Standard dose trivalent inactivated influenza vaccine

Drug

0.5 mL standard dose trivalent inactivated influenza vaccine

Primary outcomes

  1. Local Reactions After Each Vaccination

    Time frame: From baseline to 7 days after each vaccination

    Number of participants with local reactions after each vaccination

  2. Systemic Reaction

    Time frame: From baseline to 7 days after each vaccination

    Number of participants with systemic reactions after each vaccination

Secondary outcomes

  1. Immunogenicity: Number of Participants With a Post-titer Greater Than or Equal to a Fourfold Titer Rise

    Time frame: About 6 months after last dose of vaccine.

    Greater than or equal to a Fourfold titer rise three strains (A/California/7/09/H1N1, A/Perth/16/2009/ H3N2, B/Brisbane/60/2008)

  2. Immunogenicity:Number of Participants With a Pre-titer ≥1:40

    Time frame: About 6 months after last dose of vaccine.

    Pre-titer ≥1:40 for three strains (A/California/7/09/H1N1, A/Perth/16/2009/ H3N2, B/Brisbane/60/2008)

  3. Immunogenicity: Number of Participants With a Post-titer ≥1:40

    Time frame: About 6 months after last dose of vaccine.

    Post-titer ≥1:40 for three strains (A/California/7/09/H1N1, A/Perth/16/2009/ H3N2, B/Brisbane/60/2008)

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

    Time frame: baseline

    Geometric mean titers pre-vaccine (A/California/7/09/H1N1, A/Perth/16/2009/ H3N2, B/Brisbane/60/2008)

  5. Immunogenicity: Geometric Mean Titers Post-vaccine in Study Participants

    Time frame: About 6 months after last dose of vaccine.

    Geometric mean titers post-vaccine (A/California/7/09/H1N1, A/Perth/16/2009/ H3N2, B/Brisbane/60/2008)

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Oct 7, 2010
Registry last updated
May 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.