NCT01525004

Standard Dose Versus High-Dose Inactivated Flu Vaccine in Pediatric Solid Organ Transplant Patients

Randomized, Double Blind, Comparison of Standard Dose Trivalent Inactivated Influenza Vaccine in Pediatric Solid Organ Transplant Patients

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Vanderbilt University · Academic / Other
• Sex: All
• Age: 3 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

This is a phase I trial in which the both the safety and immunogenicity of the standard dose flu vaccine will be compared with high dose flu vaccine in children that have undergone solid organ transplantation (SOT).

Detailed description

A prospective, randomized, double-blind phase 1 safety and immunogenicity study of the HD compared with the SD TIV in pediatric patients between the ages of three and 17 yr that have undergone SOT (Clin-Trials.gov. NCT01525004) was conducted. Subjects were randomized in a 2:1 fashion to receive 0.5 mL of either the HD (60 μg) or SD (15 μg) TIV intramuscularly. Subjects \<9 yr of age received either one or two doses of the vaccine based on ACIP recommendations \[19\]. The study was approved by Institutional Review Boards at both institutions (Vanderbilt University, Nashville, TN, and the University of Pittsburgh, Pittsburgh, PA) and conducted during the 2011-2012 influenza season. Subjects were randomly allocated to either the HD or SD group by a computer-generated allocation system. Participants, their families, and research staff who performed clinical evaluations remained blinded to the child's assigned dosage, while designated unblinded nurses administered the requisite vaccine.

Conditions

• Pediatric Solid Organ Transplant Patients

Interventions

Type	Name	Description
DRUG	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.
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

Timeline

• Start date: 2011-09-01
• Primary completion: 2012-06-01
• Completion: 2012-12-01
• First posted: 2012-02-02
• Last updated: 2016-08-16

Locations

1 site across 1 country: United States