Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2025-12-24 @ 9:12 PM
NCT ID:
NCT01525004
Brief 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.
Study:
NCT01525004
Study Brief:
Protocol Section:
NCT01525004