The purpose of this study is to determine whether Fluzone High Dose increases the immune response to the influenza antigens contained in the vaccine compared to standard-dose Fluzone in immunocompromised children and young adults. Safety and efficacy data will also be collected.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
16
A single-dose of high-dose influenza vaccine will be administered to subjects randomized to this arm
A single-dose of standard-dose influenza vaccine will be administered to subjects randomized to this arm
Children's Hospital Colorado
Aurora, Colorado, United States
Number of Episodes of Influenza and Influenza-Like-Illness Reported in High Dose and Standard Dose Vaccination Groups
Gathered data on influenza and influenza-like-illness during the influenza season for which the subject was vaccinated. Reported numbers of episodes of PCR-diagnosed influenza and rates of reported Influenza-Like-Illness (ILI) from Questionnaire #2 and also that were obtained from medical records. Data were categorized by the following: 1. Polymerase chain reaction (PCR)-proven diagnosis of influenza performed at Children's Hospital Colorado (CHC) 2. Diagnosis of influenza by non-PCR rapid-influenza test 3. Diagnosis of ILI (from questionnaire #2). \[Centers for Disease Control (CDC) definition of ILI: Fever ≥ 100°F AND cough or sore throat in the absence of another known cause other than influenza for the illness.\]
Time frame: up to 10 months after vaccination
Number of Subjects Seroprotected at Timepoint 2 in High Dose and Standard Dose Vaccination Groups
Measure hemagglutinin inhibition (HAI) on blood samples #2 for all subjects, which is the sample drawn at the "peak" of the immune response. Compare number of subjects who are seroprotected (reaching HAI ≥ 1:40) between the high-dose and standard-dose recipients..
Time frame: blood draw at 10-45 days post-vaccination
Number of Adverse Events Definitely or Possibly Related to Vaccination Reported Within 14 Days of Vaccination
Number of adverse events reported within the 14 days after vaccination by each subject within each patient group. Data collected from that reported in safety questionnaires and in Safety Diary that spanned the 14 days post-vaccination.
Time frame: 0-14 days after vaccination
Number of Subjects With Seroconversion From T1 to T2 in the High Dose and Standard Dose Vaccine Groups
HAI was measured on blood samples #1 and #2 for all subjects. Seroconversion is defined as a four-fold increase in antibody level between the high-dose and standard-dose recipients within each patient group was performed.
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Time frame: 10-45 days post-vaccination
Number of Participants Seroprotected at Timepoint 3 in High Dose and Standard Dose Vaccination Groups
Measure HAI on blood sample #3, drawn May-September following vaccination. Report number who still have HAI ≥ 1:40 in the high-dose and standard-dose groups.
Time frame: at least 5 months post vaccination
Change in Disease Status From Vaccination Through June of the Following Year
Evaluate disease status changes reported by subject on Questionnaire #2 as well as changes reported in clinic notes over the course of the influenza season. Subjects considered "worse" had worsening function of transplanted organ or complications related to underlying condition (e.g. dialysis) or new diagnosis of disease considered serious by PI.
Time frame: up to 9 months post-vaccination
Number of Adverse Events Considered Definitely or Possibly Related to Vaccination Through Sept 30 of the Year Following Vaccination.
Data gathered from the following 1. Safety data in 1st 14 days (safety surveys and safety diary) 2. Safety survey at day 30-45 regarding any unplanned health care visit or other AE during the 30 days after vaccine 3. On-going passive surveillance of adverse events (AEs)/serious adverse events (SAEs) throughout course of influenza season of enrollment 4. Chart review of each participant by PI through Sept 30 of the year following vaccine Data collection stopped in September following enrollment.
Time frame: (1) Date of vaccine through day 30 post-vaccine; (2) Day 31 post-vaccine through September 30 of the year following vaccine