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.]

Row 1: Number of influenza episodes diagnosed by PCR Row 2: Number of influenza episodes diagnosed by non-PCR rapid test Row 3: Number of influenza-like-illness (ILI) episodes reported by participants from the time of vaccination through June of the following year (end of flu season).

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..

All participants had blood drawn before vaccination and at timepoint 2. The influenza vaccine had the same subtypes during the two season. Data were analyzed for the 3 subtypes contained in the trivalent vaccine, H1N1, H3N2, B (Yamagata).

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.

All adverse events that may have been related are included in this analysis. Events considered not-related were excluded. More information on these AEs is included in the Adverse Events section. All AEs were reviewed by the study DSMB.

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.

All participants had blood drawn at baseline (T1) and 10-45 days after vaccination (T2). Analysis was done for the 3 influenza subtypes in the trivalent influenza vaccine. The influenza vaccine was the same in 2013-2014 and 2014-2015.

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.

Number of subjects seroprotected at T3 for each of the vaccine subtypes. 3 subjects in the HD group and 4 subjects in the SD group were lost-to-follow-up by T3 and not included in this analysis.

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.

One subject in the high-dose group was originally on dialysis, but received a kidney transplant during the follow-up period. This subject was excluded from the analysis on change in baseline medical condition.

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.

Data used included: active reporting through day 30, survey at end of season, and chart review for data through Sept 30 of the year following vaccination.

This secondary objective was included as exploratory and we plan to add additional analyses when funding is secured. There is no anticipated date when we will have this completed. (No immunogenicity studies have been done besides HAI.) For other immunogenicity: would compare results of blood draw #1 and #2 between the high-dose and standard-dose recipients for each patient group for any of the following: antibody avidity, microneutralization, T-cell interferon, T-cell IL-2, B-cell Immunoglobulin G (IgG) and B-cell Immunoglobulin A (IgA).

Seroprotection (HAI>=1:40) and seroconversion (4-fold increase) together have been found to be a better predictor of vaccine effectiveness. Patients had to have both a 4-fold rise in HAI and have HAI>=40 to be counted

For T3, only 4 participants in the high-dose group and 5 participants in the standard-dose group were analyzed due to loss-to-follow-up.