Solid Organ Transplant Recipient (Liver, Kidney, Heart), Rheumatologic Disorder, Human Immunodeficiency Virus (HIV), Bone Marrow Transplant (BMT), Dialysis
Conditions
Brief summary
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.
Interventions
BIOLOGICALFluzone High Dose
A single-dose of high-dose influenza vaccine will be administered to subjects randomized to this arm
BIOLOGICALFluzone
A single-dose of standard-dose influenza vaccine will be administered to subjects randomized to this arm
Sponsors
Colorado Clinical & Translational Sciences Institute
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
5 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥ 5 years and ≤ 35 years * Receiving influenza vaccination in Children's Hospital Colorado (CHC) clinic as part of routine clinical care * Only supposed to receive one dose of influenza vaccine * Rheumatology patients: must be on some type of immunosuppressive or immunomodulatory medication at the time of immunization and considered at least moderately immunosuppressed in the opinion of the primary rheumatologist. Basic guidelines for rheumatology patients: (1) Any patient receiving monoclonal antibody therapy (i.e., infliximab, etanercept, tocilizumab, anakinra) must also be taking another immunosuppressive/immunomodulatory medication; (2) Patients taking steroids as monotherapy must be on a dose of ≥ 2mg/kg/day OR ≥ 20mg/day; (3) Patients on combination therapy where the dose of a single drug may not be very high, but the combination is considered moderately or severely immunosuppressive will be eligible. * Bone Marrow Transplant patients: all patients in clinic eligible * Oncology patients: must be on some type of chemotherapy * Hemodialysis patients: must be on dialysis * Child Health Immunodeficiency Program (CHIP) patients: must have a known diagnosis of HIV * Solid Organ Transplant patients: post-transplant, influenza vaccine recommended by primary transplant physician
Exclusion criteria
* Rheumatology patients: if receiving any of the monoclonal antibodies, etanercept, infliximab, adalimumab, tocilizumab, atlizumab, or anakinra, must also be taking at least one other immunosuppressive/immunomodulatory medication * Unable to come for scheduled follow-up appointments * History of anaphylaxis reaction to influenza vaccination in the past * Severe allergic reaction to any component of the vaccine, including egg protein, or after previous dose of any influenza vaccine * History of Guillain-Barre syndrome ever in the past in the subject or in a parent or a sibling of the subject * Allergy to latex * Intravenous immuneglobulin (IVIG) within in 4 weeks preceding any blood draw * Receiving an investigational agent as part of another study or other medical treatment (investigational = not-FDA approved for any indication) * Subject not enrolled in other studies that prohibit him/her from enrolling in this study * Blood draw contraindicated * Pregnancy * Breastfeeding * Received a polysaccharide vaccine (pneumovax) w/in 3 weeks of the vaccination * Absolute neutrophil count (ANC) \< 500/uL at the time of vaccination or could potentially have ANC 500/uL during the 5 days after vaccination * Platelet count \< 50,000/uL at the time of vaccination * If a subject has a temperature ≥ 100.4°F at the time of enrollment, then the subject must choose to not enroll or delay immunization until afebrile. * Receiving influenza vaccination past December 15 of influenza season.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Seroprotected at Timepoint 2 in High Dose and Standard Dose Vaccination Groups | blood draw at 10-45 days post-vaccination | 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.. |
| Number of Episodes of Influenza and Influenza-Like-Illness Reported in High Dose and Standard Dose Vaccination Groups | up to 10 months after vaccination | 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). \[Centers for Disease Control (CDC) definition of ILI: Fever ≥ 100°F AND cough or sore throat in the absence of another known cause other than influenza for the illness.\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Seroconversion From T1 to T2 in the High Dose and Standard Dose Vaccine Groups | 10-45 days post-vaccination | 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. |
| Change in Disease Status From Vaccination Through June of the Following Year | up to 9 months post-vaccination | 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. |
| Number of Adverse Events Considered Definitely or Possibly Related to Vaccination Through Sept 30 of the Year Following Vaccination. | (1) Date of vaccine through day 30 post-vaccine; (2) Day 31 post-vaccine through September 30 of the year following vaccine | 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. |
| Number of Participants Seroprotected at Timepoint 3 in High Dose and Standard Dose Vaccination Groups | at least 5 months post vaccination | 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 Adverse Events Definitely or Possibly Related to Vaccination Reported Within 14 Days of Vaccination | 0-14 days after 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Additional Measures of Immunogenicity in High Dose and Standard Dose Vaccinations | 10-45 days post-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). |
| Numbers of Subjects Who Were Both Seroprotected and Who Seroconverted at T2 and T3 After Vaccination | (1) T2 measured 14-45 days post-vaccination; (2) T3 measured June 1-Sept 30 post-vaccination (end-of season), following vaccination | 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 |
Countries
United States
Participant flow
Recruitment details
Study subjects were recruited over two influenza seasons, 2013-2014 and 2014-2015. Subjects were recruited from the Dialysis unit and Rheumatology clinic in 2013-2014 by referral from clinicians. Subjects were recruited by mailed letter to Solid Organ Transplant recipients in 2014-2015.
Pre-assignment details
In 2013-2014, 4 subjects chose not to enroll after learning more about the study. In 2014-2015, 2 subjects chose not to enroll after learning about the study. All potential subjects met pre-screening criteria. No subjects were excluded from the study by study personnel.
Participants by arm
| Arm | Count |
|---|---|
| Fluzone High Dose Fluzone High Dose 0.5 mL intramuscularly (IM) given once
Fluzone High Dose: A single-dose of high-dose influenza vaccine will be administered to subjects randomized to this arm | 7 |
| Fluzone Standard Dose Fluzone 0.5mL IM given once
Fluzone: A single-dose of standard-dose influenza vaccine will be administered to subjects randomized to this arm | 9 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Timepoint 3 (T3): 3rd Blood Draw | Lost to Follow-up | 3 | 4 |
Baseline characteristics
| Characteristic | Total | Fluzone Standard Dose | Fluzone High Dose |
|---|---|---|---|
| Age, Continuous | 15 years | 15 years | 15 years |
| Cohort Dialysis | 7 Participants | 4 Participants | 3 Participants |
| Cohort Rheumatoloty | 1 Participants | 1 Participants | 0 Participants |
| Cohort Solid organ transplant | 8 Participants | 4 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 4 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 5 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 14 Participants | 8 Participants | 6 Participants |
| Sex: Female, Male Female | 10 Participants | 5 Participants | 5 Participants |
| Sex: Female, Male Male | 6 Participants | 4 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 9 |
| other Total, other adverse events | 6 / 7 | 7 / 9 |
| serious Total, serious adverse events | 1 / 7 | 1 / 9 |
Outcome results
Primary
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
Population: 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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluzone High Dose | Number of Episodes of Influenza and Influenza-Like-Illness Reported in High Dose and Standard Dose Vaccination Groups | Row 1: Number of Influenza diagnosed by PCR | 1 episodes of illness |
| Fluzone High Dose | Number of Episodes of Influenza and Influenza-Like-Illness Reported in High Dose and Standard Dose Vaccination Groups | Row 2: # of Influenza diagnosis by non-PCR test | 0 episodes of illness |
| Fluzone High Dose | Number of Episodes of Influenza and Influenza-Like-Illness Reported in High Dose and Standard Dose Vaccination Groups | Row 3: Number of Influenza-like-illness | 2 episodes of illness |
| Fluzone Standard Dose | Number of Episodes of Influenza and Influenza-Like-Illness Reported in High Dose and Standard Dose Vaccination Groups | Row 1: Number of Influenza diagnosed by PCR | 1 episodes of illness |
| Fluzone Standard Dose | Number of Episodes of Influenza and Influenza-Like-Illness Reported in High Dose and Standard Dose Vaccination Groups | Row 2: # of Influenza diagnosis by non-PCR test | 0 episodes of illness |
| Fluzone Standard Dose | Number of Episodes of Influenza and Influenza-Like-Illness Reported in High Dose and Standard Dose Vaccination Groups | Row 3: Number of Influenza-like-illness | 8 episodes of illness |
Primary
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
Population: 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).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluzone High Dose | Number of Subjects Seroprotected at Timepoint 2 in High Dose and Standard Dose Vaccination Groups | H1N1 | 7 Participants |
| Fluzone High Dose | Number of Subjects Seroprotected at Timepoint 2 in High Dose and Standard Dose Vaccination Groups | H3N2 | 7 Participants |
| Fluzone High Dose | Number of Subjects Seroprotected at Timepoint 2 in High Dose and Standard Dose Vaccination Groups | B (Yamagata) | 7 Participants |
| Fluzone Standard Dose | Number of Subjects Seroprotected at Timepoint 2 in High Dose and Standard Dose Vaccination Groups | H1N1 | 7 Participants |
| Fluzone Standard Dose | Number of Subjects Seroprotected at Timepoint 2 in High Dose and Standard Dose Vaccination Groups | H3N2 | 9 Participants |
| Fluzone Standard Dose | Number of Subjects Seroprotected at Timepoint 2 in High Dose and Standard Dose Vaccination Groups | B (Yamagata) | 8 Participants |
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluzone High Dose | Change in Disease Status From Vaccination Through June of the Following Year | Same or better | 5 Participants |
| Fluzone High Dose | Change in Disease Status From Vaccination Through June of the Following Year | Worse | 1 Participants |
| Fluzone Standard Dose | Change in Disease Status From Vaccination Through June of the Following Year | Same or better | 9 Participants |
| Fluzone Standard Dose | Change in Disease Status From Vaccination Through June of the Following Year | Worse | 0 Participants |
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluzone High Dose | Number of Adverse Events Considered Definitely or Possibly Related to Vaccination Through Sept 30 of the Year Following Vaccination. | Day 0 (vaccination) through day 30 | 10 number of AEs reported |
| Fluzone High Dose | Number of Adverse Events Considered Definitely or Possibly Related to Vaccination Through Sept 30 of the Year Following Vaccination. | Day 31 post-vaccination, through Sept 30 | 0 number of AEs reported |
| Fluzone Standard Dose | Number of Adverse Events Considered Definitely or Possibly Related to Vaccination Through Sept 30 of the Year Following Vaccination. | Day 0 (vaccination) through day 30 | 9 number of AEs reported |
| Fluzone Standard Dose | Number of Adverse Events Considered Definitely or Possibly Related to Vaccination Through Sept 30 of the Year Following Vaccination. | Day 31 post-vaccination, through Sept 30 | 0 number of AEs reported |
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluzone High Dose | Number of Adverse Events Definitely or Possibly Related to Vaccination Reported Within 14 Days of Vaccination | Other AEs - Grade 1 | 2 number of AEs reported |
| Fluzone High Dose | Number of Adverse Events Definitely or Possibly Related to Vaccination Reported Within 14 Days of Vaccination | Local site reaction - grade 1 | 7 number of AEs reported |
| Fluzone High Dose | Number of Adverse Events Definitely or Possibly Related to Vaccination Reported Within 14 Days of Vaccination | Local site reaction - grade 2 | 1 number of AEs reported |
| Fluzone Standard Dose | Number of Adverse Events Definitely or Possibly Related to Vaccination Reported Within 14 Days of Vaccination | Local site reaction - grade 1 | 8 number of AEs reported |
| Fluzone Standard Dose | Number of Adverse Events Definitely or Possibly Related to Vaccination Reported Within 14 Days of Vaccination | Local site reaction - grade 2 | 0 number of AEs reported |
| Fluzone Standard Dose | Number of Adverse Events Definitely or Possibly Related to Vaccination Reported Within 14 Days of Vaccination | Other AEs - Grade 1 | 1 number of AEs reported |
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluzone High Dose | Number of Participants Seroprotected at Timepoint 3 in High Dose and Standard Dose Vaccination Groups | H1N1 | 4 Participants |
| Fluzone High Dose | Number of Participants Seroprotected at Timepoint 3 in High Dose and Standard Dose Vaccination Groups | H3N2 | 4 Participants |
| Fluzone High Dose | Number of Participants Seroprotected at Timepoint 3 in High Dose and Standard Dose Vaccination Groups | B (Yamagata) | 4 Participants |
| Fluzone Standard Dose | Number of Participants Seroprotected at Timepoint 3 in High Dose and Standard Dose Vaccination Groups | H1N1 | 4 Participants |
| Fluzone Standard Dose | Number of Participants Seroprotected at Timepoint 3 in High Dose and Standard Dose Vaccination Groups | H3N2 | 5 Participants |
| Fluzone Standard Dose | Number of Participants Seroprotected at Timepoint 3 in High Dose and Standard Dose Vaccination Groups | B (Yamagata) | 5 Participants |
Secondary
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.
Time frame: 10-45 days post-vaccination
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluzone High Dose | Number of Subjects With Seroconversion From T1 to T2 in the High Dose and Standard Dose Vaccine Groups | H1N1 | 3 Participants |
| Fluzone High Dose | Number of Subjects With Seroconversion From T1 to T2 in the High Dose and Standard Dose Vaccine Groups | H3N2 | 5 Participants |
| Fluzone High Dose | Number of Subjects With Seroconversion From T1 to T2 in the High Dose and Standard Dose Vaccine Groups | B (Yamagata) | 3 Participants |
| Fluzone Standard Dose | Number of Subjects With Seroconversion From T1 to T2 in the High Dose and Standard Dose Vaccine Groups | H1N1 | 1 Participants |
| Fluzone Standard Dose | Number of Subjects With Seroconversion From T1 to T2 in the High Dose and Standard Dose Vaccine Groups | H3N2 | 5 Participants |
| Fluzone Standard Dose | Number of Subjects With Seroconversion From T1 to T2 in the High Dose and Standard Dose Vaccine Groups | B (Yamagata) | 3 Participants |
Other Pre-specified
Additional Measures of Immunogenicity in High Dose and Standard Dose Vaccinations
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).
Time frame: 10-45 days post-vaccination
Other Pre-specified
Numbers of Subjects Who Were Both Seroprotected and Who Seroconverted at T2 and T3 After Vaccination
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
Time frame: (1) T2 measured 14-45 days post-vaccination; (2) T3 measured June 1-Sept 30 post-vaccination (end-of season), following vaccination
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluzone High Dose | Numbers of Subjects Who Were Both Seroprotected and Who Seroconverted at T2 and T3 After Vaccination | T2 - H1N1 | 3 Participants |
| Fluzone High Dose | Numbers of Subjects Who Were Both Seroprotected and Who Seroconverted at T2 and T3 After Vaccination | T2 - H3N2 | 5 Participants |
| Fluzone High Dose | Numbers of Subjects Who Were Both Seroprotected and Who Seroconverted at T2 and T3 After Vaccination | T2 - B (Yamagata) | 3 Participants |
| Fluzone High Dose | Numbers of Subjects Who Were Both Seroprotected and Who Seroconverted at T2 and T3 After Vaccination | T3 - H1N1 | 1 Participants |
| Fluzone High Dose | Numbers of Subjects Who Were Both Seroprotected and Who Seroconverted at T2 and T3 After Vaccination | T3 - H3N2 | 0 Participants |
| Fluzone High Dose | Numbers of Subjects Who Were Both Seroprotected and Who Seroconverted at T2 and T3 After Vaccination | T3 - B (Yamagata) | 1 Participants |
| Fluzone Standard Dose | Numbers of Subjects Who Were Both Seroprotected and Who Seroconverted at T2 and T3 After Vaccination | T3 - H3N2 | 1 Participants |
| Fluzone Standard Dose | Numbers of Subjects Who Were Both Seroprotected and Who Seroconverted at T2 and T3 After Vaccination | T2 - H1N1 | 1 Participants |
| Fluzone Standard Dose | Numbers of Subjects Who Were Both Seroprotected and Who Seroconverted at T2 and T3 After Vaccination | T3 - H1N1 | 0 Participants |
| Fluzone Standard Dose | Numbers of Subjects Who Were Both Seroprotected and Who Seroconverted at T2 and T3 After Vaccination | T2 - H3N2 | 5 Participants |
| Fluzone Standard Dose | Numbers of Subjects Who Were Both Seroprotected and Who Seroconverted at T2 and T3 After Vaccination | T3 - B (Yamagata) | 0 Participants |
| Fluzone Standard Dose | Numbers of Subjects Who Were Both Seroprotected and Who Seroconverted at T2 and T3 After Vaccination | T2 - B (Yamagata) | 3 Participants |