Immune Response, Influenza, Human
Conditions
Brief summary
The purpose of this study is to evaluate immunologic response to different types of influenza vaccine among children/adolescents/young adults 4-21 years of age. This is a randomized controlled trial (RCT), that will assess immune response in about 440 participants (about 220 per vaccine arm) pre- and post-vaccination to FluMist (live attenuated influenza vaccine given by nasal administration) and Flucelvax (egg-free cell-culture inactivated influenza vaccine).
Detailed description
This is a non-blinded, randomized controlled trial analyzing influenza vaccine immunogenicity response in children/adolescents/young adults aged 4-21 years given one of two FDA approved and licensed influenza vaccines: FluMist (live attenuated influenza vaccine by nasal administration) and Flucelvax (egg-free cell-culture inactivated influenza vaccine). This study will enroll about 440 healthy participants, about 220 per vaccine arm. Participants will be randomized in blocks of 4 using a 1:1 allocation to receive either FluMist or Flucelvax. Blood work will be conducted on all participants at baseline prior to vaccine receipt and post-vaccination at Day 7 (range 6-9 days) and Day 28 (range 21-35 days). The primary objective of the study is to determine pre- and post-serologic responses to each vaccine type.
Interventions
BIOLOGICALFluMist live attenuated influenza vaccine
Participants randomized to this study influenza vaccine arm will receive FluMist live attenuated influenza vaccine at baseline after the baseline blood draw is complete.
BIOLOGICALFlucelvax inactivated influenza vaccine
Participants randomized to this study influenza vaccine arm will receive Flucelvax cell-culture inactivated influenza vaccine at baseline after the baseline blood draw is complete.
Sponsors
Centers for Disease Control and Prevention
Richard Zimmerman MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 21 Years
Healthy volunteers
Yes
Inclusion criteria
* aged 4-21 years; * has prior vaccination history available (which can be determined based either on medical record review or through state registry review); * plans to receive the current seasonal influenza vaccination at one of the recruiting sites
Exclusion criteria
* unable or unwilling to completed required study activities, including informed consent, randomization to vaccine, and bloodwork; * has already received influenza vaccine for the current season; * has a known immunocompromising condition or is on an immunosuppressing medication (e.g., high dose steroids \>10 days); * is known to be pregnant; * has a history of severe allergy to eggs or to influenza vaccine or any of its components
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Seroconversion Response In 2020 | Post-vaccination (at Day 28 timepoint) | Rows in data tables represent different influenza antigens measured in 2020. Hemagglutination inhibition (HI) assay was conducted to assess immunologic outcome. Seroconversion is defined as a 4-fold or higher rise in HI titer post-vaccination given a pre-vaccination HI titer of \>=10 and a final HI titer of \>=40. |
| Number of Participants With Seroconversion Response In 2019 | Post-vaccination (at Day 28 timepoint) | Rows in data tables represent different influenza antigens measured in 2019. Hemagglutination inhibition (HI) assay was conducted to assess immunologic outcome. Seroconversion is defined as a 4-fold or higher rise in HI titer post-vaccination given a pre-vaccination HI titer of \>=10 and a final HI titer of \>=40. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Seroprotection Response in 2019 | Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 28 timepoint) | Rows in data tables represent different influenza antigens measured in 2019. Hemagglutination inhibition (HI) assay was conducted to assess immunologic outcome. Seroprotection is defined as a HI titer \>= 1:110 at either time point. |
| Geometric Mean Titers (GMTs) at Each Time Point 2019 | Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 28 timepoint) | Rows in data tables represent different influenza antigens measured in 2019. Hemagglutination inhibition assay was conducted to assess immunologic outcome. GMTs is defined as the anti-log of the mean of the log2 HI titers |
| Number of Participants With Seroprotection Response in 2020 | Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 28 timepoint) | Rows in data tables represent different influenza antigens measured in 2020. Hemagglutination inhibition (HI) assay was conducted to assess immunologic outcome. Seroprotection is defined as a HI titer \>= 1:110 at either time point. |
| Geometric Mean Titers (GMTs) at Each Time Point 2020 | Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 28 timepoint) | Rows in data tables represent different influenza antigens measured in 2020. Hemagglutination inhibition assay will be conducted to assess immunologic outcome. GMTs is defined as the anti-log of the mean of the log2 HI titers |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| FluMist Live Attenuated Influenza Vaccine 2019 Participants receiving live attenuated FluMist influenza vaccine will receive 0.2 mL given intranasally
FluMist live attenuated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive FluMist live attenuated influenza vaccine at baseline after the baseline blood draw is complete. | 108 |
| Flucelvax Inactivated Influenza Vaccine 2019 Participants receiving inactivated Flucelvax influenza vaccine will receive 0.5 mL given intramuscularly
Flucelvax inactivated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive Flucelvax cell-culture inactivated influenza vaccine at baseline after the baseline blood draw is complete. | 110 |
| FluMist Live Attenuated Influenza Vaccine 2020 Participants receiving live attenuated FluMist influenza vaccine will receive 0.2 mL given intranasally
FluMist live attenuated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive FluMist live attenuated influenza vaccine at baseline after the baseline blood draw is complete. | 127 |
| Flucelvax Inactivated Influenza Vaccine 2020 Participants receiving inactivated Flucelvax influenza vaccine will receive 0.5 mL given intramuscularly
Flucelvax inactivated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive Flucelvax cell-culture inactivated influenza vaccine at baseline after the baseline blood draw is complete. | 120 |
| Total | 465 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 5 | 3 | 5 |
| Overall Study | Physician Decision | 0 | 1 | 0 | 0 |
| Overall Study | Specimen loss | 3 | 3 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 1 | 5 | 2 |
Baseline characteristics
| Characteristic | FluMist Live Attenuated Influenza Vaccine 2019 | Flucelvax Inactivated Influenza Vaccine 2019 | FluMist Live Attenuated Influenza Vaccine 2020 | Flucelvax Inactivated Influenza Vaccine 2020 | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 47 Participants | 56 Participants | 76 Participants | 74 Participants | 253 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 61 Participants | 54 Participants | 51 Participants | 46 Participants | 212 Participants |
| Age, Continuous | 16.8 years STANDARD_DEVIATION 4.6 | 16.6 years STANDARD_DEVIATION 4.2 | 15.6 years STANDARD_DEVIATION 5 | 15.1 years STANDARD_DEVIATION 5.2 | 16.0 years STANDARD_DEVIATION 4.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 6 Participants | 6 Participants | 4 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 99 Participants | 104 Participants | 120 Participants | 116 Participants | 439 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 7 Participants | 4 Participants | 5 Participants | 22 Participants |
| Race (NIH/OMB) Black or African American | 43 Participants | 41 Participants | 33 Participants | 21 Participants | 138 Participants |
| Race (NIH/OMB) More than one race | 10 Participants | 9 Participants | 6 Participants | 9 Participants | 34 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 2 Participants | 4 Participants | 1 Participants | 11 Participants |
| Race (NIH/OMB) White | 45 Participants | 51 Participants | 79 Participants | 84 Participants | 259 Participants |
| Region of Enrollment United States | 108 participants | 110 participants | 127 participants | 120 participants | 465 participants |
| Sex: Female, Male Female | 67 Participants | 71 Participants | 57 Participants | 59 Participants | 254 Participants |
| Sex: Female, Male Male | 41 Participants | 39 Participants | 70 Participants | 61 Participants | 211 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 235 | 0 / 230 |
| other Total, other adverse events | 0 / 235 | 0 / 230 |
| serious Total, serious adverse events | 0 / 235 | 0 / 230 |
Outcome results
Primary
Number of Participants With Seroconversion Response In 2019
Rows in data tables represent different influenza antigens measured in 2019. Hemagglutination inhibition (HI) assay was conducted to assess immunologic outcome. Seroconversion is defined as a 4-fold or higher rise in HI titer post-vaccination given a pre-vaccination HI titer of \>=10 and a final HI titer of \>=40.
Time frame: Post-vaccination (at Day 28 timepoint)
Population: 2019 Participants
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| FluMist Live Attenuated Influenza Vaccine 2019 | Number of Participants With Seroconversion Response In 2019 | A/H3N2-A/Kansas egg grown virus | 11 Participants |
| FluMist Live Attenuated Influenza Vaccine 2019 | Number of Participants With Seroconversion Response In 2019 | B/Victoria-B/Colorado | 9 Participants |
| FluMist Live Attenuated Influenza Vaccine 2019 | Number of Participants With Seroconversion Response In 2019 | A/H3N2-A/Kansas cell grown virus | 8 Participants |
| FluMist Live Attenuated Influenza Vaccine 2019 | Number of Participants With Seroconversion Response In 2019 | B/Yamagata-B/Phuket | 4 Participants |
| FluMist Live Attenuated Influenza Vaccine 2019 | Number of Participants With Seroconversion Response In 2019 | A/H1N1-A/Brisbane | 5 Participants |
| Flucelvax Inactivated Influenza Vaccine 2019 | Number of Participants With Seroconversion Response In 2019 | B/Yamagata-B/Phuket | 29 Participants |
| Flucelvax Inactivated Influenza Vaccine 2019 | Number of Participants With Seroconversion Response In 2019 | A/H1N1-A/Brisbane | 33 Participants |
| Flucelvax Inactivated Influenza Vaccine 2019 | Number of Participants With Seroconversion Response In 2019 | A/H3N2-A/Kansas egg grown virus | 44 Participants |
| Flucelvax Inactivated Influenza Vaccine 2019 | Number of Participants With Seroconversion Response In 2019 | A/H3N2-A/Kansas cell grown virus | 47 Participants |
| Flucelvax Inactivated Influenza Vaccine 2019 | Number of Participants With Seroconversion Response In 2019 | B/Victoria-B/Colorado | 28 Participants |
p-value: <0.001Chi-squared
Primary
Number of Participants With Seroconversion Response In 2020
Rows in data tables represent different influenza antigens measured in 2020. Hemagglutination inhibition (HI) assay was conducted to assess immunologic outcome. Seroconversion is defined as a 4-fold or higher rise in HI titer post-vaccination given a pre-vaccination HI titer of \>=10 and a final HI titer of \>=40.
Time frame: Post-vaccination (at Day 28 timepoint)
Population: 2020 Participants
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| FluMist Live Attenuated Influenza Vaccine 2019 | Number of Participants With Seroconversion Response In 2020 | A/H1N1-A/Hawaii66 egg based antigen | 8 Participants |
| FluMist Live Attenuated Influenza Vaccine 2019 | Number of Participants With Seroconversion Response In 2020 | A/H1N1-A/Hawaii70 cell based antigen | 10 Participants |
| FluMist Live Attenuated Influenza Vaccine 2019 | Number of Participants With Seroconversion Response In 2020 | A/H1N1-A/Delaware | 2 Participants |
| FluMist Live Attenuated Influenza Vaccine 2019 | Number of Participants With Seroconversion Response In 2020 | A/H3N2-A/Hong Kong | 14 Participants |
| FluMist Live Attenuated Influenza Vaccine 2019 | Number of Participants With Seroconversion Response In 2020 | B/Victoria-B/Washington | 13 Participants |
| FluMist Live Attenuated Influenza Vaccine 2019 | Number of Participants With Seroconversion Response In 2020 | B/Yamagata-B/Phuket | 11 Participants |
| Flucelvax Inactivated Influenza Vaccine 2019 | Number of Participants With Seroconversion Response In 2020 | B/Victoria-B/Washington | 36 Participants |
| Flucelvax Inactivated Influenza Vaccine 2019 | Number of Participants With Seroconversion Response In 2020 | A/H1N1-A/Hawaii66 egg based antigen | 59 Participants |
| Flucelvax Inactivated Influenza Vaccine 2019 | Number of Participants With Seroconversion Response In 2020 | A/H3N2-A/Hong Kong | 48 Participants |
| Flucelvax Inactivated Influenza Vaccine 2019 | Number of Participants With Seroconversion Response In 2020 | A/H1N1-A/Hawaii70 cell based antigen | 58 Participants |
| Flucelvax Inactivated Influenza Vaccine 2019 | Number of Participants With Seroconversion Response In 2020 | B/Yamagata-B/Phuket | 32 Participants |
| Flucelvax Inactivated Influenza Vaccine 2019 | Number of Participants With Seroconversion Response In 2020 | A/H1N1-A/Delaware | 38 Participants |
p-value: <0.001Chi-squared
Secondary
Geometric Mean Titers (GMTs) at Each Time Point 2019
Rows in data tables represent different influenza antigens measured in 2019. Hemagglutination inhibition assay was conducted to assess immunologic outcome. GMTs is defined as the anti-log of the mean of the log2 HI titers
Time frame: Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 28 timepoint)
Population: 2019 Participants
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| FluMist Live Attenuated Influenza Vaccine 2019 | Geometric Mean Titers (GMTs) at Each Time Point 2019 | A/H1N1-A/Brisbane: Day 0 | 94 titer |
| FluMist Live Attenuated Influenza Vaccine 2019 | Geometric Mean Titers (GMTs) at Each Time Point 2019 | A/H1N1-A/Brisbane: Day 28 | 108 titer |
| FluMist Live Attenuated Influenza Vaccine 2019 | Geometric Mean Titers (GMTs) at Each Time Point 2019 | A/H3N2-A/Kansas egg grown virus: Day 0 | 75 titer |
| FluMist Live Attenuated Influenza Vaccine 2019 | Geometric Mean Titers (GMTs) at Each Time Point 2019 | A/H3N2-A/Kansas egg grown virus: Day 28 | 96 titer |
| FluMist Live Attenuated Influenza Vaccine 2019 | Geometric Mean Titers (GMTs) at Each Time Point 2019 | A/H3N2-A/Kansas cell grown virus: Day 0 | 50 titer |
| FluMist Live Attenuated Influenza Vaccine 2019 | Geometric Mean Titers (GMTs) at Each Time Point 2019 | A/H3N2-A/Kansas cell grown virus: Day 28 | 63 titer |
| FluMist Live Attenuated Influenza Vaccine 2019 | Geometric Mean Titers (GMTs) at Each Time Point 2019 | B/Victoria-B/Colorado: Day 0 | 65 titer |
| FluMist Live Attenuated Influenza Vaccine 2019 | Geometric Mean Titers (GMTs) at Each Time Point 2019 | B/Victoria-B/Colorado: Day 28 | 78 titer |
| FluMist Live Attenuated Influenza Vaccine 2019 | Geometric Mean Titers (GMTs) at Each Time Point 2019 | B/Yamagata-B/Phuket: Day 0 | 101 titer |
| FluMist Live Attenuated Influenza Vaccine 2019 | Geometric Mean Titers (GMTs) at Each Time Point 2019 | B/Yamagata-B/Phuket: Day 28 | 107 titer |
| Flucelvax Inactivated Influenza Vaccine 2019 | Geometric Mean Titers (GMTs) at Each Time Point 2019 | B/Victoria-B/Colorado: Day 28 | 158 titer |
| Flucelvax Inactivated Influenza Vaccine 2019 | Geometric Mean Titers (GMTs) at Each Time Point 2019 | A/H1N1-A/Brisbane: Day 0 | 90 titer |
| Flucelvax Inactivated Influenza Vaccine 2019 | Geometric Mean Titers (GMTs) at Each Time Point 2019 | A/H3N2-A/Kansas cell grown virus: Day 28 | 136 titer |
| Flucelvax Inactivated Influenza Vaccine 2019 | Geometric Mean Titers (GMTs) at Each Time Point 2019 | A/H1N1-A/Brisbane: Day 28 | 269 titer |
| Flucelvax Inactivated Influenza Vaccine 2019 | Geometric Mean Titers (GMTs) at Each Time Point 2019 | B/Yamagata-B/Phuket: Day 28 | 215 titer |
| Flucelvax Inactivated Influenza Vaccine 2019 | Geometric Mean Titers (GMTs) at Each Time Point 2019 | A/H3N2-A/Kansas egg grown virus: Day 0 | 78 titer |
| Flucelvax Inactivated Influenza Vaccine 2019 | Geometric Mean Titers (GMTs) at Each Time Point 2019 | B/Victoria-B/Colorado: Day 0 | 65 titer |
| Flucelvax Inactivated Influenza Vaccine 2019 | Geometric Mean Titers (GMTs) at Each Time Point 2019 | A/H3N2-A/Kansas egg grown virus: Day 28 | 205 titer |
| Flucelvax Inactivated Influenza Vaccine 2019 | Geometric Mean Titers (GMTs) at Each Time Point 2019 | B/Yamagata-B/Phuket: Day 0 | 89 titer |
| Flucelvax Inactivated Influenza Vaccine 2019 | Geometric Mean Titers (GMTs) at Each Time Point 2019 | A/H3N2-A/Kansas cell grown virus: Day 0 | 46 titer |
p-value: 0.79t-test, 2 sided
p-value: 0.79t-test, 2 sided
p-value: 0.56t-test, 2 sided
p-value: 0.95t-test, 2 sided
p-value: 0.44t-test, 2 sided
p-value: <0.001t-test, 2 sided
Secondary
Geometric Mean Titers (GMTs) at Each Time Point 2020
Rows in data tables represent different influenza antigens measured in 2020. Hemagglutination inhibition assay will be conducted to assess immunologic outcome. GMTs is defined as the anti-log of the mean of the log2 HI titers
Time frame: Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 28 timepoint)
Population: 2020 Participants
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| FluMist Live Attenuated Influenza Vaccine 2019 | Geometric Mean Titers (GMTs) at Each Time Point 2020 | A/H1N1-A/Hawaii66 egg grown virus: Day 0 | 42 titer |
| FluMist Live Attenuated Influenza Vaccine 2019 | Geometric Mean Titers (GMTs) at Each Time Point 2020 | A/H1N1-A/Hawaii66 egg grown virus: Day 28 | 51 titer |
| FluMist Live Attenuated Influenza Vaccine 2019 | Geometric Mean Titers (GMTs) at Each Time Point 2020 | A/H1N1-A/Hawaii70 cell grown virus: Day 0 | 97 titer |
| FluMist Live Attenuated Influenza Vaccine 2019 | Geometric Mean Titers (GMTs) at Each Time Point 2020 | A/H1N1-A/Hawaii70 cell grown virus: Day 28 | 121 titer |
| FluMist Live Attenuated Influenza Vaccine 2019 | Geometric Mean Titers (GMTs) at Each Time Point 2020 | A/H1N1-A/Delaware: Day 0 | 58 titer |
| FluMist Live Attenuated Influenza Vaccine 2019 | Geometric Mean Titers (GMTs) at Each Time Point 2020 | A/H1N1-A/Delaware: Day 28 | 62 titer |
| FluMist Live Attenuated Influenza Vaccine 2019 | Geometric Mean Titers (GMTs) at Each Time Point 2020 | A/H3N2-A/Hong Kong: Day 0 | 174 titer |
| FluMist Live Attenuated Influenza Vaccine 2019 | Geometric Mean Titers (GMTs) at Each Time Point 2020 | A/H3N2-A/Hong Kong: Day 28 | 234 titer |
| FluMist Live Attenuated Influenza Vaccine 2019 | Geometric Mean Titers (GMTs) at Each Time Point 2020 | B/Victoria-B/Washington: Day 0 | 92 titer |
| FluMist Live Attenuated Influenza Vaccine 2019 | Geometric Mean Titers (GMTs) at Each Time Point 2020 | B/Victoria-B/Washington: Day 28 | 116 titer |
| FluMist Live Attenuated Influenza Vaccine 2019 | Geometric Mean Titers (GMTs) at Each Time Point 2020 | B/Yamagata-B/Phuket: Day 0 | 98 titer |
| FluMist Live Attenuated Influenza Vaccine 2019 | Geometric Mean Titers (GMTs) at Each Time Point 2020 | B/Yamagata-B/Phuket: Day 28 | 114 titer |
| Flucelvax Inactivated Influenza Vaccine 2019 | Geometric Mean Titers (GMTs) at Each Time Point 2020 | B/Yamagata-B/Phuket: Day 0 | 87 titer |
| Flucelvax Inactivated Influenza Vaccine 2019 | Geometric Mean Titers (GMTs) at Each Time Point 2020 | A/H1N1-A/Hawaii66 egg grown virus: Day 0 | 34 titer |
| Flucelvax Inactivated Influenza Vaccine 2019 | Geometric Mean Titers (GMTs) at Each Time Point 2020 | A/H3N2-A/Hong Kong: Day 0 | 119 titer |
| Flucelvax Inactivated Influenza Vaccine 2019 | Geometric Mean Titers (GMTs) at Each Time Point 2020 | A/H1N1-A/Hawaii66 egg grown virus: Day 28 | 171 titer |
| Flucelvax Inactivated Influenza Vaccine 2019 | Geometric Mean Titers (GMTs) at Each Time Point 2020 | B/Victoria-B/Washington: Day 28 | 212 titer |
| Flucelvax Inactivated Influenza Vaccine 2019 | Geometric Mean Titers (GMTs) at Each Time Point 2020 | A/H1N1-A/Hawaii70 cell grown virus: Day 0 | 84 titer |
| Flucelvax Inactivated Influenza Vaccine 2019 | Geometric Mean Titers (GMTs) at Each Time Point 2020 | A/H3N2-A/Hong Kong: Day 28 | 370 titer |
| Flucelvax Inactivated Influenza Vaccine 2019 | Geometric Mean Titers (GMTs) at Each Time Point 2020 | A/H1N1-A/Hawaii70 cell grown virus: Day 28 | 380 titer |
| Flucelvax Inactivated Influenza Vaccine 2019 | Geometric Mean Titers (GMTs) at Each Time Point 2020 | B/Yamagata-B/Phuket: Day 28 | 214 titer |
| Flucelvax Inactivated Influenza Vaccine 2019 | Geometric Mean Titers (GMTs) at Each Time Point 2020 | A/H1N1-A/Delaware: Day 0 | 46 titer |
| Flucelvax Inactivated Influenza Vaccine 2019 | Geometric Mean Titers (GMTs) at Each Time Point 2020 | B/Victoria-B/Washington: Day 0 | 88 titer |
| Flucelvax Inactivated Influenza Vaccine 2019 | Geometric Mean Titers (GMTs) at Each Time Point 2020 | A/H1N1-A/Delaware: Day 28 | 120 titer |
p-value: 0.01t-test, 2 sided
p-value: 0.78t-test, 2 sided
p-value: 0.36t-test, 2 sided
p-value: <0.0001t-test, 2 sided
p-value: 0.22t-test, 2 sided
p-value: 0.25t-test, 2 sided
p-value: 0.13t-test, 2 sided
p-value: 0.06t-test, 2 sided
Secondary
Number of Participants With Seroprotection Response in 2019
Rows in data tables represent different influenza antigens measured in 2019. Hemagglutination inhibition (HI) assay was conducted to assess immunologic outcome. Seroprotection is defined as a HI titer \>= 1:110 at either time point.
Time frame: Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 28 timepoint)
Population: 2019 Participants
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| FluMist Live Attenuated Influenza Vaccine 2019 | Number of Participants With Seroprotection Response in 2019 | A/H1N1-A/Birsbane:Day 0 | 54 Participants |
| FluMist Live Attenuated Influenza Vaccine 2019 | Number of Participants With Seroprotection Response in 2019 | A/H1N1-A/Birsbane:Day 28 | 58 Participants |
| FluMist Live Attenuated Influenza Vaccine 2019 | Number of Participants With Seroprotection Response in 2019 | A/H3N2-AKansas egg grown virus: Day 0 | 34 Participants |
| FluMist Live Attenuated Influenza Vaccine 2019 | Number of Participants With Seroprotection Response in 2019 | A/H3N2-AKansas egg grown virus: Day 28 | 41 Participants |
| FluMist Live Attenuated Influenza Vaccine 2019 | Number of Participants With Seroprotection Response in 2019 | A/H3N2-AKansas cell grown virus: Day 0 | 14 Participants |
| FluMist Live Attenuated Influenza Vaccine 2019 | Number of Participants With Seroprotection Response in 2019 | A/H3N2-AKansas cell grown virus: Day 28 | 26 Participants |
| FluMist Live Attenuated Influenza Vaccine 2019 | Number of Participants With Seroprotection Response in 2019 | B/Victoria-B/Colorado: Day 0 | 34 Participants |
| FluMist Live Attenuated Influenza Vaccine 2019 | Number of Participants With Seroprotection Response in 2019 | B/Victoria-B/Colorado: Day 28 | 36 Participants |
| FluMist Live Attenuated Influenza Vaccine 2019 | Number of Participants With Seroprotection Response in 2019 | B/Yamagata-B/Phuket: Day 0 | 57 Participants |
| FluMist Live Attenuated Influenza Vaccine 2019 | Number of Participants With Seroprotection Response in 2019 | B/Yamagata-B/Phuket: Day 28 | 57 Participants |
| Flucelvax Inactivated Influenza Vaccine 2019 | Number of Participants With Seroprotection Response in 2019 | B/Victoria-B/Colorado: Day 28 | 71 Participants |
| Flucelvax Inactivated Influenza Vaccine 2019 | Number of Participants With Seroprotection Response in 2019 | A/H1N1-A/Birsbane:Day 0 | 61 Participants |
| Flucelvax Inactivated Influenza Vaccine 2019 | Number of Participants With Seroprotection Response in 2019 | A/H3N2-AKansas cell grown virus: Day 28 | 65 Participants |
| Flucelvax Inactivated Influenza Vaccine 2019 | Number of Participants With Seroprotection Response in 2019 | A/H1N1-A/Birsbane:Day 28 | 93 Participants |
| Flucelvax Inactivated Influenza Vaccine 2019 | Number of Participants With Seroprotection Response in 2019 | B/Yamagata-B/Phuket: Day 28 | 84 Participants |
| Flucelvax Inactivated Influenza Vaccine 2019 | Number of Participants With Seroprotection Response in 2019 | A/H3N2-AKansas egg grown virus: Day 0 | 41 Participants |
| Flucelvax Inactivated Influenza Vaccine 2019 | Number of Participants With Seroprotection Response in 2019 | B/Victoria-B/Colorado: Day 0 | 34 Participants |
| Flucelvax Inactivated Influenza Vaccine 2019 | Number of Participants With Seroprotection Response in 2019 | A/H3N2-AKansas egg grown virus: Day 28 | 77 Participants |
| Flucelvax Inactivated Influenza Vaccine 2019 | Number of Participants With Seroprotection Response in 2019 | B/Yamagata-B/Phuket: Day 0 | 51 Participants |
| Flucelvax Inactivated Influenza Vaccine 2019 | Number of Participants With Seroprotection Response in 2019 | A/H3N2-AKansas cell grown virus: Day 0 | 24 Participants |
p-value: <0.001Chi-squared
p-value: 0.4Chi-squared
p-value: 0.36Chi-squared
p-value: 0.08Chi-squared
p-value: 0.91Chi-squared
p-value: 0.31Chi-squared
Secondary
Number of Participants With Seroprotection Response in 2020
Rows in data tables represent different influenza antigens measured in 2020. Hemagglutination inhibition (HI) assay was conducted to assess immunologic outcome. Seroprotection is defined as a HI titer \>= 1:110 at either time point.
Time frame: Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 28 timepoint)
Population: 2020 Participants
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| FluMist Live Attenuated Influenza Vaccine 2019 | Number of Participants With Seroprotection Response in 2020 | A/H1N1-A/Hawaii66 egg: Day 0 | 25 Participants |
| FluMist Live Attenuated Influenza Vaccine 2019 | Number of Participants With Seroprotection Response in 2020 | A/H1N1-A/Hawaii66 egg: Day 28 | 33 Participants |
| FluMist Live Attenuated Influenza Vaccine 2019 | Number of Participants With Seroprotection Response in 2020 | A/H1N1-A/Hawaii70 cell grown virus: Day 0 | 59 Participants |
| FluMist Live Attenuated Influenza Vaccine 2019 | Number of Participants With Seroprotection Response in 2020 | A/H1N1-A/Hawaii70 cell grown virus: Day 28 | 65 Participants |
| FluMist Live Attenuated Influenza Vaccine 2019 | Number of Participants With Seroprotection Response in 2020 | A/H1N1-A/Delaware: Day 0 | 37 Participants |
| FluMist Live Attenuated Influenza Vaccine 2019 | Number of Participants With Seroprotection Response in 2020 | A/H1N1-A/Delaware: Day 28 | 43 Participants |
| FluMist Live Attenuated Influenza Vaccine 2019 | Number of Participants With Seroprotection Response in 2020 | A/H3N2-A/Hong Kong: Day 0 | 90 Participants |
| FluMist Live Attenuated Influenza Vaccine 2019 | Number of Participants With Seroprotection Response in 2020 | A/H3N2-A/Hong Kong: Day 28 | 102 Participants |
| FluMist Live Attenuated Influenza Vaccine 2019 | Number of Participants With Seroprotection Response in 2020 | B/Victoria-B/Washington: Day 0 | 62 Participants |
| FluMist Live Attenuated Influenza Vaccine 2019 | Number of Participants With Seroprotection Response in 2020 | B/Victoria-B/Washington: Day 28 | 71 Participants |
| FluMist Live Attenuated Influenza Vaccine 2019 | Number of Participants With Seroprotection Response in 2020 | B/Yamagata-B/Phuket: Day 0 | 66 Participants |
| FluMist Live Attenuated Influenza Vaccine 2019 | Number of Participants With Seroprotection Response in 2020 | B/Yamagata-B/Phuket: Day 28 | 64 Participants |
| Flucelvax Inactivated Influenza Vaccine 2019 | Number of Participants With Seroprotection Response in 2020 | B/Yamagata-B/Phuket: Day 0 | 54 Participants |
| Flucelvax Inactivated Influenza Vaccine 2019 | Number of Participants With Seroprotection Response in 2020 | A/H1N1-A/Hawaii66 egg: Day 0 | 25 Participants |
| Flucelvax Inactivated Influenza Vaccine 2019 | Number of Participants With Seroprotection Response in 2020 | A/H3N2-A/Hong Kong: Day 0 | 73 Participants |
| Flucelvax Inactivated Influenza Vaccine 2019 | Number of Participants With Seroprotection Response in 2020 | A/H1N1-A/Hawaii66 egg: Day 28 | 79 Participants |
| Flucelvax Inactivated Influenza Vaccine 2019 | Number of Participants With Seroprotection Response in 2020 | B/Victoria-B/Washington: Day 28 | 86 Participants |
| Flucelvax Inactivated Influenza Vaccine 2019 | Number of Participants With Seroprotection Response in 2020 | A/H1N1-A/Hawaii70 cell grown virus: Day 0 | 54 Participants |
| Flucelvax Inactivated Influenza Vaccine 2019 | Number of Participants With Seroprotection Response in 2020 | A/H3N2-A/Hong Kong: Day 28 | 99 Participants |
| Flucelvax Inactivated Influenza Vaccine 2019 | Number of Participants With Seroprotection Response in 2020 | A/H1N1-A/Hawaii70 cell grown virus: Day 28 | 102 Participants |
| Flucelvax Inactivated Influenza Vaccine 2019 | Number of Participants With Seroprotection Response in 2020 | B/Yamagata-B/Phuket: Day 28 | 92 Participants |
| Flucelvax Inactivated Influenza Vaccine 2019 | Number of Participants With Seroprotection Response in 2020 | A/H1N1-A/Delaware: Day 0 | 32 Participants |
| Flucelvax Inactivated Influenza Vaccine 2019 | Number of Participants With Seroprotection Response in 2020 | B/Victoria-B/Washington: Day 0 | 59 Participants |
| Flucelvax Inactivated Influenza Vaccine 2019 | Number of Participants With Seroprotection Response in 2020 | A/H1N1-A/Delaware: Day 28 | 65 Participants |
p-value: 0.83Chi-squared
p-value: 0.79Chi-squared
p-value: 0.65Chi-squared
p-value: 0.06Chi-squared
p-value: 0.98Chi-squared
p-value: 0.24Chi-squared
p-value: <0.01Chi-squared
p-value: 0.66Chi-squared