Immune Response, Influenza, Human
Conditions
Keywords
inactivated, influenza, vaccine
Brief summary
The purpose of this study is to evaluate immunologic response to different types of influenza vaccine among children/adolescents/young adults 4-20 years of age. This is a randomized controlled trial (RCT), that will assess immune response in 120 participants (60 per vaccine arm) pre- and post-vaccination to Flucelvax (egg-free inactivated flu shot) and Fluzone (egg-based inactivated flu shot).
Detailed description
This is a non-blinded, randomized controlled trial analyzing influenza vaccine immunogenicity response in children/adolescents/young adults aged 4-20 years given one of two FDA approved and licensed influenza vaccines: Flucelvax (egg-free inactivated flu shot) and Fluzone (egg-based inactivated flu shot). This study will enroll 120 healthy participants, 60 per vaccine arm. Participants will be randomized using a 1:1 allocation to receive either Flucelvax or Fluzone. 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 21 (range 21-35 days). The primary objective of the study is to determine pre and post serologic,responses to each vaccine type.
Interventions
BIOLOGICALFlucelvax inactivated influenza vaccine
Participants randomized to this study influenza vaccine arm will receive Flucelvax inactivated influenza vaccine at baseline after the baseline blood draw is complete. (Provided that this vaccine is available clinically in time for the study.)
BIOLOGICALFluzone inactivated influenza vaccine
Participants randomized to this study influenza vaccine arm will receive Fluzone inactivated influenza vaccine at baseline after the baseline blood draw is complete. (Provided that this vaccine is available clinically in time for the study.)
Sponsors
Centers for Disease Control and Prevention
Richard Zimmerman MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
1:1 RCT allocation to one of two influenza vaccines: Flucelvax or Fluzone.
Eligibility
Sex/Gender
ALL
Age
4 Years to 20 Years
Healthy volunteers
Yes
Inclusion criteria
* aged 4-20 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 |
|---|---|---|
| Determining Seroconversion Response - Change in HI Titers From Pre- to Post Vaccination | Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 21 timepoint) | Hemagglutination inhibition (HI) assay will be 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Determining Seroprotection Level at Each Time Point | Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 21 timepoint) | Hemagglutination inhibition assay will be conducted to assess immunologic outcome. Seroprotection is defined as a HI titer \>= 1:110 at either time point. |
| Determining Geometric Mean Titers (GMTs) at Each Time Point | Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 21 timepoint) | 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 |
|---|---|
| Flucelvax Inactivated Influenza Vaccine 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 inactivated influenza vaccine at baseline after the baseline blood draw is complete. (Provided that this vaccine is available clinically in time for the study.) | 85 |
| Fluzone Inactivated Influenza Vaccine Participants receiving inactivated Fluzone influenza vaccine will receive 0.5 mL given intramuscularly
Fluzone inactivated influenza vaccine: Participants randomized to this study influenza vaccine arm will receive Fluzone inactivated influenza vaccine at baseline after the baseline blood draw is complete. (Provided that this vaccine is available clinically in time for the study.) | 81 |
| Total | 166 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 7 | 5 |
| Overall Study | Specimens not in lab batch shipment | 1 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | Flucelvax Inactivated Influenza Vaccine | Total | Fluzone Inactivated Influenza Vaccine |
|---|---|---|---|
| Age, Continuous | 14.03 years | 14.07 years | 14.21 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 53 Participants | 103 Participants | 50 Participants |
| Race (NIH/OMB) More than one race | 7 Participants | 14 Participants | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 14 Participants | 28 Participants | 14 Participants |
| Region of Enrollment United States | 85 participants | 166 participants | 81 participants |
| Sex: Female, Male Female | 39 Participants | 79 Participants | 40 Participants |
| Sex: Female, Male Male | 36 Participants | 69 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 85 | 0 / 81 |
| other Total, other adverse events | 0 / 85 | 0 / 81 |
| serious Total, serious adverse events | 0 / 85 | 0 / 81 |
Outcome results
Primary
Determining Seroconversion Response - Change in HI Titers From Pre- to Post Vaccination
Hemagglutination inhibition (HI) assay will be 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.
Time frame: Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 21 timepoint)
Population: Participants who completed study through day 21
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Flucelvax Inactivated Influenza Vaccine | Determining Seroconversion Response - Change in HI Titers From Pre- to Post Vaccination | Vaccine Strain: A/H1N1 | 20 Participants |
| Flucelvax Inactivated Influenza Vaccine | Determining Seroconversion Response - Change in HI Titers From Pre- to Post Vaccination | Vaccine Strain: A/H3N2 | 9 Participants |
| Flucelvax Inactivated Influenza Vaccine | Determining Seroconversion Response - Change in HI Titers From Pre- to Post Vaccination | Vaccine Strain: B/Colorado | 22 Participants |
| Flucelvax Inactivated Influenza Vaccine | Determining Seroconversion Response - Change in HI Titers From Pre- to Post Vaccination | Vaccine Strain: B/Phuket | 14 Participants |
| Fluzone Inactivated Influenza Vaccine | Determining Seroconversion Response - Change in HI Titers From Pre- to Post Vaccination | Vaccine Strain: B/Phuket | 9 Participants |
| Fluzone Inactivated Influenza Vaccine | Determining Seroconversion Response - Change in HI Titers From Pre- to Post Vaccination | Vaccine Strain: A/H1N1 | 14 Participants |
| Fluzone Inactivated Influenza Vaccine | Determining Seroconversion Response - Change in HI Titers From Pre- to Post Vaccination | Vaccine Strain: B/Colorado | 24 Participants |
| Fluzone Inactivated Influenza Vaccine | Determining Seroconversion Response - Change in HI Titers From Pre- to Post Vaccination | Vaccine Strain: A/H3N2 | 11 Participants |
p-value: 0.28Chi-squared
p-value: 0.64Chi-squared
p-value: 0.64Chi-squared
p-value: 0.23Chi-squared
Secondary
Determining Geometric Mean Titers (GMTs) at Each Time Point
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 21 timepoint)
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Flucelvax Inactivated Influenza Vaccine | Determining Geometric Mean Titers (GMTs) at Each Time Point | Vaccine Strain: B/Colorado : Day 0 | 6.55 Dilution |
| Flucelvax Inactivated Influenza Vaccine | Determining Geometric Mean Titers (GMTs) at Each Time Point | Vaccine Strain: A/H1N1 : Day 0 | 6.63 Dilution |
| Flucelvax Inactivated Influenza Vaccine | Determining Geometric Mean Titers (GMTs) at Each Time Point | Vaccine Strain: B/Colorado : Day 21 | 7.56 Dilution |
| Flucelvax Inactivated Influenza Vaccine | Determining Geometric Mean Titers (GMTs) at Each Time Point | Vaccine Strain: A/H3N2 : Day 0 | 7.42 Dilution |
| Flucelvax Inactivated Influenza Vaccine | Determining Geometric Mean Titers (GMTs) at Each Time Point | Vaccine Strain: B/Phuket : Day 0 | 6.78 Dilution |
| Flucelvax Inactivated Influenza Vaccine | Determining Geometric Mean Titers (GMTs) at Each Time Point | Vaccine Strain: A/H3N2 : Day 21 | 7.90 Dilution |
| Flucelvax Inactivated Influenza Vaccine | Determining Geometric Mean Titers (GMTs) at Each Time Point | Vaccine Strain: B/Phuket : Day 21 | 7.34 Dilution |
| Flucelvax Inactivated Influenza Vaccine | Determining Geometric Mean Titers (GMTs) at Each Time Point | Vaccine Strain: A/H1N1 : Day 21 | 8.08 Dilution |
| Fluzone Inactivated Influenza Vaccine | Determining Geometric Mean Titers (GMTs) at Each Time Point | Vaccine Strain: B/Phuket : Day 21 | 7.46 Dilution |
| Fluzone Inactivated Influenza Vaccine | Determining Geometric Mean Titers (GMTs) at Each Time Point | Vaccine Strain: A/H1N1 : Day 0 | 6.42 Dilution |
| Fluzone Inactivated Influenza Vaccine | Determining Geometric Mean Titers (GMTs) at Each Time Point | Vaccine Strain: A/H1N1 : Day 21 | 7.76 Dilution |
| Fluzone Inactivated Influenza Vaccine | Determining Geometric Mean Titers (GMTs) at Each Time Point | Vaccine Strain: A/H3N2 : Day 21 | 7.96 Dilution |
| Fluzone Inactivated Influenza Vaccine | Determining Geometric Mean Titers (GMTs) at Each Time Point | Vaccine Strain: B/Colorado : Day 0 | 6.42 Dilution |
| Fluzone Inactivated Influenza Vaccine | Determining Geometric Mean Titers (GMTs) at Each Time Point | Vaccine Strain: B/Colorado : Day 21 | 7.71 Dilution |
| Fluzone Inactivated Influenza Vaccine | Determining Geometric Mean Titers (GMTs) at Each Time Point | Vaccine Strain: B/Phuket : Day 0 | 6.52 Dilution |
| Fluzone Inactivated Influenza Vaccine | Determining Geometric Mean Titers (GMTs) at Each Time Point | Vaccine Strain: A/H3N2 : Day 0 | 6.94 Dilution |
p-value: 0.49Kruskal-Wallis
p-value: 0.23Kruskal-Wallis
p-value: 0.1Kruskal-Wallis
p-value: 0.86Kruskal-Wallis
p-value: 0.73Kruskal-Wallis
p-value: 0.67Kruskal-Wallis
p-value: 0.36Kruskal-Wallis
p-value: 0.65Kruskal-Wallis
Secondary
Determining Seroprotection Level at Each Time Point
Hemagglutination inhibition assay will be 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 21 timepoint)
Population: Data was analyzed on participants who completed day 21 visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Flucelvax Inactivated Influenza Vaccine | Determining Seroprotection Level at Each Time Point | Vaccine Strain: A/H1N1 : Day 0 | 45 Participants |
| Flucelvax Inactivated Influenza Vaccine | Determining Seroprotection Level at Each Time Point | Vaccine Strain: A/H1N1 : Day 21 | 66 Participants |
| Flucelvax Inactivated Influenza Vaccine | Determining Seroprotection Level at Each Time Point | Vaccine Strain: A/H3N2 : Day 0 | 51 Participants |
| Flucelvax Inactivated Influenza Vaccine | Determining Seroprotection Level at Each Time Point | Vaccine Strain: A/H3N2 : Day 21 | 62 Participants |
| Flucelvax Inactivated Influenza Vaccine | Determining Seroprotection Level at Each Time Point | Vaccine Strain: B/Colorado : Day 0 | 37 Participants |
| Flucelvax Inactivated Influenza Vaccine | Determining Seroprotection Level at Each Time Point | Vaccine Strain: B/Colorado : Day 21 | 56 Participants |
| Flucelvax Inactivated Influenza Vaccine | Determining Seroprotection Level at Each Time Point | Vaccine Strain: B/Phuket : Day 0 | 48 Participants |
| Flucelvax Inactivated Influenza Vaccine | Determining Seroprotection Level at Each Time Point | Vaccine Strain: B/Phuket : Day 21 | 61 Participants |
| Fluzone Inactivated Influenza Vaccine | Determining Seroprotection Level at Each Time Point | Vaccine Strain: B/Phuket : Day 21 | 53 Participants |
| Fluzone Inactivated Influenza Vaccine | Determining Seroprotection Level at Each Time Point | Vaccine Strain: A/H1N1 : Day 0 | 39 Participants |
| Fluzone Inactivated Influenza Vaccine | Determining Seroprotection Level at Each Time Point | Vaccine Strain: B/Colorado : Day 0 | 35 Participants |
| Fluzone Inactivated Influenza Vaccine | Determining Seroprotection Level at Each Time Point | Vaccine Strain: A/H1N1 : Day 21 | 58 Participants |
| Fluzone Inactivated Influenza Vaccine | Determining Seroprotection Level at Each Time Point | Vaccine Strain: B/Phuket : Day 0 | 41 Participants |
| Fluzone Inactivated Influenza Vaccine | Determining Seroprotection Level at Each Time Point | Vaccine Strain: A/H3N2 : Day 0 | 45 Participants |
| Fluzone Inactivated Influenza Vaccine | Determining Seroprotection Level at Each Time Point | Vaccine Strain: B/Colorado : Day 21 | 56 Participants |
| Fluzone Inactivated Influenza Vaccine | Determining Seroprotection Level at Each Time Point | Vaccine Strain: A/H3N2 : Day 21 | 60 Participants |
p-value: 0.42Chi-squared
p-value: 0.16Chi-squared
p-value: 0.42Chi-squared
p-value: 0.94Chi-squared
p-value: 0.87Chi-squared
p-value: 0.77Chi-squared
p-value: 0.33Chi-squared
p-value: 0.21Chi-squared