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| ID | Type | Description | Link |
|---|---|---|---|
| CDCU01IP001035 | Other Grant/Funding Number | Centers for Disease Control and Prevention |
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| Name | Class |
|---|---|
| Centers for Disease Control and Prevention | FED |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flucelvax inactivated influenza vaccine | Active Comparator | Participants receiving inactivated Flucelvax influenza vaccine will receive 0.5 mL given intramuscularly |
|
| Fluzone inactivated influenza vaccine | Active Comparator | Participants receiving inactivated Fluzone influenza vaccine will receive 0.5 mL given intramuscularly |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flucelvax inactivated influenza vaccine | Biological | 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.) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 21 timepoint) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 21 timepoint) |
| Determining Geometric Mean Titers (GMTs) at Each Time Point |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard K Zimmerman, MD, MPH, MA | University of Pittsburgh, School of Medicine, Dept. Family Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Academic Pediatrics | Pittsburgh | Pennsylvania | 15213 | United States | ||
| University of Pittsburgh Department of Family Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32580919 | Derived | Moehling KK, Zimmerman RK, Nowalk MP, Jeng Lin C, Martin JM, Alcorn JF, Susick M, Burroughs A, Holiday C, Flannery B, Levine MZ. A randomized controlled trial of antibody response to 2018-19 cell-based vs. egg-based quadrivalent inactivated influenza vaccine in children. Vaccine. 2020 Jul 14;38(33):5171-5177. doi: 10.1016/j.vaccine.2020.06.023. Epub 2020 Jun 21. |
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Individual participant data that underlie the results reported in the primary article, after deidentification, will be placed at the site mentioned below.
Beginning 9 months and ending 36 months after article publication.
Researchers who provide a methodologically sound proposal and have appropriate data security and privacy plans in place
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| ID | Title | Description |
|---|---|---|
| FG000 | 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.) |
| FG001 | 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.) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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.) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Only subjects who completed the study to day 21 were included in this analysis |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Participants who completed study through day 21 | Posted | Count of Participants | Participants | Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 21 timepoint) |
|
1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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.) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard Zimmerman, MD | University of Pittsburgh, Department of Family Medicine | 412-383-2354 | zimmrk@upmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 20, 2018 | Nov 7, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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1:1 RCT allocation to one of two influenza vaccines: Flucelvax or Fluzone.
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| Fluzone inactivated influenza vaccine | Biological | 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.) |
|
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 |
| Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 21 timepoint) |
| Pittsburgh |
| Pennsylvania |
| 15260 |
| United States |
| Specimens not in lab batch shipment |
|
| BG001 | 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.) |
| BG002 | Total | Total of all reporting groups |
| Median |
| Inter-Quartile Range |
| years |
|
| Sex: Female, Male | Only participants who completed the study through day 21 were included in this analysis | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Only data on participants who completed day 21 of the study are reported. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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.) |
|
|
|
| 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. | Data was analyzed on participants who completed day 21 visit. | Posted | Count of Participants | Participants | Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 21 timepoint) |
|
|
|
|
| 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 | Posted | Geometric Mean | 95% Confidence Interval | Dilution | Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 21 timepoint) |
|
|
|
|
| 0 |
| 85 |
| 0 |
| 85 |
| 0 |
| 85 |
| EG001 | 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.) | 0 | 81 | 0 | 81 | 0 | 81 |
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Vaccine Strain: A/H3N2 : Day 0 |
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| Vaccine Strain: A/H3N2 : Day 21 |
|
| Vaccine Strain: B/Colorado : Day 0 |
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| Vaccine Strain: B/Colorado : Day 21 |
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| Vaccine Strain: B/Phuket : Day 0 |
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| Vaccine Strain: B/Phuket : Day 21 |
|
Vaccine Strain: A/H1N1: Day 21
| Other |
| Chi-squared | 0.42 | Vaccine Strain: A/H3N2: Day 0 | Other |
| Chi-squared | 0.94 | Vaccine Strain: A/H3N2: Day 21 | Other |
| Chi-squared | 0.87 | Vaccine Strain: B/Colorado :Day 0 | Other |
| Chi-squared | 0.77 | Vaccine Strain: B/Colorado : Day 21 | Other |
| Chi-squared | 0.33 | Vaccine Strain: B/Phuket: Day 0 | Other |
| Chi-squared | 0.21 | Vaccine Strain: B/Phuket: Day 21 | Other |
| Vaccine Strain: A/H3N2 : Day 0 |
|
| Vaccine Strain: A/H3N2 : Day 21 |
|
| Vaccine Strain: B/Colorado : Day 0 |
|
| Vaccine Strain: B/Colorado : Day 21 |
|
| Vaccine Strain: B/Phuket : Day 0 |
|
| Vaccine Strain: B/Phuket : Day 21 |
|
Vaccine Strain: A/H1N1: Day 21 |
| Other |
| Kruskal-Wallis | 0.10 | Vaccine Strain: A/H3N2: Day 0 | Other |
| Kruskal-Wallis | 0.86 | Vaccine Strain: A/H3N2: Day 21 | Other |
| Kruskal-Wallis | 0.73 | Vaccine Strain: B/Colorado: Day 0 | Other |
| Kruskal-Wallis | 0.67 | Vaccine Strain: B/Colorado: Day 21 | Other |
| Kruskal-Wallis | 0.36 | Vaccine Strain: B/Phuket: Day 0 | Other |
| Kruskal-Wallis | 0.65 | Vaccine Strain: B/Phuket: Day 21 | Other |