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| ID | Type | Description | Link |
|---|---|---|---|
| 1U01|P001035-01 | 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 4-21 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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FluMist live attenuated influenza vaccine | Active Comparator | Participants receiving live attenuated FluMist influenza vaccine will receive 0.2 mL given intranasally |
|
| Flucelvax inactivated influenza vaccine | Active Comparator | Participants receiving inactivated Flucelvax influenza vaccine will receive 0.5 mL given intramuscularly |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FluMist live attenuated influenza vaccine | Biological | Participants randomized to this study influenza vaccine arm will receive FluMist live attenuated influenza vaccine at baseline after the baseline blood draw is complete. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Post-vaccination (at Day 28 timepoint) |
| 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. | Post-vaccination (at Day 28 timepoint) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 28 timepoint) |
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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 |
|---|---|---|---|
| 37232430 | Derived | Williams KV, Li ZN, Zhai B, Alcorn JF, Nowalk MP, Levine MZ, Kim SS, Flannery B, Moehling Geffel K, Merranko AJ, Collins M, Susick M, Clarke KS, Zimmerman RK, Martin JM. A Randomized Controlled Trial to Compare Immunogenicity to Cell-Based Versus Live-Attenuated Influenza Vaccines in Children. J Pediatric Infect Dis Soc. 2023 Jun 30;12(6):342-352. doi: 10.1093/jpids/piad033. |
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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 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | 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. | 2019 Participants | Posted | Count of Participants | Participants | Post-vaccination (at Day 28 timepoint) |
|
5 weeks in relation to baseline
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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 | FluMist Live Attenuated Influenza Vaccine | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Katherine Williams | University of Pittsburgh | 412-383-1979 | kvw3@pitt.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Sep 3, 2020 | Aug 16, 2021 | Prot_SAP_ICF_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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| Flucelvax inactivated influenza vaccine | Biological | 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. |
|
| 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 | Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 28 timepoint) |
| 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. | Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 28 timepoint) |
| 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 | Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 28 timepoint) |
| Pittsburgh |
| Pennsylvania |
| 15260 |
| United States |
| Physician Decision |
|
| Withdrawal by Subject |
|
| Specimen loss |
|
| BG001 |
| 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. |
|
|
|
| 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. | 2020 Participants | Posted | Count of Participants | Participants | Post-vaccination (at Day 28 timepoint) |
|
|
|
|
| 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. | 2019 Participants | Posted | Count of Participants | Participants | Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 28 timepoint) |
|
|
|
|
| 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 | 2019 Participants | Posted | Geometric Mean | 95% Confidence Interval | titer | Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 28 timepoint) |
|
|
|
|
| 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. | 2020 Participants | Posted | Count of Participants | Participants | Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 28 timepoint) |
|
|
|
|
| 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 | 2020 Participants | Posted | Geometric Mean | 95% Confidence Interval | titer | Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 28 timepoint) |
|
|
|
|
| 0 |
| 235 |
| 0 |
| 235 |
| 0 |
| 235 |
| EG001 | 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 cell-culture inactivated influenza vaccine at baseline after the baseline blood draw is complete. | 0 | 230 | 0 | 230 | 0 | 230 |
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| A/H1N1-A/Delaware |
|
| A/H3N2-A/Hong Kong |
|
| B/Victoria-B/Washington |
|
| B/Yamagata-B/Phuket |
|
| A/H3N2-AKansas egg grown virus: Day 0 |
|
| A/H3N2-AKansas egg grown virus: Day 28 |
|
| A/H3N2-AKansas cell grown virus: Day 0 |
|
| A/H3N2-AKansas cell grown virus: Day 28 |
|
| B/Victoria-B/Colorado: Day 0 |
|
| B/Victoria-B/Colorado: Day 28 |
|
| B/Yamagata-B/Phuket: Day 0 |
|
| B/Yamagata-B/Phuket: Day 28 |
|
Day 0, A/H1N1-A/Brisbane |
| Other |
| Chi-squared | 0.36 | Day 0 A/H1N1-A/Kansas egg grown virus | Other |
| Chi-squared | 0.08 | Day 0 A/H1N1-A/Kansas cell grown virus | Other |
| Chi-squared | 0.91 | Day 0 B/Victoria-B/Colorado | Other |
| Chi-squared | 0.31 | Day 0 B/Yamagata-B/Phuket | Other |
| A/H3N2-A/Kansas egg grown virus: Day 0 |
|
| A/H3N2-A/Kansas egg grown virus: Day 28 |
|
| A/H3N2-A/Kansas cell grown virus: Day 0 |
|
| A/H3N2-A/Kansas cell grown virus: Day 28 |
|
| B/Victoria-B/Colorado: Day 0 |
|
| B/Victoria-B/Colorado: Day 28 |
|
| B/Yamagata-B/Phuket: Day 0 |
|
| B/Yamagata-B/Phuket: Day 28 |
|
Day 0 A/H3N2-A/Kansas egg grown virus |
| Other |
| t-test, 2 sided | 0.56 | Day 0 A/H3N2-A/Kansas cell grown virus | Other |
| t-test, 2 sided | 0.95 | Day 0 B/Victoria-B/Colorado | Other |
| t-test, 2 sided | 0.44 | Day 0 B/Yamagata-B/Phuket | Other |
| t-test, 2 sided | <0.001 | Day 28 for all listed variables | Other |
| A/H1N1-A/Hawaii70 cell grown virus: Day 0 |
|
| A/H1N1-A/Hawaii70 cell grown virus: Day 28 |
|
| A/H1N1-A/Delaware: Day 0 |
|
| A/H1N1-A/Delaware: Day 28 |
|
| A/H3N2-A/Hong Kong: Day 0 |
|
| A/H3N2-A/Hong Kong: Day 28 |
|
| B/Victoria-B/Washington: Day 0 |
|
| B/Victoria-B/Washington: Day 28 |
|
| B/Yamagata-B/Phuket: Day 0 |
|
| B/Yamagata-B/Phuket: Day 28 |
|
| 0.79 |
| Other |
| Chi-squared | Day 0: A/H1N1-A/Delaware | 0.65 | Other |
| Chi-squared | Day 0: A/H3N2-A/Hong Kong | 0.06 | Other |
| Chi-squared | Day 0: B/Victoria-B/Washington | 0.98 | Other |
| Chi-squared | Day 0: B/Yamagata-B/Phuket | 0.24 | Other |
| Chi-squared | Day 28: A/H1N1-A/Hawaii66-egg based antigen, A/H1N1-A/Hawaii70-cell based antigen, A/H1N1-A/Delaware, B/Victoria-B/Washington, B/Yamagata-B/Phuket | <0.01 | Other |
| Chi-squared | A/H3N2-A/Hong Kong | 0.66 | Other |
| A/H1N1-A/Hawaii70 cell grown virus: Day 0 |
|
| A/H1N1-A/Hawaii70 cell grown virus: Day 28 |
|
| A/H1N1-A/Delaware: Day 0 |
|
| A/H1N1-A/Delaware: Day 28 |
|
| A/H3N2-A/Hong Kong: Day 0 |
|
| A/H3N2-A/Hong Kong: Day 28 |
|
| B/Victoria-B/Washington: Day 0 |
|
| B/Victoria-B/Washington: Day 28 |
|
| B/Yamagata-B/Phuket: Day 0 |
|
| B/Yamagata-B/Phuket: Day 28 |
|
Day 0: A/H1N1-A/Hawaii70 cell based antigen |
| Other |
| t-test, 2 sided | 0.13 | Day 0: A/H1N1-A/Delaware | Other |
| t-test, 2 sided | 0.06 | Day 0: A/H3N2-A/Hong Kong | Other |
| t-test, 2 sided | 0.78 | Day 0: B/Victoria-B/Washington | Other |
| t-test, 2 sided | 0.36 | Day 0: B/Yamagata-B/Phuket | Other |
| t-test, 2 sided | <0.0001 | Day 28: A/H1N1-A/Hawaii66 egg based antigen, A/H1N1-A/Hawaii70 cell based antigen, A/H1N1-A/Delaware, B/Victoria-B/Washington, B/Yamagata-B/Phuket | Other |
| t-test, 2 sided | 0.01 | Day 28: A/H3N2-A/Hong Kong | Other |