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| ID | Type | Description | Link |
|---|---|---|---|
| 200-2016-91806 | Other Grant/Funding Number | Centers for Disease Control and Prevention |
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| Name | Class |
|---|---|
| Abt Associates | INDUSTRY |
| Clalit Research Institute | OTHER |
| Soroka University Medical Center | OTHER |
| Rabin Medical Center |
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This randomized, open-label, active-controlled trial will assess humoral immune responses to a single dose of 2019-20 recombinant hemagglutinin quadrivalent influenza vaccines (RIV4) compared with standard egg-based unadjuvanted quadrivalent influenza vaccines (IIV4) among healthcare personnel (HCP) vaccinated during the previous 2018-19 season with IIV4. The trial will be conducted at two hospital sites in Israel during the 2019-20 influenza season among HCP who were enrolled in the Study of Healthcare Personnel with Influenza and other Respiratory Viruses in Israel (SHIRI).
This is a randomized, open-label study design. Starting in July 2019, approximately 550 to 700 HCP from two hospitals (275-350 per hospital site) in Israel will be enrolled. Following completion of a written consent form, participants will complete an enrollment survey and grant permission for review of information collected during the SHIRI study, including vaccination status and immune response during the SHIRI study years. Participants will complete an enrollment survey and grant permission to include and integrate information collected during the SHIRI study into the current study's data, including health history, influenza vaccination history, and immune response to vaccination during the SHIRI study years. HCP will be randomly assigned 1:1 to receive a single dose of IIV4 licensed in Israel (expected to be Vaxigrip® Quadrivalent, 15µg of HA per strain) or RIV4 (Flublok® Quadrivalent by Sanofi Pasteur, 45µg of HA per strain) during August-October of 2019. Adverse events following vaccination will be monitored and documented. Blood specimens will be collected prior to vaccination and approximately 28 days after to evaluate immune responses to vaccination.
Eligible HCP who were already vaccinated with Vaxigrip, the vaccine that is routinely available in Israel, at the time they are approached to join the study, will be invited to join the study as part of the Vaxigrip arm. Like randomized participants, participants who were vaccinated with Vaxigrip outside the study will complete a written consent form, an enrollment survey and grant permission for review of information collected during the SHIRI study, including vaccination status and immune response during the SHIRI study years. As part of the consent form, participants will record the estimated date that they received the vaccine, and the location, and will authorize study staff to verify the date of current-year Vaxigrip vaccination in the Clalit EMR and with the hospital vaccination staff. Participants will complete an enrollment survey and grant permission to include and integrate information collected during the SHIRI study into the current study's data, including health history, influenza vaccination history, and immune response to vaccination during the SHIRI study years. Blood specimens will be collected approximately 28 days after to evaluate immune responses to vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RIV4 (Flublok Quadrivalent) | Active Comparator | Flublok® Quadrivalent by Sanofi Pasteur, 45µg of HA per strain |
|
| IIV4 (Vaxigrip Quadrivalent) | Active Comparator | VaxigripTetra™ by Sanofi, Inc., 15µg of HA per strain, egg-based |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flublok™ Quadrivalent by Sanofi, Inc. | Biological | 0.5 mL intramuscular dose of Flublok |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-vaccination Geometric Mean Titer Against Influenza Virus A/H1N1 | The geometric mean of antibody titers following a single dose of RIV4 or IIV4 as measured by hemagglutination inhibition (HI) for influenza virus A/H1N1 | Day 28 days after vaccination |
| Geometric Mean Titer Ratio (GMR) Against Influenza Virus A/H1N1 | The ratio of the pre- vs. post-vaccination titer against influenza virus A/H1N1 following a single dose of RIV4 versus IIV4. | 0 to 28 days after vaccination |
| Post-vaccination Geometric Mean Titer Against Egg-grown Influenza Virus A/H3N2 | The geometric mean of antibody titers following a single dose of RIV4 or IIV4 as measured by hemagglutination inhibition (HI) for egg-grown influenza virus A/H3N2 | Day 28 days after vaccination |
| Geometric Mean Titer Ratio (GMR) Against Egg-grown Influenza Virus A/H3N2 | The ratio of the pre- vs. post-vaccination titer against egg-grown influenza virus A/H3N2 following a single dose of RIV4 versus IIV4. | 0 to 28 days after vaccination |
| Post-vaccination GMT Against Cell-grown Influenza Virus A/H3N2 | The geometric mean of antibody titers following a single dose of RIV4 or IIV4 as measured by hemagglutination inhibition (HI) for cell-grown influenza virus A/H3N2 | Day 28 days after vaccination |
| Geometric Mean Titer Ratio (GMR) Against Cell-grown Influenza Virus A/H3N2 | The ratio of the pre- vs. post-vaccination titer against cell-grown influenza virus A/H3N2 following a single dose of RIV4 versus IIV4. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark G Thompson, PhD | Centers for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soroka Medical Center | Beersheba | Israel | ||||
| Rabin Medical Center-Beilinson |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30400834 | Background | Hirsch A, Katz MA, Laufer Peretz A, Greenberg D, Wendlandt R, Shemer Avni Y, Newes-Adeyi G, Gofer I, Leventer-Roberts M, Davidovitch N, Rosenthal A, Gur-Arie R, Hertz T, Glatman-Freedman A, Monto AS, Azziz-Baumgartner E, Ferdinands JM, Martin ET, Malosh RE, Neyra Quijandria JM, Levine M, Campbell W, Balicer R, Thompson MG; SHIRI workgroup. Study of Healthcare Personnel with Influenza and other Respiratory Viruses in Israel (SHIRI): study protocol. BMC Infect Dis. 2018 Nov 6;18(1):550. doi: 10.1186/s12879-018-3444-7. | |
| 39395753 |
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No current plans
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577 HCP were randomly allocated to receive either IIV4 or RIV4. Due to a delay in the delivery of RIV4 vaccines, 67 participants randomized to receive RIV4 had already been vaccinated in the community with IIV4 before the study started. Because they received the same IIV4 brand (Vaxigrip) as the study control vaccine, we allowed them to continue in the study as controls.
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| ID | Title | Description |
|---|---|---|
| FG000 | RIV4 (Flublok Quadrivalent) | Flublok® Quadrivalent by Sanofi Pasteur, 45µg of HA per strain Flublok™ Quadrivalent by Sanofi, Inc.: 0.5 mL intramuscular dose of Flublok |
| FG001 | IIV4 (Vaxigrip Quadrivalent) | VaxigripTetra™ by Sanofi, Inc., 15µg of HA per strain, egg-based VaxigripTetra™ by Sanofi, Inc.: 0.5 mL intramuscular dose of Vaxigrip |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | RIV4 (Flublok Quadrivalent) | Flublok® Quadrivalent by Sanofi Pasteur, 45µg of HA per strain Flublok™ Quadrivalent by Sanofi, Inc.: 0.5 mL intramuscular dose of Flublok |
| BG001 | IIV4 (Vaxigrip Quadrivalent) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Post-vaccination Geometric Mean Titer Against Influenza Virus A/H1N1 | The geometric mean of antibody titers following a single dose of RIV4 or IIV4 as measured by hemagglutination inhibition (HI) for influenza virus A/H1N1 | Influenza A(H1N1)pdm09 Hemagglutination Inhibition Assay Outcome | Posted | Geometric Mean | 95% Confidence Interval | titers | Day 28 days after vaccination |
|
28 days
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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 | RIV4 (Flublok Quadrivalent) | Flublok® Quadrivalent by Sanofi Pasteur, 45µg of HA per strain Flublok™ Quadrivalent by Sanofi, Inc.: 0.5 mL intramuscular dose of Flublok |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ashley Fowlkes | Centers for Disease Control and Prevention | 4046394830 | afowlkes@cdc.gov |
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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 | Dec 8, 2019 | Sep 29, 2023 | 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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| OTHER |
| University of Michigan | OTHER |
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Open-label trial. Eligible HCP who report already having been vaccinated with Vaxigrip at the time they are approached to join the study will be eligible to participate.
| VaxigripTetra™ by Sanofi, Inc. | Biological | 0.5 mL intramuscular dose of Vaxigrip |
|
| 0 to 28 days after vaccination |
| Post-vaccination Geometric Mean Titer Against Influenza B(Victoria) | The geometric mean of antibody titers following a single dose of RIV4 or IIV4 as measured by hemagglutination inhibition (HI) for Influenza B(Victoria) | Day 28 days after vaccination |
| Geometric Mean Titer Ratio (GMR) Against Influenza B(Victoria) | The ratio of the pre- vs. post-vaccination titer against Influenza B(Victoria) following a single dose of RIV4 versus IIV4. | 0 to 28 days after vaccination |
| Post-vaccination Geometric Mean Titer Against Influenza B(Yamagata) | The geometric mean of antibody titers following a single dose of RIV4 or IIV4 as measured by hemagglutination inhibition (HI) for Influenza B(Yamagata) | Day 28 days after vaccination |
| Geometric Mean Titer Ratio (GMR) Against Influenza B(Yamagata) | The ratio of the pre- vs. post-vaccination titer against Influenza B(Yamagata) following a single dose of RIV4 versus IIV4. | 0 to 28 days after vaccination |
| Petah Tikva |
| Israel |
| Derived |
| Fowlkes AL, Peretz A, Greenberg D, Hirsch A, Martin ET, Levine MZ, Edwards L, Radke S, Lauring AS, Ferdinands JM, Zhang C, Yoo YM, Dreiher J, Newes-Adeyi G, Azziz-Baumgartner E, Fry AM, Monto AS, Balicer R, Thompson MG, Katz MA. Randomised immunogenicity trial comparing 2019-2020 recombinant and egg-based influenza vaccines among frequently vaccinated healthcare personnel in Israel. Int J Infect Dis. 2024 Dec;149:107260. doi: 10.1016/j.ijid.2024.107260. Epub 2024 Oct 10. |
VaxigripTetra™ by Sanofi, Inc., 15µg of HA per strain, egg-based
VaxigripTetra™ by Sanofi, Inc.: 0.5 mL intramuscular dose of Vaxigrip
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Geometric Mean Titer Ratio (GMR) Against Influenza Virus A/H1N1 | The ratio of the pre- vs. post-vaccination titer against influenza virus A/H1N1 following a single dose of RIV4 versus IIV4. | Influenza A(H1N1)pdm09 Hemagglutination Inhibition Assay Outcome | Posted | Geometric Mean | 95% Confidence Interval | Mean-Fold Change | 0 to 28 days after vaccination |
|
|
|
| Primary | Post-vaccination Geometric Mean Titer Against Egg-grown Influenza Virus A/H3N2 | The geometric mean of antibody titers following a single dose of RIV4 or IIV4 as measured by hemagglutination inhibition (HI) for egg-grown influenza virus A/H3N2 | Egg-grown influenza A(H3N2) Hemagglutination Inhibition Assay Outcome | Posted | Geometric Mean | 95% Confidence Interval | titers | Day 28 days after vaccination |
|
|
|
| Primary | Geometric Mean Titer Ratio (GMR) Against Egg-grown Influenza Virus A/H3N2 | The ratio of the pre- vs. post-vaccination titer against egg-grown influenza virus A/H3N2 following a single dose of RIV4 versus IIV4. | egg-grown influenza virus A/H3N2 Hemagglutination Inhibition Assay Outcome | Posted | Geometric Mean | 95% Confidence Interval | Mean-Fold Change | 0 to 28 days after vaccination |
|
|
|
| Primary | Post-vaccination GMT Against Cell-grown Influenza Virus A/H3N2 | The geometric mean of antibody titers following a single dose of RIV4 or IIV4 as measured by hemagglutination inhibition (HI) for cell-grown influenza virus A/H3N2 | Cell-grown influenza A(H3N2) Hemagglutination Inhibition Assay Outcome | Posted | Geometric Mean | 95% Confidence Interval | Titers | Day 28 days after vaccination |
|
|
|
| Primary | Geometric Mean Titer Ratio (GMR) Against Cell-grown Influenza Virus A/H3N2 | The ratio of the pre- vs. post-vaccination titer against cell-grown influenza virus A/H3N2 following a single dose of RIV4 versus IIV4. | Cell-grown influenza virus A/H3N2 Hemagglutination Inhibition Assay Outcome | Posted | Geometric Mean | 95% Confidence Interval | Mean-Fold Change | 0 to 28 days after vaccination |
|
|
|
| Primary | Post-vaccination Geometric Mean Titer Against Influenza B(Victoria) | The geometric mean of antibody titers following a single dose of RIV4 or IIV4 as measured by hemagglutination inhibition (HI) for Influenza B(Victoria) | Influenza B(Victoria) Hemagglutination Inhibition Assay Outcome | Posted | Geometric Mean | 95% Confidence Interval | titers | Day 28 days after vaccination |
|
|
|
| Primary | Geometric Mean Titer Ratio (GMR) Against Influenza B(Victoria) | The ratio of the pre- vs. post-vaccination titer against Influenza B(Victoria) following a single dose of RIV4 versus IIV4. | Influenza B(Victoria) Hemagglutination Inhibition Assay Outcome | Posted | Geometric Mean | 95% Confidence Interval | Mean-Fold Change | 0 to 28 days after vaccination |
|
|
|
| Primary | Post-vaccination Geometric Mean Titer Against Influenza B(Yamagata) | The geometric mean of antibody titers following a single dose of RIV4 or IIV4 as measured by hemagglutination inhibition (HI) for Influenza B(Yamagata) | Influenza B(Yamagata) Hemagglutination Inhibition Assay Outcome | Posted | Geometric Mean | 95% Confidence Interval | titers | Day 28 days after vaccination |
|
|
|
| Primary | Geometric Mean Titer Ratio (GMR) Against Influenza B(Yamagata) | The ratio of the pre- vs. post-vaccination titer against Influenza B(Yamagata) following a single dose of RIV4 versus IIV4. | Influenza virus B(Yamagata) Hemagglutination Inhibition Assay Outcome | Posted | Geometric Mean | 95% Confidence Interval | Mean-Fold Change | 0 to 28 days after vaccination |
|
|
|
| 0 |
| 203 |
| 0 |
| 203 |
| 0 |
| 203 |
| EG001 | IIV4 (Vaxigrip Quadrivalent) | VaxigripTetra™ by Sanofi, Inc., 15µg of HA per strain, egg-based VaxigripTetra™ by Sanofi, Inc.: 0.5 mL intramuscular dose of Vaxigrip | 0 | 334 | 0 | 334 | 0 | 334 |
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |