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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-002785-13 | EudraCT Number |
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This phase 3 clinical study is a randomized, observer-blind, comparator-controlled, multicenter study of QIVc versus a US-licensed comparator QIV in children 6 months through 47 months of age. The purpose of this study is to demonstrate that vaccination with QIVc elicits an immune response that is noninferior to that of a US-licensed comparator QIV containing the same virus strains, in children 6 months through 47 months of age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QIVc | Experimental | Cell-derived Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains |
|
| Comparator QIV | Active Comparator | Comparator Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QIVc | Biological | Previously vaccinated subjects received a 0.5 mL intramuscular dose of QIVc on Day 1; not previously vaccinated subjects received a 0.5 mL intramuscular dose of QIVc on Day 1 and Day 29. |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity Endpoint: Geometric Mean Titer (GMT) and GMT Ratio Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HAI) Assay Using Cell-derived Target Viruses | The GMT ratio is defined as the geometric mean of the postvaccination (28 days after last vaccination) HAI titer for the Comparator QIV divided by the geometric mean of the postvaccination HAI titer for QIVc. | Day 29 for previously vaccinated subjects; Day 57 for not previously vaccinated subjects |
| Immunogenicity Endpoint: Seroconversion Rates (SCR) and Differences in SCR Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HAI Assay Using Cell-derived Target Viruses | The SCR is defined as the percentage of subjects with either a prevaccination HAI titer <1:10 and a postvaccination HAI titer ≥1:40, or a prevaccination HAI titer ≥1:10 and a ≥4-fold increase in postvaccination HAI titer. The SCR difference is defined as the Comparator QIV SCR minus the QIVc SCR. | Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects |
| Immunogenicity Endpoint: GMT and GMT Ratio Against the A/H3N2 Vaccine Strain by Microneutralization (MN) Assay Using Cell-derived Target Viruses | The GMT ratio is defined as the geometric mean of the postvaccination (28 days after last vaccination) MN titer for the Comparator QIV divided by the geometric mean of the postvaccination MN titer for QIVc. | Day 29 for previously vaccinated subjects; Day 57 for not previously vaccinated subjects |
| Immunogenicity Endpoint: SCR and Difference in SCR Against the A/H3N2 Vaccine Strain by MN Assay Using Cell-derived Target Viruses | The SCR is defined as the percentage of subjects with either a prevaccination MN titer <1:10 and a postvaccination MN titer ≥1:40, or a prevaccination MN titer ≥1:10 and a ≥4-fold increase in postvaccination MN titer. The SCR difference is defined as the Comparator QIV SCR minus the QIVc SCR. |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity Endpoint: GMT and GMT Ratio Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HAI Assay Using Egg-derived Target Viruses | The GMT ratio is defined as the geometric mean of the postvaccination (28 days after last vaccination) HAI titer for the Comparator QIV divided by the geometric mean of the postvaccination HAI titer for QIVc. | Day 1 and Day 29 for previously vaccinated subjects; Day 1 and Day 57 for not previously vaccinated subjects |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Program Director | Seqirus | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 84035 CCR Research | Mobile | Alabama | 36608 | United States | ||
| 84040 Southland Clnical Research Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36214072 | Derived | Essink BJ, Heeringa M, Jeanfreau RJ, Finn D, Matassa V, Edelman J, Hohenboken M, Molrine D. Safety and Immunogenicity of Cell-Based Quadrivalent Influenza Vaccine: A Randomized Trial. Pediatrics. 2022 Nov 1;150(5):e2022057509. doi: 10.1542/peds.2022-057509. |
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In total, 2414 subjects were enrolled in the study.
Subjects were enrolled in the 2019/2020 Northern Hemisphere influenza season from 47 centers in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | QIVc | Cell-derived Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains |
| FG001 | Comparator QIV | Comparator Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 9, 2019 | Aug 23, 2021 |
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The trial is designed as an observer-blind study. During the treatment period of the study designated unblinded nurse(s), physician(s), or other qualified health care professional will be responsible for administering the study vaccine to the subjects.
|
| Comparator QIV | Biological | Previously vaccinated subjects received a dose of Comparator QIV on Day 1; not previously vaccinated subjects received a dose of Comparator QIV on Day 1 and Day 29. Subjects 6 months through 35 months of age received a 0.25 mL intramuscular dose of Comparator QIV; subjects 36 months through 47 months of age received a 0.5 mL intramuscular dose of Comparator QIV. |
|
|
| Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects |
| Immunogenicity Endpoint: SCR and Difference in SCR Against the A/H1N1, B/Victoria and B/ Yamagata Vaccine Strains by HAI Assay Using Egg-derived Target Viruses | The SCR is defined as the percentage of subjects with either a prevaccination HAI titer <1:10 and a postvaccination HAI titer ≥1:40, or a prevaccination HAI titer ≥1:10 and a ≥4-fold increase in postvaccination HAI titer. The SCR difference is defined as the Comparator QIV SCR minus the QIVc SCR. | Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects |
| Immunogenicity Endpoint: GMT and GMT Ratio Against the A/H3N2 Vaccine Strain by MN Assay Using Egg-derived Target Viruses | The GMT ratio is defined as the geometric mean of the postvaccination (28 days after last vaccination) MN titer for the Comparator QIV divided by the geometric mean of the postvaccination MN titer for QIVc. | Day 1 and Day 29 for previously vaccinated subjects; Day 1 and Day 57 for not previously vaccinated subjects |
| Immunogenicity Endpoint: SCR and Difference in SCR Against the A/H3N2 Vaccine Strain by MN Assay Using Egg-derived Target Viruses | The SCR is defined as the percentage of subjects with either a prevaccination MN titer <1:10 and a postvaccination MN titer ≥1:40, or a prevaccination MN titer ≥1:10 and a ≥4-fold increase in postvaccination MN titer. The SCR difference is defined as the Comparator QIV SCR minus the QIVc SCR. | Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects |
| Immunogenicity Endpoint: Geometric Mean Ratio (GMR) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HAI Assay Using Cell-derived and Egg-derived Target Viruses | GMR is defined as the geometric mean of the (within-subject) fold increase in serum HAI GMT postvaccination (Day 29/57) compared to prevaccination (Day 1). | Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects |
| Immunogenicity Endpoint: GMR Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by MN Assay Using Cell-derived and Egg-derived Target Viruses | GMR is defined as the geometric mean of the (within-subject) fold increase in serum MN GMT postvaccination (Day 29/57) compared to prevaccination (Day 1). | Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects |
| Immunogenicity Endpoint: GMR Against the A/H3N2 Vaccine Strain by MN Assay Using Cell-derived and Egg-derived Target Viruses | GMR is defined as the geometric mean of the (within-subject) fold increase in serum MN GMT postvaccination (Day 29/57) compared to prevaccination (Day 1). | Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects |
| Safety Endpoint: Percentage of Subjects With Solicited Adverse Events (AEs) | The percentage of subjects with at least one solicited AE Day 1 through Day 7 after any study vaccination. | Day 1 to Day 7 after each vaccination (Day 1 to Day 7 for previously vaccinated subjects; Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects) |
| Safety Endpoint: Percentage of Subjects With Any Unsolicited AEs | The percentage of subjects with at least one unsolicited AE from Day 1 to Day 29 for previously vaccinated subjects and from Day 1 to Day 57 for not previously vaccinated subjects. Related AEs = considered at least possibly related to study vaccination by the investigator; Severity = based on the greatest severity associated with a preferred term for a reported AE. | Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects |
| Safety Endpoint: Percentage of Subjects With Any Serious Adverse Events (SAEs), New Onset of Chronic Disease (NOCD) or AEs Leading to Withdrawal During the Entire Study Period | The percentage of subjects with any SAE, NOCD or AE leading to withdrawal during the study period from Day 1 to Day 181 for previously vaccinated subjects or from Day 1 to Day 209 for not previously vaccinated subjects. Definitions: SAEs = AEs defined as any untoward medical occurrence that at any dose resulted in one or more of the following: 1. Death, 2. Life-threatening 3. Required/prolonged hospitalization 4. Persistent or significant disability/incapacity 5. congenital anomaly/or birth defect 6. An important and significant medical event that may not be immediately life threatening or resulting in death or hospitalization but, based on appropriate medical judgment, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above | Day 1 to Day 181 for previously vaccinated subjects; Day 1 to Day 209 for not previously vaccinated subjects |
| Anaheim |
| California |
| 92804 |
| United States |
| 84044 Premier Health Research Center | Downey | California | 90240 | United States |
| 84028 Orange County Research Institute | Ontario | California | 91763 | United States |
| 84029 Center for Clinical Trials | Paramount | California | 90723 | United States |
| 84012 Benchmark Research | Sacramento | California | 95864 | United States |
| 84006 California Research Foundation | San Diego | California | 92123-1881 | United States |
| 84001 Acevedo Clincal Research Associates | Miami | Florida | 33142 | United States |
| 84005 Sunshine Research Center | Opa-locka | Florida | 33054 | United States |
| 84052 Tekton Research | Chamblee | Georgia | 30341 | United States |
| 84036 Advanced Clinical Research | Meridian | Idaho | 83642 | United States |
| 84027 Heartland Research Associates | El Dorado | Kansas | 67042 | United States |
| 84020 Heartland Research Associates | Newton | Kansas | 67114 | United States |
| 84014 Heartland Research Associates | Wichita | Kansas | 67205 | United States |
| 84026 Heartland Research Associates | Wichita | Kansas | 67207 | United States |
| 84041 Kentucky Pediatric/ Adult Research | Bardstown | Kentucky | 40004 | United States |
| 84009 Bluegrass Clinical Research Inc. | Louisville | Kentucky | 40291 | United States |
| 84008 Meridian Clinical Research | Baton Rouge | Louisiana | 70806 | United States |
| 84046 ACC Pediatric Research | Haughton | Louisiana | 71037 | United States |
| 84004 Benchmark Research | Metairie | Louisiana | 70006 | United States |
| 84022 Med Pharmics | Metairie | Louisiana | 70006 | United States |
| 84053 MedPharmics | Gulfport | Mississippi | 39503 | United States |
| 84051 Office of Craig A. Spiegel | Bridgeton | Missouri | 63044 | United States |
| 84016 Center for Pharmaceutical Research | Kansas City | Missouri | 64114 | United States |
| 84037 Meridian Clinical Research | Norfolk | Nebraska | 68701 | United States |
| 84017 Meridian Clinical Research | Omaha | Nebraska | 68116 | United States |
| 84033 Med Pharmics | Albuquerque | New Mexico | 87102 | United States |
| 84013 Regional Clinical Research | Binghamton | New York | 13901 | United States |
| 84045 Dayton Clinical | Dayton | Ohio | 45406 | United States |
| 84003 PriMed Clinical Research | Dayton | Ohio | 45419 | United States |
| 84015 Meridian Clinical Research | Dakota Dunes | South Dakota | 57049 | United States |
| 84032 Clinical Research Associates | Nashville | Tennessee | 37203 | United States |
| 84007 Benchmark Research | Austin | Texas | 78705 | United States |
| 84023 Ventavia Research Group | Fort Worth | Texas | 76104 | United States |
| 84042 Universtiy of North Texas Health Science Center | Fort Worth | Texas | 76107 | United States |
| 84043 Benchmark Research | Fort Worth | Texas | 76135 | United States |
| 84047 Ventavia Research Group | Houston | Texas | 77008 | United States |
| 84011 West Houston Clinical Research | Houston | Texas | 77055 | United States |
| 84019 Ventavia Research Group | Keller | Texas | 76248 | United States |
| 84021 Benchmark Research | San Angelo | Texas | 76904 | United States |
| 84002 Tekton Research | San Antonio | Texas | 78240 | United States |
| 84025 Pediatric Healthcare of NW Houston | Tomball | Texas | 77375 | United States |
| 84018 Tanner Clinic | Layton | Utah | 84041 | United States |
| 84050 JBR Clinical Research Group | Salt Lake City | Utah | 84107 | United States |
| 84048 J. Lewis Research/Foothill Family Clinic South | Salt Lake City | Utah | 84121 | United States |
| 84031 Advanced Clinical Research | West Jordan | Utah | 84088 | United States |
| 84039 Pediatric Research of Charlottesville | Charlottesville | Virginia | 22902 | United States |
| Received Study Vaccine |
|
| COMPLETED |
|
| NOT COMPLETED |
|
Full Analysis Set (FAS), defined as all enrolled subjects who were randomized and received a study vaccination.
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| ID | Title | Description |
|---|---|---|
| BG000 | QIVc | Cell-derived Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains |
| BG001 | Comparator QIV | Comparator Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains |
| BG002 | Total | Total of all reporting groups |
| 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 | Participants |
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| Age, Continuous | Mean | Standard Deviation | months |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
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| 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 | Immunogenicity Endpoint: Geometric Mean Titer (GMT) and GMT Ratio Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HAI) Assay Using Cell-derived Target Viruses | The GMT ratio is defined as the geometric mean of the postvaccination (28 days after last vaccination) HAI titer for the Comparator QIV divided by the geometric mean of the postvaccination HAI titer for QIVc. | Per Protocol Set (PPS): All subjects in the FAS who received vaccine on Day 1, provided serology specimens which yielded valid serology assay results from both Day 1 and Day 29 (previously vaccinated subjects) or Day 1 and Day 57 (not previously vaccinated subjects) and for whom there was no protocol deviation that was medically assessed as having potential to impact the immunogenicity results. 1092 and 575 subjects in the QIVc and Comparator QIV groups had HAI assay data for this outcome. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Day 29 for previously vaccinated subjects; Day 57 for not previously vaccinated subjects |
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| Primary | Immunogenicity Endpoint: Seroconversion Rates (SCR) and Differences in SCR Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HAI Assay Using Cell-derived Target Viruses | The SCR is defined as the percentage of subjects with either a prevaccination HAI titer <1:10 and a postvaccination HAI titer ≥1:40, or a prevaccination HAI titer ≥1:10 and a ≥4-fold increase in postvaccination HAI titer. The SCR difference is defined as the Comparator QIV SCR minus the QIVc SCR. | PPS (1092 and 575 subjects in the QIVc and Comparator QIV groups, respectively, had HAI assay data for this outcome) | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects |
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| Primary | Immunogenicity Endpoint: GMT and GMT Ratio Against the A/H3N2 Vaccine Strain by Microneutralization (MN) Assay Using Cell-derived Target Viruses | The GMT ratio is defined as the geometric mean of the postvaccination (28 days after last vaccination) MN titer for the Comparator QIV divided by the geometric mean of the postvaccination MN titer for QIVc. | PPS (1078 and 572 subjects in the QIVc and Comparator QIV groups, respectively, had MN assay data for this outcome) | Posted | Geometric Mean | 95% Confidence Interval | Titer | Day 29 for previously vaccinated subjects; Day 57 for not previously vaccinated subjects |
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| Primary | Immunogenicity Endpoint: SCR and Difference in SCR Against the A/H3N2 Vaccine Strain by MN Assay Using Cell-derived Target Viruses | The SCR is defined as the percentage of subjects with either a prevaccination MN titer <1:10 and a postvaccination MN titer ≥1:40, or a prevaccination MN titer ≥1:10 and a ≥4-fold increase in postvaccination MN titer. The SCR difference is defined as the Comparator QIV SCR minus the QIVc SCR. | PPS (1078 and 572 subjects in the QIVc and Comparator QIV groups, respectively, had MN assay data for this outcome) | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects |
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| Secondary | Immunogenicity Endpoint: GMT and GMT Ratio Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HAI Assay Using Egg-derived Target Viruses | The GMT ratio is defined as the geometric mean of the postvaccination (28 days after last vaccination) HAI titer for the Comparator QIV divided by the geometric mean of the postvaccination HAI titer for QIVc. | PPS (1092 and 575 subjects in the QIVc and Comparator QIV groups, respectively, had HAI assay data for this outcome) | Posted | Geometric Mean | 95% Confidence Interval | Titer | Day 1 and Day 29 for previously vaccinated subjects; Day 1 and Day 57 for not previously vaccinated subjects |
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| Secondary | Immunogenicity Endpoint: SCR and Difference in SCR Against the A/H1N1, B/Victoria and B/ Yamagata Vaccine Strains by HAI Assay Using Egg-derived Target Viruses | The SCR is defined as the percentage of subjects with either a prevaccination HAI titer <1:10 and a postvaccination HAI titer ≥1:40, or a prevaccination HAI titer ≥1:10 and a ≥4-fold increase in postvaccination HAI titer. The SCR difference is defined as the Comparator QIV SCR minus the QIVc SCR. | PPS (1092 and 575 subjects in the QIVc and Comparator QIV groups, respectively, had HAI assay data for this outcome) | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects |
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| Secondary | Immunogenicity Endpoint: GMT and GMT Ratio Against the A/H3N2 Vaccine Strain by MN Assay Using Egg-derived Target Viruses | The GMT ratio is defined as the geometric mean of the postvaccination (28 days after last vaccination) MN titer for the Comparator QIV divided by the geometric mean of the postvaccination MN titer for QIVc. | PPS (1079 and 572 subjects in the QIVc and Comparator QIV groups, respectively, had MN assay data for this outcome) | Posted | Geometric Mean | 95% Confidence Interval | Titer | Day 1 and Day 29 for previously vaccinated subjects; Day 1 and Day 57 for not previously vaccinated subjects |
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| Secondary | Immunogenicity Endpoint: SCR and Difference in SCR Against the A/H3N2 Vaccine Strain by MN Assay Using Egg-derived Target Viruses | The SCR is defined as the percentage of subjects with either a prevaccination MN titer <1:10 and a postvaccination MN titer ≥1:40, or a prevaccination MN titer ≥1:10 and a ≥4-fold increase in postvaccination MN titer. The SCR difference is defined as the Comparator QIV SCR minus the QIVc SCR. | PPS (1079 and 572 subjects in the QIVc and Comparator QIV groups, respectively, had MN assay data for this outcome) | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects |
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| Secondary | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HAI Assay Using Cell-derived and Egg-derived Target Viruses | GMR is defined as the geometric mean of the (within-subject) fold increase in serum HAI GMT postvaccination (Day 29/57) compared to prevaccination (Day 1). | PPS (1092 and 575 subjects in the QIVc and Comparator QIV groups, respectively, had HAI assay data for this outcome) | Posted | Number | 95% Confidence Interval | Geometric mean ratio | Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects |
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| Secondary | Immunogenicity Endpoint: GMR Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by MN Assay Using Cell-derived and Egg-derived Target Viruses | GMR is defined as the geometric mean of the (within-subject) fold increase in serum MN GMT postvaccination (Day 29/57) compared to prevaccination (Day 1). | PPS (A randomly selected subset of subjects; 195 and 122 subjects in the QIVc and Comparator QIV groups, respectively, had MN assay data for this outcome) The MN assays for A/H1N1, B/Yamagata, and B/Victoria strains were only evaluated for cell-derived target viruses. Data were not collected for egg-derived target viruses. | Posted | Number | 95% Confidence Interval | Geometric mean ratio | Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects |
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| Secondary | Immunogenicity Endpoint: GMR Against the A/H3N2 Vaccine Strain by MN Assay Using Cell-derived and Egg-derived Target Viruses | GMR is defined as the geometric mean of the (within-subject) fold increase in serum MN GMT postvaccination (Day 29/57) compared to prevaccination (Day 1). | PPS (1078 and 572 subjects in the QIVc and Comparator QIV groups, respectively, had MN assay data for the outcome of GMR against the A/H3N2 vaccine strain by MN assay using cell-derived target viruses; 1079 and 572 subjects in the QIVc and Comparator QIV groups, respectively, had data for the outcome of GMR against the A/H3N2 vaccine strain by MN assay using egg-derived target viruses) | Posted | Number | 95% Confidence Interval | Geometric mean ratio | Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects |
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| Secondary | Safety Endpoint: Percentage of Subjects With Solicited Adverse Events (AEs) | The percentage of subjects with at least one solicited AE Day 1 through Day 7 after any study vaccination. | Solicited Safety Set, defined as all subjects in the FAS with any solicited AE data. | Posted | Count of Participants | Participants | Day 1 to Day 7 after each vaccination (Day 1 to Day 7 for previously vaccinated subjects; Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects) |
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| Secondary | Safety Endpoint: Percentage of Subjects With Any Unsolicited AEs | The percentage of subjects with at least one unsolicited AE from Day 1 to Day 29 for previously vaccinated subjects and from Day 1 to Day 57 for not previously vaccinated subjects. Related AEs = considered at least possibly related to study vaccination by the investigator; Severity = based on the greatest severity associated with a preferred term for a reported AE. | Unsolicited Safety Set, defined as all subjects in the FAS with any unsolicited AE data. | Posted | Count of Participants | Participants | Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects |
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| Secondary | Safety Endpoint: Percentage of Subjects With Any Serious Adverse Events (SAEs), New Onset of Chronic Disease (NOCD) or AEs Leading to Withdrawal During the Entire Study Period | The percentage of subjects with any SAE, NOCD or AE leading to withdrawal during the study period from Day 1 to Day 181 for previously vaccinated subjects or from Day 1 to Day 209 for not previously vaccinated subjects. Definitions: SAEs = AEs defined as any untoward medical occurrence that at any dose resulted in one or more of the following: 1. Death, 2. Life-threatening 3. Required/prolonged hospitalization 4. Persistent or significant disability/incapacity 5. congenital anomaly/or birth defect 6. An important and significant medical event that may not be immediately life threatening or resulting in death or hospitalization but, based on appropriate medical judgment, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above | Unsolicited Safety Set | Posted | Count of Participants | Participants | Day 1 to Day 181 for previously vaccinated subjects; Day 1 to Day 209 for not previously vaccinated subjects |
|
SAEs: Day 1 to Day 181 for previously vaccinated subjects; Day 1 to Day 209 for not previously vaccinated subjects Nonserious unsolicited AEs: Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects Solicited AEs: Day 1 to Day 7 after each vaccination (Day 1 to Day 7 for previously vaccinated subjects; Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects)
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section.
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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 | QIVc | Cell-derived Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains | 2 | 1,597 | 15 | 1,597 | 926 | 1,597 |
| EG001 | Comparator QIV | Comparator Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains | 0 | 805 | 7 | 805 | 490 | 805 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Seizure | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Unresponsive to stimuli | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Volvulus | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Ligamentitis | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
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| Bronchiolitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Rhinovirus infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Abscess of eyelid | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Adenoviral encephalitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Enterovirus infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Metapneumovirus infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Pneumonia bacterial | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Respiratory syncytial virus bronchiolitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Respiratory syncytial virus infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Injection site induration | General disorders | Solicited AE | Systematic Assessment |
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| Injection site erythema | General disorders | Solicited AE | Systematic Assessment |
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| Injection site ecchymosis | General disorders | Solicited AE | Systematic Assessment |
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| Injection site tenderness | General disorders | Solicited AE | Systematic Assessment |
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| Change of eating habits | Metabolism and nutrition disorders | Solicited AE | Systematic Assessment |
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| Sleepiness | Nervous system disorders | Solicited AE | Systematic Assessment |
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| Vomiting/throwing up | Gastrointestinal disorders | Solicited AE | Systematic Assessment |
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| Diarrhea/loose stools | Gastrointestinal disorders | Solicited AE | Systematic Assessment |
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| Irritability | Psychiatric disorders | Solicited AE | Systematic Assessment |
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| Fever (≥38.0°C) | General disorders | Solicited AE | Systematic Assessment |
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Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Seqirus Clinical Trial Manager | Seqirus | 1-855-358-8966 | seqirus.clinicaltrials@Seqirus.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 13, 2020 | Aug 23, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D014777 | Virus Diseases |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| Other |
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| B/Victoria |
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| Non-inferiority, B/Yamagata, GMT ratio, Day 29/57 Non-inferiority of the Day 29/57 immune response to the B/Yamagata vaccine strain calculated by GMT ratio (Comparator QIV GMT divided by QIVc GMT) | GMT ratio | 0.73 | 2-Sided | 95 | 0.656 | 0.809 | Non-Inferiority | The non-inferiority criterion was that the upper limit of the 2-sided 95% CI did not exceed the prespecified non-inferiority margin of 1.5 for the Day 29/57 GMT ratio (adjusted analysis). |
| Non-inferiority, B/Victoria, GMT ratio, Day 29/57 Non-inferiority of the Day 29/57 immune response to the B/Victoria vaccine strain calculated by GMT ratio (Comparator QIV GMT divided by QIVc GMT) | GMT ratio | 0.88 | 2-Sided | 95 | 0.791 | 0.972 | Non-Inferiority | The non-inferiority criterion was that the upper limit of the 2-sided 95% CI did not exceed the prespecified non-inferiority margin of 1.5 for the Day 29/57 GMT ratio (adjusted analysis). |
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