Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects
Sponsor
Seqirus (Industry)
Overall Status
Completed
CT.gov ID
NCT04074928
Collaborator
(none)
2,414
47
2
11.9
51.4
4.3
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
2414 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
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.
Primary Purpose:
Prevention
Official Title:
A Phase 3, Randomized, Observer-Blind, Multicenter, Noninferiority Study to Evaluate Safety and Immunogenicity of a Cell-Based Quadrivalent Subunit Influenza Virus Vaccine (QIVc) and a United States Licensed Quadrivalent Influenza Virus Vaccine (QIV) in Healthy Subjects 6 Months Through 47 Months
Actual Study Start Date
:
Sep 6, 2019
Actual Primary Completion Date
:
Sep 3, 2020
Actual Study Completion Date
:
Sep 3, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: QIVc Cell-derived Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains |
Biological: QIVc
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.
Other Names:
|
| Active Comparator: Comparator QIV Comparator Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains |
Biological: Comparator QIV
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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 [Day 29 for previously vaccinated subjects; Day 57 for not previously vaccinated subjects]
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.
- 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 [Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects]
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.
- Immunogenicity Endpoint: GMT and GMT Ratio Against the A/H3N2 Vaccine Strain by Microneutralization (MN) Assay Using Cell-derived Target Viruses [Day 29 for previously vaccinated subjects; Day 57 for not previously vaccinated subjects]
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.
- Immunogenicity Endpoint: SCR and Difference in SCR Against the A/H3N2 Vaccine Strain by MN Assay Using Cell-derived Target Viruses [Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects]
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.
Secondary Outcome Measures
- 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 [Day 1 and Day 29 for previously vaccinated subjects; Day 1 and Day 57 for not previously vaccinated subjects]
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.
- 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 [Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects]
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.
- Immunogenicity Endpoint: GMT and GMT Ratio Against the A/H3N2 Vaccine Strain by MN Assay Using Egg-derived Target Viruses [Day 1 and Day 29 for previously vaccinated subjects; Day 1 and Day 57 for not previously vaccinated subjects]
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.
- Immunogenicity Endpoint: SCR and Difference in SCR Against the A/H3N2 Vaccine Strain by MN Assay Using Egg-derived Target Viruses [Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects]
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.
- 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 [Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects]
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).
- 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 [Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects]
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).
- Immunogenicity Endpoint: GMR Against the A/H3N2 Vaccine Strain by MN Assay Using Cell-derived and Egg-derived Target Viruses [Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects]
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).
- Safety Endpoint: Percentage of Subjects With Solicited Adverse Events (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)]
The percentage of subjects with at least one solicited AE Day 1 through Day 7 after any study vaccination.
- Safety Endpoint: Percentage of Subjects With Any Unsolicited AEs [Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects]
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.
- 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 [Day 1 to Day 181 for previously vaccinated subjects; Day 1 to Day 209 for not previously vaccinated subjects]
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
Eligibility Criteria
Criteria
Ages Eligible for Study:
6 Months
to 47 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Individuals of 6 through 47 months of age on the day of informed consent.
-
Individuals whose parent(s)/Legally Acceptable Representative (LAR) have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
-
Individuals who can comply with study procedures including follow-up
-
Individual is in generally good health as per the Investigator's medical judgement
Exclusion Criteria:
-
Acute (severe) febrile illness
-
History of any anaphylaxis, serious vaccine reactions or hypersensitivity, including allergic reactions, to any component of vaccine or medical equipment whose use is foreseen in this study
-
A known history of Guillain-Barre Syndrome or other demyelinating diseases such as encephalomyelitis and transverse myelitis
-
Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study
-
Received influenza vaccination or has had documented influenza disease in the last 6 months prior to informed consent.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 84035 CCR Research | Mobile | Alabama | United States | 36608 |
| 2 | 84040 Southland Clnical Research Center | Anaheim | California | United States | 92804 |
| 3 | 84044 Premier Health Research Center | Downey | California | United States | 90240 |
| 4 | 84028 Orange County Research Institute | Ontario | California | United States | 91763 |
| 5 | 84029 Center for Clinical Trials | Paramount | California | United States | 90723 |
| 6 | 84012 Benchmark Research | Sacramento | California | United States | 95864 |
| 7 | 84006 California Research Foundation | San Diego | California | United States | 92123-1881 |
| 8 | 84001 Acevedo Clincal Research Associates | Miami | Florida | United States | 33142 |
| 9 | 84005 Sunshine Research Center | Opa-locka | Florida | United States | 33054 |
| 10 | 84052 Tekton Research | Chamblee | Georgia | United States | 30341 |
| 11 | 84036 Advanced Clinical Research | Meridian | Idaho | United States | 83642 |
| 12 | 84027 Heartland Research Associates | El Dorado | Kansas | United States | 67042 |
| 13 | 84020 Heartland Research Associates | Newton | Kansas | United States | 67114 |
| 14 | 84014 Heartland Research Associates | Wichita | Kansas | United States | 67205 |
| 15 | 84026 Heartland Research Associates | Wichita | Kansas | United States | 67207 |
| 16 | 84041 Kentucky Pediatric/ Adult Research | Bardstown | Kentucky | United States | 40004 |
| 17 | 84009 Bluegrass Clinical Research Inc. | Louisville | Kentucky | United States | 40291 |
| 18 | 84008 Meridian Clinical Research | Baton Rouge | Louisiana | United States | 70806 |
| 19 | 84046 ACC Pediatric Research | Haughton | Louisiana | United States | 71037 |
| 20 | 84004 Benchmark Research | Metairie | Louisiana | United States | 70006 |
| 21 | 84022 Med Pharmics | Metairie | Louisiana | United States | 70006 |
| 22 | 84053 MedPharmics | Gulfport | Mississippi | United States | 39503 |
| 23 | 84051 Office of Craig A. Spiegel | Bridgeton | Missouri | United States | 63044 |
| 24 | 84016 Center for Pharmaceutical Research | Kansas City | Missouri | United States | 64114 |
| 25 | 84037 Meridian Clinical Research | Norfolk | Nebraska | United States | 68701 |
| 26 | 84017 Meridian Clinical Research | Omaha | Nebraska | United States | 68116 |
| 27 | 84033 Med Pharmics | Albuquerque | New Mexico | United States | 87102 |
| 28 | 84013 Regional Clinical Research | Binghamton | New York | United States | 13901 |
| 29 | 84045 Dayton Clinical | Dayton | Ohio | United States | 45406 |
| 30 | 84003 PriMed Clinical Research | Dayton | Ohio | United States | 45419 |
| 31 | 84015 Meridian Clinical Research | Dakota Dunes | South Dakota | United States | 57049 |
| 32 | 84032 Clinical Research Associates | Nashville | Tennessee | United States | 37203 |
| 33 | 84007 Benchmark Research | Austin | Texas | United States | 78705 |
| 34 | 84023 Ventavia Research Group | Fort Worth | Texas | United States | 76104 |
| 35 | 84042 Universtiy of North Texas Health Science Center | Fort Worth | Texas | United States | 76107 |
| 36 | 84043 Benchmark Research | Fort Worth | Texas | United States | 76135 |
| 37 | 84047 Ventavia Research Group | Houston | Texas | United States | 77008 |
| 38 | 84011 West Houston Clinical Research | Houston | Texas | United States | 77055 |
| 39 | 84019 Ventavia Research Group | Keller | Texas | United States | 76248 |
| 40 | 84021 Benchmark Research | San Angelo | Texas | United States | 76904 |
| 41 | 84002 Tekton Research | San Antonio | Texas | United States | 78240 |
| 42 | 84025 Pediatric Healthcare of NW Houston | Tomball | Texas | United States | 77375 |
| 43 | 84018 Tanner Clinic | Layton | Utah | United States | 84041 |
| 44 | 84050 JBR Clinical Research Group | Salt Lake City | Utah | United States | 84107 |
| 45 | 84048 J. Lewis Research/Foothill Family Clinic South | Salt Lake City | Utah | United States | 84121 |
| 46 | 84031 Advanced Clinical Research | West Jordan | Utah | United States | 84088 |
| 47 | 84039 Pediatric Research of Charlottesville | Charlottesville | Virginia | United States | 22902 |
Sponsors and Collaborators
- Seqirus
Investigators
- Study Director: Clinical Program Director, Seqirus
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Seqirus
ClinicalTrials.gov Identifier:
NCT04074928
Other Study ID Numbers:
- V130_10
- 2020-002785-13
First Posted:
Aug 30, 2019
Last Update Posted:
Jan 12, 2022
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Seqirus
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Subjects were enrolled in the 2019/2020 Northern Hemisphere influenza season from 47 centers in the United States. |
|---|---|
| Pre-assignment Detail | In total, 2414 subjects were enrolled in the study. |
| Arm/Group Title | QIVc | Comparator QIV |
|---|---|---|
| Arm/Group Description | Cell-derived Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains | Comparator Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains |
| Period Title: Overall Study | ||
| STARTED | 1605 | 809 |
| Received Study Vaccine | 1597 | 805 |
| COMPLETED | 1370 | 710 |
| NOT COMPLETED | 235 | 99 |
Baseline Characteristics
| Arm/Group Title | QIVc | Comparator QIV | Total |
|---|---|---|---|
| Arm/Group Description | Cell-derived Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains | Comparator Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains | Total of all reporting groups |
| Overall Participants | 1597 | 805 | 2402 |
| Age (Count of Participants) | |||
| <=18 years |
1597
100%
|
805
100%
|
2402
100%
|
| Between 18 and 65 years |
0
0%
|
0
0%
|
0
0%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
| Age (months) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [months] |
28.1
(11.54)
|
28.2
(11.63)
|
28.1
(11.57)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
794
49.7%
|
399
49.6%
|
1193
49.7%
|
| Male |
803
50.3%
|
406
50.4%
|
1209
50.3%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
434
27.2%
|
226
28.1%
|
660
27.5%
|
| Not Hispanic or Latino |
1160
72.6%
|
575
71.4%
|
1735
72.2%
|
| Unknown or Not Reported |
3
0.2%
|
4
0.5%
|
7
0.3%
|
| Race/Ethnicity, Customized (Count of Participants) | |||
| American Indian or Alaska Native |
11
0.7%
|
11
1.4%
|
22
0.9%
|
| Asian |
13
0.8%
|
8
1%
|
21
0.9%
|
| Native Hawaiian or Other Pacific Islander |
8
0.5%
|
6
0.7%
|
14
0.6%
|
| Black or African American |
455
28.5%
|
209
26%
|
664
27.6%
|
| White |
1039
65.1%
|
539
67%
|
1578
65.7%
|
| Other |
71
4.4%
|
32
4%
|
103
4.3%
|
| Region of Enrollment (Count of Participants) | |||
| United States |
1597
100%
|
805
100%
|
2402
100%
|
Outcome Measures
| Title | 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 |
|---|---|
| Description | 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. |
| Time Frame | Day 29 for previously vaccinated subjects; Day 57 for not previously vaccinated subjects |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | QIVc | Comparator QIV |
|---|---|---|
| Arm/Group Description | Cell-derived Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains | Comparator Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains |
| Measure Participants | 1092 | 575 |
| A/H1N1 |
78.0
|
57.3
|
| B/Yamagata |
35.6
|
26.0
|
| B/Victoria |
22.4
|
19.6
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | QIVc, Comparator QIV |
|---|---|---|
| Comments | Non-inferiority, A/H1N1, GMT ratio, Day 29/57 Non-inferiority of the Day 29/57 immune response to the A/H1N1 vaccine strain calculated by GMT ratio (Comparator QIV GMT divided by QIVc GMT) | |
| Type of Statistical Test | Non-Inferiority | |
| Comments | 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). | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | GMT ratio |
| Estimated Value | 0.73 | |
| Confidence Interval |
(2-Sided) 95% 0.645 to 0.836 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | QIVc, Comparator QIV |
|---|---|---|
| Comments | 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) | |
| Type of Statistical Test | Non-Inferiority | |
| Comments | 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). | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | GMT ratio |
| Estimated Value | 0.73 | |
| Confidence Interval |
(2-Sided) 95% 0.656 to 0.809 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | QIVc, Comparator QIV |
|---|---|---|
| Comments | 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) | |
| Type of Statistical Test | Non-Inferiority | |
| Comments | 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). | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | GMT ratio |
| Estimated Value | 0.88 | |
| Confidence Interval |
(2-Sided) 95% 0.791 to 0.972 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | 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 |
|---|---|
| Description | 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. |
| Time Frame | Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects |
Outcome Measure Data
| Analysis Population Description |
|---|
| PPS (1092 and 575 subjects in the QIVc and Comparator QIV groups, respectively, had HAI assay data for this outcome) |
| Arm/Group Title | QIVc | Comparator QIV |
|---|---|---|
| Arm/Group Description | Cell-derived Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains | Comparator Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains |
| Measure Participants | 1092 | 575 |
| A/H1N1 |
58.24
3.6%
|
46.78
5.8%
|
| B/Yamagata |
46.52
2.9%
|
31.65
3.9%
|
| B/Victoria |
30.31
1.9%
|
24.35
3%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | QIVc, Comparator QIV |
|---|---|---|
| Comments | Non-inferiority, A/H1N1, SCR difference, Day 29/57 Non-inferiority of the immune response to the A/H1N1 vaccine strain by SCR difference (Comparator QIV SCR minus QIVc SCR) | |
| Type of Statistical Test | Non-Inferiority | |
| Comments | The non-inferiority criterion was that the upper limit of the 2-sided 95% CI did not exceed the prespecified non-inferiority margin of 10% for the Day 29/57 SCR difference. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | SCR difference |
| Estimated Value | -11.46 | |
| Confidence Interval |
(2-Sided) 95% -16.447 to -6.423 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | QIVc, Comparator QIV |
|---|---|---|
| Comments | Non-inferiority, B/Yamagata, SCR difference, Day 29/57 Non-inferiority of the immune response to the B/Yamagata vaccine strain by SCR difference (Comparator QIV SCR minus QIVc SCR) | |
| Type of Statistical Test | Non-Inferiority | |
| Comments | The non-inferiority criterion was that the upper limit of the 2-sided 95% CI did not exceed the prespecified non-inferiority margin of 10% for the Day 29/57 SCR difference. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | SCR difference |
| Estimated Value | -14.87 | |
| Confidence Interval |
(2-Sided) 95% -19.610 to -9.983 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | QIVc, Comparator QIV |
|---|---|---|
| Comments | Non-inferiority, B/Victoria, SCR difference, Day 29/57 Non-inferiority of the immune response to the B/Victoria vaccine strain by SCR difference (Comparator QIV SCR minus QIVc SCR) | |
| Type of Statistical Test | Non-Inferiority | |
| Comments | The non-inferiority criterion was that the upper limit of the 2-sided 95% CI did not exceed the prespecified non-inferiority margin of 10% for the Day 29/57 SCR difference. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | SCR difference |
| Estimated Value | -5.96 | |
| Confidence Interval |
(2-Sided) 95% -10.327 to -1.440 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Immunogenicity Endpoint: GMT and GMT Ratio Against the A/H3N2 Vaccine Strain by Microneutralization (MN) Assay Using Cell-derived Target Viruses |
|---|---|
| Description | 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. |
| Time Frame | Day 29 for previously vaccinated subjects; Day 57 for not previously vaccinated subjects |
Outcome Measure Data
| Analysis Population Description |
|---|
| PPS (1078 and 572 subjects in the QIVc and Comparator QIV groups, respectively, had MN assay data for this outcome) |
| Arm/Group Title | QIVc | Comparator QIV |
|---|---|---|
| Arm/Group Description | Cell-derived Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains | Comparator Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains |
| Measure Participants | 1078 | 572 |
| Geometric Mean (95% Confidence Interval) [Titer] |
23.1
|
23.9
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | QIVc, Comparator QIV |
|---|---|---|
| Comments | Non-inferiority, A/H3N2, GMT ratio, Day 29/57 Non-inferiority of the Day 29/57 immune response to the A/H3N2 vaccine strain calculated by GMT ratio (Comparator QIV GMT divided by QIVc GMT) | |
| Type of Statistical Test | Non-Inferiority | |
| Comments | The noninferiority criterion was that the upper limit of the 2-sided 95% CI did not exceed the prespecified noninferiority margin of 1.5 for the Day 29/57 GMT ratio (adjusted analysis). | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | GMT ratio |
| Estimated Value | 1.04 | |
| Confidence Interval |
(2-Sided) 95% 0.927 to 1.160 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Immunogenicity Endpoint: SCR and Difference in SCR Against the A/H3N2 Vaccine Strain by MN Assay Using Cell-derived Target Viruses |
|---|---|
| Description | 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. |
| Time Frame | Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects |
Outcome Measure Data
| Analysis Population Description |
|---|
| PPS (1078 and 572 subjects in the QIVc and Comparator QIV groups, respectively, had MN assay data for this outcome) |
| Arm/Group Title | QIVc | Comparator QIV |
|---|---|---|
| Arm/Group Description | Cell-derived Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains | Comparator Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains |
| Measure Participants | 1078 | 572 |
| Number (95% Confidence Interval) [Percentage of participants] |
27.64
1.7%
|
30.77
3.8%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | QIVc, Comparator QIV |
|---|---|---|
| Comments | Non-inferiority, A/H3N2, SCR difference, Day 29/57 Non-inferiority of the immune response to the A/H3N2 vaccine strain by SCR difference (Comparator QIV SCR minus QIVc SCR) | |
| Type of Statistical Test | Non-Inferiority | |
| Comments | The non-inferiority criterion was that the upper limit of the 2-sided 95% CI did not exceed the prespecified non-inferiority margin of 10% for the Day 29/57 SCR difference. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | SCR difference |
| Estimated Value | 3.13 | |
| Confidence Interval |
(2-Sided) 95% -1.443 to 7.812 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | 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 |
|---|---|
| Description | 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. |
| Time Frame | Day 1 and Day 29 for previously vaccinated subjects; Day 1 and Day 57 for not previously vaccinated subjects |
Outcome Measure Data
| Analysis Population Description |
|---|
| PPS (1092 and 575 subjects in the QIVc and Comparator QIV groups, respectively, had HAI assay data for this outcome) |
| Arm/Group Title | QIVc | Comparator QIV |
|---|---|---|
| Arm/Group Description | Cell-derived Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains | Comparator Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains |
| Measure Participants | 1092 | 575 |
| A/H1N1 Day 1 HAI GMT |
14.0
|
13.9
|
| A/H1N1 Day 29/57 HAI GMT |
92.2
|
82.9
|
| B/Yamagata Day 1 HAI GMT |
6.7
|
6.7
|
| B/Yamagata Day 29/57 HAI GMT |
23.0
|
24.7
|
| B/Victoria Day 1 HAI GMT |
6.1
|
6.0
|
| B/Victoria Day 29/57 HAI GMT |
13.6
|
14.8
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | QIVc, Comparator QIV |
|---|---|---|
| Comments | A/H1N1, GMT ratio, Day 29/57 | |
| Type of Statistical Test | Other | |
| Comments | No formal statistical testing was planned for this secondary outcome measure. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | GMT ratio |
| Estimated Value | 0.90 | |
| Confidence Interval |
(2-Sided) 95% 0.790 to 1.024 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | QIVc, Comparator QIV |
|---|---|---|
| Comments | B/Yamagata, GMT ratio, Day 29/57 | |
| Type of Statistical Test | Other | |
| Comments | No formal statistical testing was planned for this secondary outcome measure. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | GMT ratio |
| Estimated Value | 1.08 | |
| Confidence Interval |
(2-Sided) 95% 0.968 to 1.195 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | QIVc, Comparator QIV |
|---|---|---|
| Comments | B/Victoria, GMT ratio, Day 29/57 | |
| Type of Statistical Test | Other | |
| Comments | No formal statistical testing was planned for this secondary outcome measure. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | GMT ratio |
| Estimated Value | 1.09 | |
| Confidence Interval |
(2-Sided) 95% 0.986 to 1.202 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | 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 |
|---|---|
| Description | 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. |
| Time Frame | Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects |
Outcome Measure Data
| Analysis Population Description |
|---|
| PPS (1092 and 575 subjects in the QIVc and Comparator QIV groups, respectively, had HAI assay data for this outcome) |
| Arm/Group Title | QIVc | Comparator QIV |
|---|---|---|
| Arm/Group Description | Cell-derived Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains | Comparator Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains |
| Measure Participants | 1092 | 575 |
| A/H1N1 HAI SCR |
58.52
3.7%
|
56.00
7%
|
| B/Yamagata HAI SCR |
38.64
2.4%
|
38.61
4.8%
|
| B/Victoria HAI SCR |
19.69
1.2%
|
20.87
2.6%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | QIVc, Comparator QIV |
|---|---|---|
| Comments | A/H1N1, SCR difference, Day 29/57 | |
| Type of Statistical Test | Other | |
| Comments | No formal statistical testing was planned for this secondary outcome measure. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | SCR difference |
| Estimated Value | -2.52 | |
| Confidence Interval |
(2-Sided) 95% -7.526 to 2.461 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | QIVc, Comparator QIV |
|---|---|---|
| Comments | B/Yamagata, SCR difference, Day 29/57 | |
| Type of Statistical Test | Other | |
| Comments | No formal statistical testing was planned for this secondary outcome measure. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | SCR difference |
| Estimated Value | -0.04 | |
| Confidence Interval |
(2-Sided) 95% -4.912 to 4.911 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | QIVc, Comparator QIV |
|---|---|---|
| Comments | B/Victoria, SCR difference, Day 29/57 | |
| Type of Statistical Test | Other | |
| Comments | No formal statistical testing was planned for this secondary outcome measure. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | SCR difference |
| Estimated Value | 1.18 | |
| Confidence Interval |
(2-Sided) 95% -2.805 to 5.353 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Immunogenicity Endpoint: GMT and GMT Ratio Against the A/H3N2 Vaccine Strain by MN Assay Using Egg-derived Target Viruses |
|---|---|
| Description | 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. |
| Time Frame | Day 1 and Day 29 for previously vaccinated subjects; Day 1 and Day 57 for not previously vaccinated subjects |
Outcome Measure Data
| Analysis Population Description |
|---|
| PPS (1079 and 572 subjects in the QIVc and Comparator QIV groups, respectively, had MN assay data for this outcome) |
| Arm/Group Title | QIVc | Comparator QIV |
|---|---|---|
| Arm/Group Description | Cell-derived Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains | Comparator Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains |
| Measure Participants | 1079 | 572 |
| A/H3N2 Day 1 MN GMT |
12.9
|
12.6
|
| A/H3N2 Day 29/57 MN GMT |
43.4
|
44.7
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | QIVc, Comparator QIV |
|---|---|---|
| Comments | A/H3N2, GMT ratio, Day 29/57 | |
| Type of Statistical Test | Other | |
| Comments | No formal statistical testing was planned for this secondary outcome measure. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | GMT ratio |
| Estimated Value | 1.03 | |
| Confidence Interval |
(2-Sided) 95% 0.914 to 1.165 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Immunogenicity Endpoint: SCR and Difference in SCR Against the A/H3N2 Vaccine Strain by MN Assay Using Egg-derived Target Viruses |
|---|---|
| Description | 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. |
| Time Frame | Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects |
Outcome Measure Data
| Analysis Population Description |
|---|
| PPS (1079 and 572 subjects in the QIVc and Comparator QIV groups, respectively, had MN assay data for this outcome) |
| Arm/Group Title | QIVc | Comparator QIV |
|---|---|---|
| Arm/Group Description | Cell-derived Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains | Comparator Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains |
| Measure Participants | 1079 | 572 |
| Number (95% Confidence Interval) [Percentage of participants] |
37.44
2.3%
|
39.34
4.9%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | QIVc, Comparator QIV |
|---|---|---|
| Comments | A/H3N2, SCR difference, Day 29/57 | |
| Type of Statistical Test | Other | |
| Comments | No formal statistical testing was planned for this secondary outcome measure. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | SCR difference |
| Estimated Value | 1.89 | |
| Confidence Interval |
(2-Sided) 95% -3.006 to 6.856 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | 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 |
|---|---|
| Description | 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). |
| Time Frame | Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects |
Outcome Measure Data
| Analysis Population Description |
|---|
| PPS (1092 and 575 subjects in the QIVc and Comparator QIV groups, respectively, had HAI assay data for this outcome) |
| Arm/Group Title | QIVc | Comparator QIV |
|---|---|---|
| Arm/Group Description | Cell-derived Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains | Comparator Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains |
| Measure Participants | 1092 | 575 |
| A/H1N1 (cell) HAI GMR |
5.34
|
3.97
|
| B/Yamagata (cell) HAI GMR |
4.12
|
3.03
|
| B/Victoria (cell) HAI GMR |
2.65
|
2.31
|
| A/H1N1 (egg) HAI GMR |
5.67
|
5.11
|
| B/Yamagata (egg) HAI GMR |
3.04
|
3.27
|
| B/Victoria (egg) HAI GMR |
2.14
|
2.33
|
| Title | 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 |
|---|---|
| Description | 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). |
| Time Frame | Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | QIVc | Comparator QIV |
|---|---|---|
| Arm/Group Description | Cell-derived Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains | Comparator Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains |
| Measure Participants | 195 | 122 |
| A/H1N1 (cell) MN GMR |
5.74
|
4.29
|
| B/Yamagata (cell) MN GMR |
3.14
|
2.86
|
| B/Victoria (cell) MN GMR |
1.88
|
1.63
|
| Title | Immunogenicity Endpoint: GMR Against the A/H3N2 Vaccine Strain by MN Assay Using Cell-derived and Egg-derived Target Viruses |
|---|---|
| Description | 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). |
| Time Frame | Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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) |
| Arm/Group Title | QIVc | Comparator QIV |
|---|---|---|
| Arm/Group Description | Cell-derived Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains | Comparator Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains |
| Measure Participants | 1079 | 572 |
| A/H3N2 (cell) MN GMR |
2.11
|
2.19
|
| A/H3N2 (egg) MN GMR |
3.13
|
3.22
|
| Title | Safety Endpoint: Percentage of Subjects With Solicited Adverse Events (AEs) |
|---|---|
| Description | The percentage of subjects with at least one solicited AE Day 1 through Day 7 after any study vaccination. |
| Time Frame | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Solicited Safety Set, defined as all subjects in the FAS with any solicited AE data. |
| Arm/Group Title | QIVc | Comparator QIV |
|---|---|---|
| Arm/Group Description | Cell-derived Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains | Comparator Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains |
| Measure Participants | 1564 | 784 |
| Solicited AEs |
940
58.9%
|
491
61%
|
| Solicited Local AEs |
656
41.1%
|
350
43.5%
|
| Solicited Systemic AEs |
681
42.6%
|
358
44.5%
|
| Analgesic/Antipyretic Use |
240
15%
|
136
16.9%
|
| Title | Safety Endpoint: Percentage of Subjects With Any Unsolicited AEs |
|---|---|
| Description | 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. |
| Time Frame | Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects |
Outcome Measure Data
| Analysis Population Description |
|---|
| Unsolicited Safety Set, defined as all subjects in the FAS with any unsolicited AE data. |
| Arm/Group Title | QIVc | Comparator QIV |
|---|---|---|
| Arm/Group Description | Cell-derived Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains | Comparator Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains |
| Measure Participants | 1597 | 805 |
| Any AE |
418
26.2%
|
207
25.7%
|
| Any AE (Mild) |
308
19.3%
|
164
20.4%
|
| Any AE (Moderate) |
98
6.1%
|
41
5.1%
|
| Any AE (Severe) |
12
0.8%
|
2
0.2%
|
| Related AE |
70
4.4%
|
36
4.5%
|
| Title | 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 |
|---|---|
| Description | 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 |
| Time Frame | Day 1 to Day 181 for previously vaccinated subjects; Day 1 to Day 209 for not previously vaccinated subjects |
Outcome Measure Data
| Analysis Population Description |
|---|
| Unsolicited Safety Set |
| Arm/Group Title | QIVc | Comparator QIV |
|---|---|---|
| Arm/Group Description | Cell-derived Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains | Comparator Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains |
| Measure Participants | 1597 | 805 |
| SAE |
15
0.9%
|
7
0.9%
|
| Related SAE |
0
0%
|
0
0%
|
| AE leading to study withdrawal |
3
0.2%
|
0
0%
|
| NOCD |
22
1.4%
|
13
1.6%
|
| Death |
2
0.1%
|
0
0%
|
Adverse Events
| Time Frame | 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) | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section. | |||
| Arm/Group Title | QIVc | Comparator QIV | ||
| Arm/Group Description | Cell-derived Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains | Comparator Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains | ||
All Cause Mortality |
||||
| QIVc | Comparator QIV | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/1597 (0.1%) | 0/805 (0%) | ||
Serious Adverse Events |
||||
| QIVc | Comparator QIV | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 15/1597 (0.9%) | 7/805 (0.9%) | ||
| Gastrointestinal disorders | ||||
| Constipation | 0/1597 (0%) | 1/805 (0.1%) | ||
| Volvulus | 1/1597 (0.1%) | 0/805 (0%) | ||
| Infections and infestations | ||||
| Bronchiolitis | 1/1597 (0.1%) | 3/805 (0.4%) | ||
| Pneumonia | 3/1597 (0.2%) | 0/805 (0%) | ||
| Rhinovirus infection | 1/1597 (0.1%) | 1/805 (0.1%) | ||
| Abscess of eyelid | 1/1597 (0.1%) | 0/805 (0%) | ||
| Adenoviral encephalitis | 1/1597 (0.1%) | 0/805 (0%) | ||
| Enterovirus infection | 1/1597 (0.1%) | 0/805 (0%) | ||
| Metapneumovirus infection | 0/1597 (0%) | 1/805 (0.1%) | ||
| Pneumonia bacterial | 1/1597 (0.1%) | 0/805 (0%) | ||
| Respiratory syncytial virus bronchiolitis | 1/1597 (0.1%) | 0/805 (0%) | ||
| Respiratory syncytial virus infection | 1/1597 (0.1%) | 0/805 (0%) | ||
| Injury, poisoning and procedural complications | ||||
| Road traffic accident | 1/1597 (0.1%) | 0/805 (0%) | ||
| Metabolism and nutrition disorders | ||||
| Dehydration | 1/1597 (0.1%) | 1/805 (0.1%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Ligamentitis | 1/1597 (0.1%) | 0/805 (0%) | ||
| Nervous system disorders | ||||
| Seizure | 2/1597 (0.1%) | 0/805 (0%) | ||
| Unresponsive to stimuli | 0/1597 (0%) | 1/805 (0.1%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Acute Respiratory Failure | 1/1597 (0.1%) | 0/805 (0%) | ||
| Asthma | 2/1597 (0.1%) | 1/805 (0.1%) | ||
Other (Not Including Serious) Adverse Events |
||||
| QIVc | Comparator QIV | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 926/1597 (58%) | 490/805 (60.9%) | ||
| Gastrointestinal disorders | ||||
| Vomiting/throwing up | 106/1564 (6.8%) | 49/784 (6.3%) | ||
| Diarrhea/loose stools | 280/1564 (17.9%) | 128/784 (16.3%) | ||
| General disorders | ||||
| Injection site induration | 270/1564 (17.3%) | 125/784 (15.9%) | ||
| Injection site erythema | 403/1564 (25.8%) | 193/784 (24.6%) | ||
| Injection site ecchymosis | 168/1564 (10.7%) | 85/784 (10.8%) | ||
| Injection site tenderness | 436/1564 (27.9%) | 235/784 (30%) | ||
| Fever (≥38.0°C) | 107/1564 (6.8%) | 54/784 (6.9%) | ||
| Infections and infestations | ||||
| Upper respiratory tract infection | 59/1597 (3.7%) | 44/805 (5.5%) | ||
| Metabolism and nutrition disorders | ||||
| Change of eating habits | 272/1564 (17.4%) | 138/784 (17.6%) | ||
| Nervous system disorders | ||||
| Sleepiness | 420/1564 (26.9%) | 200/784 (25.5%) | ||
| Psychiatric disorders | ||||
| Irritability | 436/1564 (27.9%) | 232/784 (29.6%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Seqirus Clinical Trial Manager |
|---|---|
| Organization | Seqirus |
| Phone | 1-855-358-8966 |
| seqirus.clinicaltrials@Seqirus.com |
Responsible Party:
Seqirus
ClinicalTrials.gov Identifier:
NCT04074928
Other Study ID Numbers:
- V130_10
- 2020-002785-13
First Posted:
Aug 30, 2019
Last Update Posted:
Jan 12, 2022
Last Verified:
Dec 1, 2021