Phase 3 Safety and Immunogenicity Study of aQIV in Elderly Adults
Sponsor
Seqirus (Industry)
Overall Status
Completed
CT.gov ID
NCT03314662
Collaborator
(none)
1,778
20
3
7
88.9
12.8
Study Details
Study Description
Brief Summary
This phase 3 study is a randomized, double-blinded, comparator controlled, parallel-group, multicenter study of aQIV versus the US-licensed 2017-2018 adjuvanted trivalent influenza vaccine (aTIV-1, Fluad), and versus an adjuvanted trivalent influenza vaccine (aTIV-2), containing the alternate B strain.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
1778 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
The trial is designed as a double-blind study
Primary Purpose:
Prevention
Official Title:
A Phase 3, Randomized, Double-Blind, Controlled, Multicenter, Clinical Study to Evaluate Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Subunit Influenza Vaccine in Comparison With an MF59-Adjuvanted Trivalent Subunit Influenza Vaccine and an MF59-Adjuvanted Trivalent Subunit Influenza Vaccine Containing the Alternate B Strain, in Adults Aged 65 Years and Above
Actual Study Start Date
:
Oct 17, 2017
Actual Primary Completion Date
:
Dec 11, 2017
Actual Study Completion Date
:
May 17, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: aQIV MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV) contains each of the 2 influenza type A strains and each of the two influenza type B strains in the vaccine. |
Biological: MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV)
The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for quadrivalent vaccines.
|
| Experimental: aTIV-1 Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1) contains each of the 2 influenza type A strains and one influenza type B strain in the vaccine. |
Biological: Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1)
The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines.
|
| Experimental: aTIV-2 MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine contains each of the 2 influenza type A strains and alternate influenza type B strain in the vaccine. |
Biological: MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine Containing the Alternate B Strain (aTIV-2)
The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines except the B strain present in this vaccine is the second/alternate B strain recommended for inclusion in quadrivalent vaccines (ie, Alternate B strain).
|
Outcome Measures
Primary Outcome Measures
- Immunogenicity Endpoint: The Geometric Mean Titer (GMT) and GMT Ratio for the Four Strains Included in the Vaccine, Non-inferiority Analysis. [Day 22]
The GMT of the post-vaccination (Day 22) hemagglutination inhibition (HI) titer. The GMT ratio was defined as the GMT for aTIV-1 (or aTIV-2) over the GMT for aQIV for all of the four strains.
- Immunogenicity Endpoint: The Difference Between the Seroconversion Rate (SCR) for the Four Strains Included in the Vaccine, Non-inferiority Analysis [Day 22]
The SCR is defined as the percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >= 1:40 or a pre-vaccination HI titer >= 1:10 and a >= 4-fold increase in post-vaccination HI titer. The SCR Difference is defined as the difference between the SCR of post- vaccination (Day 22) HI titer for aTIV-1 (or aTIV-2) and the SCR of post-vaccination (Day 22) HI titer for aQIV. aTIV-1 and aTIV-2 vaccine groups are pooled for the analysis of A-H1N1 and A-H3N2 strains. For B/Victoria TIV=TIV-1. For B/Yamagata TIV=TIV-2.
- Immunogenicity Endpoint: The Percentage of Subjects Achieving SCR for Hemagglutination Inhibition (HI) Antibody for the Four Strains Included in the Vaccine. [Day 22]
The percentage of subjects vaccinated with aQIV achieving SCR at Day 22 was assessed for each of the 4 strains. SCR was defined as the percentage of subjects with either a pre-vaccination HI titer <1:10 and a post-vaccination HI titer ≥1:40 or a pre-vaccination HI titer ≥1:10 and a ≥4-fold increase in post-vaccination HI titer. Assessment criteria was considered fulfilled if the lower bound of the two-sided 95% confidence interval for the percentage of subjects achieving SCR for HI antibody should meet or exceed 30%.
- Immunogenicity Endpoint: The Percent of Subjects Achieving an HI Antibody Titer ≥ 1:40 for the Four Strains Included in the Vaccines. [Day 22]
The percentage of subjects vaccinated with aQIV achieving HI antibody titers ≥ 1:40 at Day 22 was assessed for each of the 4 strains. Assessment criteria was considered fulfilled if the lower bound of the two-sided 95% confidence interval for the percentage of subjects achieving a post-vaccination HI antibody titer ≥ 1:40 should meet or exceed 60%.
Secondary Outcome Measures
- Immunogenicity Endpoint: Geometric Mean Titers (GMT) Against Homologous Strains [Day 1 and Day 22]
For the assessment of GMTs using HI assay, aTIV-1 and aTIV-2 vaccine groups were pooled for the analysis of A-H1N1 and A-H3N2 strains. aTIV-1 and aTIV-2 vaccine groups are pooled for the analysis of A-H1N1 and A-H3N2 strains. For B-Victoria TIV=aTIV-1. For B-Yamagata TIV=aTIV-2. The immunologic superiority in HI antibody responses for the alternate B strain (eg, the influenza B strain included in the aQIV but not in the aTIV formulation) were assessed for each aTIV separately, using the GMT ratio (aTIV/aQIV) at Day 22.
- Immunogenicity Endpoint: Geometric Mean Ratio (GMR) of Post Vaccination HI Titer Over the Pre-vaccination HI Titer Against Homologous Strains [Day 22/Day 1]
The GMR was assessed as the postvaccination HI titer divided by the prevaccination HI titer (Day 22/Day 1). aTIV-1 and aTIV-2 vaccine groups were pooled for the analysis of A-H1N1 and A-H3N2 strains. For B-Victoria TIV=aTIV-1. For B-Yamagata TIV=aTIV-2.
- Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 Against Homologous Strains [Day 1 and Day 22]
The percentage of subjects with HI titer of ≥1:40 at Day 1 (prevaccination) and Day 22 (postvaccination) was assessed for homologous strains. aTIV-1 and aTIV-2 vaccine groups are pooled for the analysis of A-H1N1 and A-H3N2 strains. For B/Victoria TIV=TIV-1. For B/Yamagata TIV=TIV-2.
- Immunogenicity Endpoint: The Percentage of Subjects With SCR Against Homologous Strains [Day 22]
The SCR was defined as the percentage of subjects with either a prevaccination HI titer <1:10 and a postvaccination HI titer ≥1:40 or a prevaccination HI titer ≥1:10 and a ≥4-fold increase in postvaccination HI titer. For assessment if SCR using HI assay, aTIV-1 and aTIV-2 vaccine groups were pooled for the analysis of A-H1N1 and A-H3N2 strains. For B-Victoria TIV=aTIV-1. For B-Yamagata TIV=aTIV-2. The immunologic superiority in HI antibody responses for the alternate B strain (eg, the influenza B strain included in the aQIV but not in the aTIV formulation) were assessed for each aTIV separately, using the difference in SCR (aTIV-aQIV) at Day 22.
- Safety Endpoint: Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following Vaccination [Day 1 through Day 7]
Safety of vaccination was assessed in terms of percentage of subjects reporting solicited AEs up to 7 days after vaccination.
- Safety Endpoint: Number of Subjects With Unsolicited AEs [Day 1 through Day 22]
Safety of vaccination was assessed in terms of percentage of subjects reporting unsolicited AEs up to 21 days after vaccination.
- Safety Endpoint: Number of Subjects With Serious AEs (SAEs), AEs Leading to Withdrawal From the Study, New Onset of Chronic Diseases (NOCDs) and AEs of Special Interest (AESIs) [Day 1 through Day 181]
Safety of vaccination was assessed in terms of percentage of subjects reporting SAEs, AEs leading to withdrawal, NOCDs, and AESIs and medically attended AE up to 180 days after vaccination.
Eligibility Criteria
Criteria
Ages Eligible for Study:
65 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Males and females ≥ 65 years old who are healthy or have co-morbidities
-
Individuals who or whose legal representative(s) have voluntarily given written consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry
-
Ability to attend all scheduled visits and to comply with study procedures including diary card completion and follow-up
Exclusion Criteria:
-
History of behavioral or cognitive impairment or psychiatric condition
-
Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study
-
Abnormal function of the immune system
-
Receipt of any influenza vaccine within 6 months prior to enrollment in this study, or plan to receive influenza vaccine prior to the Day 22 blood collection
-
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
Additional eligibility criteria may be discussed by contacting the site.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Coastal Clinical Research, Inc. | Mobile | Alabama | United States | 36608 |
| 2 | Anaheim Clinical Trials | Anaheim | California | United States | 92801 |
| 3 | Paradigm clinical Research Centers, Inc | Redding | California | United States | 96001 |
| 4 | Clinical Research of South Florida, an AMR Company | Coral Gables | Florida | United States | 33134 |
| 5 | Meridan Clinical Research, LLC | Savannah | Georgia | United States | 31406 |
| 6 | Advanced Clinical Research | Meridian | Idaho | United States | 83642 |
| 7 | Johnson County Clin-Trials | Lenexa | Kansas | United States | 66219 |
| 8 | Heartland Research Associates, LLC - An AMR Company | Newton | Kansas | United States | 67114 |
| 9 | Heartland Research Associates, LLC - An AMR Company | Wichita | Kansas | United States | 67207 |
| 10 | Center for Pharmaceutical Research, LLC | Kansas City | Missouri | United States | 64114 |
| 11 | Sundance Clinical Research, LLC | Saint Louis | Missouri | United States | 63141 |
| 12 | Meridian Clinical Research, LLC | Omaha | Nebraska | United States | 68134 |
| 13 | United Medical Associates | Binghamton | New York | United States | 13901 |
| 14 | Rapid Medical Research, Inc. | Cleveland | Ohio | United States | 44122 |
| 15 | Medical Research South | Charleston | South Carolina | United States | 29407 |
| 16 | New Orleans Center for Clinical Research | Knoxville | Tennessee | United States | 37920 |
| 17 | Benchmark Research | Fort Worth | Texas | United States | 76135 |
| 18 | Benchmark Research | San Angelo | Texas | United States | 76904 |
| 19 | Martin Diagnostic Clinic | Tomball | Texas | United States | 77375 |
| 20 | Advanced Clinical Research | West Jordan | Utah | United States | 84088 |
Sponsors and Collaborators
- Seqirus
Investigators
- Study Director: Clinical Scientist, Seqirus
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Seqirus
ClinicalTrials.gov Identifier:
NCT03314662
Other Study ID Numbers:
- V118_20
First Posted:
Oct 19, 2017
Last Update Posted:
Jul 22, 2020
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | 20 study centers in the United States |
|---|---|
| Pre-assignment Detail | All enrolled subjects were randomized. |
| Arm/Group Title | aQIV | aTIV-1 | aTIV-2 |
|---|---|---|---|
| Arm/Group Description | MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV) contains each of the 2 influenza type A strains and each of the two influenza type B strains in the vaccine.The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for quadrivalent vaccines. | Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1) contains each of the 2 influenza type A strains and one influenza type B strain in the vaccine.The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines. | MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine contains each of the 2 influenza type A strains and alternate influenza type B strain in the vaccine.The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines except the B strain present in this vaccine is the second/alternate B strain recommended for inclusion in quadrivalent vaccines (ie, Alternate B strain). |
| Period Title: Overall Study | |||
| STARTED | 889 | 445 | 444 |
| Treated | 888 | 444 | 444 |
| COMPLETED | 881 | 440 | 439 |
| NOT COMPLETED | 8 | 5 | 5 |
Baseline Characteristics
| Arm/Group Title | aQIV | aTIV-1 | aTIV-2 | Total |
|---|---|---|---|---|
| Arm/Group Description | MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV) contains each of the 2 influenza type A strains and each of the two influenza type B strains in the vaccine. The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for quadrivalent vaccines. | Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1) contains each of the 2 influenza type A strains and one influenza type B strain in the vaccine. The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines. | MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine contains each of the 2 influenza type A strains and alternate influenza type B strain in the vaccine.The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines except the B strain present in this vaccine is the second/alternate B strain recommended for inclusion in quadrivalent vaccines (ie, Alternate B strain). | Total of all reporting groups |
| Overall Participants | 889 | 445 | 444 | 1778 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
72.4
(5.54)
|
72.4
(5.60)
|
72.6
(5.46)
|
72.5
(5.53)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
517
58.2%
|
249
56%
|
241
54.3%
|
1007
56.6%
|
| Male |
372
41.8%
|
196
44%
|
203
45.7%
|
771
43.4%
|
| Race/Ethnicity, Customized (Count of Participants) | ||||
| White |
814
91.6%
|
403
90.6%
|
411
92.6%
|
1628
91.6%
|
| Black or African American |
59
6.6%
|
37
8.3%
|
29
6.5%
|
125
7%
|
| Asian |
9
1%
|
2
0.4%
|
1
0.2%
|
12
0.7%
|
| Native Hawaiian or Pacific Islander |
1
0.1%
|
1
0.2%
|
0
0%
|
2
0.1%
|
| American Indian or Alaska Native |
5
0.6%
|
0
0%
|
2
0.5%
|
7
0.4%
|
| Other |
1
0.1%
|
2
0.4%
|
1
0.2%
|
4
0.2%
|
| Race/Ethnicity, Customized (Count of Participants) | ||||
| Hispanic or Latino |
59
6.6%
|
37
8.3%
|
31
7%
|
127
7.1%
|
| Not Hispanic or Latino |
827
93%
|
408
91.7%
|
410
92.3%
|
1645
92.5%
|
| Not Reported |
2
0.2%
|
0
0%
|
2
0.5%
|
4
0.2%
|
| Unknown |
1
0.1%
|
0
0%
|
1
0.2%
|
2
0.1%
|
| Region of Enrollment (participants) [Number] | ||||
| United States |
889
100%
|
445
100%
|
444
100%
|
1778
100%
|
| Height (cm) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [cm] |
167.54
(9.350)
|
167.92
(10.535)
|
168.38
(10.646)
|
167.84
(9.990)
|
| Weight (kg) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [kg] |
83.24
(19.064)
|
84.18
(8.963)
|
84.24
(17.825)
|
83.73
(18.731)
|
| BMI (kg/m^2) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [kg/m^2] |
29.60
(6.157)
|
29.79
(5.858)
|
29.69
(5.647)
|
29.67
(5.956)
|
| Influenza Vaccination History (Count of Participants) | ||||
| No |
129
14.5%
|
65
14.6%
|
43
9.7%
|
237
13.3%
|
| Yes |
760
85.5%
|
380
85.4%
|
401
90.3%
|
1541
86.7%
|
| Total Risk Score (Comorbidity) (units on a scale) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [units on a scale] |
46.0
(33.50)
|
44.6
(30.25)
|
46.5
(34.15)
|
45.8
(32.88)
|
Outcome Measures
| Title | Immunogenicity Endpoint: The Geometric Mean Titer (GMT) and GMT Ratio for the Four Strains Included in the Vaccine, Non-inferiority Analysis. |
|---|---|
| Description | The GMT of the post-vaccination (Day 22) hemagglutination inhibition (HI) titer. The GMT ratio was defined as the GMT for aTIV-1 (or aTIV-2) over the GMT for aQIV for all of the four strains. |
| Time Frame | Day 22 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The per protocol set (PPS) Immunogenicity comprised all subjects who were randomized, received at least 1 study vaccination, and provided immunogenicity data at Day 1 and Day 22, and who did not have any major protocol deviations that were assessed as potentially impacting on immunogenicity results |
| Arm/Group Title | aQIV | aTIV-1 | aTIV-2 | aTIV-1/aTIV-2 |
|---|---|---|---|---|
| Arm/Group Description | MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV) contains each of the 2 influenza type A strains and each of the 2 influenza type B strains in the vaccine. The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for quadrivalent vaccines. | Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1) contains each of the 2 influenza type A strains and one influenza type B strain in the vaccine. The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines. | MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-2) contains each of the 2 influenza type A strains and alternate influenza type B strain in the vaccine. The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines except the B strain present in this vaccine is the second/alternate B strain recommended for inclusion in quadrivalent vaccines (ie, Alternate B strain). | Pooled Subjects Treated with aTIV-1 and aTIV-2 |
| Measure Participants | 872 | 436 | 433 | 869 |
| A/H1N1 |
65.01
|
NA
|
NA
|
75.16
|
| A/H3N2 |
294.91
|
NA
|
NA
|
293.31
|
| B/Yamagata |
24.67
|
15.96
|
24.30
|
NA
|
| B/Victoria |
30.78
|
30.13
|
21.80
|
NA
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | aQIV, aTIV-1, aTIV-2 |
|---|---|---|
| Comments | Comparison Group Selection: aTIV/aQIV - for strain A/H1N1 | |
| Type of Statistical Test | Non-Inferiority | |
| Comments | aQIV was considered non-inferior to aTIV-1 or aTIV-2 if the upper bound of the two-sided 95% confidence interval (CI) for the ratios of GMTs (aTIV/aQIV) do not exceed 1.5 | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | GMT ratio (aTIV/aQIV) |
| Estimated Value | 1.16 | |
| Confidence Interval |
(2-Sided) 95% 1.05 to 1.27 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | GMT ratios (adjusted) obtained from a GLM fitted on log-transformed (base 10) post-vaccination HI titer as outcome variable and covariate terms: treatment, pre-vaccination HI titer (log10 transformed), age, sex, vaccination history, study site | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | aQIV, aTIV-1, aTIV-2 |
|---|---|---|
| Comments | Comparison Group Selection: aTIV/aQIV - performed for strain A/H3N2 | |
| Type of Statistical Test | Non-Inferiority | |
| Comments | aQIV was considered non-inferior to aTIV-1 or aTIV-2 if the upper bound of the two-sided 95% confidence interval (CI) for the ratios of GMTs (aTIV/aQIV) do not exceed 1.5 | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | GMT ratio: (aTIV/aQIV |
| Estimated Value | 0.99 | |
| Confidence Interval |
(2-Sided) 95% 0.90 to 1.09 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | GMT ratios (adjusted) obtained from a GLM fitted on log-transformed (base 10) post-vaccination HI titer as outcome variable and covariate terms: treatment, pre-vaccination HI titer (log 10 transformed), age, sex, vaccination history, study site | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | aQIV, aTIV-1, aTIV-2 |
|---|---|---|
| Comments | Comparison Group Selection: aQIV/aTIV - performed for strain B/Yamagata | |
| Type of Statistical Test | Non-Inferiority | |
| Comments | aQIV was considered non-inferior to aTIV-1 or aTIV-2 if the upper bound of the two-sided 95% confidence interval (CI) for the ratios of GMTs (aTIV/aQIV) do not exceed 1.5. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | GMT ratio: aTIV/aQIV |
| Estimated Value | 0.99 | |
| Confidence Interval |
(2-Sided) 95% 0.90 to 1.08 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | GMT ratios (adjusted) obtained from a GLM fitted on log-transformed (base 10) post-vaccination HI titer as outcome variable and covariate terms: treatment, pre-vaccination HI titer (log10 transformed), age, sex, vaccination history, study site | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | aQIV, aTIV-1, aTIV-2 |
|---|---|---|
| Comments | Comparison Group Selection: aQIV/aTIV - performed for strain B/Victoria | |
| Type of Statistical Test | Non-Inferiority | |
| Comments | aQIV was considered non-inferior to aTIV-1 or aTIV-2 if the upper bound of the two-sided 95% confidence interval (CI) for the ratios of GMTs (aTIV/aQIV) do not exceed 1.5. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | GMT ratio: (aTIV/aQIV)] |
| Estimated Value | 0.98 | |
| Confidence Interval |
(2-Sided) 95% 0.89 to 1.08 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | GMT ratios (adjusted) obtained from a GLM fitted on log-transformed (base 10) post-vaccination HI titer as outcome variable and covariate terms: treatment, pre-vaccination HI titer (log10 transformed), age, sex, vaccination history, study site | |
| Title | Immunogenicity Endpoint: The Difference Between the Seroconversion Rate (SCR) for the Four Strains Included in the Vaccine, Non-inferiority Analysis |
|---|---|
| Description | The SCR is defined as the percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >= 1:40 or a pre-vaccination HI titer >= 1:10 and a >= 4-fold increase in post-vaccination HI titer. The SCR Difference is defined as the difference between the SCR of post- vaccination (Day 22) HI titer for aTIV-1 (or aTIV-2) and the SCR of post-vaccination (Day 22) HI titer for aQIV. aTIV-1 and aTIV-2 vaccine groups are pooled for the analysis of A-H1N1 and A-H3N2 strains. For B/Victoria TIV=TIV-1. For B/Yamagata TIV=TIV-2. |
| Time Frame | Day 22 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The per protocol set (PPS) Immunogenicity comprised all subjects who were randomized, received at least 1 study vaccination, and provided immunogenicity data at Day 1 and Day 22, and who did not have any major protocol deviations that were assessed as potentially impacting on immunogenicity results. |
| Arm/Group Title | aQIV | aTIV-1 | aTIV-2 |
|---|---|---|---|
| Arm/Group Description | MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV) contains each of the 2 influenza type A strains and each of the 2 influenza type B strains in the vaccine. The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for quadrivalent vaccines. | Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1) contains each of the 2 influenza type A strains and one influenza type B strain in the vaccine. The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines | MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-2) contains each of the 2 influenza type A strains and alternate influenza type B strain in the vaccine. The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines except the B strain present in this vaccine is the second/alternate B strain recommended for inclusion in quadrivalent vaccines (ie, Alternate B strain) |
| Measure Participants | 872 | 436 | 433 |
| A/H1N1 |
35.21
|
39.45
|
37.41
|
| A/H3N2 |
39.33
|
39.70
|
37.18
|
| B/Yamagata |
16.4
|
NA
|
15.47
|
| B/Victoria |
13.42
|
12.16
|
NA
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | aQIV, aTIV-1, aTIV-2 |
|---|---|---|
| Comments | Comparison Group Selection: aTIV minus aQIV - for strain A/H1N1 | |
| Type of Statistical Test | Non-Inferiority | |
| Comments | aQIV was considered non-inferior to aTIV-1 or aTIV-2 if the upper bound of the two-sided 95% CI for the differences between the SCRs (aTIV - aQIV) do not exceed 10% for each of the four strains | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | SCR difference (aTIV minus aQIV) |
| Estimated Value | 3.23 | |
| Confidence Interval |
(2-Sided) 95% -1.30 to 7.76 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | aQIV, aTIV-1, aTIV-2 |
|---|---|---|
| Comments | Comparison Group Selection: aTIV minus aQIV - for strain A/H3N2 | |
| Type of Statistical Test | Non-Inferiority | |
| Comments | aQIV was considered non-inferior to aTIV-1 or aTIV-2 if the upper bound of the two-sided 95% CI for the differences between the SCRs (aTIV - aQIV) do not exceed 10% for each of the four strains | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | SCR difference (aTIV minus aQIV) |
| Estimated Value | 0.37 | |
| Confidence Interval |
(2-Sided) 95% -4.23 to 4.96 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | aQIV, aTIV-1, aTIV-2 |
|---|---|---|
| Comments | Comparison Group Selection: aTIV minus aQIV - for strain B-Yamagata | |
| Type of Statistical Test | Non-Inferiority | |
| Comments | aQIV was considered non-inferior to aTIV-1 or aTIV-2 if the upper bound of the two-sided 95% CI for the differences between the SCRs (aTIV - aQIV) do not exceed 10% for each of the four strains | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | SCR difference (aTIV minus aQIV)] |
| Estimated Value | -0.93 | |
| Confidence Interval |
(2-Sided) 95% -5.13 to 3.27 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | aQIV, aTIV-1, aTIV-2 |
|---|---|---|
| Comments | Comparison Group Selection: aTIV minus aQIV - for strain B-Victoria | |
| Type of Statistical Test | Non-Inferiority | |
| Comments | aQIV was considered non-inferior to aTIV-1 or aTIV-2 if the upper bound of the two-sided 95% CI for the differences between the SCRs (aTIV - aQIV) do not exceed 10% for each of the four strains | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Other [SCR difference (aTIV minus aQIV)] |
| Estimated Value | -1.26 | |
| Confidence Interval |
(2-Sided) 95% -5.07 to 2.55 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Immunogenicity Endpoint: The Percentage of Subjects Achieving SCR for Hemagglutination Inhibition (HI) Antibody for the Four Strains Included in the Vaccine. |
|---|---|
| Description | The percentage of subjects vaccinated with aQIV achieving SCR at Day 22 was assessed for each of the 4 strains. SCR was defined as the percentage of subjects with either a pre-vaccination HI titer <1:10 and a post-vaccination HI titer ≥1:40 or a pre-vaccination HI titer ≥1:10 and a ≥4-fold increase in post-vaccination HI titer. Assessment criteria was considered fulfilled if the lower bound of the two-sided 95% confidence interval for the percentage of subjects achieving SCR for HI antibody should meet or exceed 30%. |
| Time Frame | Day 22 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PPS Immunogenicity comprised all subjects who were randomized, received at least 1 study vaccination, and provided immunogenicity data at Day 1 and Day 22, and who did not have any major protocol deviations that were assessed as potentially impacting on immunogenicity results. |
| Arm/Group Title | aQIV | aTIV-1 | aTIV-2 |
|---|---|---|---|
| Arm/Group Description | MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV) contains each of the 2 influenza type A strains and each of the 2 influenza type B strains in the vaccine. | Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1) contains each of the 2 influenza type A strains and one influenza type B strain in the vaccine. The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines | MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-2) contains each of the 2 influenza type A strains and alternate influenza type B strain in the vaccine. The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines except the B strain present in this vaccine is the second/alternate B strain recommended for inclusion in quadrivalent vaccines (ie, Alternate B strain) |
| Measure Participants | 872 | 436 | 433 |
| A/H1N1 |
35.21
|
39.45
|
37.41
|
| A/H3N2 |
39.33
|
39.70
|
37.18
|
| B/Yamagata |
16.40
|
NA
|
15.47
|
| B/Victoria |
13.42
|
12.16
|
NA
|
| Title | Immunogenicity Endpoint: The Percent of Subjects Achieving an HI Antibody Titer ≥ 1:40 for the Four Strains Included in the Vaccines. |
|---|---|
| Description | The percentage of subjects vaccinated with aQIV achieving HI antibody titers ≥ 1:40 at Day 22 was assessed for each of the 4 strains. Assessment criteria was considered fulfilled if the lower bound of the two-sided 95% confidence interval for the percentage of subjects achieving a post-vaccination HI antibody titer ≥ 1:40 should meet or exceed 60%. |
| Time Frame | Day 22 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PPS Immunogenicity comprised all subjects who were randomized, received at least 1 study vaccination, and provided immunogenicity data at Day 1 and Day 22, and who did not have any major protocol deviations that were assessed as potentially impacting on immunogenicity results. |
| Arm/Group Title | aQIV | aTIV-1 | aTIV-2 |
|---|---|---|---|
| Arm/Group Description | MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV) contains each of the 2 influenza type A strains and each of the 2 influenza type B strains in the vaccine. | Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1) contains each of the 2 influenza type A strains and one influenza type B strain in the vaccine. The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines | MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-2) contains each of the 2 influenza type A strains and alternate influenza type B strain in the vaccine. The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines except the B strain present in this vaccine is the second/alternate B strain recommended for inclusion in quadrivalent vaccines (ie, Alternate B strain) |
| Measure Participants | 872 | 436 | 433 |
| A/H1N1 |
69.38
|
71.79
|
68.82
|
| A/H3N2 |
93.92
|
94.72
|
94.92
|
| B/Yamagata |
32.80
|
21.79
|
36.95
|
| B/Victoria |
38.19
|
36.93
|
24.48
|
| Title | Immunogenicity Endpoint: Geometric Mean Titers (GMT) Against Homologous Strains |
|---|---|
| Description | For the assessment of GMTs using HI assay, aTIV-1 and aTIV-2 vaccine groups were pooled for the analysis of A-H1N1 and A-H3N2 strains. aTIV-1 and aTIV-2 vaccine groups are pooled for the analysis of A-H1N1 and A-H3N2 strains. For B-Victoria TIV=aTIV-1. For B-Yamagata TIV=aTIV-2. The immunologic superiority in HI antibody responses for the alternate B strain (eg, the influenza B strain included in the aQIV but not in the aTIV formulation) were assessed for each aTIV separately, using the GMT ratio (aTIV/aQIV) at Day 22. |
| Time Frame | Day 1 and Day 22 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PPS Immunogenicity comprised all subjects who were randomized, received at least 1 study vaccination, and provided immunogenicity data at Day 1 and Day 22, and who did not have any major protocol deviations that were assessed as potentially impacting on immunogenicity results. |
| Arm/Group Title | aQIV | aTIV-1 | aTIV-2 | aTIV-1/aTIV-2 |
|---|---|---|---|---|
| Arm/Group Description | MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV) contains each of the 2 influenza type A strains and each of the two influenza type B strains in the vaccine. MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV): The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for quadrivalent vaccines. | Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1) contains each of the 2 influenza type A strains and one influenza type B strain in the vaccine. Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1): The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines. | MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine contains each of the 2 influenza type A strains and alternate influenza type B strain in the vaccine. MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine Containing the Alternate B Strain (aTIV-2): The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines except the B strain present in this vaccine is the second/alternate B strain recommended for inclusion in quadrivalent vaccines (ie, Alternate B strain). | Pooled Subjects Treated with aTIV-1 and aTIV-2. |
| Measure Participants | 872 | 436 | 433 | 869 |
| A/H1N1 Day 1 |
19.07
|
NA
|
NA
|
18.77
|
| A/H1N1 Day 22 |
57.07
|
NA
|
NA
|
63.73
|
| A/H3N2 Day 1 |
73.27
|
NA
|
NA
|
71.83
|
| A/H3N2 Day 22 |
245.85
|
NA
|
NA
|
236.27
|
| B/Yamagata Day 1 |
10.41
|
NA
|
10.76
|
NA
|
| B/Yamagata Day 22 |
21.15
|
NA
|
20.74
|
NA
|
| B/Victoria Day 1 |
14.15
|
15.18
|
NA
|
NA
|
| B/Victoria Day 22 |
24.91
|
25.54
|
NA
|
NA
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | aQIV, aTIV-1 |
|---|---|---|
| Comments | B/Yamagata strain: GMT Ratio (aTIV/aQIV) | |
| Type of Statistical Test | Superiority | |
| Comments | Superiority of aQIV vs. aTIV-1 for the alternate B strain was assessed using the GMT ratio (GMTaTIV/GMTaQIV); Superiority was declared if the upper limit of the two-sided 95% CI for the GMT ratio (aTIV/aQIV) was <1. The superiority comparison was based on the Full Analysis Set (FAS) Immunogenicity comprised all subjects who were randomized, received at least 1 study vaccination, and provided immunogenicity data at Day 1 and Day 22. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | GMT ratio |
| Estimated Value | 0.64 | |
| Confidence Interval |
(2-Sided) 95% 0.58 to 0.70 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | aQIV, aTIV-2 |
|---|---|---|
| Comments | B/Victoria Strain: GMT Ratio (aTIV/aQIV) | |
| Type of Statistical Test | Superiority | |
| Comments | Superiority of aQIV vs. aTIV-2 for the alternate B strain was assessed using the GMT ratio (GMTaTIV/GMTaQIV); Superiority was declared if the upper limit of the two-sided 95% CI for the GMT ratio (aTIV/aQIV) was <1. The superiority comparison was based on the FAS Immunogenicity. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | GMT ratio |
| Estimated Value | 0.71 | |
| Confidence Interval |
(2-Sided) 95% 0.64 to 0.78 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) of Post Vaccination HI Titer Over the Pre-vaccination HI Titer Against Homologous Strains |
|---|---|
| Description | The GMR was assessed as the postvaccination HI titer divided by the prevaccination HI titer (Day 22/Day 1). aTIV-1 and aTIV-2 vaccine groups were pooled for the analysis of A-H1N1 and A-H3N2 strains. For B-Victoria TIV=aTIV-1. For B-Yamagata TIV=aTIV-2. |
| Time Frame | Day 22/Day 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PPS Immunogenicity comprised all subjects who were randomized, received at least 1 study vaccination, and provided immunogenicity data at Day 1 and Day 22, and who did not have any major protocol deviations that were assessed as potentially impacting on immunogenicity results. |
| Arm/Group Title | aQIV | aTIV-1 | aTIV-2 | aTIV-1/aTIV-2 |
|---|---|---|---|---|
| Arm/Group Description | MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV) contains each of the 2 influenza type A strains and each of the two influenza type B strains in the vaccine. MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV): The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for quadrivalent vaccines. | Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1) contains each of the 2 influenza type A strains and one influenza type B strain in the vaccine. Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1): The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines. | MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine contains each of the 2 influenza type A strains and alternate influenza type B strain in the vaccine. MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine Containing the Alternate B Strain (aTIV-2): The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines except the B strain present in this vaccine is the second/alternate B strain recommended for inclusion in quadrivalent vaccines (ie, Alternate B strain). | Pooled Subjects Treated with aTIV-1 and aTIV-2. |
| Measure Participants | 872 | 436 | 433 | 869 |
| A/H1N1 |
2.99
|
NA
|
NA
|
3.40
|
| A/H3N2 |
3.36
|
NA
|
NA
|
3.29
|
| B/Yamagata |
2.03
|
NA
|
1.93
|
NA
|
| B/Victoria |
1.76
|
1.68
|
NA
|
NA
|
| Title | Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 Against Homologous Strains |
|---|---|
| Description | The percentage of subjects with HI titer of ≥1:40 at Day 1 (prevaccination) and Day 22 (postvaccination) was assessed for homologous strains. aTIV-1 and aTIV-2 vaccine groups are pooled for the analysis of A-H1N1 and A-H3N2 strains. For B/Victoria TIV=TIV-1. For B/Yamagata TIV=TIV-2. |
| Time Frame | Day 1 and Day 22 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PPS Immunogenicity comprised all subjects who were randomized, received at least 1 study vaccination, and provided immunogenicity data at Day 1 and Day 22, and who did not have any major protocol deviations that were assessed as potentially impacting on immunogenicity results. |
| Arm/Group Title | aQIV | aTIV-1 | aTIV-2 | aTIV-1/aTIV-2 |
|---|---|---|---|---|
| Arm/Group Description | MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV) contains each of the 2 influenza type A strains and each of the two influenza type B strains in the vaccine. MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV): The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for quadrivalent vaccines. | Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1) contains each of the 2 influenza type A strains and one influenza type B strain in the vaccine. Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1): The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines. | MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine contains each of the 2 influenza type A strains and alternate influenza type B strain in the vaccine. MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine Containing the Alternate B Strain (aTIV-2): The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines except the B strain present in this vaccine is the second/alternate B strain recommended for inclusion in quadrivalent vaccines (ie, Alternate B strain). | Pooled Subjects Treated with aTIV-1 and aTIV-2. |
| Measure Participants | 872 | 436 | 433 | 869 |
| A/H1N1 Day 1 |
33.26
|
NA
|
NA
|
31.07
|
| A/H1N1 Day 22 |
69.38
|
NA
|
NA
|
70.31
|
| A/H3N2 Day 1 |
70.64
|
NA
|
NA
|
70.66
|
| A/H3N2 Day 22 |
93.92
|
NA
|
NA
|
94.82
|
| B/Yamagata Day 1 |
11.12
|
NA
|
11.55
|
NA
|
| B/Yamagata Day 22 |
32.80
|
NA
|
36.95
|
NA
|
| B/Victoria Day 1 |
19.72
|
22.71
|
NA
|
NA
|
| B/Victoria Day 22 |
38.19
|
36.93
|
NA
|
NA
|
| Title | Immunogenicity Endpoint: The Percentage of Subjects With SCR Against Homologous Strains |
|---|---|
| Description | The SCR was defined as the percentage of subjects with either a prevaccination HI titer <1:10 and a postvaccination HI titer ≥1:40 or a prevaccination HI titer ≥1:10 and a ≥4-fold increase in postvaccination HI titer. For assessment if SCR using HI assay, aTIV-1 and aTIV-2 vaccine groups were pooled for the analysis of A-H1N1 and A-H3N2 strains. For B-Victoria TIV=aTIV-1. For B-Yamagata TIV=aTIV-2. The immunologic superiority in HI antibody responses for the alternate B strain (eg, the influenza B strain included in the aQIV but not in the aTIV formulation) were assessed for each aTIV separately, using the difference in SCR (aTIV-aQIV) at Day 22. |
| Time Frame | Day 22 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PPS Immunogenicity comprised all subjects who were randomized, received at least 1 study vaccination, and provided immunogenicity data at Day 1 and Day 22, and who did not have any major protocol deviations that were assessed as potentially impacting on immunogenicity results. |
| Arm/Group Title | aQIV | aTIV-1 | aTIV-2 | aTIV-1/aTIV-2 |
|---|---|---|---|---|
| Arm/Group Description | MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV) contains each of the 2 influenza type A strains and each of the two influenza type B strains in the vaccine. MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV): The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for quadrivalent vaccines. | Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1) contains each of the 2 influenza type A strains and one influenza type B strain in the vaccine. Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1): The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines. | MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine contains each of the 2 influenza type A strains and alternate influenza type B strain in the vaccine. MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine Containing the Alternate B Strain (aTIV-2): The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines except the B strain present in this vaccine is the second/alternate B strain recommended for inclusion in quadrivalent vaccines (ie, Alternate B strain). | Pooled Subjects Treated with aTIV-1 and aTIV-2. |
| Measure Participants | 872 | 436 | 433 | 869 |
| A/H1N1 |
35.21
|
NA
|
NA
|
38.43
|
| A/H3N2 |
39.33
|
NA
|
NA
|
39.70
|
| B/Yamagata |
16.40
|
NA
|
15.47
|
NA
|
| B/Victoria |
13.42
|
12.16
|
NA
|
NA
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | aQIV, aTIV-1 |
|---|---|---|
| Comments | B/Yamagata Strain: SCR Difference (aTIV-1 - aQIV). | |
| Type of Statistical Test | Superiority | |
| Comments | Superiority of aQIV vs. aTIV-1 for the alternate B strain was assessed using the difference in SCR (SCRaTIV-SCRaQIV) at Day 22. Superiority was declared if the upper limit of the two-sided 95% CI for the difference in SCRs (aTIV-aQIV) was <0, for both B strains. The superiority comparison was based on the FAS Immunogenicity. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | SCR difference |
| Estimated Value | -11.96 | |
| Confidence Interval |
(2-Sided) 95% -15.12 to -8.81 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | aQIV, aTIV-2 |
|---|---|---|
| Comments | B/Victoria Strain: SCR Difference (aTIV-2 - aQIV) | |
| Type of Statistical Test | Superiority | |
| Comments | Superiority of aQIV vs. aTIV-2 for the alternate B strain was assessed using the difference in SCR (SCRaTIV-SCRaQIV) at Day 22. Superiority was declared if the upper limit of the two-sided 95% CI for the difference in SCRs (aTIV-aQIV) was <0, for both B strains. The superiority comparison was based on the FAS Immunogenicity. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | SCR difference |
| Estimated Value | -10.82 | |
| Confidence Interval |
(2-Sided) 95% -13.54 to -8.11 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Safety Endpoint: Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following Vaccination |
|---|---|
| Description | Safety of vaccination was assessed in terms of percentage of subjects reporting solicited AEs up to 7 days after vaccination. |
| Time Frame | Day 1 through Day 7 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Solicited Safety Set consists of all subjects in the FAS who received at least one dose or partial dose of study vaccine and have provided any evaluable follow-up safety data (solicited AE data). |
| Arm/Group Title | aQIV | aTIV-1 | aTIV-2 |
|---|---|---|---|
| Arm/Group Description | MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV) contains each of the 2 influenza type A strains and each of the two influenza type B strains in the vaccine. MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV): The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for quadrivalent vaccines. | Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1) contains each of the 2 influenza type A strains and one influenza type B strain in the vaccine. Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1): The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines. | MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine contains each of the 2 influenza type A strains and alternate influenza type B strain in the vaccine. MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine Containing the Alternate B Strain (aTIV-2): The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines except the B strain present in this vaccine is the second/alternate B strain recommended for inclusion in quadrivalent vaccines (ie, Alternate B strain). |
| Measure Participants | 883 | 439 | 438 |
| Any local solicited AE |
385
43.3%
|
170
38.2%
|
167
37.6%
|
| Any systemic solicited AE |
231
26%
|
107
24%
|
110
24.8%
|
| Title | Safety Endpoint: Number of Subjects With Unsolicited AEs |
|---|---|
| Description | Safety of vaccination was assessed in terms of percentage of subjects reporting unsolicited AEs up to 21 days after vaccination. |
| Time Frame | Day 1 through Day 22 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Overall Safety Set consists of all subjects in the FAS who received at least one dose or partial dose of study vaccine and have provided any evaluable follow-up safety data. |
| Arm/Group Title | aQIV | aTIV-1 | aTIV-2 |
|---|---|---|---|
| Arm/Group Description | MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV) contains each of the 2 influenza type A strains and each of the two influenza type B strains in the vaccine. MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV): The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for quadrivalent vaccines. | Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1) contains each of the 2 influenza type A strains and one influenza type B strain in the vaccine. Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1): The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines. | MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine contains each of the 2 influenza type A strains and alternate influenza type B strain in the vaccine. MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine Containing the Alternate B Strain (aTIV-2): The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines except the B strain present in this vaccine is the second/alternate B strain recommended for inclusion in quadrivalent vaccines (ie, Alternate B strain). |
| Measure Participants | 888 | 444 | 444 |
| Count of Participants [Participants] |
136
15.3%
|
50
11.2%
|
68
15.3%
|
| Title | Safety Endpoint: Number of Subjects With Serious AEs (SAEs), AEs Leading to Withdrawal From the Study, New Onset of Chronic Diseases (NOCDs) and AEs of Special Interest (AESIs) |
|---|---|
| Description | Safety of vaccination was assessed in terms of percentage of subjects reporting SAEs, AEs leading to withdrawal, NOCDs, and AESIs and medically attended AE up to 180 days after vaccination. |
| Time Frame | Day 1 through Day 181 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Overall Safety Set consists of all subjects in the FAS who received at least one dose or partial dose of study vaccine and have provided any evaluable follow-up safety data. |
| Arm/Group Title | aQIV | aTIV-1 | aTIV-2 |
|---|---|---|---|
| Arm/Group Description | MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV) contains each of the 2 influenza type A strains and each of the two influenza type B strains in the vaccine. MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV): The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for quadrivalent vaccines. | Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1) contains each of the 2 influenza type A strains and one influenza type B strain in the vaccine. Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1): The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines. | MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine contains each of the 2 influenza type A strains and alternate influenza type B strain in the vaccine. MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine Containing the Alternate B Strain (aTIV-2): The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines except the B strain present in this vaccine is the second/alternate B strain recommended for inclusion in quadrivalent vaccines (ie, Alternate B strain). |
| Measure Participants | 888 | 444 | 444 |
| SAEs |
37
4.2%
|
28
6.3%
|
18
4.1%
|
| AEs leading to withdrawal |
0
0%
|
0
0%
|
0
0%
|
| NOCDs |
23
2.6%
|
16
3.6%
|
14
3.2%
|
| AESIs |
1
0.1%
|
1
0.2%
|
0
0%
|
Adverse Events
| Time Frame | SAEs and unsolicited AEs: Day 1 through 181; Solicited AEs: Day 1 through 7 | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||
| Arm/Group Title | aQIV | aTIV-1 | aTIV-2 | |||
| Arm/Group Description | MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV) contains each of the 2 influenza type A strains and each of the two influenza type B strains in the vaccine. MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV): The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for quadrivalent vaccines. | Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1) contains each of the 2 influenza type A strains and one influenza type B strain in the vaccine. Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1): The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines. | MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine contains each of the 2 influenza type A strains and alternate influenza type B strain in the vaccine. MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine Containing the Alternate B Strain (aTIV-2): The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines except the B strain present in this vaccine is the second/alternate B strain recommended for inclusion in quadrivalent vaccines (ie, Alternate B strain). | |||
All Cause Mortality |
||||||
| aQIV | aTIV-1 | aTIV-2 | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/888 (0.2%) | 0/444 (0%) | 0/444 (0%) | |||
Serious Adverse Events |
||||||
| aQIV | aTIV-1 | aTIV-2 | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 37/888 (4.2%) | 28/444 (6.3%) | 18/444 (4.1%) | |||
| Blood and lymphatic system disorders | ||||||
| Anaemia | 1/888 (0.1%) | 0/444 (0%) | 0/444 (0%) | |||
| Thrombocytopenia | 0/888 (0%) | 1/444 (0.2%) | 0/444 (0%) | |||
| Cardiac disorders | ||||||
| Coronary artery disease | 1/888 (0.1%) | 1/444 (0.2%) | 2/444 (0.5%) | |||
| Atrial fibrillation | 1/888 (0.1%) | 0/444 (0%) | 1/444 (0.2%) | |||
| Angina pectoris | 0/888 (0%) | 0/444 (0%) | 1/444 (0.2%) | |||
| Angina unstable | 1/888 (0.1%) | 0/444 (0%) | 0/444 (0%) | |||
| Arteriosclerosis coronary artery | 1/888 (0.1%) | 0/444 (0%) | 0/444 (0%) | |||
| Myocardial infarction | 0/888 (0%) | 1/444 (0.2%) | 0/444 (0%) | |||
| Sinus node dysfunction | 0/888 (0%) | 1/444 (0.2%) | 0/444 (0%) | |||
| Ear and labyrinth disorders | ||||||
| Vertigo | 0/888 (0%) | 1/444 (0.2%) | 0/444 (0%) | |||
| Gastrointestinal disorders | ||||||
| Abdominal pain | 1/888 (0.1%) | 0/444 (0%) | 0/444 (0%) | |||
| Diverticular perforation | 1/888 (0.1%) | 0/444 (0%) | 0/444 (0%) | |||
| Enteritis | 0/888 (0%) | 0/444 (0%) | 1/444 (0.2%) | |||
| Gastrointestinal perforation | 0/888 (0%) | 0/444 (0%) | 1/444 (0.2%) | |||
| Gastrooesophageal reflux disease | 0/888 (0%) | 1/444 (0.2%) | 0/444 (0%) | |||
| Haematochezia | 0/888 (0%) | 0/444 (0%) | 1/444 (0.2%) | |||
| Ileus paralytic | 0/888 (0%) | 0/444 (0%) | 1/444 (0.2%) | |||
| Intestinal obstruction | 1/888 (0.1%) | 0/444 (0%) | 0/444 (0%) | |||
| Large intestinal obstruction | 0/888 (0%) | 1/444 (0.2%) | 0/444 (0%) | |||
| Pancreatitis acute | 1/888 (0.1%) | 0/444 (0%) | 0/444 (0%) | |||
| Upper gastrointestinal haemorrhage | 0/888 (0%) | 0/444 (0%) | 1/444 (0.2%) | |||
| General disorders | ||||||
| Death | 2/888 (0.2%) | 0/444 (0%) | 0/444 (0%) | |||
| Asthenia | 0/888 (0%) | 0/444 (0%) | 1/444 (0.2%) | |||
| Chest pain | 1/888 (0.1%) | 0/444 (0%) | 0/444 (0%) | |||
| Non-cardiac chest pain | 0/888 (0%) | 1/444 (0.2%) | 0/444 (0%) | |||
| Hepatobiliary disorders | ||||||
| Cholelithiasis | 0/888 (0%) | 1/444 (0.2%) | 1/444 (0.2%) | |||
| Cholangitis acute | 0/888 (0%) | 1/444 (0.2%) | 0/444 (0%) | |||
| Hepatic failure | 0/888 (0%) | 1/444 (0.2%) | 0/444 (0%) | |||
| Infections and infestations | ||||||
| Pneumonia | 7/888 (0.8%) | 4/444 (0.9%) | 1/444 (0.2%) | |||
| Influenza | 1/888 (0.1%) | 0/444 (0%) | 2/444 (0.5%) | |||
| Sepsis | 1/888 (0.1%) | 1/444 (0.2%) | 0/444 (0%) | |||
| Abscess intestinal | 0/888 (0%) | 0/444 (0%) | 1/444 (0.2%) | |||
| Cellulitis | 1/888 (0.1%) | 0/444 (0%) | 0/444 (0%) | |||
| Pneumonia bacterial | 1/888 (0.1%) | 0/444 (0%) | 0/444 (0%) | |||
| Pyelonephritis | 1/888 (0.1%) | 0/444 (0%) | 0/444 (0%) | |||
| Respiratory syncytial virus infection | 0/888 (0%) | 1/444 (0.2%) | 0/444 (0%) | |||
| Urinary tract infection | 1/888 (0.1%) | 0/444 (0%) | 0/444 (0%) | |||
| Viral pericarditis | 0/888 (0%) | 1/444 (0.2%) | 0/444 (0%) | |||
| Injury, poisoning and procedural complications | ||||||
| Femur fracture | 1/888 (0.1%) | 0/444 (0%) | 0/444 (0%) | |||
| Humerus fracture | 0/888 (0%) | 1/444 (0.2%) | 0/444 (0%) | |||
| Lower limb fracture | 1/888 (0.1%) | 0/444 (0%) | 0/444 (0%) | |||
| Overdose | 0/888 (0%) | 1/444 (0.2%) | 0/444 (0%) | |||
| Procedural dizziness | 0/888 (0%) | 1/444 (0.2%) | 0/444 (0%) | |||
| Road traffic accident | 0/888 (0%) | 1/444 (0.2%) | 0/444 (0%) | |||
| Scapula fracture | 1/888 (0.1%) | 0/444 (0%) | 0/444 (0%) | |||
| Skin abrasion | 1/888 (0.1%) | 0/444 (0%) | 0/444 (0%) | |||
| Spinal compression fracture | 1/888 (0.1%) | 0/444 (0%) | 0/444 (0%) | |||
| Subdural haematoma | 1/888 (0.1%) | 0/444 (0%) | 0/444 (0%) | |||
| Metabolism and nutrition disorders | ||||||
| Hyperglycaemia | 1/888 (0.1%) | 1/444 (0.2%) | 0/444 (0%) | |||
| Dehydration | 1/888 (0.1%) | 0/444 (0%) | 0/444 (0%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Osteoarthritis | 3/888 (0.3%) | 3/444 (0.7%) | 0/444 (0%) | |||
| Lumbar spinal stenosis | 0/888 (0%) | 1/444 (0.2%) | 0/444 (0%) | |||
| Spinal column stenosis | 0/888 (0%) | 0/444 (0%) | 1/444 (0.2%) | |||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Bladder cancer | 0/888 (0%) | 0/444 (0%) | 1/444 (0.2%) | |||
| Breast cancer | 0/888 (0%) | 1/444 (0.2%) | 0/444 (0%) | |||
| Breast cancer in situ | 0/888 (0%) | 1/444 (0.2%) | 0/444 (0%) | |||
| Non-small cell lung cancer | 0/888 (0%) | 0/444 (0%) | 1/444 (0.2%) | |||
| Ovarian cancer stage IV | 1/888 (0.1%) | 0/444 (0%) | 0/444 (0%) | |||
| Pituitary tumour benign | 0/888 (0%) | 1/444 (0.2%) | 0/444 (0%) | |||
| Skin cancer | 1/888 (0.1%) | 0/444 (0%) | 0/444 (0%) | |||
| Nervous system disorders | ||||||
| Carotid artery stenosis | 1/888 (0.1%) | 2/444 (0.5%) | 0/444 (0%) | |||
| Amyotrophic lateral sclerosis | 0/888 (0%) | 1/444 (0.2%) | 0/444 (0%) | |||
| Encephalopathy | 0/888 (0%) | 0/444 (0%) | 1/444 (0.2%) | |||
| Ischaemic cerebral infarction | 0/888 (0%) | 1/444 (0.2%) | 0/444 (0%) | |||
| Loss of consciousness | 0/888 (0%) | 1/444 (0.2%) | 0/444 (0%) | |||
| Presyncope | 1/888 (0.1%) | 0/444 (0%) | 0/444 (0%) | |||
| Seizure | 1/888 (0.1%) | 0/444 (0%) | 0/444 (0%) | |||
| Syncope | 0/888 (0%) | 1/444 (0.2%) | 0/444 (0%) | |||
| Psychiatric disorders | ||||||
| Confusional state | 1/888 (0.1%) | 0/444 (0%) | 0/444 (0%) | |||
| Renal and urinary disorders | ||||||
| Acute kidney injury | 1/888 (0.1%) | 1/444 (0.2%) | 0/444 (0%) | |||
| Renal mass | 1/888 (0.1%) | 0/444 (0%) | 0/444 (0%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Dyspnoea | 0/888 (0%) | 1/444 (0.2%) | 1/444 (0.2%) | |||
| Chronic obstructive pulmonary disease | 0/888 (0%) | 0/444 (0%) | 1/444 (0.2%) | |||
| Vascular disorders | ||||||
| Thrombosis | 0/888 (0%) | 1/444 (0.2%) | 1/444 (0.2%) | |||
| Accelerated hypertension | 0/888 (0%) | 1/444 (0.2%) | 0/444 (0%) | |||
| Aortic aneurysm | 0/888 (0%) | 0/444 (0%) | 1/444 (0.2%) | |||
| Aortic dissection | 1/888 (0.1%) | 0/444 (0%) | 0/444 (0%) | |||
| Hypotension | 0/888 (0%) | 0/444 (0%) | 1/444 (0.2%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| aQIV | aTIV-1 | aTIV-2 | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 461/888 (51.9%) | 217/444 (48.9%) | 215/444 (48.4%) | |||
| Gastrointestinal disorders | ||||||
| Diarrhea | 48/888 (5.4%) | 24/444 (5.4%) | 30/444 (6.8%) | |||
| General disorders | ||||||
| Redness | 188/888 (21.2%) | 77/444 (17.3%) | 81/444 (18.2%) | |||
| Swelling | 134/888 (15.1%) | 69/444 (15.5%) | 64/444 (14.4%) | |||
| Pain | 275/888 (31%) | 125/444 (28.2%) | 109/444 (24.5%) | |||
| Fatigue | 144/888 (16.2%) | 67/444 (15.1%) | 52/444 (11.7%) | |||
| Ecchymosis | 69/888 (7.8%) | 28/444 (6.3%) | 23/444 (5.2%) | |||
| Other | 48/888 (5.4%) | 12/444 (2.7%) | 17/444 (3.8%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Myalgia | 71/888 (8%) | 34/444 (7.7%) | 31/444 (7%) | |||
| Arthralgia | 80/888 (9%) | 37/444 (8.3%) | 31/444 (7%) | |||
| Nervous system disorders | ||||||
| Headache | 105/888 (11.8%) | 46/444 (10.4%) | 49/444 (11%) | |||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Seqirus Clinical Trial Disclosure Manager |
|---|---|
| Organization | Seqirus |
| Phone | Phone: 1-855-358-8966 |
| Seqirus.ClinicalTrials@Seqirus.com |
Responsible Party:
Seqirus
ClinicalTrials.gov Identifier:
NCT03314662
Other Study ID Numbers:
- V118_20
First Posted:
Oct 19, 2017
Last Update Posted:
Jul 22, 2020
Last Verified:
Jul 1, 2020