Influenza, Human
Conditions
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.
Interventions
The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for quadrivalent vaccines.
BIOLOGICALLicensed 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.
BIOLOGICALMF59-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).
Sponsors
Seqirus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The trial is designed as a double-blind study
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
Recruitment details
20 study centers in the United States
Pre-assignment details
All enrolled subjects were randomized.
Participants by arm
| Arm | Count |
|---|---|
| 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. The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for quadrivalent vaccines. | 889 |
| 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. The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines. | 445 |
| 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.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). | 444 |
| Total | 1,778 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 2 | 0 | 0 |
| Overall Study | Lost to Follow-up | 5 | 4 | 4 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 1 |
Baseline characteristics
| Characteristic | aTIV-1 | Total | aQIV | aTIV-2 |
|---|---|---|---|---|
| Age, Continuous | 72.4 years STANDARD_DEVIATION 5.6 | 72.5 years STANDARD_DEVIATION 5.53 | 72.4 years STANDARD_DEVIATION 5.54 | 72.6 years STANDARD_DEVIATION 5.46 |
| BMI | 29.79 kg/m^2 STANDARD_DEVIATION 5.858 | 29.67 kg/m^2 STANDARD_DEVIATION 5.956 | 29.60 kg/m^2 STANDARD_DEVIATION 6.157 | 29.69 kg/m^2 STANDARD_DEVIATION 5.647 |
| Height | 167.92 cm STANDARD_DEVIATION 10.535 | 167.84 cm STANDARD_DEVIATION 9.99 | 167.54 cm STANDARD_DEVIATION 9.35 | 168.38 cm STANDARD_DEVIATION 10.646 |
| Influenza Vaccination History No | 65 Participants | 237 Participants | 129 Participants | 43 Participants |
| Influenza Vaccination History Yes | 380 Participants | 1541 Participants | 760 Participants | 401 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 7 Participants | 5 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants | 12 Participants | 9 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 37 Participants | 125 Participants | 59 Participants | 29 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 37 Participants | 127 Participants | 59 Participants | 31 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Pacific Islander | 1 Participants | 2 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 408 Participants | 1645 Participants | 827 Participants | 410 Participants |
| Race/Ethnicity, Customized Not Reported | 0 Participants | 4 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 4 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Unknown | 0 Participants | 2 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 403 Participants | 1628 Participants | 814 Participants | 411 Participants |
| Region of Enrollment United States | 445 participants | 1778 participants | 889 participants | 444 participants |
| Sex: Female, Male Female | 249 Participants | 1007 Participants | 517 Participants | 241 Participants |
| Sex: Female, Male Male | 196 Participants | 771 Participants | 372 Participants | 203 Participants |
| Total Risk Score (Comorbidity) | 44.6 units on a scale STANDARD_DEVIATION 30.25 | 45.8 units on a scale STANDARD_DEVIATION 32.88 | 46.0 units on a scale STANDARD_DEVIATION 33.5 | 46.5 units on a scale STANDARD_DEVIATION 34.15 |
| Weight | 84.18 kg STANDARD_DEVIATION 8.963 | 83.73 kg STANDARD_DEVIATION 18.731 | 83.24 kg STANDARD_DEVIATION 19.064 | 84.24 kg STANDARD_DEVIATION 17.825 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 888 | 0 / 444 | 0 / 444 |
| other Total, other adverse events | 461 / 888 | 217 / 444 | 215 / 444 |
| serious Total, serious adverse events | 37 / 888 | 28 / 444 | 18 / 444 |
Outcome results
Primary
Immunogenicity Endpoint: The Difference Between the Seroconversion Rate (SCR) for the Four Strains Included in the Vaccine, Non-inferiority Analysis
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| aQIV | Immunogenicity Endpoint: The Difference Between the Seroconversion Rate (SCR) for the Four Strains Included in the Vaccine, Non-inferiority Analysis | A/H1N1 | 35.21 percentage of subjects |
| aQIV | Immunogenicity Endpoint: The Difference Between the Seroconversion Rate (SCR) for the Four Strains Included in the Vaccine, Non-inferiority Analysis | A/H3N2 | 39.33 percentage of subjects |
| aQIV | Immunogenicity Endpoint: The Difference Between the Seroconversion Rate (SCR) for the Four Strains Included in the Vaccine, Non-inferiority Analysis | B/Yamagata | 16.4 percentage of subjects |
| aQIV | Immunogenicity Endpoint: The Difference Between the Seroconversion Rate (SCR) for the Four Strains Included in the Vaccine, Non-inferiority Analysis | B/Victoria | 13.42 percentage of subjects |
| aTIV-1 | Immunogenicity Endpoint: The Difference Between the Seroconversion Rate (SCR) for the Four Strains Included in the Vaccine, Non-inferiority Analysis | B/Victoria | 12.16 percentage of subjects |
| aTIV-1 | Immunogenicity Endpoint: The Difference Between the Seroconversion Rate (SCR) for the Four Strains Included in the Vaccine, Non-inferiority Analysis | A/H1N1 | 39.45 percentage of subjects |
| aTIV-1 | Immunogenicity Endpoint: The Difference Between the Seroconversion Rate (SCR) for the Four Strains Included in the Vaccine, Non-inferiority Analysis | B/Yamagata | NA percentage of subjects |
| aTIV-1 | Immunogenicity Endpoint: The Difference Between the Seroconversion Rate (SCR) for the Four Strains Included in the Vaccine, Non-inferiority Analysis | A/H3N2 | 39.70 percentage of subjects |
| aTIV-2 | Immunogenicity Endpoint: The Difference Between the Seroconversion Rate (SCR) for the Four Strains Included in the Vaccine, Non-inferiority Analysis | B/Victoria | NA percentage of subjects |
| aTIV-2 | Immunogenicity Endpoint: The Difference Between the Seroconversion Rate (SCR) for the Four Strains Included in the Vaccine, Non-inferiority Analysis | A/H3N2 | 37.18 percentage of subjects |
| aTIV-2 | Immunogenicity Endpoint: The Difference Between the Seroconversion Rate (SCR) for the Four Strains Included in the Vaccine, Non-inferiority Analysis | B/Yamagata | 15.47 percentage of subjects |
| aTIV-2 | Immunogenicity Endpoint: The Difference Between the Seroconversion Rate (SCR) for the Four Strains Included in the Vaccine, Non-inferiority Analysis | A/H1N1 | 37.41 percentage of subjects |
Comparison: Comparison Group Selection: aTIV minus aQIV - for strain A/H1N195% CI: [-1.3, 7.76]
Comparison: Comparison Group Selection: aTIV minus aQIV - for strain A/H3N295% CI: [-4.23, 4.96]
Comparison: Comparison Group Selection: aTIV minus aQIV - for strain B-Yamagata95% CI: [-5.13, 3.27]
Comparison: Comparison Group Selection: aTIV minus aQIV - for strain B-Victoria95% CI: [-5.07, 2.55]
Primary
Immunogenicity Endpoint: The Geometric Mean Titer (GMT) and GMT Ratio for the Four Strains Included in the Vaccine, Non-inferiority Analysis.
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
Population: 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 | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| aQIV | Immunogenicity Endpoint: The Geometric Mean Titer (GMT) and GMT Ratio for the Four Strains Included in the Vaccine, Non-inferiority Analysis. | A/H1N1 | 65.01 Geometric mean titer |
| aQIV | Immunogenicity Endpoint: The Geometric Mean Titer (GMT) and GMT Ratio for the Four Strains Included in the Vaccine, Non-inferiority Analysis. | A/H3N2 | 294.91 Geometric mean titer |
| aQIV | Immunogenicity Endpoint: The Geometric Mean Titer (GMT) and GMT Ratio for the Four Strains Included in the Vaccine, Non-inferiority Analysis. | B/Yamagata | 24.67 Geometric mean titer |
| aQIV | Immunogenicity Endpoint: The Geometric Mean Titer (GMT) and GMT Ratio for the Four Strains Included in the Vaccine, Non-inferiority Analysis. | B/Victoria | 30.78 Geometric mean titer |
| aTIV-1 | Immunogenicity Endpoint: The Geometric Mean Titer (GMT) and GMT Ratio for the Four Strains Included in the Vaccine, Non-inferiority Analysis. | A/H3N2 | NA Geometric mean titer |
| aTIV-1 | Immunogenicity Endpoint: The Geometric Mean Titer (GMT) and GMT Ratio for the Four Strains Included in the Vaccine, Non-inferiority Analysis. | B/Yamagata | 15.96 Geometric mean titer |
| aTIV-1 | Immunogenicity Endpoint: The Geometric Mean Titer (GMT) and GMT Ratio for the Four Strains Included in the Vaccine, Non-inferiority Analysis. | B/Victoria | 30.13 Geometric mean titer |
| aTIV-1 | Immunogenicity Endpoint: The Geometric Mean Titer (GMT) and GMT Ratio for the Four Strains Included in the Vaccine, Non-inferiority Analysis. | A/H1N1 | NA Geometric mean titer |
| aTIV-2 | Immunogenicity Endpoint: The Geometric Mean Titer (GMT) and GMT Ratio for the Four Strains Included in the Vaccine, Non-inferiority Analysis. | B/Yamagata | 24.30 Geometric mean titer |
| aTIV-2 | Immunogenicity Endpoint: The Geometric Mean Titer (GMT) and GMT Ratio for the Four Strains Included in the Vaccine, Non-inferiority Analysis. | A/H3N2 | NA Geometric mean titer |
| aTIV-2 | Immunogenicity Endpoint: The Geometric Mean Titer (GMT) and GMT Ratio for the Four Strains Included in the Vaccine, Non-inferiority Analysis. | B/Victoria | 21.80 Geometric mean titer |
| aTIV-2 | Immunogenicity Endpoint: The Geometric Mean Titer (GMT) and GMT Ratio for the Four Strains Included in the Vaccine, Non-inferiority Analysis. | A/H1N1 | NA Geometric mean titer |
| aTIV-1/aTIV-2 | Immunogenicity Endpoint: The Geometric Mean Titer (GMT) and GMT Ratio for the Four Strains Included in the Vaccine, Non-inferiority Analysis. | B/Victoria | NA Geometric mean titer |
| aTIV-1/aTIV-2 | Immunogenicity Endpoint: The Geometric Mean Titer (GMT) and GMT Ratio for the Four Strains Included in the Vaccine, Non-inferiority Analysis. | A/H3N2 | 293.31 Geometric mean titer |
| aTIV-1/aTIV-2 | Immunogenicity Endpoint: The Geometric Mean Titer (GMT) and GMT Ratio for the Four Strains Included in the Vaccine, Non-inferiority Analysis. | A/H1N1 | 75.16 Geometric mean titer |
| aTIV-1/aTIV-2 | Immunogenicity Endpoint: The Geometric Mean Titer (GMT) and GMT Ratio for the Four Strains Included in the Vaccine, Non-inferiority Analysis. | B/Yamagata | NA Geometric mean titer |
Comparison: Comparison Group Selection: aTIV/aQIV - for strain A/H1N195% CI: [1.05, 1.27]
Comparison: Comparison Group Selection: aTIV/aQIV - performed for strain A/H3N295% CI: [0.9, 1.09]
Comparison: Comparison Group Selection: aQIV/aTIV - performed for strain B/Yamagata95% CI: [0.9, 1.08]
Comparison: Comparison Group Selection: aQIV/aTIV - performed for strain B/Victoria95% CI: [0.89, 1.08]
Primary
Immunogenicity Endpoint: The Percentage of Subjects Achieving SCR for Hemagglutination Inhibition (HI) Antibody for the Four Strains Included in the Vaccine.
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| aQIV | Immunogenicity Endpoint: The Percentage of Subjects Achieving SCR for Hemagglutination Inhibition (HI) Antibody for the Four Strains Included in the Vaccine. | A/H1N1 | 35.21 Percentage of subjects |
| aQIV | Immunogenicity Endpoint: The Percentage of Subjects Achieving SCR for Hemagglutination Inhibition (HI) Antibody for the Four Strains Included in the Vaccine. | A/H3N2 | 39.33 Percentage of subjects |
| aQIV | Immunogenicity Endpoint: The Percentage of Subjects Achieving SCR for Hemagglutination Inhibition (HI) Antibody for the Four Strains Included in the Vaccine. | B/Yamagata | 16.40 Percentage of subjects |
| aQIV | Immunogenicity Endpoint: The Percentage of Subjects Achieving SCR for Hemagglutination Inhibition (HI) Antibody for the Four Strains Included in the Vaccine. | B/Victoria | 13.42 Percentage of subjects |
| aTIV-1 | Immunogenicity Endpoint: The Percentage of Subjects Achieving SCR for Hemagglutination Inhibition (HI) Antibody for the Four Strains Included in the Vaccine. | B/Victoria | 12.16 Percentage of subjects |
| aTIV-1 | Immunogenicity Endpoint: The Percentage of Subjects Achieving SCR for Hemagglutination Inhibition (HI) Antibody for the Four Strains Included in the Vaccine. | A/H1N1 | 39.45 Percentage of subjects |
| aTIV-1 | Immunogenicity Endpoint: The Percentage of Subjects Achieving SCR for Hemagglutination Inhibition (HI) Antibody for the Four Strains Included in the Vaccine. | B/Yamagata | NA Percentage of subjects |
| aTIV-1 | Immunogenicity Endpoint: The Percentage of Subjects Achieving SCR for Hemagglutination Inhibition (HI) Antibody for the Four Strains Included in the Vaccine. | A/H3N2 | 39.70 Percentage of subjects |
| aTIV-2 | Immunogenicity Endpoint: The Percentage of Subjects Achieving SCR for Hemagglutination Inhibition (HI) Antibody for the Four Strains Included in the Vaccine. | B/Victoria | NA Percentage of subjects |
| aTIV-2 | Immunogenicity Endpoint: The Percentage of Subjects Achieving SCR for Hemagglutination Inhibition (HI) Antibody for the Four Strains Included in the Vaccine. | A/H3N2 | 37.18 Percentage of subjects |
| aTIV-2 | Immunogenicity Endpoint: The Percentage of Subjects Achieving SCR for Hemagglutination Inhibition (HI) Antibody for the Four Strains Included in the Vaccine. | B/Yamagata | 15.47 Percentage of subjects |
| aTIV-2 | Immunogenicity Endpoint: The Percentage of Subjects Achieving SCR for Hemagglutination Inhibition (HI) Antibody for the Four Strains Included in the Vaccine. | A/H1N1 | 37.41 Percentage of subjects |
Primary
Immunogenicity Endpoint: The Percent of Subjects Achieving an HI Antibody Titer ≥ 1:40 for the Four Strains Included in the Vaccines.
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| aQIV | Immunogenicity Endpoint: The Percent of Subjects Achieving an HI Antibody Titer ≥ 1:40 for the Four Strains Included in the Vaccines. | A/H1N1 | 69.38 Percentage of subjects |
| aQIV | Immunogenicity Endpoint: The Percent of Subjects Achieving an HI Antibody Titer ≥ 1:40 for the Four Strains Included in the Vaccines. | A/H3N2 | 93.92 Percentage of subjects |
| aQIV | Immunogenicity Endpoint: The Percent of Subjects Achieving an HI Antibody Titer ≥ 1:40 for the Four Strains Included in the Vaccines. | B/Yamagata | 32.80 Percentage of subjects |
| aQIV | Immunogenicity Endpoint: The Percent of Subjects Achieving an HI Antibody Titer ≥ 1:40 for the Four Strains Included in the Vaccines. | B/Victoria | 38.19 Percentage of subjects |
| aTIV-1 | Immunogenicity Endpoint: The Percent of Subjects Achieving an HI Antibody Titer ≥ 1:40 for the Four Strains Included in the Vaccines. | B/Victoria | 36.93 Percentage of subjects |
| aTIV-1 | Immunogenicity Endpoint: The Percent of Subjects Achieving an HI Antibody Titer ≥ 1:40 for the Four Strains Included in the Vaccines. | A/H1N1 | 71.79 Percentage of subjects |
| aTIV-1 | Immunogenicity Endpoint: The Percent of Subjects Achieving an HI Antibody Titer ≥ 1:40 for the Four Strains Included in the Vaccines. | B/Yamagata | 21.79 Percentage of subjects |
| aTIV-1 | Immunogenicity Endpoint: The Percent of Subjects Achieving an HI Antibody Titer ≥ 1:40 for the Four Strains Included in the Vaccines. | A/H3N2 | 94.72 Percentage of subjects |
| aTIV-2 | Immunogenicity Endpoint: The Percent of Subjects Achieving an HI Antibody Titer ≥ 1:40 for the Four Strains Included in the Vaccines. | B/Victoria | 24.48 Percentage of subjects |
| aTIV-2 | Immunogenicity Endpoint: The Percent of Subjects Achieving an HI Antibody Titer ≥ 1:40 for the Four Strains Included in the Vaccines. | A/H3N2 | 94.92 Percentage of subjects |
| aTIV-2 | Immunogenicity Endpoint: The Percent of Subjects Achieving an HI Antibody Titer ≥ 1:40 for the Four Strains Included in the Vaccines. | B/Yamagata | 36.95 Percentage of subjects |
| aTIV-2 | Immunogenicity Endpoint: The Percent of Subjects Achieving an HI Antibody Titer ≥ 1:40 for the Four Strains Included in the Vaccines. | A/H1N1 | 68.82 Percentage of subjects |
Secondary
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) of Post Vaccination HI Titer Over the Pre-vaccination HI Titer Against Homologous Strains
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
Population: 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 | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| aQIV | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) of Post Vaccination HI Titer Over the Pre-vaccination HI Titer Against Homologous Strains | A/H3N2 | 3.36 geometric mean ratio |
| aQIV | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) of Post Vaccination HI Titer Over the Pre-vaccination HI Titer Against Homologous Strains | B/Yamagata | 2.03 geometric mean ratio |
| aQIV | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) of Post Vaccination HI Titer Over the Pre-vaccination HI Titer Against Homologous Strains | B/Victoria | 1.76 geometric mean ratio |
| aQIV | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) of Post Vaccination HI Titer Over the Pre-vaccination HI Titer Against Homologous Strains | A/H1N1 | 2.99 geometric mean ratio |
| aTIV-1 | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) of Post Vaccination HI Titer Over the Pre-vaccination HI Titer Against Homologous Strains | B/Yamagata | NA geometric mean ratio |
| aTIV-1 | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) of Post Vaccination HI Titer Over the Pre-vaccination HI Titer Against Homologous Strains | B/Victoria | 1.68 geometric mean ratio |
| aTIV-1 | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) of Post Vaccination HI Titer Over the Pre-vaccination HI Titer Against Homologous Strains | A/H1N1 | NA geometric mean ratio |
| aTIV-1 | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) of Post Vaccination HI Titer Over the Pre-vaccination HI Titer Against Homologous Strains | A/H3N2 | NA geometric mean ratio |
| aTIV-2 | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) of Post Vaccination HI Titer Over the Pre-vaccination HI Titer Against Homologous Strains | B/Victoria | NA geometric mean ratio |
| aTIV-2 | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) of Post Vaccination HI Titer Over the Pre-vaccination HI Titer Against Homologous Strains | B/Yamagata | 1.93 geometric mean ratio |
| aTIV-2 | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) of Post Vaccination HI Titer Over the Pre-vaccination HI Titer Against Homologous Strains | A/H1N1 | NA geometric mean ratio |
| aTIV-2 | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) of Post Vaccination HI Titer Over the Pre-vaccination HI Titer Against Homologous Strains | A/H3N2 | NA geometric mean ratio |
| aTIV-1/aTIV-2 | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) of Post Vaccination HI Titer Over the Pre-vaccination HI Titer Against Homologous Strains | A/H1N1 | 3.40 geometric mean ratio |
| aTIV-1/aTIV-2 | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) of Post Vaccination HI Titer Over the Pre-vaccination HI Titer Against Homologous Strains | B/Yamagata | NA geometric mean ratio |
| aTIV-1/aTIV-2 | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) of Post Vaccination HI Titer Over the Pre-vaccination HI Titer Against Homologous Strains | A/H3N2 | 3.29 geometric mean ratio |
| aTIV-1/aTIV-2 | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) of Post Vaccination HI Titer Over the Pre-vaccination HI Titer Against Homologous Strains | B/Victoria | NA geometric mean ratio |
Secondary
Immunogenicity Endpoint: Geometric Mean Titers (GMT) Against Homologous Strains
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
Population: 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 | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| aQIV | Immunogenicity Endpoint: Geometric Mean Titers (GMT) Against Homologous Strains | A/H1N1 Day 1 | 19.07 geometric mean titer |
| aQIV | Immunogenicity Endpoint: Geometric Mean Titers (GMT) Against Homologous Strains | A/H1N1 Day 22 | 57.07 geometric mean titer |
| aQIV | Immunogenicity Endpoint: Geometric Mean Titers (GMT) Against Homologous Strains | A/H3N2 Day 1 | 73.27 geometric mean titer |
| aQIV | Immunogenicity Endpoint: Geometric Mean Titers (GMT) Against Homologous Strains | A/H3N2 Day 22 | 245.85 geometric mean titer |
| aQIV | Immunogenicity Endpoint: Geometric Mean Titers (GMT) Against Homologous Strains | B/Yamagata Day 1 | 10.41 geometric mean titer |
| aQIV | Immunogenicity Endpoint: Geometric Mean Titers (GMT) Against Homologous Strains | B/Yamagata Day 22 | 21.15 geometric mean titer |
| aQIV | Immunogenicity Endpoint: Geometric Mean Titers (GMT) Against Homologous Strains | B/Victoria Day 1 | 14.15 geometric mean titer |
| aQIV | Immunogenicity Endpoint: Geometric Mean Titers (GMT) Against Homologous Strains | B/Victoria Day 22 | 24.91 geometric mean titer |
| aTIV-1 | Immunogenicity Endpoint: Geometric Mean Titers (GMT) Against Homologous Strains | B/Yamagata Day 22 | NA geometric mean titer |
| aTIV-1 | Immunogenicity Endpoint: Geometric Mean Titers (GMT) Against Homologous Strains | B/Yamagata Day 1 | NA geometric mean titer |
| aTIV-1 | Immunogenicity Endpoint: Geometric Mean Titers (GMT) Against Homologous Strains | A/H1N1 Day 22 | NA geometric mean titer |
| aTIV-1 | Immunogenicity Endpoint: Geometric Mean Titers (GMT) Against Homologous Strains | B/Victoria Day 22 | 25.54 geometric mean titer |
| aTIV-1 | Immunogenicity Endpoint: Geometric Mean Titers (GMT) Against Homologous Strains | B/Victoria Day 1 | 15.18 geometric mean titer |
| aTIV-1 | Immunogenicity Endpoint: Geometric Mean Titers (GMT) Against Homologous Strains | A/H3N2 Day 22 | NA geometric mean titer |
| aTIV-1 | Immunogenicity Endpoint: Geometric Mean Titers (GMT) Against Homologous Strains | A/H3N2 Day 1 | NA geometric mean titer |
| aTIV-1 | Immunogenicity Endpoint: Geometric Mean Titers (GMT) Against Homologous Strains | A/H1N1 Day 1 | NA geometric mean titer |
| aTIV-2 | Immunogenicity Endpoint: Geometric Mean Titers (GMT) Against Homologous Strains | B/Victoria Day 1 | NA geometric mean titer |
| aTIV-2 | Immunogenicity Endpoint: Geometric Mean Titers (GMT) Against Homologous Strains | A/H3N2 Day 1 | NA geometric mean titer |
| aTIV-2 | Immunogenicity Endpoint: Geometric Mean Titers (GMT) Against Homologous Strains | A/H3N2 Day 22 | NA geometric mean titer |
| aTIV-2 | Immunogenicity Endpoint: Geometric Mean Titers (GMT) Against Homologous Strains | B/Yamagata Day 1 | 10.76 geometric mean titer |
| aTIV-2 | Immunogenicity Endpoint: Geometric Mean Titers (GMT) Against Homologous Strains | B/Yamagata Day 22 | 20.74 geometric mean titer |
| aTIV-2 | Immunogenicity Endpoint: Geometric Mean Titers (GMT) Against Homologous Strains | B/Victoria Day 22 | NA geometric mean titer |
| aTIV-2 | Immunogenicity Endpoint: Geometric Mean Titers (GMT) Against Homologous Strains | A/H1N1 Day 1 | NA geometric mean titer |
| aTIV-2 | Immunogenicity Endpoint: Geometric Mean Titers (GMT) Against Homologous Strains | A/H1N1 Day 22 | NA geometric mean titer |
| aTIV-1/aTIV-2 | Immunogenicity Endpoint: Geometric Mean Titers (GMT) Against Homologous Strains | A/H3N2 Day 1 | 71.83 geometric mean titer |
| aTIV-1/aTIV-2 | Immunogenicity Endpoint: Geometric Mean Titers (GMT) Against Homologous Strains | A/H3N2 Day 22 | 236.27 geometric mean titer |
| aTIV-1/aTIV-2 | Immunogenicity Endpoint: Geometric Mean Titers (GMT) Against Homologous Strains | A/H1N1 Day 22 | 63.73 geometric mean titer |
| aTIV-1/aTIV-2 | Immunogenicity Endpoint: Geometric Mean Titers (GMT) Against Homologous Strains | A/H1N1 Day 1 | 18.77 geometric mean titer |
| aTIV-1/aTIV-2 | Immunogenicity Endpoint: Geometric Mean Titers (GMT) Against Homologous Strains | B/Yamagata Day 1 | NA geometric mean titer |
| aTIV-1/aTIV-2 | Immunogenicity Endpoint: Geometric Mean Titers (GMT) Against Homologous Strains | B/Victoria Day 22 | NA geometric mean titer |
| aTIV-1/aTIV-2 | Immunogenicity Endpoint: Geometric Mean Titers (GMT) Against Homologous Strains | B/Victoria Day 1 | NA geometric mean titer |
| aTIV-1/aTIV-2 | Immunogenicity Endpoint: Geometric Mean Titers (GMT) Against Homologous Strains | B/Yamagata Day 22 | NA geometric mean titer |
Comparison: B/Yamagata strain: GMT Ratio (aTIV/aQIV)95% CI: [0.58, 0.7]
Comparison: B/Victoria Strain: GMT Ratio (aTIV/aQIV)95% CI: [0.64, 0.78]
Secondary
Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 Against Homologous Strains
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| aQIV | Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 Against Homologous Strains | A/H1N1 Day 1 | 33.26 percentage of subjects |
| aQIV | Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 Against Homologous Strains | A/H1N1 Day 22 | 69.38 percentage of subjects |
| aQIV | Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 Against Homologous Strains | A/H3N2 Day 1 | 70.64 percentage of subjects |
| aQIV | Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 Against Homologous Strains | A/H3N2 Day 22 | 93.92 percentage of subjects |
| aQIV | Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 Against Homologous Strains | B/Yamagata Day 1 | 11.12 percentage of subjects |
| aQIV | Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 Against Homologous Strains | B/Yamagata Day 22 | 32.80 percentage of subjects |
| aQIV | Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 Against Homologous Strains | B/Victoria Day 1 | 19.72 percentage of subjects |
| aQIV | Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 Against Homologous Strains | B/Victoria Day 22 | 38.19 percentage of subjects |
| aTIV-1 | Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 Against Homologous Strains | B/Yamagata Day 22 | NA percentage of subjects |
| aTIV-1 | Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 Against Homologous Strains | B/Yamagata Day 1 | NA percentage of subjects |
| aTIV-1 | Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 Against Homologous Strains | A/H1N1 Day 22 | NA percentage of subjects |
| aTIV-1 | Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 Against Homologous Strains | B/Victoria Day 22 | 36.93 percentage of subjects |
| aTIV-1 | Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 Against Homologous Strains | B/Victoria Day 1 | 22.71 percentage of subjects |
| aTIV-1 | Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 Against Homologous Strains | A/H3N2 Day 22 | NA percentage of subjects |
| aTIV-1 | Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 Against Homologous Strains | A/H3N2 Day 1 | NA percentage of subjects |
| aTIV-1 | Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 Against Homologous Strains | A/H1N1 Day 1 | NA percentage of subjects |
| aTIV-2 | Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 Against Homologous Strains | B/Victoria Day 1 | NA percentage of subjects |
| aTIV-2 | Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 Against Homologous Strains | A/H3N2 Day 1 | NA percentage of subjects |
| aTIV-2 | Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 Against Homologous Strains | A/H3N2 Day 22 | NA percentage of subjects |
| aTIV-2 | Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 Against Homologous Strains | B/Yamagata Day 1 | 11.55 percentage of subjects |
| aTIV-2 | Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 Against Homologous Strains | B/Yamagata Day 22 | 36.95 percentage of subjects |
| aTIV-2 | Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 Against Homologous Strains | B/Victoria Day 22 | NA percentage of subjects |
| aTIV-2 | Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 Against Homologous Strains | A/H1N1 Day 1 | NA percentage of subjects |
| aTIV-2 | Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 Against Homologous Strains | A/H1N1 Day 22 | NA percentage of subjects |
| aTIV-1/aTIV-2 | Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 Against Homologous Strains | A/H3N2 Day 1 | 70.66 percentage of subjects |
| aTIV-1/aTIV-2 | Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 Against Homologous Strains | A/H3N2 Day 22 | 94.82 percentage of subjects |
| aTIV-1/aTIV-2 | Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 Against Homologous Strains | A/H1N1 Day 22 | 70.31 percentage of subjects |
| aTIV-1/aTIV-2 | Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 Against Homologous Strains | A/H1N1 Day 1 | 31.07 percentage of subjects |
| aTIV-1/aTIV-2 | Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 Against Homologous Strains | B/Yamagata Day 1 | NA percentage of subjects |
| aTIV-1/aTIV-2 | Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 Against Homologous Strains | B/Victoria Day 22 | NA percentage of subjects |
| aTIV-1/aTIV-2 | Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 Against Homologous Strains | B/Victoria Day 1 | NA percentage of subjects |
| aTIV-1/aTIV-2 | Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 Against Homologous Strains | B/Yamagata Day 22 | NA percentage of subjects |
Secondary
Immunogenicity Endpoint: The Percentage of Subjects With SCR Against Homologous Strains
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| aQIV | Immunogenicity Endpoint: The Percentage of Subjects With SCR Against Homologous Strains | B/Yamagata | 16.40 Percentage of subjects |
| aQIV | Immunogenicity Endpoint: The Percentage of Subjects With SCR Against Homologous Strains | A/H3N2 | 39.33 Percentage of subjects |
| aQIV | Immunogenicity Endpoint: The Percentage of Subjects With SCR Against Homologous Strains | A/H1N1 | 35.21 Percentage of subjects |
| aQIV | Immunogenicity Endpoint: The Percentage of Subjects With SCR Against Homologous Strains | B/Victoria | 13.42 Percentage of subjects |
| aTIV-1 | Immunogenicity Endpoint: The Percentage of Subjects With SCR Against Homologous Strains | A/H3N2 | NA Percentage of subjects |
| aTIV-1 | Immunogenicity Endpoint: The Percentage of Subjects With SCR Against Homologous Strains | A/H1N1 | NA Percentage of subjects |
| aTIV-1 | Immunogenicity Endpoint: The Percentage of Subjects With SCR Against Homologous Strains | B/Yamagata | NA Percentage of subjects |
| aTIV-1 | Immunogenicity Endpoint: The Percentage of Subjects With SCR Against Homologous Strains | B/Victoria | 12.16 Percentage of subjects |
| aTIV-2 | Immunogenicity Endpoint: The Percentage of Subjects With SCR Against Homologous Strains | A/H1N1 | NA Percentage of subjects |
| aTIV-2 | Immunogenicity Endpoint: The Percentage of Subjects With SCR Against Homologous Strains | B/Yamagata | 15.47 Percentage of subjects |
| aTIV-2 | Immunogenicity Endpoint: The Percentage of Subjects With SCR Against Homologous Strains | A/H3N2 | NA Percentage of subjects |
| aTIV-2 | Immunogenicity Endpoint: The Percentage of Subjects With SCR Against Homologous Strains | B/Victoria | NA Percentage of subjects |
| aTIV-1/aTIV-2 | Immunogenicity Endpoint: The Percentage of Subjects With SCR Against Homologous Strains | A/H3N2 | 39.70 Percentage of subjects |
| aTIV-1/aTIV-2 | Immunogenicity Endpoint: The Percentage of Subjects With SCR Against Homologous Strains | B/Yamagata | NA Percentage of subjects |
| aTIV-1/aTIV-2 | Immunogenicity Endpoint: The Percentage of Subjects With SCR Against Homologous Strains | B/Victoria | NA Percentage of subjects |
| aTIV-1/aTIV-2 | Immunogenicity Endpoint: The Percentage of Subjects With SCR Against Homologous Strains | A/H1N1 | 38.43 Percentage of subjects |
Comparison: B/Yamagata Strain: SCR Difference (aTIV-1 - aQIV).95% CI: [-15.12, -8.81]
Comparison: B/Victoria Strain: SCR Difference (aTIV-2 - aQIV)95% CI: [-13.54, -8.11]
Secondary
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)
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
Population: 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 | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| aQIV | 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) | SAEs | 37 Participants |
| aQIV | 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) | AEs leading to withdrawal | 0 Participants |
| aQIV | 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) | NOCDs | 23 Participants |
| aQIV | 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) | AESIs | 1 Participants |
| aTIV-1 | 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) | AESIs | 1 Participants |
| aTIV-1 | 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) | SAEs | 28 Participants |
| aTIV-1 | 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) | NOCDs | 16 Participants |
| aTIV-1 | 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) | AEs leading to withdrawal | 0 Participants |
| aTIV-2 | 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) | AESIs | 0 Participants |
| aTIV-2 | 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) | AEs leading to withdrawal | 0 Participants |
| aTIV-2 | 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) | NOCDs | 14 Participants |
| aTIV-2 | 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) | SAEs | 18 Participants |
Secondary
Safety Endpoint: Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following Vaccination
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
Population: 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 | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| aQIV | Safety Endpoint: Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following Vaccination | Any local solicited AE | 385 Participants |
| aQIV | Safety Endpoint: Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following Vaccination | Any systemic solicited AE | 231 Participants |
| aTIV-1 | Safety Endpoint: Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following Vaccination | Any local solicited AE | 170 Participants |
| aTIV-1 | Safety Endpoint: Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following Vaccination | Any systemic solicited AE | 107 Participants |
| aTIV-2 | Safety Endpoint: Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following Vaccination | Any local solicited AE | 167 Participants |
| aTIV-2 | Safety Endpoint: Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following Vaccination | Any systemic solicited AE | 110 Participants |
Secondary
Safety Endpoint: Number of Subjects With Unsolicited AEs
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
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| aQIV | Safety Endpoint: Number of Subjects With Unsolicited AEs | 136 Participants |
| aTIV-1 | Safety Endpoint: Number of Subjects With Unsolicited AEs | 50 Participants |
| aTIV-2 | Safety Endpoint: Number of Subjects With Unsolicited AEs | 68 Participants |