Healthy Volunteers, Influenza Immunization
Conditions
Brief summary
Primary Objective: To demonstrate that QIV-HD induced an immune response (as assessed by hemagglutination inhibition \[HAI\] geometric mean titers \[GMTs\] and seroconversion rates) that was superior to responses induced by QIV-SD for the 4 virus strains at 28 days post-vaccination in all participants. Secondary Objective: * To describe the immune response induced by QIV-HD and QIV-SD by HAI measurement method in all participants. * To describe the safety profile of all participants in each study group.
Detailed description
Study duration per participant was approximately 28 days including: 1 day of screening and vaccination, a safety follow-up telephone call and an end of study visit approximately at Day 8 and 28 after vaccination, respectively.
Interventions
BIOLOGICALHigh-Dose Quadrivalent Influenza Vaccine, (Zonal Purified, Split Virus) 2020-2021 Strains (QIV-HD)
Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: IM
BIOLOGICALLocal Standard-Dose Inactivated Quadrivalent Influenza Vaccine, 2020-2021 Strains (QIV-SD)
Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: SC
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Modified double-blind: the participant and the Investigator remain unaware of the treatment assignments throughout the study. An unblinded qualified trial staff member will administer the appropriate vaccine but will not be involved in the immunogenicity and safety evaluations.
Intervention model description
Participants randomized in each group were stratified by site and age (60 to 64, 65 to 74, and 75 years of age and older).
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
: * Aged greater than or equal to (\>=) 60 years on the day of inclusion. * Able to attend all scheduled visits and complied with all study procedures.
Exclusion criteria
* Participation at the time of study enrollment (or in the 4 weeks preceding the study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure. * Receipt of any vaccination with live vaccines within the past 27 days preceding the study vaccination or any vaccination with inactivated vaccines within the past 6 days preceding the study vaccination, or planned receipt of any vaccine prior to Visit 02. * Previous vaccination against influenza (in the preceding 6 months) with either the study vaccine or another vaccine. * Receipt of immune globulins, blood or blood-derived products in the past 3 months. * Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months). * Known systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the study or to a vaccine containing any of the same substances. * Thrombocytopenia or bleeding disorder, contraindicating IM vaccination based on Investigator's judgment. * Alcohol or substance abuse that, in the opinion of the Investigator might interfere with the study conduct or completion. * Chronic illness that, in the opinion of the Investigator, was at a stage where it might interfere with study conduct or completion. * Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e.,parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study. * Personal or family history of Guillain-Barré syndrome. * Neoplastic disease or any hematologic malignancy (except localized skin or prostate cancer that is stable at the time of vaccination in the absence of therapy and participants who have a history of neoplastic disease and have been disease free for \>=5 years). * Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature \>=37.5 degree Celsius). A prospective participant was not be included in the study until the condition had resolved or the febrile event had subsided. * History of convulsions. * Any condition that in the opinion of the Investigator could interfere with the evaluation of the vaccine. The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 28 | Day 28 (post-vaccination) | GMTs of anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1, A/H3N2-like, B/Victoria-like, and B/Yamagata. Titers were expressed in terms of 1/dilution. |
| Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens: Superiority Analysis | Day 28 (post-vaccination) | Anti-influenza antibodies were measured by HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2-like, B/Victoria-like, and B/Yamagata. Seroconversion was defined as either a pre-vaccination HAI titer less than (\<) 10 (1/dilution) and a post-vaccination titer \>=40 (1/dilution) or a pre-vaccination titer \>=10 (1/dilution) and a \>= four-fold increase in post-vaccination titer at Day 28. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens | Day 28 (post-vaccination) | Anti-influenza antibodies were measured by HAI assay for 6 influenza virus strains: A/H1N1, A/H3N2, A/H3N2-like, B/Victoria, B/Victoria-like, and B/Yamagata. Seroconversion was defined as either a pre-vaccination HAI titer \<10 (1/dilution) and a post-vaccination titer \>=40 (1/dilution) or a pre-vaccination titer \>=10 (1/dilution) and a \>= four-fold increase in post-vaccination titer at Day 28. |
| Percentage of Participants With HAI Titers >=40 (1/Dilution) Against Influenza Antigens | Day 0 (pre-vaccination), Day 28 (post-vaccination) | Anti-influenza antibodies were measured using HAI assay method for 6 influenza virus strains: A/H1N1, A/H3N2, A/H3N2-like, B/Victoria, B/Victoria-like, and B/Yamagata. Percentage of participants with HAI titers \>=40 (1/dilution) is reported in the outcome measure. |
| Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs) | Within 30 minutes post-vaccination | An AE was any untoward medical occurrence in a patient or in a clinical investigation participant administered a medicinal product and which did not necessarily have a casual relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. All participants were observed for 30 minutes after vaccination, and any unsolicited AEs that occurred during that time were recorded as immediate unsolicited AEs in the CRB. |
| GMTs of Influenza Vaccine Antibodies at Day 0 and Day 28 | Day 0 (pre-vaccination) and Day 28 (post-vaccination) | GMTs of anti-influenza antibodies were measured using HAI assay for 6 influenza virus strains: A/H1N1, A/H3N2, A/H3N2-like, B/Victoria, B/Victoria-like, and B/Yamagata. Titers were expressed in terms of 1/dilution. |
| Number of Participants Reporting Unsolicited Adverse Events (AEs) | Within 28 days post-vaccination | An AE was any untoward medical occurrence in a patient or in a clinical investigation participant administered a medicinal product and which did not necessarily have a casual relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. |
| Number of Participants Reporting Serious Adverse Events (SAEs) | From Day 0 up to Day 28 post-vaccination | A SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. |
| Number of Participants Reporting Solicited Injection Site and Systemic Reactions | Within 7 days post-vaccination | A solicited reaction was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the CRB and considered as related to the product administered. Solicited injection site reactions included injection site pain, injection site erythema, injection site swelling, injection site induration, and injection site bruising. Solicited systemic reactions included fever, headache, malaise, myalgia and shivering. |
| Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine Antibodies | Day 0 (pre-vaccination), Day 28 (post-vaccination) | GMTs of anti-influenza antibodies were measured using HAI assay for 6 influenza virus strains: A/H1N1, A/H3N2, A/H3N2-like, B/Victoria, B/Victoria-like, and B/Yamagata. GMTRs were calculated as the ratio of GMTs post-vaccination (on Day 28) and pre-vaccination (on Day 0). |
Countries
Japan
Participant flow
Recruitment details
The study was conducted at 10 active centers in Japan.
Pre-assignment details
A total of 2100 participants were enrolled and randomized between 21 October 2020 to 14 January 2021.
Participants by arm
| Arm | Count |
|---|---|
| QIV-HD Participants received a single injection of 0.7 milliliters (mL) high dose quadrivalent influenza vaccine (QIV-HD), intramuscularly (IM) at Day 0. | 1,049 |
| QIV-SD Participants received a single injection of 0.5 mL standard-dose quadrivalent influenza vaccine (QIV-SD), subcutaneously (SC) at Day 0. | 1,051 |
| Total Title | 2,100 |
| Total | 4,200 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 3 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | QIV-SD | Total Title | QIV-HD |
|---|---|---|---|
| Age, Continuous | 68.4 years STANDARD_DEVIATION 4.96 | 68.3 years STANDARD_DEVIATION 4.93 | 68.2 years STANDARD_DEVIATION 4.89 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1051 Participants | 2100 Participants | 1049 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 504 Participants | 990 Participants | 486 Participants |
| Sex: Female, Male Male | 547 Participants | 1110 Participants | 563 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1,049 | 0 / 1,051 |
| other Total, other adverse events | 614 / 1,049 | 569 / 1,051 |
| serious Total, serious adverse events | 2 / 1,049 | 5 / 1,051 |
Outcome results
Primary
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 28
GMTs of anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1, A/H3N2-like, B/Victoria-like, and B/Yamagata. Titers were expressed in terms of 1/dilution.
Time frame: Day 28 (post-vaccination)
Population: Analysis was performed on full analysis set (FAS) population which included all randomized participants who received at least one dose of the study vaccine and had a post-vaccination blood sample HAI result for at least one strain. Here, 'Number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| QIV-HD | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 28 | A/H1N1 | 309.0 titers |
| QIV-HD | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 28 | A/H3N2-like | 540.0 titers |
| QIV-HD | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 28 | B/Victoria-like | 354.8 titers |
| QIV-HD | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 28 | B/Yamagata | 795.8 titers |
| QIV-SD | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 28 | B/Yamagata | 254.7 titers |
| QIV-SD | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 28 | A/H1N1 | 110.0 titers |
| QIV-SD | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 28 | B/Victoria-like | 139.2 titers |
| QIV-SD | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 28 | A/H3N2-like | 239.9 titers |
Comparison: A/H1N195% CI: [2.46, 3.2]
Comparison: A/H3N2-like95% CI: [2.03, 2.5]
Comparison: B/Victoria-like95% CI: [2.31, 2.81]
Comparison: B/Yamagata95% CI: [2.85, 3.42]
Primary
Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens: Superiority Analysis
Anti-influenza antibodies were measured by HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2-like, B/Victoria-like, and B/Yamagata. Seroconversion was defined as either a pre-vaccination HAI titer less than (\<) 10 (1/dilution) and a post-vaccination titer \>=40 (1/dilution) or a pre-vaccination titer \>=10 (1/dilution) and a \>= four-fold increase in post-vaccination titer at Day 28.
Time frame: Day 28 (post-vaccination)
Population: Analysis was performed on FAS population. Here, 'number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| QIV-HD | Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens: Superiority Analysis | A/H1N1 | 77.6 percentage of participants |
| QIV-HD | Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens: Superiority Analysis | A/H3N2-like | 75.4 percentage of participants |
| QIV-HD | Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens: Superiority Analysis | B/Victoria-like | 79.2 percentage of participants |
| QIV-HD | Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens: Superiority Analysis | B/Yamagata | 74.4 percentage of participants |
| QIV-SD | Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens: Superiority Analysis | B/Yamagata | 39.0 percentage of participants |
| QIV-SD | Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens: Superiority Analysis | A/H1N1 | 47.9 percentage of participants |
| QIV-SD | Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens: Superiority Analysis | B/Victoria-like | 47.8 percentage of participants |
| QIV-SD | Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens: Superiority Analysis | A/H3N2-like | 47.3 percentage of participants |
Comparison: A/H1N195% CI: [25.7, 33.5]
Comparison: A/H3N2-like95% CI: [24, 32]
Comparison: B/Victoria-like95% CI: [27.4, 35.2]
Comparison: B/Yamagata95% CI: [31.4, 39.3]
Secondary
Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine Antibodies
GMTs of anti-influenza antibodies were measured using HAI assay for 6 influenza virus strains: A/H1N1, A/H3N2, A/H3N2-like, B/Victoria, B/Victoria-like, and B/Yamagata. GMTRs were calculated as the ratio of GMTs post-vaccination (on Day 28) and pre-vaccination (on Day 0).
Time frame: Day 0 (pre-vaccination), Day 28 (post-vaccination)
Population: Analysis was performed on FAS population. Here, 'Number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| QIV-HD | Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine Antibodies | A/H1N1 | 21.33 ratio |
| QIV-HD | Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine Antibodies | A/H3N2 | 13.14 ratio |
| QIV-HD | Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine Antibodies | A/H3N2-like | 13.23 ratio |
| QIV-HD | Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine Antibodies | B/Victoria | 17.06 ratio |
| QIV-HD | Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine Antibodies | B/Victoria-like | 14.97 ratio |
| QIV-HD | Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine Antibodies | B/Yamagata | 11.29 ratio |
| QIV-SD | Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine Antibodies | B/Victoria-like | 6.27 ratio |
| QIV-SD | Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine Antibodies | A/H1N1 | 7.33 ratio |
| QIV-SD | Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine Antibodies | B/Victoria | 6.17 ratio |
| QIV-SD | Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine Antibodies | A/H3N2 | 5.86 ratio |
| QIV-SD | Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine Antibodies | B/Yamagata | 4.21 ratio |
| QIV-SD | Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine Antibodies | A/H3N2-like | 5.85 ratio |
Secondary
GMTs of Influenza Vaccine Antibodies at Day 0 and Day 28
GMTs of anti-influenza antibodies were measured using HAI assay for 6 influenza virus strains: A/H1N1, A/H3N2, A/H3N2-like, B/Victoria, B/Victoria-like, and B/Yamagata. Titers were expressed in terms of 1/dilution.
Time frame: Day 0 (pre-vaccination) and Day 28 (post-vaccination)
Population: Analysis was performed on FAS population. Here, 'Number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| QIV-HD | GMTs of Influenza Vaccine Antibodies at Day 0 and Day 28 | A/H1N1: Day 0 | 14.5 titers |
| QIV-HD | GMTs of Influenza Vaccine Antibodies at Day 0 and Day 28 | A/H1N1: Day 28 | 309.0 titers |
| QIV-HD | GMTs of Influenza Vaccine Antibodies at Day 0 and Day 28 | A/H3N2: Day 0 | 54.9 titers |
| QIV-HD | GMTs of Influenza Vaccine Antibodies at Day 0 and Day 28 | A/H3N2: Day 28 | 721.4 titers |
| QIV-HD | GMTs of Influenza Vaccine Antibodies at Day 0 and Day 28 | A/H3N2-like: Day 0 | 40.8 titers |
| QIV-HD | GMTs of Influenza Vaccine Antibodies at Day 0 and Day 28 | A/H3N2-like: Day 28 | 540.0 titers |
| QIV-HD | GMTs of Influenza Vaccine Antibodies at Day 0 and Day 28 | B/Victoria: Day 0 | 26.3 titers |
| QIV-HD | GMTs of Influenza Vaccine Antibodies at Day 0 and Day 28 | B/Victoria: Day 28 | 447.3 titers |
| QIV-HD | GMTs of Influenza Vaccine Antibodies at Day 0 and Day 28 | B/Victoria-like: Day 0 | 23.7 titers |
| QIV-HD | GMTs of Influenza Vaccine Antibodies at Day 0 and Day 28 | B/Victoria-like: Day 28 | 354.8 titers |
| QIV-HD | GMTs of Influenza Vaccine Antibodies at Day 0 and Day 28 | B/Yamagata: Day 0 | 70.4 titers |
| QIV-HD | GMTs of Influenza Vaccine Antibodies at Day 0 and Day 28 | B/Yamagata: Day 28 | 795.8 titers |
| QIV-SD | GMTs of Influenza Vaccine Antibodies at Day 0 and Day 28 | B/Yamagata: Day 0 | 60.4 titers |
| QIV-SD | GMTs of Influenza Vaccine Antibodies at Day 0 and Day 28 | A/H1N1: Day 0 | 14.9 titers |
| QIV-SD | GMTs of Influenza Vaccine Antibodies at Day 0 and Day 28 | B/Victoria: Day 0 | 24.7 titers |
| QIV-SD | GMTs of Influenza Vaccine Antibodies at Day 0 and Day 28 | A/H1N1: Day 28 | 110.0 titers |
| QIV-SD | GMTs of Influenza Vaccine Antibodies at Day 0 and Day 28 | B/Victoria-like: Day 28 | 139.2 titers |
| QIV-SD | GMTs of Influenza Vaccine Antibodies at Day 0 and Day 28 | A/H3N2: Day 0 | 54.6 titers |
| QIV-SD | GMTs of Influenza Vaccine Antibodies at Day 0 and Day 28 | B/Victoria: Day 28 | 152.0 titers |
| QIV-SD | GMTs of Influenza Vaccine Antibodies at Day 0 and Day 28 | A/H3N2: Day 28 | 319.9 titers |
| QIV-SD | GMTs of Influenza Vaccine Antibodies at Day 0 and Day 28 | B/Yamagata: Day 28 | 254.7 titers |
| QIV-SD | GMTs of Influenza Vaccine Antibodies at Day 0 and Day 28 | A/H3N2-like: Day 0 | 41.0 titers |
| QIV-SD | GMTs of Influenza Vaccine Antibodies at Day 0 and Day 28 | B/Victoria-like: Day 0 | 22.3 titers |
| QIV-SD | GMTs of Influenza Vaccine Antibodies at Day 0 and Day 28 | A/H3N2-like: Day 28 | 239.9 titers |
Secondary
Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs)
An AE was any untoward medical occurrence in a patient or in a clinical investigation participant administered a medicinal product and which did not necessarily have a casual relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. All participants were observed for 30 minutes after vaccination, and any unsolicited AEs that occurred during that time were recorded as immediate unsolicited AEs in the CRB.
Time frame: Within 30 minutes post-vaccination
Population: Analysis was performed on safety analysis set (SafAS) population which included participants who had received the study vaccine and had any safety data available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| QIV-HD | Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs) | 0 Participants |
| QIV-SD | Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs) | 1 Participants |
Secondary
Number of Participants Reporting Serious Adverse Events (SAEs)
A SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event.
Time frame: From Day 0 up to Day 28 post-vaccination
Population: Analysis was performed on the SafAS population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| QIV-HD | Number of Participants Reporting Serious Adverse Events (SAEs) | 2 Participants |
| QIV-SD | Number of Participants Reporting Serious Adverse Events (SAEs) | 5 Participants |
Secondary
Number of Participants Reporting Solicited Injection Site and Systemic Reactions
A solicited reaction was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the CRB and considered as related to the product administered. Solicited injection site reactions included injection site pain, injection site erythema, injection site swelling, injection site induration, and injection site bruising. Solicited systemic reactions included fever, headache, malaise, myalgia and shivering.
Time frame: Within 7 days post-vaccination
Population: Analysis was performed on the SafAS population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| QIV-HD | Number of Participants Reporting Solicited Injection Site and Systemic Reactions | Injection site pain | 503 Participants |
| QIV-HD | Number of Participants Reporting Solicited Injection Site and Systemic Reactions | Injection site erythema | 86 Participants |
| QIV-HD | Number of Participants Reporting Solicited Injection Site and Systemic Reactions | Injection site swelling | 82 Participants |
| QIV-HD | Number of Participants Reporting Solicited Injection Site and Systemic Reactions | Injection site induration | 52 Participants |
| QIV-HD | Number of Participants Reporting Solicited Injection Site and Systemic Reactions | Injection site bruising | 5 Participants |
| QIV-HD | Number of Participants Reporting Solicited Injection Site and Systemic Reactions | Fever | 8 Participants |
| QIV-HD | Number of Participants Reporting Solicited Injection Site and Systemic Reactions | Headache | 105 Participants |
| QIV-HD | Number of Participants Reporting Solicited Injection Site and Systemic Reactions | Malaise | 102 Participants |
| QIV-HD | Number of Participants Reporting Solicited Injection Site and Systemic Reactions | Myalgia | 197 Participants |
| QIV-HD | Number of Participants Reporting Solicited Injection Site and Systemic Reactions | Shivering | 51 Participants |
| QIV-SD | Number of Participants Reporting Solicited Injection Site and Systemic Reactions | Malaise | 59 Participants |
| QIV-SD | Number of Participants Reporting Solicited Injection Site and Systemic Reactions | Injection site pain | 334 Participants |
| QIV-SD | Number of Participants Reporting Solicited Injection Site and Systemic Reactions | Fever | 1 Participants |
| QIV-SD | Number of Participants Reporting Solicited Injection Site and Systemic Reactions | Injection site erythema | 328 Participants |
| QIV-SD | Number of Participants Reporting Solicited Injection Site and Systemic Reactions | Shivering | 25 Participants |
| QIV-SD | Number of Participants Reporting Solicited Injection Site and Systemic Reactions | Injection site swelling | 185 Participants |
| QIV-SD | Number of Participants Reporting Solicited Injection Site and Systemic Reactions | Headache | 75 Participants |
| QIV-SD | Number of Participants Reporting Solicited Injection Site and Systemic Reactions | Injection site induration | 107 Participants |
| QIV-SD | Number of Participants Reporting Solicited Injection Site and Systemic Reactions | Myalgia | 130 Participants |
| QIV-SD | Number of Participants Reporting Solicited Injection Site and Systemic Reactions | Injection site bruising | 11 Participants |
Secondary
Number of Participants Reporting Unsolicited Adverse Events (AEs)
An AE was any untoward medical occurrence in a patient or in a clinical investigation participant administered a medicinal product and which did not necessarily have a casual relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination.
Time frame: Within 28 days post-vaccination
Population: Analysis was performed on SafAS population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| QIV-HD | Number of Participants Reporting Unsolicited Adverse Events (AEs) | 71 Participants |
| QIV-SD | Number of Participants Reporting Unsolicited Adverse Events (AEs) | 85 Participants |
Secondary
Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens
Anti-influenza antibodies were measured by HAI assay for 6 influenza virus strains: A/H1N1, A/H3N2, A/H3N2-like, B/Victoria, B/Victoria-like, and B/Yamagata. Seroconversion was defined as either a pre-vaccination HAI titer \<10 (1/dilution) and a post-vaccination titer \>=40 (1/dilution) or a pre-vaccination titer \>=10 (1/dilution) and a \>= four-fold increase in post-vaccination titer at Day 28.
Time frame: Day 28 (post-vaccination)
Population: Analysis was performed on FAS population. Here, 'Number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| QIV-HD | Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens | A/H1N1 | 77.6 percentage of participants |
| QIV-HD | Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens | A/H3N2 | 76.4 percentage of participants |
| QIV-HD | Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens | A/H3N2-like | 75.4 percentage of participants |
| QIV-HD | Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens | B/Victoria | 82.1 percentage of participants |
| QIV-HD | Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens | B/Victoria-like | 79.2 percentage of participants |
| QIV-HD | Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens | B/Yamagata | 74.4 percentage of participants |
| QIV-SD | Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens | B/Victoria-like | 47.8 percentage of participants |
| QIV-SD | Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens | A/H1N1 | 47.9 percentage of participants |
| QIV-SD | Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens | B/Victoria | 47.4 percentage of participants |
| QIV-SD | Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens | A/H3N2 | 48.2 percentage of participants |
| QIV-SD | Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens | B/Yamagata | 39.0 percentage of participants |
| QIV-SD | Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens | A/H3N2-like | 47.3 percentage of participants |
Secondary
Percentage of Participants With HAI Titers >=40 (1/Dilution) Against Influenza Antigens
Anti-influenza antibodies were measured using HAI assay method for 6 influenza virus strains: A/H1N1, A/H3N2, A/H3N2-like, B/Victoria, B/Victoria-like, and B/Yamagata. Percentage of participants with HAI titers \>=40 (1/dilution) is reported in the outcome measure.
Time frame: Day 0 (pre-vaccination), Day 28 (post-vaccination)
Population: Analysis was performed on FAS population. Here, 'Number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| QIV-HD | Percentage of Participants With HAI Titers >=40 (1/Dilution) Against Influenza Antigens | A/H3N2: Day 0 | 52.3 percentage of participants |
| QIV-HD | Percentage of Participants With HAI Titers >=40 (1/Dilution) Against Influenza Antigens | B/Victoria: Day 0 | 29.7 percentage of participants |
| QIV-HD | Percentage of Participants With HAI Titers >=40 (1/Dilution) Against Influenza Antigens | B/Victoria: Day 28 | 97.9 percentage of participants |
| QIV-HD | Percentage of Participants With HAI Titers >=40 (1/Dilution) Against Influenza Antigens | A/H1N1: Day 28 | 85.1 percentage of participants |
| QIV-HD | Percentage of Participants With HAI Titers >=40 (1/Dilution) Against Influenza Antigens | B/Victoria-like: Day 0 | 25.1 percentage of participants |
| QIV-HD | Percentage of Participants With HAI Titers >=40 (1/Dilution) Against Influenza Antigens | A/H3N2-like: Day 0 | 43.9 percentage of participants |
| QIV-HD | Percentage of Participants With HAI Titers >=40 (1/Dilution) Against Influenza Antigens | B/Victoria-like: Day 28 | 96.8 percentage of participants |
| QIV-HD | Percentage of Participants With HAI Titers >=40 (1/Dilution) Against Influenza Antigens | A/H3N2: Day 28 | 98.9 percentage of participants |
| QIV-HD | Percentage of Participants With HAI Titers >=40 (1/Dilution) Against Influenza Antigens | B/Yamagata: Day 0 | 60.6 percentage of participants |
| QIV-HD | Percentage of Participants With HAI Titers >=40 (1/Dilution) Against Influenza Antigens | A/H3N2-like: Day 28 | 96.8 percentage of participants |
| QIV-HD | Percentage of Participants With HAI Titers >=40 (1/Dilution) Against Influenza Antigens | B/Yamagata: Day 28 | 98.9 percentage of participants |
| QIV-HD | Percentage of Participants With HAI Titers >=40 (1/Dilution) Against Influenza Antigens | A/H1N1: Day 0 | 16.1 percentage of participants |
| QIV-SD | Percentage of Participants With HAI Titers >=40 (1/Dilution) Against Influenza Antigens | B/Yamagata: Day 28 | 92.3 percentage of participants |
| QIV-SD | Percentage of Participants With HAI Titers >=40 (1/Dilution) Against Influenza Antigens | A/H1N1: Day 0 | 18.2 percentage of participants |
| QIV-SD | Percentage of Participants With HAI Titers >=40 (1/Dilution) Against Influenza Antigens | A/H1N1: Day 28 | 67.6 percentage of participants |
| QIV-SD | Percentage of Participants With HAI Titers >=40 (1/Dilution) Against Influenza Antigens | A/H3N2: Day 0 | 51.7 percentage of participants |
| QIV-SD | Percentage of Participants With HAI Titers >=40 (1/Dilution) Against Influenza Antigens | A/H3N2: Day 28 | 93.4 percentage of participants |
| QIV-SD | Percentage of Participants With HAI Titers >=40 (1/Dilution) Against Influenza Antigens | B/Victoria: Day 0 | 27.8 percentage of participants |
| QIV-SD | Percentage of Participants With HAI Titers >=40 (1/Dilution) Against Influenza Antigens | A/H3N2-like: Day 0 | 43.7 percentage of participants |
| QIV-SD | Percentage of Participants With HAI Titers >=40 (1/Dilution) Against Influenza Antigens | A/H3N2-like: Day 28 | 88.4 percentage of participants |
| QIV-SD | Percentage of Participants With HAI Titers >=40 (1/Dilution) Against Influenza Antigens | B/Victoria: Day 28 | 81.4 percentage of participants |
| QIV-SD | Percentage of Participants With HAI Titers >=40 (1/Dilution) Against Influenza Antigens | B/Victoria-like: Day 0 | 24.1 percentage of participants |
| QIV-SD | Percentage of Participants With HAI Titers >=40 (1/Dilution) Against Influenza Antigens | B/Victoria-like: Day 28 | 79.8 percentage of participants |
| QIV-SD | Percentage of Participants With HAI Titers >=40 (1/Dilution) Against Influenza Antigens | B/Yamagata: Day 0 | 56.9 percentage of participants |