Influenza
Conditions
Keywords
Influenza, Fluzone® Intradermal vaccine, Influenza Virus Vaccine USP Quadrivalent, Influenza Virus Vaccine USP Trivalent Types A and B
Brief summary
The aim of the study is to demonstrate safety and immunogenicity of the quadrivalent influenza intradermal (QIV-ID) vaccine compared to the trivalent influenza vaccine (TIV) containing the B strain from the primary (Yamagata) lineage (TIV-ID1) and the trivalent influenza vaccine containing B strain from the alternate (Victoria) lineage (TIV-ID2) vaccines in producing protection against four strains of influenza virus. Primary Objective: * To demonstrate that QIV-ID induces an immune response (as assessed by hemagglutination inhibition (HAI) geometric mean titers (GMTs) and seroconversion rates) that is non-inferior to responses induced by TIV-ID1 and TIV-ID2 for the 4 virus strains at 28 days post-vaccination. Secondary Objectives: * To demonstrate that each B strain in QIV-ID induces an immune response (as assessed by HAI GMTs and seroconversion rates) that is superior to the response induced by the TIV-ID that does not contain the corresponding B strain. * To describe the rate of post-vaccination seroprotection induced by QIV-ID and TIV-ID. * To describe post-vaccination immunogenicity stratified by age (18-49 years and 50-64 years), race, ethnicity, gender, previous vaccination status, and baseline seropositivity status. * To describe the safety profile for subjects who receive QIV-ID and TIV-ID. Observational Objectives: * To demonstrate non-inferiority of QIV-ID compared to TIV-ID in terms of all Grade 2 or Grade 3 solicited systemic reactions combined * To demonstrate non-inferiority of QIV-ID compared to TIV-ID in terms of all Grade 3 solicited injection site reactions combined.
Detailed description
All participants will receive a single dose of their assigned vaccine on Day 0. A subset of the participants will be assessed for immunologic response on Day 0 before vaccination and Day 28 after vaccination. All subjects will be monitored for safety for up to 6 months after vaccination.
Interventions
BIOLOGICALInfluenza Virus Vaccine USP Quadrivalent, (Zonal Purified Subvirion) 2012 2013 Formulation
0.1mL, Intradermal
BIOLOGICALInfluenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone® Intradermal
0.1mL, Intradermal
BIOLOGICALInfluenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone Intradermal
0.1mL, Intradermal
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Aged 18 through 64 years on the day of inclusion * Informed consent form (ICF) has been signed and dated * Able to attend all scheduled visits and to comply with all trial procedures.
Exclusion criteria
* Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination and until at least 4 weeks after vaccination) * Participation at the time of trial enrollment (or in the 4 weeks preceding the trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure * Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following trial vaccination * Vaccination against influenza in the past 6 months * 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 any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances * History of thrombocytopenia * Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion * Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily * Current alcohol abuse or drug addiction * Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion * Identified as an Investigator or employee of the Investigator or trial center with direct involvement in the proposed trial, 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 trial * 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 subjects who have a history of neoplastic disease and who have been disease free for ≥ 5 years.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Day 28 post-vaccination | Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay. |
| Number of Participants With Seroconversion to Influenza Virus Vaccine Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Day 28 post-vaccination | Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay. Seroconversion was defined as titer\< 10 (1/dil) on Day 0 and post injection titer ≥ 40 (1/dil) on Day 28, or titer ≥10 (1/dil) on Day 0 and a ≥4 fold increase in titer (1/dil) on Day 28). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers Against the Influenza Virus Antigens Before and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Day 0 (pre-vaccination) and Day 28 post-vaccination | Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay. |
| Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before (Baseline) and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Day 0 (pre-vaccination) and Day 28 post-vaccination | Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay. Seroprotection was defined as titer ≥ 40 \[1/dil\] at baseline and 28 days after vaccination. |
| Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Day 0 up to Day 7 post-vaccination | Solicited injection site: Pain, Erythema, Swelling, Induration, Ecchymosis, and Pruritus; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3 injection site: Pain and Pruritus Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis \>100 mm. Grade 3 systemic reactions: Fever ≥39˚C; Headache, Malaise, Myalgia, and Shivering Significant preventing daily activity. |
Countries
United States
Participant flow
Recruitment details
The study participants were enrolled from 22 October 2012 to 28 May 2013 at 38 clinic sites in the United States.
Pre-assignment details
A total of 3360 participants who met all of the inclusion and none of the exclusion criteria were randomized, 3355 received one of the trial vaccines and their data are presented in this report.
Participants by arm
| Arm | Count |
|---|---|
| QIV ID Vaccine Group Adults 18 to \<65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine | 1,672 |
| TIV ID1 Vaccine Group Adults 18 to \<65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1) | 837 |
| TIV ID2 Vaccine Group Adults 18 to \<65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2) | 846 |
| Total | 3,355 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 |
| Overall Study | Lost to Follow-up | 8 | 10 | 1 |
| Overall Study | Protocol Violation | 2 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 6 | 6 | 7 |
Baseline characteristics
| Characteristic | TIV ID1 Vaccine Group | TIV ID2 Vaccine Group | QIV ID Vaccine Group | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 837 Participants | 846 Participants | 1672 Participants | 3355 Participants |
| Age, Continuous | 41.2 Years STANDARD_DEVIATION 13.5 | 41.9 Years STANDARD_DEVIATION 13.3 | 41.6 Years STANDARD_DEVIATION 13.2 | 41.6 Years STANDARD_DEVIATION 13.3 |
| Region of Enrollment United States | 837 Participants | 846 Participants | 1672 Participants | 3355 Participants |
| Sex: Female, Male Female | 505 Participants | 528 Participants | 1022 Participants | 2055 Participants |
| Sex: Female, Male Male | 332 Participants | 318 Participants | 650 Participants | 1300 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 883 / 1,672 | 395 / 837 | 420 / 846 |
| serious Total, serious adverse events | 20 / 1,672 | 14 / 837 | 11 / 846 |
Outcome results
Primary
Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route
Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay.
Time frame: Day 28 post-vaccination
Population: Geometric mean titers against the influenza virus antigens were assessed in the Per-protocol Analysis Set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| QIV ID Vaccine Group | Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | B/Brisbane/60/2008 (B2; N=1041, 538, 533) | 136 Titers |
| QIV ID Vaccine Group | Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | B/Texas/6/2011 (B1; N=1041, 539, 533) | 105 Titers |
| QIV ID Vaccine Group | Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | A/H3N2 (N=1041, 538, 533) | 368 Titers |
| QIV ID Vaccine Group | Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | A/H1N1 (N=1041, 539, 533) | 589 Titers |
| TIV ID1 Vaccine Group | Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | B/Texas/6/2011 (B1; N=1041, 539, 533) | 93.5 Titers |
| TIV ID1 Vaccine Group | Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | A/H3N2 (N=1041, 538, 533) | 413 Titers |
| TIV ID1 Vaccine Group | Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | A/H1N1 (N=1041, 539, 533) | 728 Titers |
| TIV ID1 Vaccine Group | Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | B/Brisbane/60/2008 (B2; N=1041, 538, 533) | 66.7 Titers |
| TIV ID2 Vaccine Group | Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | A/H3N2 (N=1041, 538, 533) | 447 Titers |
| TIV ID2 Vaccine Group | Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | A/H1N1 (N=1041, 539, 533) | 635 Titers |
| TIV ID2 Vaccine Group | Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | B/Brisbane/60/2008 (B2; N=1041, 538, 533) | 130 Titers |
| TIV ID2 Vaccine Group | Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | B/Texas/6/2011 (B1; N=1041, 539, 533) | 54.0 Titers |
Primary
Number of Participants With Seroconversion to Influenza Virus Vaccine Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route
Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay. Seroconversion was defined as titer\< 10 (1/dil) on Day 0 and post injection titer ≥ 40 (1/dil) on Day 28, or titer ≥10 (1/dil) on Day 0 and a ≥4 fold increase in titer (1/dil) on Day 28).
Time frame: Day 28 post-vaccination
Population: Seroconversion to the influenza virus antigens were assessed in the Per Protocol Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| QIV ID Vaccine Group | Number of Participants With Seroconversion to Influenza Virus Vaccine Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | A/H1N1 (N=1041, 539, 533) | 600 Participants |
| QIV ID Vaccine Group | Number of Participants With Seroconversion to Influenza Virus Vaccine Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | A/H3N2 (N=1040, 538, 533) | 608 Participants |
| QIV ID Vaccine Group | Number of Participants With Seroconversion to Influenza Virus Vaccine Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | B/Texas/6/2011 (B1; N=1041, 539, 533) | 580 Participants |
| QIV ID Vaccine Group | Number of Participants With Seroconversion to Influenza Virus Vaccine Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | B/Brisbane/60/2008 (B2; N=1041, 538, 533) | 525 Participants |
| TIV ID1 Vaccine Group | Number of Participants With Seroconversion to Influenza Virus Vaccine Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | B/Brisbane/60/2008 (B2; N=1041, 538, 533) | 119 Participants |
| TIV ID1 Vaccine Group | Number of Participants With Seroconversion to Influenza Virus Vaccine Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | A/H1N1 (N=1041, 539, 533) | 333 Participants |
| TIV ID1 Vaccine Group | Number of Participants With Seroconversion to Influenza Virus Vaccine Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | B/Texas/6/2011 (B1; N=1041, 539, 533) | 253 Participants |
| TIV ID1 Vaccine Group | Number of Participants With Seroconversion to Influenza Virus Vaccine Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | A/H3N2 (N=1040, 538, 533) | 326 Participants |
| TIV ID2 Vaccine Group | Number of Participants With Seroconversion to Influenza Virus Vaccine Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | B/Brisbane/60/2008 (B2; N=1041, 538, 533) | 235 Participants |
| TIV ID2 Vaccine Group | Number of Participants With Seroconversion to Influenza Virus Vaccine Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | A/H3N2 (N=1040, 538, 533) | 314 Participants |
| TIV ID2 Vaccine Group | Number of Participants With Seroconversion to Influenza Virus Vaccine Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | B/Texas/6/2011 (B1; N=1041, 539, 533) | 131 Participants |
| TIV ID2 Vaccine Group | Number of Participants With Seroconversion to Influenza Virus Vaccine Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | A/H1N1 (N=1041, 539, 533) | 314 Participants |
Secondary
Geometric Mean Titers Against the Influenza Virus Antigens Before and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route
Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay.
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Population: Geometric mean titers against the influenza virus antigens were assessed in the Per Protocol Analysis Set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| QIV ID Vaccine Group | Geometric Mean Titers Against the Influenza Virus Antigens Before and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | A/H1N1 Day 0 (N=1041, 539, 533) | 66.3 Titers |
| QIV ID Vaccine Group | Geometric Mean Titers Against the Influenza Virus Antigens Before and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | A/H1N1 Day 28 (N=1041, 539, 533) | 589 Titers |
| QIV ID Vaccine Group | Geometric Mean Titers Against the Influenza Virus Antigens Before and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | A/H3N2 Day 0 (N=1040, 539, 533) | 52.3 Titers |
| QIV ID Vaccine Group | Geometric Mean Titers Against the Influenza Virus Antigens Before and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | A/H3N2 Day 28 (N=1041, 538, 533) | 368 Titers |
| QIV ID Vaccine Group | Geometric Mean Titers Against the Influenza Virus Antigens Before and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | B1 Day 0 (N=1041, 539, 533) | 21.7 Titers |
| QIV ID Vaccine Group | Geometric Mean Titers Against the Influenza Virus Antigens Before and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | B1 Day 28 (N=1041, 539, 533) | 105 Titers |
| QIV ID Vaccine Group | Geometric Mean Titers Against the Influenza Virus Antigens Before and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | B2 Day 0 (N=1041, 539, 533) | 26.8 Titers |
| QIV ID Vaccine Group | Geometric Mean Titers Against the Influenza Virus Antigens Before and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | B2 Day 28 (N=1041, 538, 533) | 136 Titers |
| TIV ID1 Vaccine Group | Geometric Mean Titers Against the Influenza Virus Antigens Before and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | A/H3N2 Day 0 (N=1040, 539, 533) | 56.5 Titers |
| TIV ID1 Vaccine Group | Geometric Mean Titers Against the Influenza Virus Antigens Before and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | B2 Day 0 (N=1041, 539, 533) | 29.7 Titers |
| TIV ID1 Vaccine Group | Geometric Mean Titers Against the Influenza Virus Antigens Before and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | A/H3N2 Day 28 (N=1041, 538, 533) | 413 Titers |
| TIV ID1 Vaccine Group | Geometric Mean Titers Against the Influenza Virus Antigens Before and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | B1 Day 0 (N=1041, 539, 533) | 24.7 Titers |
| TIV ID1 Vaccine Group | Geometric Mean Titers Against the Influenza Virus Antigens Before and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | B1 Day 28 (N=1041, 539, 533) | 93.5 Titers |
| TIV ID1 Vaccine Group | Geometric Mean Titers Against the Influenza Virus Antigens Before and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | A/H1N1 Day 0 (N=1041, 539, 533) | 65.2 Titers |
| TIV ID1 Vaccine Group | Geometric Mean Titers Against the Influenza Virus Antigens Before and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | A/H1N1 Day 28 (N=1041, 539, 533) | 728 Titers |
| TIV ID1 Vaccine Group | Geometric Mean Titers Against the Influenza Virus Antigens Before and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | B2 Day 28 (N=1041, 538, 533) | 66.7 Titers |
| TIV ID2 Vaccine Group | Geometric Mean Titers Against the Influenza Virus Antigens Before and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | A/H3N2 Day 0 (N=1040, 539, 533) | 55.7 Titers |
| TIV ID2 Vaccine Group | Geometric Mean Titers Against the Influenza Virus Antigens Before and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | A/H1N1 Day 28 (N=1041, 539, 533) | 635 Titers |
| TIV ID2 Vaccine Group | Geometric Mean Titers Against the Influenza Virus Antigens Before and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | A/H1N1 Day 0 (N=1041, 539, 533) | 66.2 Titers |
| TIV ID2 Vaccine Group | Geometric Mean Titers Against the Influenza Virus Antigens Before and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | A/H3N2 Day 28 (N=1041, 538, 533) | 447 Titers |
| TIV ID2 Vaccine Group | Geometric Mean Titers Against the Influenza Virus Antigens Before and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | B2 Day 0 (N=1041, 539, 533) | 25.4 Titers |
| TIV ID2 Vaccine Group | Geometric Mean Titers Against the Influenza Virus Antigens Before and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | B1 Day 28 (N=1041, 539, 533) | 54.0 Titers |
| TIV ID2 Vaccine Group | Geometric Mean Titers Against the Influenza Virus Antigens Before and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | B1 Day 0 (N=1041, 539, 533) | 22.2 Titers |
| TIV ID2 Vaccine Group | Geometric Mean Titers Against the Influenza Virus Antigens Before and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | B2 Day 28 (N=1041, 538, 533) | 130 Titers |
Secondary
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route
Solicited injection site: Pain, Erythema, Swelling, Induration, Ecchymosis, and Pruritus; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3 injection site: Pain and Pruritus Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis \>100 mm. Grade 3 systemic reactions: Fever ≥39˚C; Headache, Malaise, Myalgia, and Shivering Significant preventing daily activity.
Time frame: Day 0 up to Day 7 post-vaccination
Population: Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| QIV ID Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Injection site Ecchymosis (N=1656,820,838) | 43 Participants |
| QIV ID Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Grade 3 Injection site Pain (N=1656,820,838) | 24 Participants |
| QIV ID Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Grade 3 Myalgia (N=1656,820,838) | 43 Participants |
| QIV ID Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Fever (N=1649,819,836) | 13 Participants |
| QIV ID Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Myalgia (N=1656,820,838) | 564 Participants |
| QIV ID Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Grade 3 Injection site Erythema (N=1656,820,838) | 7 Participants |
| QIV ID Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Grade 3 Malaise (N=1656,820,838) | 49 Participants |
| QIV ID Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Grade 3 Fever (N=1649,819,836) | 3 Participants |
| QIV ID Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Malaise (N=1656,820,838) | 459 Participants |
| QIV ID Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Grade 3 Headache (N=1656,820,838) | 53 Participants |
| QIV ID Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Injection site Pruritus (N=1656,820,838) | 862 Participants |
| QIV ID Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Grade 3 Injection site Ecchymosis (N=1656,820,838) | 0 Participants |
| QIV ID Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Injection site Swelling (N=1655,820,838) | 322 Participants |
| QIV ID Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Headache (N=1656,820,838) | 548 Participants |
| QIV ID Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Grade 3 Injection site Pruritus (N=1656,820,838) | 47 Participants |
| QIV ID Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Grade 3 Injection site Swelling (N=1655,820,838) | 2 Participants |
| QIV ID Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Injection site Pain (N=1656,820,838) | 883 Participants |
| QIV ID Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Grade 3 Shivering (N=1656,820,838) | 24 Participants |
| QIV ID Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Injection site Induration (N=1656,820,837) | 282 Participants |
| QIV ID Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Injection site Erythema (N=1656,820,838) | 607 Participants |
| QIV ID Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Shivering (N=1656,820,838) | 200 Participants |
| QIV ID Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Grade 3 Injection site Induration (N=1656,820,837) | 1 Participants |
| TIV ID1 Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Grade 3 Injection site Swelling (N=1655,820,838) | 0 Participants |
| TIV ID1 Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Injection site Pain (N=1656,820,838) | 395 Participants |
| TIV ID1 Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Grade 3 Injection site Pain (N=1656,820,838) | 10 Participants |
| TIV ID1 Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Injection site Erythema (N=1656,820,838) | 279 Participants |
| TIV ID1 Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Grade 3 Injection site Erythema (N=1656,820,838) | 1 Participants |
| TIV ID1 Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Injection site Swelling (N=1655,820,838) | 121 Participants |
| TIV ID1 Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Injection site Induration (N=1656,820,837) | 111 Participants |
| TIV ID1 Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Injection site Ecchymosis (N=1656,820,838) | 15 Participants |
| TIV ID1 Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Grade 3 Injection site Ecchymosis (N=1656,820,838) | 0 Participants |
| TIV ID1 Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Fever (N=1649,819,836) | 6 Participants |
| TIV ID1 Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Grade 3 Headache (N=1656,820,838) | 20 Participants |
| TIV ID1 Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Malaise (N=1656,820,838) | 216 Participants |
| TIV ID1 Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Grade 3 Malaise (N=1656,820,838) | 15 Participants |
| TIV ID1 Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Myalgia (N=1656,820,838) | 238 Participants |
| TIV ID1 Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Grade 3 Myalgia (N=1656,820,838) | 12 Participants |
| TIV ID1 Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Shivering (N=1656,820,838) | 85 Participants |
| TIV ID1 Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Grade 3 Shivering (N=1656,820,838) | 5 Participants |
| TIV ID1 Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Injection site Pruritus (N=1656,820,838) | 372 Participants |
| TIV ID1 Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Grade 3 Injection site Pruritus (N=1656,820,838) | 15 Participants |
| TIV ID1 Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Grade 3 Injection site Induration (N=1656,820,837) | 0 Participants |
| TIV ID1 Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Grade 3 Fever (N=1649,819,836) | 1 Participants |
| TIV ID1 Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Headache (N=1656,820,838) | 257 Participants |
| TIV ID2 Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Injection site Ecchymosis (N=1656,820,838) | 15 Participants |
| TIV ID2 Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Grade 3 Injection site Erythema (N=1656,820,838) | 3 Participants |
| TIV ID2 Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Grade 3 Myalgia (N=1656,820,838) | 21 Participants |
| TIV ID2 Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Injection site Induration (N=1656,820,837) | 94 Participants |
| TIV ID2 Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Injection site Erythema (N=1656,820,838) | 269 Participants |
| TIV ID2 Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Shivering (N=1656,820,838) | 94 Participants |
| TIV ID2 Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Grade 3 Injection site Swelling (N=1655,820,838) | 0 Participants |
| TIV ID2 Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Injection site Pain (N=1656,820,838) | 420 Participants |
| TIV ID2 Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Grade 3 Injection site Pain (N=1656,820,838) | 12 Participants |
| TIV ID2 Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Injection site Swelling (N=1655,820,838) | 123 Participants |
| TIV ID2 Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Headache (N=1656,820,838) | 278 Participants |
| TIV ID2 Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Injection site Pruritus (N=1656,820,838) | 374 Participants |
| TIV ID2 Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Grade 3 Headache (N=1656,820,838) | 15 Participants |
| TIV ID2 Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Grade 3 Fever (N=1649,819,836) | 0 Participants |
| TIV ID2 Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Grade 3 Injection site Pruritus (N=1656,820,838) | 19 Participants |
| TIV ID2 Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Malaise (N=1656,820,838) | 255 Participants |
| TIV ID2 Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Fever (N=1649,819,836) | 4 Participants |
| TIV ID2 Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Grade 3 Shivering (N=1656,820,838) | 13 Participants |
| TIV ID2 Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Grade 3 Malaise (N=1656,820,838) | 21 Participants |
| TIV ID2 Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Grade 3 Injection site Ecchymosis (N=1656,820,838) | 0 Participants |
| TIV ID2 Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Grade 3 Injection site Induration (N=1656,820,837) | 0 Participants |
| TIV ID2 Vaccine Group | Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | Myalgia (N=1656,820,838) | 261 Participants |
Secondary
Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before (Baseline) and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route
Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay. Seroprotection was defined as titer ≥ 40 \[1/dil\] at baseline and 28 days after vaccination.
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Population: Seroprotection against influenza virus antigens was assessed in the Per Protocol Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| QIV ID Vaccine Group | Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before (Baseline) and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | A/H1N1 Day 0 (N=1041, 539, 533) | 672 Participants |
| QIV ID Vaccine Group | Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before (Baseline) and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | A/H1N1 Day 28 (N=1041, 539, 533) | 1014 Participants |
| QIV ID Vaccine Group | Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before (Baseline) and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | A/H3N2 Day 0 (N=1040, 539, 533) | 655 Participants |
| QIV ID Vaccine Group | Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before (Baseline) and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | A/H3N2 Day 28 (N=1041, 538, 533) | 1008 Participants |
| QIV ID Vaccine Group | Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before (Baseline) and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | B1 Day 0 (N=1041, 539, 533) | 335 Participants |
| QIV ID Vaccine Group | Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before (Baseline) and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | B1 Day 28 (N=1041, 539, 533) | 923 Participants |
| QIV ID Vaccine Group | Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before (Baseline) and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | B2 Day 0 (N=1041, 539, 533) | 467 Participants |
| QIV ID Vaccine Group | Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before (Baseline) and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | B2 Day 28 (N=1041, 538, 533) | 976 Participants |
| TIV ID1 Vaccine Group | Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before (Baseline) and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | A/H3N2 Day 0 (N=1040, 539, 533) | 340 Participants |
| TIV ID1 Vaccine Group | Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before (Baseline) and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | B2 Day 0 (N=1041, 539, 533) | 262 Participants |
| TIV ID1 Vaccine Group | Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before (Baseline) and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | A/H3N2 Day 28 (N=1041, 538, 533) | 526 Participants |
| TIV ID1 Vaccine Group | Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before (Baseline) and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | B1 Day 0 (N=1041, 539, 533) | 210 Participants |
| TIV ID1 Vaccine Group | Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before (Baseline) and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | B1 Day 28 (N=1041, 539, 533) | 464 Participants |
| TIV ID1 Vaccine Group | Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before (Baseline) and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | A/H1N1 Day 0 (N=1041, 539, 533) | 334 Participants |
| TIV ID1 Vaccine Group | Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before (Baseline) and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | A/H1N1 Day 28 (N=1041, 539, 533) | 537 Participants |
| TIV ID1 Vaccine Group | Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before (Baseline) and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | B2 Day 28 (N=1041, 538, 533) | 403 Participants |
| TIV ID2 Vaccine Group | Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before (Baseline) and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | A/H3N2 Day 0 (N=1040, 539, 533) | 332 Participants |
| TIV ID2 Vaccine Group | Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before (Baseline) and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | A/H1N1 Day 28 (N=1041, 539, 533) | 524 Participants |
| TIV ID2 Vaccine Group | Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before (Baseline) and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | A/H1N1 Day 0 (N=1041, 539, 533) | 353 Participants |
| TIV ID2 Vaccine Group | Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before (Baseline) and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | A/H3N2 Day 28 (N=1041, 538, 533) | 519 Participants |
| TIV ID2 Vaccine Group | Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before (Baseline) and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | B2 Day 0 (N=1041, 539, 533) | 224 Participants |
| TIV ID2 Vaccine Group | Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before (Baseline) and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | B1 Day 28 (N=1041, 539, 533) | 351 Participants |
| TIV ID2 Vaccine Group | Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before (Baseline) and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | B1 Day 0 (N=1041, 539, 533) | 172 Participants |
| TIV ID2 Vaccine Group | Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before (Baseline) and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route | B2 Day 28 (N=1041, 538, 533) | 477 Participants |