Influenza
Conditions
Keywords
Influenza, Quadrivalent Inactivated Influenza Vaccine, Trivalent Inactivated Influenza Vaccine, Influenza viruses
Brief summary
The aim of the study is to evaluate a prototype quadrivalent influenza vaccine (QIV), the licensed 2010-2011 trivalent influenza vaccine (TIV) containing the primary B strain, and the investigational TIV containing the alternate B strain in adult subjects. Primary Objective: * To demonstrate non-inferiority of antibody responses to QIV compared with licensed 2010-2011 TIV (containing the primary B strain) and investigational TIV (containing the alternate B strain) as assessed by geometric mean titer (GMT) ratios for each of the four virus strains separately among subjects 65 years of age and older Observational Objective: * To describe the safety profiles of TIV among subjects 18 years of age and older and QIV in subjects 65 years and older, as assessed by solicited injection site and systemic adverse events (AEs) collected for 7 days post-vaccination, unsolicited adverse events collected from 21 days post-vaccination, and adverse events of special interest and serious adverse events (SAEs) collected from Visit 1 to Visit 2.
Detailed description
All participants will receive a single dose of their assigned vaccine during Visit 1. They will be followed up for safety and immunogenicity through Day 21 post-vaccination (Visit 2)
Interventions
BIOLOGICALInvestigational Quadrivalent Inactivated Influenza Vaccine, No Preservative
0.5 mL, Intramuscular
BIOLOGICALInvestigational Trivalent Inactivated Influenza Vaccine, No Preservative
0.5 mL, Intramuscular
BIOLOGICALFluzone®: 2010-2011 Trivalent Inactivated Influenza Vaccine, No Preservative
0.5 mL, Intramuscular
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 No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subject is 18 years of age or older 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. * For a woman of childbearing potential, use of an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination until at least 4 weeks post-vaccination.
Exclusion criteria
* Known pregnancy, or a positive urine pregnancy test. * Currently breastfeeding a child. * History of serious adverse reaction to any influenza vaccine. * Receipt of any vaccine in the 4 weeks preceding the trial vaccination. * Planned receipt of any vaccine between Visit 1 and Visit 2. * Participation in another interventional clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first study vaccination or during the course of the study. * Receipt of any influenza vaccine since 01 August 2010 (including 2009 H1N1 monovalent vaccine). * Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances. * Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response. * Thrombocytopenia, bleeding disorder, or receipt of anticoagulants contraindicating intramuscular vaccination. * Any condition that in the opinion of the Investigator would pose a health risk to the subject if enrolled or could interfere with the evaluation of the vaccine. * Personal history of Guillain-Barré Syndrome (GBS). * 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). * Any chronic illness that, in the opinion of the Investigator, is not well controlled or that may interfere with trial conduct or completion or with assessment of adverse events. * Known seropositivity for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C. * Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily. * Current alcohol or drug use that, in the opinion of the Investigator, might interfere with the ability to comply with trial procedures. * Identified as employees of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members (i.e., immediate, husband, wife and their children, adopted or natural) of the employees or the Investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines With Corresponding B Strain in Participants Aged 65 Years and Older. | Day 21 post-vaccination | Immunogenicity outcomes were assessed in serum samples by hemagglutination inhibition (HAI) assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10. |
| Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or After Trivalent Influenza Vaccines Without Corresponding B Strain in Participants Aged 65 Years and Older. | Day 21 post-vaccination | Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10. |
| Geometric Mean Titers Against the Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines (TIV) in Participants Aged 18 Years or Older | Day 0 and Day 21 post-vaccination | Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Seroconversion Against Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years and Older | Day 21 post-vaccination | Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10. Seroconversion was defined as either a pre-vaccination HAI titer \<1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and ≥ four-fold increase in post-vaccination titer. |
| Seroconversion Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines (TIV) With Corresponding B Strains in Participants Aged 65 Years and Older. | Day 21 post-vaccination | Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \< 10. Seroconversion was defined as either a pre-vaccination HAI titer \< 1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and ≥ four-fold increase in post-vaccination titer. |
| Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. | Day 0 up to day 21 post-vaccination | Solicited injection site reactions: Pain, Erythema and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 Injection site reactions: Pain - Significant; prevents daily activity; Erythema and Swelling \>100 mm. Grade 3 solicited systemic reactions: Fever (Temperature) ≥102.1°F; Headache, Malaise, and Myalgia - Significant; prevents daily activity. |
| Seroconversion Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines Without Corresponding B Strain in Participants Aged 65 Years and Older. | Day 21 post-vaccination | Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10. Seroconversion was defined as either a pre-vaccination HAI titer \< 1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥ 1:10 and ≥ four-fold increase in post-vaccination titers. |
| Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years or Older. | Day 21 post-vaccination | Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10. Seroprotection was defined as a pre-vaccination and post-vaccination titer ≥ 1:40 (l/dil) |
Countries
United States
Participant flow
Recruitment details
The study participants were enrolled from 08 October through 01 December 2010 in 12 clinic centers in the US.
Pre-assignment details
A total of 739 participants who met all the inclusion criteria and none of the exclusion criteria were enrolled, randomized and vaccinated in the study.
Participants by arm
| Arm | Count |
|---|---|
| Group 1 (Investigational Quadrivalent Influenza Vaccine) Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine | 225 |
| Group 2 (Investigational Trivalent Influenza Vaccine) Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine | 225 |
| Group 3 (Licensed Trivalent Influenza Vaccine) Participants aged 65 years and older who received the received the Licensed 2010-2011 Trivalent Influenza Vaccine | 225 |
| Group 4 (Licensed Trivalent Influenza Vaccine) Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine | 64 |
| Total | 739 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 | 0 | 0 |
| Overall Study | Protocol Violation | 0 | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | Group 2 (Investigational Trivalent Influenza Vaccine) | Group 3 (Licensed Trivalent Influenza Vaccine) | Group 1 (Investigational Quadrivalent Influenza Vaccine) | Group 4 (Licensed Trivalent Influenza Vaccine) | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 225 Participants | 225 Participants | 225 Participants | 0 Participants | 675 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 64 Participants | 64 Participants |
| Age Continuous | 72.8 Years STANDARD_DEVIATION 5.6 | 72.8 Years STANDARD_DEVIATION 5.3 | 72.4 Years STANDARD_DEVIATION 5.7 | 46.0 Years STANDARD_DEVIATION 11.6 | 70.4 Years STANDARD_DEVIATION 9.8 |
| Region of Enrollment United States | 225 Participants | 225 Participants | 225 Participants | 64 Participants | 739 Participants |
| Sex: Female, Male Female | 121 Participants | 126 Participants | 129 Participants | 27 Participants | 403 Participants |
| Sex: Female, Male Male | 104 Participants | 99 Participants | 96 Participants | 37 Participants | 336 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 73 / 225 | 52 / 225 | 64 / 225 | 31 / 64 |
| serious Total, serious adverse events | 0 / 225 | 1 / 225 | 2 / 225 | 0 / 64 |
Outcome results
Primary
Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or After Trivalent Influenza Vaccines Without Corresponding B Strain in Participants Aged 65 Years and Older.
Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10.
Time frame: Day 21 post-vaccination
Population: Geometric Mean Titers to the influenza vaccine B strains (cross-reactive antibody) were determined in randomized and vaccinated participants, per-protocol population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1 (Investigational Quadrivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or After Trivalent Influenza Vaccines Without Corresponding B Strain in Participants Aged 65 Years and Older. | B/Brisbane/60/2008 (220, 221, 0, 0) | 73.8 Titers |
| Group 1 (Investigational Quadrivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or After Trivalent Influenza Vaccines Without Corresponding B Strain in Participants Aged 65 Years and Older. | B/Florida/04/2006 (220, 0, 219, 0) | 61.1 Titers |
| Group 2 (Investigational Trivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or After Trivalent Influenza Vaccines Without Corresponding B Strain in Participants Aged 65 Years and Older. | B/Brisbane/60/2008 (220, 221, 0, 0) | 42.2 Titers |
| Group 2 (Investigational Trivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or After Trivalent Influenza Vaccines Without Corresponding B Strain in Participants Aged 65 Years and Older. | B/Florida/04/2006 (220, 0, 219, 0) | NA Titers |
| Group 3 (Licensed Trivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or After Trivalent Influenza Vaccines Without Corresponding B Strain in Participants Aged 65 Years and Older. | B/Brisbane/60/2008 (220, 221, 0, 0) | NA Titers |
| Group 3 (Licensed Trivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or After Trivalent Influenza Vaccines Without Corresponding B Strain in Participants Aged 65 Years and Older. | B/Florida/04/2006 (220, 0, 219, 0) | 28.5 Titers |
Primary
Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines With Corresponding B Strain in Participants Aged 65 Years and Older.
Immunogenicity outcomes were assessed in serum samples by hemagglutination inhibition (HAI) assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10.
Time frame: Day 21 post-vaccination
Population: Geometric mean titers to the influenza vaccine B antigens were determined in randomized and vaccinated participants, per-protocol population. Data presented for participants with valid serology results for the B antigens, including results reported as less or greater than lower limit of quantitation (\<LLOQ or \>ULOQ).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1 (Investigational Quadrivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines With Corresponding B Strain in Participants Aged 65 Years and Older. | B/Brisbane/60/2008 (220, 0, 219, 0) | 73.8 Titers |
| Group 1 (Investigational Quadrivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines With Corresponding B Strain in Participants Aged 65 Years and Older. | B/Florida/04/2006 (220, 221, 0, 0) | 61.1 Titers |
| Group 2 (Investigational Trivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines With Corresponding B Strain in Participants Aged 65 Years and Older. | B/Brisbane/60/2008 (220, 0, 219, 0) | NA Titers |
| Group 2 (Investigational Trivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines With Corresponding B Strain in Participants Aged 65 Years and Older. | B/Florida/04/2006 (220, 221, 0, 0) | 54.8 Titers |
| Group 3 (Licensed Trivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines With Corresponding B Strain in Participants Aged 65 Years and Older. | B/Brisbane/60/2008 (220, 0, 219, 0) | 57.9 Titers |
| Group 3 (Licensed Trivalent Influenza Vaccine) | Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines With Corresponding B Strain in Participants Aged 65 Years and Older. | B/Florida/04/2006 (220, 221, 0, 0) | NA Titers |
Primary
Geometric Mean Titers Against the Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines (TIV) in Participants Aged 18 Years or Older
Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10.
Time frame: Day 0 and Day 21 post-vaccination
Population: Geometric Mean Titers to the influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1 (Investigational Quadrivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines (TIV) in Participants Aged 18 Years or Older | A/H1N1, Pre-vaccination | 21.7 Titers |
| Group 1 (Investigational Quadrivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines (TIV) in Participants Aged 18 Years or Older | A/H1N1, Post-vaccination | 231 Titers |
| Group 1 (Investigational Quadrivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines (TIV) in Participants Aged 18 Years or Older | A/H3N2, Pre-vaccination | 52.3 Titers |
| Group 1 (Investigational Quadrivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines (TIV) in Participants Aged 18 Years or Older | A/H3N2, Post vaccination | 501 Titers |
| Group 1 (Investigational Quadrivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines (TIV) in Participants Aged 18 Years or Older | B/Brisbane, Pre-vaccination | 27.1 Titers |
| Group 1 (Investigational Quadrivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines (TIV) in Participants Aged 18 Years or Older | B/Brisbane, Post-vaccination | 73.8 Titers |
| Group 1 (Investigational Quadrivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines (TIV) in Participants Aged 18 Years or Older | B/Florida, Pre-vaccination | 20.2 Titers |
| Group 1 (Investigational Quadrivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines (TIV) in Participants Aged 18 Years or Older | B/Florida, Post-vaccination | 61.1 Titers |
| Group 2 (Investigational Trivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines (TIV) in Participants Aged 18 Years or Older | B/Brisbane, Post-vaccination | 42.2 Titers |
| Group 2 (Investigational Trivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines (TIV) in Participants Aged 18 Years or Older | B/Brisbane, Pre-vaccination | 28.5 Titers |
| Group 2 (Investigational Trivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines (TIV) in Participants Aged 18 Years or Older | A/H1N1, Post-vaccination | 271 Titers |
| Group 2 (Investigational Trivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines (TIV) in Participants Aged 18 Years or Older | B/Florida, Post-vaccination | 54.8 Titers |
| Group 2 (Investigational Trivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines (TIV) in Participants Aged 18 Years or Older | B/Florida, Pre-vaccination | 19.7 Titers |
| Group 2 (Investigational Trivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines (TIV) in Participants Aged 18 Years or Older | A/H3N2, Post vaccination | 360 Titers |
| Group 2 (Investigational Trivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines (TIV) in Participants Aged 18 Years or Older | A/H3N2, Pre-vaccination | 42.3 Titers |
| Group 2 (Investigational Trivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines (TIV) in Participants Aged 18 Years or Older | A/H1N1, Pre-vaccination | 21.1 Titers |
| Group 3 (Licensed Trivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines (TIV) in Participants Aged 18 Years or Older | B/Florida, Pre-vaccination | 18.7 Titers |
| Group 3 (Licensed Trivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines (TIV) in Participants Aged 18 Years or Older | A/H3N2, Pre-vaccination | 48.3 Titers |
| Group 3 (Licensed Trivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines (TIV) in Participants Aged 18 Years or Older | A/H3N2, Post vaccination | 291 Titers |
| Group 3 (Licensed Trivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines (TIV) in Participants Aged 18 Years or Older | B/Brisbane, Pre-vaccination | 29.0 Titers |
| Group 3 (Licensed Trivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines (TIV) in Participants Aged 18 Years or Older | B/Brisbane, Post-vaccination | 57.9 Titers |
| Group 3 (Licensed Trivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines (TIV) in Participants Aged 18 Years or Older | B/Florida, Post-vaccination | 28.5 Titers |
| Group 3 (Licensed Trivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines (TIV) in Participants Aged 18 Years or Older | A/H1N1, Pre-vaccination | 24.8 Titers |
| Group 3 (Licensed Trivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines (TIV) in Participants Aged 18 Years or Older | A/H1N1, Post-vaccination | 269 Titers |
| Group 4 (Licensed Trivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines (TIV) in Participants Aged 18 Years or Older | A/H3N2, Pre-vaccination | 33.0 Titers |
| Group 4 (Licensed Trivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines (TIV) in Participants Aged 18 Years or Older | A/H3N2, Post vaccination | 503 Titers |
| Group 4 (Licensed Trivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines (TIV) in Participants Aged 18 Years or Older | A/H1N1, Post-vaccination | 728 Titers |
| Group 4 (Licensed Trivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines (TIV) in Participants Aged 18 Years or Older | A/H1N1, Pre-vaccination | 26.7 Titers |
| Group 4 (Licensed Trivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines (TIV) in Participants Aged 18 Years or Older | B/Brisbane, Pre-vaccination | 18.9 Titers |
| Group 4 (Licensed Trivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines (TIV) in Participants Aged 18 Years or Older | B/Florida, Post-vaccination | 48.6 Titers |
| Group 4 (Licensed Trivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines (TIV) in Participants Aged 18 Years or Older | B/Florida, Pre-vaccination | 19.5 Titers |
| Group 4 (Licensed Trivalent Influenza Vaccine) | Geometric Mean Titers Against the Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines (TIV) in Participants Aged 18 Years or Older | B/Brisbane, Post-vaccination | 97.7 Titers |
Other Pre-specified
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines.
Solicited injection site reactions: Pain, Erythema and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 Injection site reactions: Pain - Significant; prevents daily activity; Erythema and Swelling \>100 mm. Grade 3 solicited systemic reactions: Fever (Temperature) ≥102.1°F; Headache, Malaise, and Myalgia - Significant; prevents daily activity.
Time frame: Day 0 up to day 21 post-vaccination
Population: Solicited injection site and systemic reactions were assessed in all randomized and vaccinated participants, safety population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 (Investigational Quadrivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. | Headache (224, 225, 224, 63) | 30 Participants |
| Group 1 (Investigational Quadrivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. | Grade 3 Fever (224, 225, 223, 63) | 1 Participants |
| Group 1 (Investigational Quadrivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. | Injection site Swelling (224, 224, 224, 63) | 4 Participants |
| Group 1 (Investigational Quadrivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. | Grade 3 Myalgia (224, 225, 224, 63) | 1 Participants |
| Group 1 (Investigational Quadrivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. | Fever (224, 225, 223, 63) | 3 Participants |
| Group 1 (Investigational Quadrivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. | Grade 3 Injection site Swelling (224, 224, 224, 63 | 0 Participants |
| Group 1 (Investigational Quadrivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. | Grade Malaise (224, 225, 224, 63) | 1 Participants |
| Group 1 (Investigational Quadrivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. | Injection site Pain (224, 225, 224, 63) | 73 Participants |
| Group 1 (Investigational Quadrivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. | Injection site Erythema (224, 224, 224, 63) | 6 Participants |
| Group 1 (Investigational Quadrivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. | Myalgia (224, 225, 224, 63) | 41 Participants |
| Group 1 (Investigational Quadrivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. | Malaise (224, 225, 224, 63) | 24 Participants |
| Group 1 (Investigational Quadrivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. | Grade 3 Headache (224, 225, 224, 63) | 1 Participants |
| Group 1 (Investigational Quadrivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. | Grade 3 Injection site Erythema (224, 224, 224, 63 | 0 Participants |
| Group 1 (Investigational Quadrivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. | Grade 3 Injection site Pain (224, 225, 224, 63) | 2 Participants |
| Group 2 (Investigational Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. | Malaise (224, 225, 224, 63) | 26 Participants |
| Group 2 (Investigational Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. | Injection site Pain (224, 225, 224, 63) | 52 Participants |
| Group 2 (Investigational Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. | Grade 3 Injection site Pain (224, 225, 224, 63) | 0 Participants |
| Group 2 (Investigational Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. | Injection site Erythema (224, 224, 224, 63) | 3 Participants |
| Group 2 (Investigational Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. | Grade 3 Injection site Erythema (224, 224, 224, 63 | 0 Participants |
| Group 2 (Investigational Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. | Injection site Swelling (224, 224, 224, 63) | 0 Participants |
| Group 2 (Investigational Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. | Grade 3 Injection site Swelling (224, 224, 224, 63 | 0 Participants |
| Group 2 (Investigational Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. | Fever (224, 225, 223, 63) | 2 Participants |
| Group 2 (Investigational Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. | Grade 3 Fever (224, 225, 223, 63) | 1 Participants |
| Group 2 (Investigational Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. | Headache (224, 225, 224, 63) | 26 Participants |
| Group 2 (Investigational Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. | Grade 3 Headache (224, 225, 224, 63) | 1 Participants |
| Group 2 (Investigational Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. | Grade Malaise (224, 225, 224, 63) | 2 Participants |
| Group 2 (Investigational Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. | Myalgia (224, 225, 224, 63) | 32 Participants |
| Group 2 (Investigational Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. | Grade 3 Myalgia (224, 225, 224, 63) | 1 Participants |
| Group 3 (Licensed Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. | Malaise (224, 225, 224, 63) | 14 Participants |
| Group 3 (Licensed Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. | Myalgia (224, 225, 224, 63) | 41 Participants |
| Group 3 (Licensed Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. | Grade 3 Injection site Pain (224, 225, 224, 63) | 0 Participants |
| Group 3 (Licensed Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. | Grade 3 Injection site Erythema (224, 224, 224, 63 | 0 Participants |
| Group 3 (Licensed Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. | Grade Malaise (224, 225, 224, 63) | 0 Participants |
| Group 3 (Licensed Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. | Injection site Pain (224, 225, 224, 63) | 64 Participants |
| Group 3 (Licensed Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. | Grade 3 Headache (224, 225, 224, 63) | 0 Participants |
| Group 3 (Licensed Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. | Grade 3 Fever (224, 225, 223, 63) | 0 Participants |
| Group 3 (Licensed Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. | Grade 3 Injection site Swelling (224, 224, 224, 63 | 0 Participants |
| Group 3 (Licensed Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. | Injection site Erythema (224, 224, 224, 63) | 3 Participants |
| Group 3 (Licensed Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. | Injection site Swelling (224, 224, 224, 63) | 3 Participants |
| Group 3 (Licensed Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. | Grade 3 Myalgia (224, 225, 224, 63) | 0 Participants |
| Group 3 (Licensed Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. | Fever (224, 225, 223, 63) | 0 Participants |
| Group 3 (Licensed Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. | Headache (224, 225, 224, 63) | 26 Participants |
| Group 4 (Licensed Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. | Fever (224, 225, 223, 63) | 2 Participants |
| Group 4 (Licensed Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. | Grade 3 Fever (224, 225, 223, 63) | 0 Participants |
| Group 4 (Licensed Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. | Myalgia (224, 225, 224, 63) | 22 Participants |
| Group 4 (Licensed Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. | Headache (224, 225, 224, 63) | 16 Participants |
| Group 4 (Licensed Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. | Injection site Erythema (224, 224, 224, 63) | 3 Participants |
| Group 4 (Licensed Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. | Grade 3 Headache (224, 225, 224, 63) | 1 Participants |
| Group 4 (Licensed Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. | Grade 3 Injection site Pain (224, 225, 224, 63) | 0 Participants |
| Group 4 (Licensed Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. | Malaise (224, 225, 224, 63) | 16 Participants |
| Group 4 (Licensed Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. | Grade 3 Myalgia (224, 225, 224, 63) | 1 Participants |
| Group 4 (Licensed Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. | Grade Malaise (224, 225, 224, 63) | 1 Participants |
| Group 4 (Licensed Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. | Injection site Swelling (224, 224, 224, 63) | 5 Participants |
| Group 4 (Licensed Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. | Injection site Pain (224, 225, 224, 63) | 31 Participants |
| Group 4 (Licensed Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. | Grade 3 Injection site Swelling (224, 224, 224, 63 | 0 Participants |
| Group 4 (Licensed Trivalent Influenza Vaccine) | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines. | Grade 3 Injection site Erythema (224, 224, 224, 63 | 0 Participants |
Other Pre-specified
Seroconversion Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines (TIV) With Corresponding B Strains in Participants Aged 65 Years and Older.
Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \< 10. Seroconversion was defined as either a pre-vaccination HAI titer \< 1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and ≥ four-fold increase in post-vaccination titer.
Time frame: Day 21 post-vaccination
Population: Seroconversion with respect to influenza vaccine B strains (corresponding B strains) was determined in randomized and vaccinated adult participants, per-protocol population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 (Investigational Quadrivalent Influenza Vaccine) | Seroconversion Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines (TIV) With Corresponding B Strains in Participants Aged 65 Years and Older. | B/Brisbane/60/2008 (220, 0, 219, 0) | 63 Participants |
| Group 1 (Investigational Quadrivalent Influenza Vaccine) | Seroconversion Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines (TIV) With Corresponding B Strains in Participants Aged 65 Years and Older. | B/Florida/04/2006 (220, 221, 0, 0) | 73 Participants |
| Group 2 (Investigational Trivalent Influenza Vaccine) | Seroconversion Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines (TIV) With Corresponding B Strains in Participants Aged 65 Years and Older. | B/Brisbane/60/2008 (220, 0, 219, 0) | NA Participants |
| Group 2 (Investigational Trivalent Influenza Vaccine) | Seroconversion Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines (TIV) With Corresponding B Strains in Participants Aged 65 Years and Older. | B/Florida/04/2006 (220, 221, 0, 0) | 69 Participants |
| Group 3 (Licensed Trivalent Influenza Vaccine) | Seroconversion Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines (TIV) With Corresponding B Strains in Participants Aged 65 Years and Older. | B/Brisbane/60/2008 (220, 0, 219, 0) | 41 Participants |
| Group 3 (Licensed Trivalent Influenza Vaccine) | Seroconversion Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines (TIV) With Corresponding B Strains in Participants Aged 65 Years and Older. | B/Florida/04/2006 (220, 221, 0, 0) | NA Participants |
Other Pre-specified
Seroconversion Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines Without Corresponding B Strain in Participants Aged 65 Years and Older.
Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10. Seroconversion was defined as either a pre-vaccination HAI titer \< 1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥ 1:10 and ≥ four-fold increase in post-vaccination titers.
Time frame: Day 21 post-vaccination
Population: Seroconversion to influenza vaccine B Strains (cross-reactive antibody) was determined in randomized and vaccinated participants, per-protocol population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 (Investigational Quadrivalent Influenza Vaccine) | Seroconversion Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines Without Corresponding B Strain in Participants Aged 65 Years and Older. | B/Brisbane/60/2008 (220, 221, 0, 0) | 63 Participants |
| Group 1 (Investigational Quadrivalent Influenza Vaccine) | Seroconversion Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines Without Corresponding B Strain in Participants Aged 65 Years and Older. | B/Florida/04/2006 (220, 0, 219, 0) | 73 Participants |
| Group 2 (Investigational Trivalent Influenza Vaccine) | Seroconversion Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines Without Corresponding B Strain in Participants Aged 65 Years and Older. | B/Brisbane/60/2008 (220, 221, 0, 0) | 19 Participants |
| Group 2 (Investigational Trivalent Influenza Vaccine) | Seroconversion Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines Without Corresponding B Strain in Participants Aged 65 Years and Older. | B/Florida/04/2006 (220, 0, 219, 0) | NA Participants |
| Group 3 (Licensed Trivalent Influenza Vaccine) | Seroconversion Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines Without Corresponding B Strain in Participants Aged 65 Years and Older. | B/Brisbane/60/2008 (220, 221, 0, 0) | NA Participants |
| Group 3 (Licensed Trivalent Influenza Vaccine) | Seroconversion Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines Without Corresponding B Strain in Participants Aged 65 Years and Older. | B/Florida/04/2006 (220, 0, 219, 0) | 20 Participants |
Other Pre-specified
Seroconversion Against Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years and Older
Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10. Seroconversion was defined as either a pre-vaccination HAI titer \<1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and ≥ four-fold increase in post-vaccination titer.
Time frame: Day 21 post-vaccination
Population: Seroconversion to influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 (Investigational Quadrivalent Influenza Vaccine) | Seroconversion Against Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years and Older | A/A1N1 | 145 Participants |
| Group 1 (Investigational Quadrivalent Influenza Vaccine) | Seroconversion Against Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years and Older | A/A3N2 | 152 Participants |
| Group 1 (Investigational Quadrivalent Influenza Vaccine) | Seroconversion Against Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years and Older | B/Brisbane/60/2008 | 63 Participants |
| Group 1 (Investigational Quadrivalent Influenza Vaccine) | Seroconversion Against Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years and Older | B/Florida/04/2006 | 73 Participants |
| Group 2 (Investigational Trivalent Influenza Vaccine) | Seroconversion Against Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years and Older | A/A3N2 | 139 Participants |
| Group 2 (Investigational Trivalent Influenza Vaccine) | Seroconversion Against Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years and Older | B/Florida/04/2006 | 69 Participants |
| Group 2 (Investigational Trivalent Influenza Vaccine) | Seroconversion Against Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years and Older | A/A1N1 | 161 Participants |
| Group 2 (Investigational Trivalent Influenza Vaccine) | Seroconversion Against Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years and Older | B/Brisbane/60/2008 | 19 Participants |
| Group 3 (Licensed Trivalent Influenza Vaccine) | Seroconversion Against Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years and Older | A/A1N1 | 146 Participants |
| Group 3 (Licensed Trivalent Influenza Vaccine) | Seroconversion Against Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years and Older | B/Florida/04/2006 | 20 Participants |
| Group 3 (Licensed Trivalent Influenza Vaccine) | Seroconversion Against Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years and Older | B/Brisbane/60/2008 | 41 Participants |
| Group 3 (Licensed Trivalent Influenza Vaccine) | Seroconversion Against Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years and Older | A/A3N2 | 122 Participants |
| Group 4 (Licensed Trivalent Influenza Vaccine) | Seroconversion Against Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years and Older | B/Florida/04/2006 | 18 Participants |
| Group 4 (Licensed Trivalent Influenza Vaccine) | Seroconversion Against Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years and Older | A/A1N1 | 46 Participants |
| Group 4 (Licensed Trivalent Influenza Vaccine) | Seroconversion Against Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years and Older | A/A3N2 | 50 Participants |
| Group 4 (Licensed Trivalent Influenza Vaccine) | Seroconversion Against Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years and Older | B/Brisbane/60/2008 | 27 Participants |
Other Pre-specified
Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years or Older.
Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as \<10. Seroprotection was defined as a pre-vaccination and post-vaccination titer ≥ 1:40 (l/dil)
Time frame: Day 21 post-vaccination
Population: Seroprotection to vaccine antigens were determined in randomized and vaccinated participants, per-protocol population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 (Investigational Quadrivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years or Older. | A/H1N1 Pre-vaccination | 70 Participants |
| Group 1 (Investigational Quadrivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years or Older. | A/H1N1 Post-vaccination | 201 Participants |
| Group 1 (Investigational Quadrivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years or Older. | A/H3N2 Pre-vaccination | 129 Participants |
| Group 1 (Investigational Quadrivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years or Older. | A/H3N2 Post-vaccination | 220 Participants |
| Group 1 (Investigational Quadrivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years or Older. | B/Brisbane Pre-vaccination | 101 Participants |
| Group 1 (Investigational Quadrivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years or Older. | B/Brisbane Post-vaccination | 171 Participants |
| Group 1 (Investigational Quadrivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years or Older. | B/Florida Pre-vaccination | 75 Participants |
| Group 1 (Investigational Quadrivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years or Older. | B/Florida Post-vaccination | 161 Participants |
| Group 2 (Investigational Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years or Older. | B/Brisbane Post-vaccination | 133 Participants |
| Group 2 (Investigational Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years or Older. | B/Brisbane Pre-vaccination | 108 Participants |
| Group 2 (Investigational Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years or Older. | A/H1N1 Post-vaccination | 203 Participants |
| Group 2 (Investigational Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years or Older. | B/Florida Post-vaccination | 149 Participants |
| Group 2 (Investigational Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years or Older. | B/Florida Pre-vaccination | 67 Participants |
| Group 2 (Investigational Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years or Older. | A/H3N2 Post-vaccination | 212 Participants |
| Group 2 (Investigational Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years or Older. | A/H3N2 Pre-vaccination | 119 Participants |
| Group 2 (Investigational Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years or Older. | A/H1N1 Pre-vaccination | 70 Participants |
| Group 3 (Licensed Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years or Older. | B/Florida Pre-vaccination | 68 Participants |
| Group 3 (Licensed Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years or Older. | A/H3N2 Pre-vaccination | 131 Participants |
| Group 3 (Licensed Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years or Older. | A/H3N2 Post-vaccination | 209 Participants |
| Group 3 (Licensed Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years or Older. | B/Brisbane Pre-vaccination | 108 Participants |
| Group 3 (Licensed Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years or Older. | B/Brisbane Post-vaccination | 157 Participants |
| Group 3 (Licensed Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years or Older. | B/Florida Post-vaccination | 101 Participants |
| Group 3 (Licensed Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years or Older. | A/H1N1 Pre-vaccination | 78 Participants |
| Group 3 (Licensed Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years or Older. | A/H1N1 Post-vaccination | 200 Participants |
| Group 4 (Licensed Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years or Older. | A/H3N2 Pre-vaccination | 27 Participants |
| Group 4 (Licensed Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years or Older. | A/H3N2 Post-vaccination | 57 Participants |
| Group 4 (Licensed Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years or Older. | A/H1N1 Post-vaccination | 58 Participants |
| Group 4 (Licensed Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years or Older. | A/H1N1 Pre-vaccination | 27 Participants |
| Group 4 (Licensed Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years or Older. | B/Brisbane Pre-vaccination | 21 Participants |
| Group 4 (Licensed Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years or Older. | B/Florida Post-vaccination | 38 Participants |
| Group 4 (Licensed Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years or Older. | B/Florida Pre-vaccination | 18 Participants |
| Group 4 (Licensed Trivalent Influenza Vaccine) | Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years or Older. | B/Brisbane Post-vaccination | 54 Participants |