Influenza
Conditions
Keywords
Influenza, Influenza virus vaccine, Fluzone® Quadrivalent Influenza Vaccine (No Preservative)
Brief summary
The aim of the study was to assess the immunogenicity and safety of Fluzone Quadrivalent influenza vaccine Southern Hemisphere (SH) 2015 formulation in participants aged 18 to 60 years as well as in participants 61 years or older. The objectives were: * To evaluate the compliance, in terms of immunogenicity, of the Fluzone Quadrivalent influenza vaccine SH 2015 formulation with the requirements of the European Medicines Agency (EMA) Note for guidance (NfG) CPMP/BWP/214/96 * To describe the immunogenicity of the Fluzone Quadrivalent influenza vaccine SH 2015 formulation * To describe the safety of the Fluzone Quadrivalent influenza vaccine SH 2015 formulation
Detailed description
All participants received 1 intramuscular dose of Fluzone Quadrivalent vaccine at the first visit. Immunogenicity and safety were assessed in all participants. Adverse events (AE) defined in EMA NfG CPMP/BWP/214/96 were collected for 3 days after vaccination, solicited AE pre-listed in the diary card were collected for 7 days after vaccination, unsolicited AEs were collected for 21 days after vaccination, and serious adverse event (SAE) information was collected throughout the study.
Interventions
BIOLOGICALFluzone Quadrivalent Influenza Vaccine
0.5-mL, Intramuscular, SH 2015 formulation
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Participants were enrolled in two age groups: participants aged 18 to 60 years and participants aged 61 years or older.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Participants were \>= 18 years of age on the day of inclusion . * Informed consent form had been signed and dated. * Able to attend all scheduled visits and to comply with all trial procedures.
Exclusion criteria
* History of serious adverse reaction to any influenza vaccine. * Receipt of any vaccine within 30 days before receiving study vaccine, or plans to receive another vaccine before Visit 2. * Participation in another interventional clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 30 days preceding the first study vaccination or during the course of the study. * Self-reported thrombocytopenia, which may be a contraindication for intramuscular vaccination, at the discretion of the Investigator. * Vaccination against influenza in the previous 12 months if administered in the context of a clinical trial or a flu vaccination campaign. * Known systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components, or a history of a life-threatening reaction to the vaccine or to a vaccine containing any of the same substances (the complete list of vaccine components is included in the Prescribing Information) . * Receipt of immune globulins, blood, or blood-derived products in the past 3 months. * Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, which may be a contraindication for intramuscular vaccination, at the discretion of the Investigator. * Participant was 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 3 weeks after vaccination). * Any condition that in the opinion of the Investigator would pose a health risk to the participant if enrolled or could interfere with the evaluation of the vaccine. * Personal history of Guillain-Barré syndrome. * 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). * Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion . * Known seropositivity for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C, as reported by the participant. (No screening procedures were implemented.) * Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily. * Current alcohol or drug addiction that, in the opinion of the Investigator, might interfere with the ability to comply with trial procedures. * Moderate or severe acute illness/infection (according to Investigator judgment) or febrile illness (temperature ≥ 38°C) on the day of vaccination. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided. * Identified as an Investigator or employee of an Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e. parent, spouse, natural or adopted child) of an Investigator or employee with direct involvement in the proposed study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Seroprotection to Influenza Vaccine Antigens at Day 0 (Pre-vaccination) and Day 21 (Post-vaccination) | Day 0 (pre-vaccination) and Day 21 (post-vaccination) | Anti-influenza antibodies were measured using hemagglutination-inhibition (HAI) assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, B Yamagata lineage. Seroprotection was defined as an antibody titer \>=40 (1/dilution \[dil\]) at pre-vaccination and post-vaccination. |
| Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 0 (Pre-vaccination) and Day 21 (Post-vaccination) | Day 0 (pre-vaccination) and Day 21 (post-vaccination) | Anti-influenza antibodies were measured using a HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, B Yamagata lineage. |
| Geometric Mean Titer Ratio (GMTR) of Influenza Vaccine Antibodies | Day 0 (pre-vaccination), Day 21 (Post-vaccination) | Anti-influenza antibodies were measured using HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, B Yamagata lineage. Geometric mean titer ratio was calculated as geometric mean titer at Day 21 divided by geometric mean titer at day 0 for each specified group. |
| Number of Participants With Seroconversion or Significant Increase to Influenza Vaccine Antigens | 21 days post-vaccination | Anti-influenza antibodies were measured using HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, B Yamagata lineage. Seroconversion was defined as participants with a pre-vaccination titer \<10 (1/dil) and a post-vaccination titer \>= 40 (1/dil). Significant increase was defined as a pre-vaccination titer \>= 10 (1/dil) and \>= 4-fold increase in post vaccination titer. Number of participants with seroconversion or significant increase to Influenza vaccine antigens were reported. |
| Number of Participants Reporting Solicited Injection Site and Systemic Reactions | Within 7 days after vaccination | A solicited reaction is an adverse event (AE) that is pre-listed in the electronic case report form (eCRF) and considered to be related to vaccination. Solicited injection site reactions: Pain (Grade 1: no interference with activity, Grade 2: some interference with activity, Grade 3: significantly prevent daily activity), erythema, swelling, induration, and ecchymosis (Grade 1: \>=25 mm to \<= 50 mm, Grade 2: \>=51 to \<=100 mm, Grade 3: \> 100 mm). Solicited systemic reactions: Fever (Grade 1: \>=38.0 degree Celsius (°C) to \<=38.4°C, Grade 2: \>=38.5°C to \<=38.9 °C, Grade 3: \>= 39°C), headache, malaise, myalgia, and shivering (Grade 1: no interference with activity, Grade 2: some interference with activity, Grade 3: significantly prevent daily activity). Number of participants with any of the Grade 1, 2 or 3 solicited injection-site and systemic reactions and Grade 3 solicited injection-site and systemic reactions were reported. |
| Number of Participants Reporting Solicited Reactions Listed in the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance | Within 3 days after vaccination | Solicited reactions listed in the CHMP note for guidance included: injection site induration \>= 50 mm for at least 4 consecutive days , injection site ecchymosis, temperature \> 38.0°C for at least one day, malaise, and shivering. |
Countries
Philippines
Participant flow
Recruitment details
Study participants were enrolled in 3 centers in the Philippines from 17 June 2015 to 26 June 2015.
Pre-assignment details
A total of 120 participants (60 for each group) were enrolled and vaccinated in the study.
Participants by arm
| Arm | Count |
|---|---|
| Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years Participants aged 18 to 60 years received one 0.5-mL dose of Fluzone Quadrivalent influenza vaccine, intramuscularly, at Day 0. | 60 |
| Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older Participants aged 61 years or older received one 0.5-mL dose of Fluzone Quadrivalent influenza vaccine, intramuscularly, at Day 0. | 60 |
| Total | 120 |
Baseline characteristics
| Characteristic | Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years | Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older | Total |
|---|---|---|---|
| Age, Continuous | 35.3 years STANDARD_DEVIATION 13.9 | 68.0 years STANDARD_DEVIATION 5.4 | 51.7 years STANDARD_DEVIATION 19.5 |
| Region of Enrollment Philippines | 60 Participants | 60 Participants | 120 Participants |
| Sex: Female, Male Female | 35 Participants | 45 Participants | 80 Participants |
| Sex: Female, Male Male | 25 Participants | 15 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 60 |
| other Total, other adverse events | 22 / 60 | 17 / 60 |
| serious Total, serious adverse events | 0 / 60 | 0 / 60 |
Outcome results
Primary
Geometric Mean Titer Ratio (GMTR) of Influenza Vaccine Antibodies
Anti-influenza antibodies were measured using HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, B Yamagata lineage. Geometric mean titer ratio was calculated as geometric mean titer at Day 21 divided by geometric mean titer at day 0 for each specified group.
Time frame: Day 0 (pre-vaccination), Day 21 (Post-vaccination)
Population: Analysis was performed on the Immunogenicity analysis set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years | Geometric Mean Titer Ratio (GMTR) of Influenza Vaccine Antibodies | A/H1N1 | 26.9 ratio |
| Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years | Geometric Mean Titer Ratio (GMTR) of Influenza Vaccine Antibodies | B Victoria | 13.1 ratio |
| Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years | Geometric Mean Titer Ratio (GMTR) of Influenza Vaccine Antibodies | A/H3N2 | 19.1 ratio |
| Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years | Geometric Mean Titer Ratio (GMTR) of Influenza Vaccine Antibodies | B Yamagata | 10.7 ratio |
| Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older | Geometric Mean Titer Ratio (GMTR) of Influenza Vaccine Antibodies | A/H3N2 | 21.0 ratio |
| Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older | Geometric Mean Titer Ratio (GMTR) of Influenza Vaccine Antibodies | A/H1N1 | 22.4 ratio |
| Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older | Geometric Mean Titer Ratio (GMTR) of Influenza Vaccine Antibodies | B Yamagata | 9.08 ratio |
| Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older | Geometric Mean Titer Ratio (GMTR) of Influenza Vaccine Antibodies | B Victoria | 18.6 ratio |
Primary
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 0 (Pre-vaccination) and Day 21 (Post-vaccination)
Anti-influenza antibodies were measured using a HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, B Yamagata lineage.
Time frame: Day 0 (pre-vaccination) and Day 21 (post-vaccination)
Population: Analysis was performed on the Immunogenicity analysis set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 0 (Pre-vaccination) and Day 21 (Post-vaccination) | A/H1N1 (Pre-Vaccination) | 74.6 Titers (1/dilutions [dil]) |
| Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 0 (Pre-vaccination) and Day 21 (Post-vaccination) | B Victoria (Pre-Vaccination) | 80.0 Titers (1/dilutions [dil]) |
| Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 0 (Pre-vaccination) and Day 21 (Post-vaccination) | B Victoria (Day 21 Post-Vaccination) | 1052 Titers (1/dilutions [dil]) |
| Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 0 (Pre-vaccination) and Day 21 (Post-vaccination) | A/H3N2 (Pre-Vaccination) | 27.8 Titers (1/dilutions [dil]) |
| Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 0 (Pre-vaccination) and Day 21 (Post-vaccination) | B Yamagata (Pre-Vaccination) | 209 Titers (1/dilutions [dil]) |
| Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 0 (Pre-vaccination) and Day 21 (Post-vaccination) | A/H1N1 (Day 21 Post-Vaccination) | 2009 Titers (1/dilutions [dil]) |
| Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 0 (Pre-vaccination) and Day 21 (Post-vaccination) | B Yamagata (Day 21 Post-Vaccination) | 2242 Titers (1/dilutions [dil]) |
| Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 0 (Pre-vaccination) and Day 21 (Post-vaccination) | A/H3N2 (Day 21 Post-Vaccination) | 532 Titers (1/dilutions [dil]) |
| Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 0 (Pre-vaccination) and Day 21 (Post-vaccination) | B Yamagata (Day 21 Post-Vaccination) | 1070 Titers (1/dilutions [dil]) |
| Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 0 (Pre-vaccination) and Day 21 (Post-vaccination) | A/H1N1 (Pre-Vaccination) | 48.4 Titers (1/dilutions [dil]) |
| Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 0 (Pre-vaccination) and Day 21 (Post-vaccination) | A/H1N1 (Day 21 Post-Vaccination) | 1083 Titers (1/dilutions [dil]) |
| Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 0 (Pre-vaccination) and Day 21 (Post-vaccination) | A/H3N2 (Pre-Vaccination) | 34.4 Titers (1/dilutions [dil]) |
| Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 0 (Pre-vaccination) and Day 21 (Post-vaccination) | A/H3N2 (Day 21 Post-Vaccination) | 723 Titers (1/dilutions [dil]) |
| Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 0 (Pre-vaccination) and Day 21 (Post-vaccination) | B Victoria (Day 21 Post-Vaccination) | 835 Titers (1/dilutions [dil]) |
| Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 0 (Pre-vaccination) and Day 21 (Post-vaccination) | B Yamagata (Pre-Vaccination) | 118 Titers (1/dilutions [dil]) |
| Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older | Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 0 (Pre-vaccination) and Day 21 (Post-vaccination) | B Victoria (Pre-Vaccination) | 44.9 Titers (1/dilutions [dil]) |
Primary
Number of Participants Reporting Solicited Injection Site and Systemic Reactions
A solicited reaction is an adverse event (AE) that is pre-listed in the electronic case report form (eCRF) and considered to be related to vaccination. Solicited injection site reactions: Pain (Grade 1: no interference with activity, Grade 2: some interference with activity, Grade 3: significantly prevent daily activity), erythema, swelling, induration, and ecchymosis (Grade 1: \>=25 mm to \<= 50 mm, Grade 2: \>=51 to \<=100 mm, Grade 3: \> 100 mm). Solicited systemic reactions: Fever (Grade 1: \>=38.0 degree Celsius (°C) to \<=38.4°C, Grade 2: \>=38.5°C to \<=38.9 °C, Grade 3: \>= 39°C), headache, malaise, myalgia, and shivering (Grade 1: no interference with activity, Grade 2: some interference with activity, Grade 3: significantly prevent daily activity). Number of participants with any of the Grade 1, 2 or 3 solicited injection-site and systemic reactions and Grade 3 solicited injection-site and systemic reactions were reported.
Time frame: Within 7 days after vaccination
Population: Analysis was performed on the safety analysis set.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years | Number of Participants Reporting Solicited Injection Site and Systemic Reactions | Any Pain | 19 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years | Number of Participants Reporting Solicited Injection Site and Systemic Reactions | Grade 3 Pain | 0 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years | Number of Participants Reporting Solicited Injection Site and Systemic Reactions | Any Erythema | 0 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years | Number of Participants Reporting Solicited Injection Site and Systemic Reactions | Grade 3 Erythema | 0 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years | Number of Participants Reporting Solicited Injection Site and Systemic Reactions | Any Swelling | 0 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years | Number of Participants Reporting Solicited Injection Site and Systemic Reactions | Grade 3 Swelling | 0 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years | Number of Participants Reporting Solicited Injection Site and Systemic Reactions | Any Induration | 1 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years | Number of Participants Reporting Solicited Injection Site and Systemic Reactions | Grade 3 Induration | 0 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years | Number of Participants Reporting Solicited Injection Site and Systemic Reactions | Any Ecchymosis | 0 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years | Number of Participants Reporting Solicited Injection Site and Systemic Reactions | Grade 3 Ecchymosis | 0 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years | Number of Participants Reporting Solicited Injection Site and Systemic Reactions | Any Fever | 1 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years | Number of Participants Reporting Solicited Injection Site and Systemic Reactions | Grade 3 Fever | 1 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years | Number of Participants Reporting Solicited Injection Site and Systemic Reactions | Any Headache | 8 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years | Number of Participants Reporting Solicited Injection Site and Systemic Reactions | Grade 3 Headache | 0 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years | Number of Participants Reporting Solicited Injection Site and Systemic Reactions | Any Malaise | 8 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years | Number of Participants Reporting Solicited Injection Site and Systemic Reactions | Grade 3 Malaise | 0 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years | Number of Participants Reporting Solicited Injection Site and Systemic Reactions | Any Myalgia | 6 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years | Number of Participants Reporting Solicited Injection Site and Systemic Reactions | Grade 3 Myalgia | 0 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years | Number of Participants Reporting Solicited Injection Site and Systemic Reactions | Any Shivering | 2 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years | Number of Participants Reporting Solicited Injection Site and Systemic Reactions | Grade 3 Shivering | 0 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older | Number of Participants Reporting Solicited Injection Site and Systemic Reactions | Grade 3 Myalgia | 0 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older | Number of Participants Reporting Solicited Injection Site and Systemic Reactions | Any Pain | 14 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older | Number of Participants Reporting Solicited Injection Site and Systemic Reactions | Any Fever | 1 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older | Number of Participants Reporting Solicited Injection Site and Systemic Reactions | Grade 3 Pain | 0 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older | Number of Participants Reporting Solicited Injection Site and Systemic Reactions | Grade 3 Malaise | 0 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older | Number of Participants Reporting Solicited Injection Site and Systemic Reactions | Any Erythema | 0 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older | Number of Participants Reporting Solicited Injection Site and Systemic Reactions | Grade 3 Fever | 1 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older | Number of Participants Reporting Solicited Injection Site and Systemic Reactions | Grade 3 Erythema | 0 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older | Number of Participants Reporting Solicited Injection Site and Systemic Reactions | Grade 3 Shivering | 0 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older | Number of Participants Reporting Solicited Injection Site and Systemic Reactions | Any Swelling | 1 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older | Number of Participants Reporting Solicited Injection Site and Systemic Reactions | Any Headache | 3 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older | Number of Participants Reporting Solicited Injection Site and Systemic Reactions | Grade 3 Swelling | 0 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older | Number of Participants Reporting Solicited Injection Site and Systemic Reactions | Any Myalgia | 4 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older | Number of Participants Reporting Solicited Injection Site and Systemic Reactions | Any Induration | 1 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older | Number of Participants Reporting Solicited Injection Site and Systemic Reactions | Grade 3 Headache | 0 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older | Number of Participants Reporting Solicited Injection Site and Systemic Reactions | Grade 3 Induration | 0 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older | Number of Participants Reporting Solicited Injection Site and Systemic Reactions | Any Shivering | 1 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older | Number of Participants Reporting Solicited Injection Site and Systemic Reactions | Any Ecchymosis | 0 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older | Number of Participants Reporting Solicited Injection Site and Systemic Reactions | Any Malaise | 2 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older | Number of Participants Reporting Solicited Injection Site and Systemic Reactions | Grade 3 Ecchymosis | 0 Participants |
Primary
Number of Participants Reporting Solicited Reactions Listed in the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance
Solicited reactions listed in the CHMP note for guidance included: injection site induration \>= 50 mm for at least 4 consecutive days , injection site ecchymosis, temperature \> 38.0°C for at least one day, malaise, and shivering.
Time frame: Within 3 days after vaccination
Population: Analysis was performed on the safety analysis set.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years | Number of Participants Reporting Solicited Reactions Listed in the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance | Injection site ecchymosis | 0 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years | Number of Participants Reporting Solicited Reactions Listed in the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance | Malaise | 7 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years | Number of Participants Reporting Solicited Reactions Listed in the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance | Temperature | 0 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years | Number of Participants Reporting Solicited Reactions Listed in the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance | Shivering | 2 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years | Number of Participants Reporting Solicited Reactions Listed in the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance | Injection site induration | 0 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older | Number of Participants Reporting Solicited Reactions Listed in the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance | Shivering | 1 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older | Number of Participants Reporting Solicited Reactions Listed in the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance | Injection site induration | 0 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older | Number of Participants Reporting Solicited Reactions Listed in the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance | Injection site ecchymosis | 0 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older | Number of Participants Reporting Solicited Reactions Listed in the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance | Temperature | 1 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older | Number of Participants Reporting Solicited Reactions Listed in the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance | Malaise | 2 Participants |
Primary
Number of Participants With Seroconversion or Significant Increase to Influenza Vaccine Antigens
Anti-influenza antibodies were measured using HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, B Yamagata lineage. Seroconversion was defined as participants with a pre-vaccination titer \<10 (1/dil) and a post-vaccination titer \>= 40 (1/dil). Significant increase was defined as a pre-vaccination titer \>= 10 (1/dil) and \>= 4-fold increase in post vaccination titer. Number of participants with seroconversion or significant increase to Influenza vaccine antigens were reported.
Time frame: 21 days post-vaccination
Population: Analysis was performed on the Immunogenicity analysis set.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years | Number of Participants With Seroconversion or Significant Increase to Influenza Vaccine Antigens | A/H1N1 | 52 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years | Number of Participants With Seroconversion or Significant Increase to Influenza Vaccine Antigens | A/H3N2 | 48 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years | Number of Participants With Seroconversion or Significant Increase to Influenza Vaccine Antigens | B Victoria | 54 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years | Number of Participants With Seroconversion or Significant Increase to Influenza Vaccine Antigens | B Yamagata | 51 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older | Number of Participants With Seroconversion or Significant Increase to Influenza Vaccine Antigens | B Yamagata | 47 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older | Number of Participants With Seroconversion or Significant Increase to Influenza Vaccine Antigens | A/H1N1 | 52 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older | Number of Participants With Seroconversion or Significant Increase to Influenza Vaccine Antigens | B Victoria | 55 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older | Number of Participants With Seroconversion or Significant Increase to Influenza Vaccine Antigens | A/H3N2 | 52 Participants |
Primary
Number of Participants With Seroprotection to Influenza Vaccine Antigens at Day 0 (Pre-vaccination) and Day 21 (Post-vaccination)
Anti-influenza antibodies were measured using hemagglutination-inhibition (HAI) assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, B Yamagata lineage. Seroprotection was defined as an antibody titer \>=40 (1/dilution \[dil\]) at pre-vaccination and post-vaccination.
Time frame: Day 0 (pre-vaccination) and Day 21 (post-vaccination)
Population: Immunogenicity analysis set included all participants who received one dose of study medication, had pre-and post-vaccination titers available and had not received vaccination against influenza in the previous 12 months if administered in the context of a clinical trial or a flu vaccination campaign.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years | Number of Participants With Seroprotection to Influenza Vaccine Antigens at Day 0 (Pre-vaccination) and Day 21 (Post-vaccination) | A/H1N1 (Pre-Vaccination) | 41 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years | Number of Participants With Seroprotection to Influenza Vaccine Antigens at Day 0 (Pre-vaccination) and Day 21 (Post-vaccination) | A/H1N1 (Day 21 Post-Vaccination) | 60 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years | Number of Participants With Seroprotection to Influenza Vaccine Antigens at Day 0 (Pre-vaccination) and Day 21 (Post-vaccination) | A/H3N2 (Pre-Vaccination) | 26 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years | Number of Participants With Seroprotection to Influenza Vaccine Antigens at Day 0 (Pre-vaccination) and Day 21 (Post-vaccination) | A/H3N2 (Day 21 Post-Vaccination) | 60 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years | Number of Participants With Seroprotection to Influenza Vaccine Antigens at Day 0 (Pre-vaccination) and Day 21 (Post-vaccination) | B Victoria (Pre-Vaccination) | 48 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years | Number of Participants With Seroprotection to Influenza Vaccine Antigens at Day 0 (Pre-vaccination) and Day 21 (Post-vaccination) | B Victoria (Day 21 Post-Vaccination) | 60 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years | Number of Participants With Seroprotection to Influenza Vaccine Antigens at Day 0 (Pre-vaccination) and Day 21 (Post-vaccination) | B Yamagata (Pre-Vaccination) | 57 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years | Number of Participants With Seroprotection to Influenza Vaccine Antigens at Day 0 (Pre-vaccination) and Day 21 (Post-vaccination) | B Yamagata (Day 21 Post-Vaccination) | 60 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older | Number of Participants With Seroprotection to Influenza Vaccine Antigens at Day 0 (Pre-vaccination) and Day 21 (Post-vaccination) | B Yamagata (Day 21 Post-Vaccination) | 60 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older | Number of Participants With Seroprotection to Influenza Vaccine Antigens at Day 0 (Pre-vaccination) and Day 21 (Post-vaccination) | A/H1N1 (Pre-Vaccination) | 37 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older | Number of Participants With Seroprotection to Influenza Vaccine Antigens at Day 0 (Pre-vaccination) and Day 21 (Post-vaccination) | B Victoria (Pre-Vaccination) | 37 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older | Number of Participants With Seroprotection to Influenza Vaccine Antigens at Day 0 (Pre-vaccination) and Day 21 (Post-vaccination) | A/H1N1 (Day 21 Post-Vaccination) | 60 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older | Number of Participants With Seroprotection to Influenza Vaccine Antigens at Day 0 (Pre-vaccination) and Day 21 (Post-vaccination) | B Yamagata (Pre-Vaccination) | 49 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older | Number of Participants With Seroprotection to Influenza Vaccine Antigens at Day 0 (Pre-vaccination) and Day 21 (Post-vaccination) | A/H3N2 (Pre-Vaccination) | 27 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older | Number of Participants With Seroprotection to Influenza Vaccine Antigens at Day 0 (Pre-vaccination) and Day 21 (Post-vaccination) | B Victoria (Day 21 Post-Vaccination) | 60 Participants |
| Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older | Number of Participants With Seroprotection to Influenza Vaccine Antigens at Day 0 (Pre-vaccination) and Day 21 (Post-vaccination) | A/H3N2 (Day 21 Post-Vaccination) | 59 Participants |