Influenza
Conditions
Keywords
safety, immunogenicity, non-inferiority, MDCK, cell culture-derived, subunit influenza vaccine, influenza prevention
Brief summary
The present study aims to evaluate the safety and immunogenicity of the new influenza subunit vaccine produced in Madin Darby Canine Kidney (MDCK) cells in healthy adult and elderly subjects.
Interventions
BIOLOGICALCell culture-derived trivalent subunit influenza vaccine (cTIV)
One vaccination (0.5 mL) of cell culture-derived influenza vaccine (cTIV) was administered in the deltoid muscle
One vaccination (0.5 mL) of egg-derived influenza virus vaccine (TIV) was administered in the deltoid muscle
Sponsors
Novartis Vaccines
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. 18 to 60 years of age (first age group) OR over 60 years of age (second age group) 2. mentally competent to understand the nature, the scope and the consequences of the study 3. able and willing to give written informed consent prior to study entry 4. available for all the visits scheduled in the study 5. residence in the study area 6. in good health as determined by: 1. medical history, 2. physical examination, 3. clinical judgment of the investigator.
Exclusion criteria
1. unable or unwilling to give written informed consent to participate in the study 2. suffering from an acute infectious disease 3. any serious disease such as: 1. cancer (except for benign or localized skin cancer and non metastatic prostate cancer not currently treated with chemotherapy),\_ 2. autoimmune disease (including rheumatoid arthritis), 3. advanced arteriosclerotic disease or complicated diabetes mellitus, 4. chronic obstructive pulmonary disease (COPD) requiring oxygen therapy, 5. acute or progressive hepatic disease, 6. acute or progressive renal disease, 7. congestive heart failure 4. surgery planned during the study period 5. bleeding diathesis 6. history of hypersensitivity to any component of the study medication or chemically related substances, such as allergy to eggs or egg products 7. known or suspected impairment/alteration of immune function resulting from: 1. receipt of immunosuppressive therapy (any cortical steroid or cancer chemotherapy), 2. receipt of immunostimulants, 3. receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within the past 3 months and for the full length of the study, 4. high risk for developing an immunocompromising disease within the past 6 months 8. history of drug or alcohol abuse 9. laboratory confirmed influenza disease in the past 6 months 10. received influenza vaccine within the past 6 months 11. received another vaccine or any investigational agent within the past 60 days, or planned vaccination within 3 weeks following the study vaccination 12. any acute respiratory disease or infections requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis was acceptable) or experienced fever ≥ 38°C within the past 3 days 13. pregnant women or women who refused to use a reliable contraceptive method throughout the study (180 days) 14. any condition which, in the opinion of the investigator, might have interfered with the evaluation of the study objectives.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentages Of Subjects Who Achieved HI Titer ≥40 After One Vaccination of Cell Culture-derived (cTIV) or Egg-derived (TIV) Influenza Subunit Vaccines | Before vaccination (day 1) and three weeks after vaccination (day 22) | Immunogenicity was measured as the percentage of adults (≥18 to ≤60 years) and elderly (≥61 years) achieving HI titers ≥40 at baseline (day 1) and three weeks (day 22) after one vaccination of cTIV or TIV vaccine for each of three vaccine strains, evaluated using the hemagglutination inhibition (HI) egg-derived antigen assay. In compliance with the requirements of the EMEA recommendations (CPMP/BWP/2490/00, CPMP/BWP/214/96), this criterion is met if the percentage of subjects achieving HI titers ≥40 is \>70% in the ≥18 to ≤60 years of age group or \>60% in the ≥61 years of age group. |
| Percentages Of Subjects Who Achieved Seroconversion Or Significant Increase In HI Titer After One Vaccination of cTIV or TIV | Three weeks after vaccination (day 22) | Seroconversion or significant in HI titer is defined as the percentage of subjects with a prevaccination HI titer \<10 (negative) to a postvaccination titer ≥40; or in subjects with prevaccination HI titer ≥10, at least a 4-fold increase in postvaccination HI titer. In compliance with the requirements of the EMEA recommendations (CPMP/BWP/2490/00, CPMP/BWP/214/96), the criterion is met if the percentage of subjects achieving seroconversion/significant increase is \>40% in the ≥18 to ≤60 years of age group or \>30% in the ≥61 years of age group. |
| Geometric Mean Ratio of Subjects After One Vaccination of cTIV or TIV | Three weeks after vaccination (day 22) | Immunogenicity was measured as the geometric mean ratio (GMR), calculated as the ratio of postvaccination to prevaccination HI Geometric Mean Titers (GMTs), three weeks after (day 22) one vaccination of cTIV or TIV. In compliance with the requirements of the EMEA recommendations (CPMP/BWP/2490/00, CPMP/BWP/214/96), this criterion is met if the GMR (day 22/day 1) in HI antibody titer is \>2.5 in the ≥18 to ≤60 years of age group or \>2.0 in the ≥61 years of age group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination | Up to 7 days postvaccination | The solicited local and systemic reactions were collected from day 1 up to and including day 7 after vaccination for both the vaccine groups. |
Countries
Poland
Participant flow
Recruitment details
Subjects were enrolled at 5 sites in Poland.
Pre-assignment details
All enrolled subjects were included in the trial.
Participants by arm
| Arm | Count |
|---|---|
| cTIV (Adults) Subjects ≥18 to ≤60 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV) | 652 |
| TIV (Adults) Subjects ≥18 to ≤60 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV) | 648 |
| cTIV (Elderly) Subjects ≥61 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV) | 678 |
| TIV (Elderly) Subjects ≥61 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV) | 676 |
| Total | 2,654 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 0 | 0 | 1 | 2 |
| Overall Study | Lost to Follow-up | 6 | 11 | 5 | 3 |
| Overall Study | Protocol Violation | 0 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 3 | 5 | 4 |
Baseline characteristics
| Characteristic | cTIV (Adults) | TIV (Adults) | cTIV (Elderly) | TIV (Elderly) | Total |
|---|---|---|---|---|---|
| Age, Continuous | 38.7 Years STANDARD_DEVIATION 12.7 | 38.3 Years STANDARD_DEVIATION 13.3 | 69.1 Years STANDARD_DEVIATION 5.7 | 68.8 Years STANDARD_DEVIATION 5.6 | 54.0 Years STANDARD_DEVIATION 18.2 |
| Sex: Female, Male Female | 376 Participants | 371 Participants | 389 Participants | 375 Participants | 1511 Participants |
| Sex: Female, Male Male | 276 Participants | 277 Participants | 289 Participants | 301 Participants | 1143 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 | 261 / 652 | 257 / 648 | 224 / 678 | 207 / 676 |
| serious Total, serious adverse events | 7 / 652 | 5 / 648 | 19 / 678 | 18 / 676 |
Outcome results
Primary
Geometric Mean Ratio of Subjects After One Vaccination of cTIV or TIV
Immunogenicity was measured as the geometric mean ratio (GMR), calculated as the ratio of postvaccination to prevaccination HI Geometric Mean Titers (GMTs), three weeks after (day 22) one vaccination of cTIV or TIV. In compliance with the requirements of the EMEA recommendations (CPMP/BWP/2490/00, CPMP/BWP/214/96), this criterion is met if the GMR (day 22/day 1) in HI antibody titer is \>2.5 in the ≥18 to ≤60 years of age group or \>2.0 in the ≥61 years of age group.
Time frame: Three weeks after vaccination (day 22)
Population: Analysis was performed on the PP set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| cTIV (Adults) | Geometric Mean Ratio of Subjects After One Vaccination of cTIV or TIV | A/H1N1 | 11 Ratio |
| cTIV (Adults) | Geometric Mean Ratio of Subjects After One Vaccination of cTIV or TIV | B | 13 Ratio |
| cTIV (Adults) | Geometric Mean Ratio of Subjects After One Vaccination of cTIV or TIV | A/H3N2 | 5.99 Ratio |
| TIV (Adults) | Geometric Mean Ratio of Subjects After One Vaccination of cTIV or TIV | A/H1N1 | 11 Ratio |
| TIV (Adults) | Geometric Mean Ratio of Subjects After One Vaccination of cTIV or TIV | B | 12 Ratio |
| TIV (Adults) | Geometric Mean Ratio of Subjects After One Vaccination of cTIV or TIV | A/H3N2 | 7.08 Ratio |
| cTIV (Elderly) | Geometric Mean Ratio of Subjects After One Vaccination of cTIV or TIV | A/H3N2 | 7.25 Ratio |
| cTIV (Elderly) | Geometric Mean Ratio of Subjects After One Vaccination of cTIV or TIV | A/H1N1 | 5.74 Ratio |
| cTIV (Elderly) | Geometric Mean Ratio of Subjects After One Vaccination of cTIV or TIV | B | 12 Ratio |
| TIV (Elderly) | Geometric Mean Ratio of Subjects After One Vaccination of cTIV or TIV | A/H1N1 | 5.96 Ratio |
| TIV (Elderly) | Geometric Mean Ratio of Subjects After One Vaccination of cTIV or TIV | B | 9.29 Ratio |
| TIV (Elderly) | Geometric Mean Ratio of Subjects After One Vaccination of cTIV or TIV | A/H3N2 | 8.36 Ratio |
Comparison: Non-inferiority testing in immune response (GMR) after one vaccination of cTIV to that of TIV vaccine for strain A/H1N1 in adults.95% CI: [0.9, 1.28]
Comparison: Non-inferiority testing in immune response (GMR) after one vaccination of cTIV to that of TIV vaccine for strain A/H3N2 in adults.95% CI: [0.72, 0.99]
Comparison: Non-inferiority testing in immune response (GMR) after one vaccination of cTIV to that of TIV vaccine for strain B in adults.95% CI: [0.99, 1.3]
Comparison: Non-inferiority testing in immune response (GMR) after one vaccination of cTIV to that of TIV vaccine for strain A/H1N1 in the elderly population.95% CI: [0.82, 1.12]
Comparison: Non-inferiority testing in immune response (GMR) after one vaccination of cTIV to that of TIV vaccine for strain A/H3N2 in the elderly population.95% CI: [0.74, 1.02]
Comparison: Non-inferiority testing in immune response (GMR) after one vaccination of cTIV to that of TIV vaccine for strain B in the elderly population.95% CI: [1.11, 1.4]
Primary
Percentages Of Subjects Who Achieved HI Titer ≥40 After One Vaccination of Cell Culture-derived (cTIV) or Egg-derived (TIV) Influenza Subunit Vaccines
Immunogenicity was measured as the percentage of adults (≥18 to ≤60 years) and elderly (≥61 years) achieving HI titers ≥40 at baseline (day 1) and three weeks (day 22) after one vaccination of cTIV or TIV vaccine for each of three vaccine strains, evaluated using the hemagglutination inhibition (HI) egg-derived antigen assay. In compliance with the requirements of the EMEA recommendations (CPMP/BWP/2490/00, CPMP/BWP/214/96), this criterion is met if the percentage of subjects achieving HI titers ≥40 is \>70% in the ≥18 to ≤60 years of age group or \>60% in the ≥61 years of age group.
Time frame: Before vaccination (day 1) and three weeks after vaccination (day 22)
Population: Analysis was done on the per-protocol (PP) set, i.e. the subjects who received the vaccination correctly; provided evaluable data before and after vaccination; and with no major protocol violations, as defined before unblinding.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| cTIV (Adults) | Percentages Of Subjects Who Achieved HI Titer ≥40 After One Vaccination of Cell Culture-derived (cTIV) or Egg-derived (TIV) Influenza Subunit Vaccines | A/H1N1 (Day 1) | 29 Percentages |
| cTIV (Adults) | Percentages Of Subjects Who Achieved HI Titer ≥40 After One Vaccination of Cell Culture-derived (cTIV) or Egg-derived (TIV) Influenza Subunit Vaccines | A/H1N1 (Day 22) | 92 Percentages |
| cTIV (Adults) | Percentages Of Subjects Who Achieved HI Titer ≥40 After One Vaccination of Cell Culture-derived (cTIV) or Egg-derived (TIV) Influenza Subunit Vaccines | A/H3N2 (Day 1) | 65 Percentages |
| cTIV (Adults) | Percentages Of Subjects Who Achieved HI Titer ≥40 After One Vaccination of Cell Culture-derived (cTIV) or Egg-derived (TIV) Influenza Subunit Vaccines | A/H3N2 (Day 22) | 99 Percentages |
| cTIV (Adults) | Percentages Of Subjects Who Achieved HI Titer ≥40 After One Vaccination of Cell Culture-derived (cTIV) or Egg-derived (TIV) Influenza Subunit Vaccines | B (Day 1) | 16 Percentages |
| cTIV (Adults) | Percentages Of Subjects Who Achieved HI Titer ≥40 After One Vaccination of Cell Culture-derived (cTIV) or Egg-derived (TIV) Influenza Subunit Vaccines | B (Day 22) | 90 Percentages |
| TIV (Adults) | Percentages Of Subjects Who Achieved HI Titer ≥40 After One Vaccination of Cell Culture-derived (cTIV) or Egg-derived (TIV) Influenza Subunit Vaccines | B (Day 22) | 91 Percentages |
| TIV (Adults) | Percentages Of Subjects Who Achieved HI Titer ≥40 After One Vaccination of Cell Culture-derived (cTIV) or Egg-derived (TIV) Influenza Subunit Vaccines | A/H3N2 (Day 22) | 99 Percentages |
| TIV (Adults) | Percentages Of Subjects Who Achieved HI Titer ≥40 After One Vaccination of Cell Culture-derived (cTIV) or Egg-derived (TIV) Influenza Subunit Vaccines | A/H1N1 (Day 1) | 33 Percentages |
| TIV (Adults) | Percentages Of Subjects Who Achieved HI Titer ≥40 After One Vaccination of Cell Culture-derived (cTIV) or Egg-derived (TIV) Influenza Subunit Vaccines | A/H3N2 (Day 1) | 63 Percentages |
| TIV (Adults) | Percentages Of Subjects Who Achieved HI Titer ≥40 After One Vaccination of Cell Culture-derived (cTIV) or Egg-derived (TIV) Influenza Subunit Vaccines | A/H1N1 (Day 22) | 92 Percentages |
| TIV (Adults) | Percentages Of Subjects Who Achieved HI Titer ≥40 After One Vaccination of Cell Culture-derived (cTIV) or Egg-derived (TIV) Influenza Subunit Vaccines | B (Day 1) | 18 Percentages |
| cTIV (Elderly) | Percentages Of Subjects Who Achieved HI Titer ≥40 After One Vaccination of Cell Culture-derived (cTIV) or Egg-derived (TIV) Influenza Subunit Vaccines | A/H1N1 (Day 22) | 85 Percentages |
| cTIV (Elderly) | Percentages Of Subjects Who Achieved HI Titer ≥40 After One Vaccination of Cell Culture-derived (cTIV) or Egg-derived (TIV) Influenza Subunit Vaccines | A/H3N2 (Day 1) | 66 Percentages |
| cTIV (Elderly) | Percentages Of Subjects Who Achieved HI Titer ≥40 After One Vaccination of Cell Culture-derived (cTIV) or Egg-derived (TIV) Influenza Subunit Vaccines | A/H3N2 (Day 22) | 97 Percentages |
| cTIV (Elderly) | Percentages Of Subjects Who Achieved HI Titer ≥40 After One Vaccination of Cell Culture-derived (cTIV) or Egg-derived (TIV) Influenza Subunit Vaccines | B (Day 22) | 90 Percentages |
| cTIV (Elderly) | Percentages Of Subjects Who Achieved HI Titer ≥40 After One Vaccination of Cell Culture-derived (cTIV) or Egg-derived (TIV) Influenza Subunit Vaccines | B (Day 1) | 23 Percentages |
| cTIV (Elderly) | Percentages Of Subjects Who Achieved HI Titer ≥40 After One Vaccination of Cell Culture-derived (cTIV) or Egg-derived (TIV) Influenza Subunit Vaccines | A/H1N1 (Day 1) | 30 Percentages |
| TIV (Elderly) | Percentages Of Subjects Who Achieved HI Titer ≥40 After One Vaccination of Cell Culture-derived (cTIV) or Egg-derived (TIV) Influenza Subunit Vaccines | B (Day 1) | 20 Percentages |
| TIV (Elderly) | Percentages Of Subjects Who Achieved HI Titer ≥40 After One Vaccination of Cell Culture-derived (cTIV) or Egg-derived (TIV) Influenza Subunit Vaccines | B (Day 22) | 89 Percentages |
| TIV (Elderly) | Percentages Of Subjects Who Achieved HI Titer ≥40 After One Vaccination of Cell Culture-derived (cTIV) or Egg-derived (TIV) Influenza Subunit Vaccines | A/H1N1 (Day 22) | 85 Percentages |
| TIV (Elderly) | Percentages Of Subjects Who Achieved HI Titer ≥40 After One Vaccination of Cell Culture-derived (cTIV) or Egg-derived (TIV) Influenza Subunit Vaccines | A/H3N2 (Day 22) | 98 Percentages |
| TIV (Elderly) | Percentages Of Subjects Who Achieved HI Titer ≥40 After One Vaccination of Cell Culture-derived (cTIV) or Egg-derived (TIV) Influenza Subunit Vaccines | A/H1N1 (Day 1) | 31 Percentages |
| TIV (Elderly) | Percentages Of Subjects Who Achieved HI Titer ≥40 After One Vaccination of Cell Culture-derived (cTIV) or Egg-derived (TIV) Influenza Subunit Vaccines | A/H3N2 (Day 1) | 59 Percentages |
Comparison: Non-inferiority testing in immune response (HI titer ≥40) of cTIV to that of TIV vaccine for strain A/H1N1 after one vaccination in adults.95% CI: [-3, 3]
Comparison: Non-inferiority testing in immune response (HI titer ≥40) of cTIV to that of TIV vaccine for strain A/H3N2 after one vaccination in adults.95% CI: [-1, 2]
Comparison: Non-inferiority testing in immune response (HI titer ≥40) of cTIV to that of TIV vaccine for strain B after one vaccination in adults.95% CI: [-3, 3]
Comparison: Non-inferiority testing in immune response (HI titer ≥40) of cTIV to that of TIV vaccine for strain A/H1N1 after one vaccination in the elderly population.95% CI: [-4, 3]
Comparison: Non-inferiority testing in immune response (HI titer ≥40) of cTIV to that of TIV vaccine for strain A/H3N2 after one vaccination in the elderly population.95% CI: [-2, 1]
Comparison: Non-inferiority testing in immune response (HI titer ≥40) of cTIV to that of TIV vaccine for strain B after one vaccination in the elderly population.95% CI: [-2, 4]
Primary
Percentages Of Subjects Who Achieved Seroconversion Or Significant Increase In HI Titer After One Vaccination of cTIV or TIV
Seroconversion or significant in HI titer is defined as the percentage of subjects with a prevaccination HI titer \<10 (negative) to a postvaccination titer ≥40; or in subjects with prevaccination HI titer ≥10, at least a 4-fold increase in postvaccination HI titer. In compliance with the requirements of the EMEA recommendations (CPMP/BWP/2490/00, CPMP/BWP/214/96), the criterion is met if the percentage of subjects achieving seroconversion/significant increase is \>40% in the ≥18 to ≤60 years of age group or \>30% in the ≥61 years of age group.
Time frame: Three weeks after vaccination (day 22)
Population: Analysis was performed on the PP set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| cTIV (Adults) | Percentages Of Subjects Who Achieved Seroconversion Or Significant Increase In HI Titer After One Vaccination of cTIV or TIV | A/H1N1 | 69 Percentages |
| cTIV (Adults) | Percentages Of Subjects Who Achieved Seroconversion Or Significant Increase In HI Titer After One Vaccination of cTIV or TIV | B | 85 Percentages |
| cTIV (Adults) | Percentages Of Subjects Who Achieved Seroconversion Or Significant Increase In HI Titer After One Vaccination of cTIV or TIV | A/H3N2 | 63 Percentages |
| TIV (Adults) | Percentages Of Subjects Who Achieved Seroconversion Or Significant Increase In HI Titer After One Vaccination of cTIV or TIV | A/H1N1 | 67 Percentages |
| TIV (Adults) | Percentages Of Subjects Who Achieved Seroconversion Or Significant Increase In HI Titer After One Vaccination of cTIV or TIV | B | 81 Percentages |
| TIV (Adults) | Percentages Of Subjects Who Achieved Seroconversion Or Significant Increase In HI Titer After One Vaccination of cTIV or TIV | A/H3N2 | 64 Percentages |
| cTIV (Elderly) | Percentages Of Subjects Who Achieved Seroconversion Or Significant Increase In HI Titer After One Vaccination of cTIV or TIV | A/H3N2 | 68 Percentages |
| cTIV (Elderly) | Percentages Of Subjects Who Achieved Seroconversion Or Significant Increase In HI Titer After One Vaccination of cTIV or TIV | A/H1N1 | 55 Percentages |
| cTIV (Elderly) | Percentages Of Subjects Who Achieved Seroconversion Or Significant Increase In HI Titer After One Vaccination of cTIV or TIV | B | 80 Percentages |
| TIV (Elderly) | Percentages Of Subjects Who Achieved Seroconversion Or Significant Increase In HI Titer After One Vaccination of cTIV or TIV | A/H1N1 | 55 Percentages |
| TIV (Elderly) | Percentages Of Subjects Who Achieved Seroconversion Or Significant Increase In HI Titer After One Vaccination of cTIV or TIV | B | 73 Percentages |
| TIV (Elderly) | Percentages Of Subjects Who Achieved Seroconversion Or Significant Increase In HI Titer After One Vaccination of cTIV or TIV | A/H3N2 | 65 Percentages |
Comparison: Non-inferiority testing in immune response (seroconversion or significant increase in HI titer) after one vaccination of cTIV to that of TIV vaccine for strain A/H1N1 in adults.95% CI: [-3, 7]
Comparison: Non-inferiority testing in immune response (seroconversion or significant increase in HI titer) after one vaccination of cTIV to that of TIV vaccine for strain A/H3N2 in adults.95% CI: [-6, 4]
Comparison: Non-inferiority testing in immune response (seroconversion or significant increase in HI titer) after one vaccination of cTIV to that of TIV vaccine for strain B in adults.95% CI: [0, 8]
Comparison: Non-inferiority testing in immune response (seroconversion or significant increase in HI titer) after one vaccination of cTIV to that of TIV vaccine for strain A/H1N1 in the elderly population.95% CI: [-6, 5]
Comparison: Non-inferiority testing in immune response (seroconversion or significant increase in HI titer) after one vaccination of cTIV to that of TIV vaccine for strain A/H3N2 in the elderly population.95% CI: [-2, 8]
Comparison: Non-inferiority testing in immune response (seroconversion or significant increase in HI titer) after one vaccination of cTIV to that of TIV vaccine for strain B in the elderly population.95% CI: [2, 11]
Secondary
Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination
The solicited local and systemic reactions were collected from day 1 up to and including day 7 after vaccination for both the vaccine groups.
Time frame: Up to 7 days postvaccination
Population: Analysis was done on Safety population i.e., all subjects with vaccination and with some post-baseline safety data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| cTIV (Adults) | Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination | Ecchymosis | 18 Number of Subjects |
| cTIV (Adults) | Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination | Fatigue | 73 Number of Subjects |
| cTIV (Adults) | Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination | Arthralgia | 31 Number of Subjects |
| cTIV (Adults) | Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination | Induration | 38 Number of Subjects |
| cTIV (Adults) | Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination | Headache | 81 Number of Subjects |
| cTIV (Adults) | Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination | Sweating | 28 Number of Subjects |
| cTIV (Adults) | Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination | Swelling | 25 Number of Subjects |
| cTIV (Adults) | Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination | Erythema | 92 Number of Subjects |
| cTIV (Adults) | Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination | Stayed home due to reaction | 14 Number of Subjects |
| cTIV (Adults) | Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination | Pain | 141 Number of Subjects |
| cTIV (Adults) | Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination | Chills | 25 Number of Subjects |
| cTIV (Adults) | Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination | Fever (≥38°C) | 2 Number of Subjects |
| cTIV (Adults) | Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination | Malaise | 74 Number of Subjects |
| cTIV (Adults) | Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination | Analgesic/antipyretic medication used | 44 Number of Subjects |
| cTIV (Adults) | Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination | Myalgia | 45 Number of Subjects |
| TIV (Adults) | Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination | Myalgia | 49 Number of Subjects |
| TIV (Adults) | Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination | Fatigue | 73 Number of Subjects |
| TIV (Adults) | Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination | Pain | 111 Number of Subjects |
| TIV (Adults) | Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination | Arthralgia | 27 Number of Subjects |
| TIV (Adults) | Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination | Erythema | 106 Number of Subjects |
| TIV (Adults) | Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination | Sweating | 27 Number of Subjects |
| TIV (Adults) | Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination | Fever (≥38°C) | 5 Number of Subjects |
| TIV (Adults) | Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination | Headache | 79 Number of Subjects |
| TIV (Adults) | Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination | Induration | 42 Number of Subjects |
| TIV (Adults) | Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination | Malaise | 74 Number of Subjects |
| TIV (Adults) | Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination | Analgesic/antipyretic medication used | 40 Number of Subjects |
| TIV (Adults) | Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination | Stayed home due to reaction | 16 Number of Subjects |
| TIV (Adults) | Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination | Chills | 29 Number of Subjects |
| TIV (Adults) | Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination | Swelling | 27 Number of Subjects |
| TIV (Adults) | Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination | Ecchymosis | 22 Number of Subjects |
| cTIV (Elderly) | Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination | Myalgia | 46 Number of Subjects |
| cTIV (Elderly) | Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination | Ecchymosis | 26 Number of Subjects |
| cTIV (Elderly) | Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination | Erythema | 72 Number of Subjects |
| cTIV (Elderly) | Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination | Induration | 37 Number of Subjects |
| cTIV (Elderly) | Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination | Swelling | 23 Number of Subjects |
| cTIV (Elderly) | Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination | Pain | 64 Number of Subjects |
| cTIV (Elderly) | Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination | Chills | 23 Number of Subjects |
| cTIV (Elderly) | Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination | Malaise | 70 Number of Subjects |
| cTIV (Elderly) | Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination | Arthralgia | 41 Number of Subjects |
| cTIV (Elderly) | Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination | Headache | 69 Number of Subjects |
| cTIV (Elderly) | Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination | Sweating | 44 Number of Subjects |
| cTIV (Elderly) | Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination | Fatigue | 73 Number of Subjects |
| cTIV (Elderly) | Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination | Fever (≥38°C) | 5 Number of Subjects |
| cTIV (Elderly) | Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination | Stayed home due to reaction | 19 Number of Subjects |
| cTIV (Elderly) | Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination | Analgesic/antipyretic medication used | 34 Number of Subjects |
| TIV (Elderly) | Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination | Malaise | 75 Number of Subjects |
| TIV (Elderly) | Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination | Erythema | 72 Number of Subjects |
| TIV (Elderly) | Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination | Fatigue | 84 Number of Subjects |
| TIV (Elderly) | Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination | Chills | 26 Number of Subjects |
| TIV (Elderly) | Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination | Pain | 32 Number of Subjects |
| TIV (Elderly) | Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination | Ecchymosis | 25 Number of Subjects |
| TIV (Elderly) | Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination | Fever (≥38°C) | 5 Number of Subjects |
| TIV (Elderly) | Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination | Swelling | 17 Number of Subjects |
| TIV (Elderly) | Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination | Induration | 29 Number of Subjects |
| TIV (Elderly) | Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination | Analgesic/antipyretic medication used | 29 Number of Subjects |
| TIV (Elderly) | Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination | Headache | 70 Number of Subjects |
| TIV (Elderly) | Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination | Arthralgia | 44 Number of Subjects |
| TIV (Elderly) | Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination | Stayed home due to reaction | 14 Number of Subjects |
| TIV (Elderly) | Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination | Sweating | 48 Number of Subjects |
| TIV (Elderly) | Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination | Myalgia | 57 Number of Subjects |