Influenza
Conditions
Keywords
Influenza, adult/elderly, flu cell culture, vaccine
Brief summary
The purpose of the study is to evaluate safety, tolerability and immunogenicity (in a subset) following a dose of a trivalent subunit influenza vaccine produced either in mammalian cells or in embryonated hen eggs, in healthy adult and elderly subjects who received either vaccine one year before (2004) in the study V58P4.
Interventions
BIOLOGICALCell culture derived influenza vaccine
as a single IM injection of 0.5 ml in the deltoid muscle, preferably of the non-dominant arm
BIOLOGICALegg-derived influenza subunit vaccine
as a single IM injection of 0.5 ml in the deltoid muscle, preferably of the non-dominant arm
Sponsors
Novartis Vaccines and Diagnostics S.r.l.
Novartis Vaccines
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. 18 to \< 61 years of age (first age group) OR 61 years of age and older (second age group) at enrolment in V58P4 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. in good health as determined by: 1. Medical history related to the previous six months, 2. Physical examination, 3. Clinical judgment of the investigator.
Exclusion criteria
1. Unwilling or unable to give written informed consent to participate in the study 2. Currently experiencing an acute infectious disease 3. Any serious disease such as, for example: 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 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 expect to receive another vaccine within 3 weeks following the study vaccination 12. Participation in another clinical trial within 90 days prior to enrollment and throughout the full length of the study 13. Any acute respiratory disease or infections requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis is acceptable) or experienced fever \_ 38°C within the past 5 days 14. Pregnant/ breast feeding women or women who refuse to use a reliable contraceptive method during the first three weeks after vaccination 15. Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Day 1 to Day 7 postvaccination | To assess the safety and tolerability in terms of number of adult and elderly subjects reporting solicited adverse events following one dose of the cTIV or the TIV vaccine . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Six-months Safety Data of Subjects After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine | Up to 6 months postvaccination | To collect additional safety data for 6 months after vaccination with one dose of cell culture derived or egg-derived influenza vaccine in terms of serious adverse events (SAEs), adverse events (AEs) necessitating a physician's visit and/or resulting in premature subject's withdrawal from study. |
| Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | Day 22 postvaccination | The haemagglutinin inhibition (HI) antibody titer response following one 0.5 mL dose of either cell derived (cTIV) or egg-derived vaccine (TIV) in adult and elderly subjects is reported as GMTs. The HI GMTs were evaluated using egg-derived antigen assay. |
| Geometric Mean Ratios (GMRs), After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | Day 22 postvaccination | Immunogenicity was assessed in terms of GMR in adult and elderly subjects following one 0.5ml dose of either the cTIV vaccine or the TIV vaccine, according to the CHMP criteria. The European licensure (CHMP) criteria was met if the mean geometric increase (GMR, day 22/day 1) in HI antibody titer is \>2.5 for adults and \>2.0 for elderly subjects. |
| Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine. | Day 22 postvaccination | Immunogenicity was assessed in terms of percentages of adult and elderly subjects achieving HI titers≥40,after one dose of either the cTIV vaccine or the TIV vaccine. European (CHMP) criteria is met if the percentage of subjects achieving HI titers ≥ 40 is \> 70% for adults and \>60% for elderly. |
| Percentages of Adult and Elderly Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | Day 22 postvaccination | Immunogenicity was assessed in terms of percentages of adult and elderly subjects showing seroconversion or significant increase in HI antibody titers after one dose of cell culture-derived or the egg-derived influenza vaccine. Seroconversion or significant increase as per European Licensure (CHMP) criteria is defined as percentage of subjects with a prevaccination HI titer \<10 to a postvaccination titer ≥ 40 for adults and ≥ 30 for elderly. Significant increase is defined as percentage of subjects with a prevaccination HI titer ≥ 10 and a ≥ 4-fold increase in postvaccination HI antibody titer. |
Countries
Poland
Participant flow
Recruitment details
Subjects were enrolled from 5 study centers in Poland.
Pre-assignment details
All subjects enrolled were included in the trial.
Participants by arm
| Arm | Count |
|---|---|
| Adults (cTIV\cTIV) + (TIV\cTIV) Subjects(18-60 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine, received one dose of cTIV in this study, one year later. | 533 |
| Elderly (cTIV\cTIV) + (TIV\cTIV) Subjects(≥61 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine, received one dose of cTIV in this study, one year later. | 572 |
| Adults (cTIV\TIV) + (TIV\TIV) Subjects (18-60 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of TIV in this study, one year later. | 534 |
| Elderly (cTIV\TIV) + (TIV\TIV) Subjects (≥61 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of TIV in this study, one year later. | 596 |
| Total | 2,235 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 | 1 |
| Overall Study | Death | 1 | 0 | 1 | 2 |
| Overall Study | Lost to Follow-up | 3 | 4 | 3 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 3 | 0 | 3 |
Baseline characteristics
| Characteristic | Adults (cTIV\cTIV) + (TIV\cTIV) | Elderly (cTIV\cTIV) + (TIV\cTIV) | Adults (cTIV\TIV) + (TIV\TIV) | Elderly (cTIV\TIV) + (TIV\TIV) | Total |
|---|---|---|---|---|---|
| Age, Continuous | 39.8 years STANDARD_DEVIATION 12.7 | 69.2 years STANDARD_DEVIATION 5.7 | 39.0 years STANDARD_DEVIATION 12.5 | 69.9 years STANDARD_DEVIATION 5.7 | 55.2 years STANDARD_DEVIATION 17.9 |
| Sex: Female, Male Female | 308 Participants | 308 Participants | 309 Participants | 353 Participants | 1278 Participants |
| Sex: Female, Male Male | 225 Participants | 264 Participants | 225 Participants | 243 Participants | 957 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 | 188 / 533 | 172 / 534 | 140 / 571 | 148 / 597 |
| serious Total, serious adverse events | 9 / 533 | 4 / 534 | 23 / 571 | 30 / 597 |
Outcome results
Primary
Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine
To assess the safety and tolerability in terms of number of adult and elderly subjects reporting solicited adverse events following one dose of the cTIV or the TIV vaccine .
Time frame: Day 1 to Day 7 postvaccination
Population: This analysis was done on safety dataset
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| cTIV\cTIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Injection site ecchymosis | 13 Participants |
| cTIV\cTIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Analgesic antipyretic medication used | 14 Participants |
| cTIV\cTIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Sweat | 10 Participants |
| cTIV\cTIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Systemic | 41 Participants |
| cTIV\cTIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Headache | 24 Participants |
| cTIV\cTIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Other | 15 Participants |
| cTIV\cTIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Injection site induration | 17 Participants |
| cTIV\cTIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Stayed at home due to reaction | 3 Participants |
| cTIV\cTIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Local | 78 Participants |
| cTIV\cTIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Arthralgia | 10 Participants |
| cTIV\cTIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Fever (≥38°C) | 2 Participants |
| cTIV\cTIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Myalgia | 19 Participants |
| cTIV\cTIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Injection site pain | 52 Participants |
| cTIV\cTIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Malaise | 20 Participants |
| cTIV\cTIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Injection site swelling | 8 Participants |
| cTIV\cTIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Fatigue | 18 Participants |
| cTIV\cTIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Injection site erythema | 32 Participants |
| cTIV\cTIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Chills | 7 Participants |
| cTIV\TIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Chills | 4 Participants |
| cTIV\TIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Systemic | 46 Participants |
| cTIV\TIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Injection site pain | 45 Participants |
| cTIV\TIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Stayed at home due to reaction | 2 Participants |
| cTIV\TIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Other | 11 Participants |
| cTIV\TIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Injection site ecchymosis | 11 Participants |
| cTIV\TIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Local | 73 Participants |
| cTIV\TIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Fever (≥38°C) | 2 Participants |
| cTIV\TIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Fatigue | 19 Participants |
| cTIV\TIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Injection site erythema | 26 Participants |
| cTIV\TIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Sweat | 8 Participants |
| cTIV\TIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Headache | 21 Participants |
| cTIV\TIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Arthralgia | 7 Participants |
| cTIV\TIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Injection site induration | 11 Participants |
| cTIV\TIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Myalgia | 20 Participants |
| cTIV\TIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Malaise | 18 Participants |
| cTIV\TIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Injection site swelling | 4 Participants |
| cTIV\TIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Analgesic antipyretic medication used | 11 Participants |
| cTIV\cTIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Injection site erythema | 22 Participants |
| cTIV\cTIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Local | 47 Participants |
| cTIV\cTIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Injection site ecchymosis | 12 Participants |
| cTIV\cTIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Injection site induration | 10 Participants |
| cTIV\cTIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Injection site swelling | 7 Participants |
| cTIV\cTIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Injection site pain | 22 Participants |
| cTIV\cTIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Systemic | 37 Participants |
| cTIV\cTIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Chills | 8 Participants |
| cTIV\cTIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Malaise | 19 Participants |
| cTIV\cTIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Myalgia | 13 Participants |
| cTIV\cTIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Arthralgia | 14 Participants |
| cTIV\cTIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Headache | 16 Participants |
| cTIV\cTIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Sweat | 10 Participants |
| cTIV\cTIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Fatigue | 22 Participants |
| cTIV\cTIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Fever (≥38°C) | 2 Participants |
| cTIV\cTIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Other | 7 Participants |
| cTIV\cTIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Stayed at home due to reaction | 3 Participants |
| cTIV\cTIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Analgesic antipyretic medication used | 7 Participants |
| cTIV\TIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Stayed at home due to reaction | 2 Participants |
| cTIV\TIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Other | 10 Participants |
| cTIV\TIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Fever (≥38°C) | 0 Participants |
| cTIV\TIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Injection site swelling | 5 Participants |
| cTIV\TIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Injection site ecchymosis | 15 Participants |
| cTIV\TIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Malaise | 19 Participants |
| cTIV\TIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Myalgia | 9 Participants |
| cTIV\TIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Chills | 7 Participants |
| cTIV\TIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Injection site induration | 7 Participants |
| cTIV\TIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Arthralgia | 14 Participants |
| cTIV\TIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Injection site pain | 21 Participants |
| cTIV\TIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Local | 51 Participants |
| cTIV\TIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Headache | 22 Participants |
| cTIV\TIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Injection site erythema | 19 Participants |
| cTIV\TIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Sweat | 11 Participants |
| cTIV\TIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Systemic | 40 Participants |
| cTIV\TIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Analgesic antipyretic medication used | 9 Participants |
| cTIV\TIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Fatigue | 24 Participants |
| TIV\TIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Injection site pain | 46 Participants |
| TIV\TIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Local | 76 Participants |
| TIV\TIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Injection site swelling | 12 Participants |
| TIV\TIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Systemic | 42 Participants |
| TIV\TIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Other | 13 Participants |
| TIV\TIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Injection site ecchymosis | 13 Participants |
| TIV\TIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Analgesic antipyretic medication used | 11 Participants |
| TIV\TIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Headache | 21 Participants |
| TIV\TIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Fever (≥38°C) | 3 Participants |
| TIV\TIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Arthralgia | 9 Participants |
| TIV\TIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Injection site erythema | 40 Participants |
| TIV\TIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Chills | 4 Participants |
| TIV\TIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Sweat | 11 Participants |
| TIV\TIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Fatigue | 23 Participants |
| TIV\TIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Malaise | 20 Participants |
| TIV\TIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Myalgia | 22 Participants |
| TIV\TIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Injection site induration | 20 Participants |
| TIV\TIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Stayed at home due to reaction | 6 Participants |
| TIV\cTIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Sweat | 13 Participants |
| TIV\cTIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Injection site swelling | 9 Participants |
| TIV\cTIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Myalgia | 19 Participants |
| TIV\cTIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Other | 12 Participants |
| TIV\cTIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Injection site pain | 63 Participants |
| TIV\cTIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Local | 84 Participants |
| TIV\cTIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Arthralgia | 11 Participants |
| TIV\cTIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Chills | 8 Participants |
| TIV\cTIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Injection site erythema | 27 Participants |
| TIV\cTIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Injection site induration | 18 Participants |
| TIV\cTIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Fatigue | 23 Participants |
| TIV\cTIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Injection site ecchymosis | 13 Participants |
| TIV\cTIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Fever (≥38°C) | 0 Participants |
| TIV\cTIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Headache | 27 Participants |
| TIV\cTIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Analgesic antipyretic medication used | 10 Participants |
| TIV\cTIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Systemic | 46 Participants |
| TIV\cTIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Malaise | 27 Participants |
| TIV\cTIV (Adults) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Stayed at home due to reaction | 3 Participants |
| TIV\TIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Fatigue | 16 Participants |
| TIV\TIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Chills | 5 Participants |
| TIV\TIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Injection site induration | 10 Participants |
| TIV\TIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Stayed at home due to reaction | 4 Participants |
| TIV\TIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Malaise | 20 Participants |
| TIV\TIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Myalgia | 10 Participants |
| TIV\TIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Arthralgia | 11 Participants |
| TIV\TIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Injection site erythema | 16 Participants |
| TIV\TIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Headache | 15 Participants |
| TIV\TIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Sweat | 7 Participants |
| TIV\TIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Injection site ecchymosis | 18 Participants |
| TIV\TIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Systemic | 37 Participants |
| TIV\TIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Fever (≥38°C) | 2 Participants |
| TIV\TIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Other | 10 Participants |
| TIV\TIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Local | 47 Participants |
| TIV\TIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Analgesic antipyretic medication used | 8 Participants |
| TIV\TIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Injection site pain | 19 Participants |
| TIV\TIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Injection site swelling | 4 Participants |
| TIV\cTIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Stayed at home due to reaction | 5 Participants |
| TIV\cTIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Other | 12 Participants |
| TIV\cTIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Malaise | 29 Participants |
| TIV\cTIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Analgesic antipyretic medication used | 10 Participants |
| TIV\cTIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Injection site induration | 14 Participants |
| TIV\cTIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Injection site swelling | 8 Participants |
| TIV\cTIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Headache | 20 Participants |
| TIV\cTIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Arthralgia | 15 Participants |
| TIV\cTIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Injection site erythema | 24 Participants |
| TIV\cTIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Myalgia | 21 Participants |
| TIV\cTIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Chills | 10 Participants |
| TIV\cTIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Injection site pain | 26 Participants |
| TIV\cTIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Systemic | 47 Participants |
| TIV\cTIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Local | 55 Participants |
| TIV\cTIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Fever (≥38°C) | 0 Participants |
| TIV\cTIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Fatigue | 26 Participants |
| TIV\cTIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Injection site ecchymosis | 11 Participants |
| TIV\cTIV (Elderly) | Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine | Sweat | 16 Participants |
Secondary
Geometric Mean Ratios (GMRs), After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects
Immunogenicity was assessed in terms of GMR in adult and elderly subjects following one 0.5ml dose of either the cTIV vaccine or the TIV vaccine, according to the CHMP criteria. The European licensure (CHMP) criteria was met if the mean geometric increase (GMR, day 22/day 1) in HI antibody titer is \>2.5 for adults and \>2.0 for elderly subjects.
Time frame: Day 22 postvaccination
Population: The analysis was done on the immunogenicity subset.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| cTIV\cTIV (Adults) | Geometric Mean Ratios (GMRs), After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | A/H1N1 strain | 2.14 Ratio |
| cTIV\cTIV (Adults) | Geometric Mean Ratios (GMRs), After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | B strain | 2.61 Ratio |
| cTIV\cTIV (Adults) | Geometric Mean Ratios (GMRs), After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | A/H3N2 strain | 11 Ratio |
| cTIV\TIV (Adults) | Geometric Mean Ratios (GMRs), After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | B strain | 2.7 Ratio |
| cTIV\TIV (Adults) | Geometric Mean Ratios (GMRs), After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | A/H3N2 strain | 6.17 Ratio |
| cTIV\TIV (Adults) | Geometric Mean Ratios (GMRs), After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | A/H1N1 strain | 2.46 Ratio |
| cTIV\cTIV (Elderly) | Geometric Mean Ratios (GMRs), After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | B strain | 2.37 Ratio |
| cTIV\cTIV (Elderly) | Geometric Mean Ratios (GMRs), After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | A/H1N1 strain | 2.2 Ratio |
| cTIV\cTIV (Elderly) | Geometric Mean Ratios (GMRs), After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | A/H3N2 strain | 12 Ratio |
| cTIV\TIV (Elderly) | Geometric Mean Ratios (GMRs), After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | A/H1N1 strain | 2.98 Ratio |
| cTIV\TIV (Elderly) | Geometric Mean Ratios (GMRs), After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | A/H3N2 strain | 7.64 Ratio |
| cTIV\TIV (Elderly) | Geometric Mean Ratios (GMRs), After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | B strain | 2.67 Ratio |
| TIV\TIV (Adults) | Geometric Mean Ratios (GMRs), After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | A/H3N2 strain | 4.09 Ratio |
| TIV\TIV (Adults) | Geometric Mean Ratios (GMRs), After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | A/H1N1 strain | 2.02 Ratio |
| TIV\TIV (Adults) | Geometric Mean Ratios (GMRs), After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | B strain | 1.81 Ratio |
| TIV\cTIV (Adults) | Geometric Mean Ratios (GMRs), After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | A/H3N2 strain | 8.05 Ratio |
| TIV\cTIV (Adults) | Geometric Mean Ratios (GMRs), After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | A/H1N1 strain | 2.91 Ratio |
| TIV\cTIV (Adults) | Geometric Mean Ratios (GMRs), After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | B strain | 2.93 Ratio |
| TIV\TIV (Elderly) | Geometric Mean Ratios (GMRs), After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | A/H3N2 strain | 6.59 Ratio |
| TIV\TIV (Elderly) | Geometric Mean Ratios (GMRs), After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | A/H1N1 strain | 2.54 Ratio |
| TIV\TIV (Elderly) | Geometric Mean Ratios (GMRs), After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | B strain | 2.64 Ratio |
| TIV\cTIV (Elderly) | Geometric Mean Ratios (GMRs), After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | A/H1N1 strain | 3.11 Ratio |
| TIV\cTIV (Elderly) | Geometric Mean Ratios (GMRs), After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | A/H3N2 strain | 12 Ratio |
| TIV\cTIV (Elderly) | Geometric Mean Ratios (GMRs), After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | B strain | 3.19 Ratio |
Secondary
Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects
The haemagglutinin inhibition (HI) antibody titer response following one 0.5 mL dose of either cell derived (cTIV) or egg-derived vaccine (TIV) in adult and elderly subjects is reported as GMTs. The HI GMTs were evaluated using egg-derived antigen assay.
Time frame: Day 22 postvaccination
Population: The analysis was done on the immunogenicity subset.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| cTIV\cTIV (Adults) | Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | A/H3N2 strain (Day 1) | 16 Titers |
| cTIV\cTIV (Adults) | Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | B strain (Day 22) | 77 Titers |
| cTIV\cTIV (Adults) | Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | A/H1N1 strain (Day 1) | 40 Titers |
| cTIV\cTIV (Adults) | Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | A/H1N1 strain (Day 22) | 87 Titers |
| cTIV\cTIV (Adults) | Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | B strain (Day 1) | 30 Titers |
| cTIV\cTIV (Adults) | Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | A/H3N2 strain (Day 22) | 173 Titers |
| cTIV\TIV (Adults) | Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | A/H1N1 strain (Day 1) | 34 Titers |
| cTIV\TIV (Adults) | Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | A/H3N2 strain (Day 22) | 109 Titers |
| cTIV\TIV (Adults) | Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | B strain (Day 1) | 26 Titers |
| cTIV\TIV (Adults) | Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | A/H1N1 strain (Day 22) | 83 Titers |
| cTIV\TIV (Adults) | Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | B strain (Day 22) | 71 Titers |
| cTIV\TIV (Adults) | Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | A/H3N2 strain (Day 1) | 18 Titers |
| cTIV\cTIV (Elderly) | Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | A/H1N1 strain (Day 1) | 26 Titers |
| cTIV\cTIV (Elderly) | Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | A/H3N2 strain (Day 1) | 20 Titers |
| cTIV\cTIV (Elderly) | Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | B strain (Day 1) | 36 Titers |
| cTIV\cTIV (Elderly) | Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | B strain (Day 22) | 84 Titers |
| cTIV\cTIV (Elderly) | Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | A/H3N2 strain (Day 22) | 229 Titers |
| cTIV\cTIV (Elderly) | Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | A/H1N1 strain (Day 22) | 57 Titers |
| cTIV\TIV (Elderly) | Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | B strain (Day 1) | 48 Titers |
| cTIV\TIV (Elderly) | Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | A/H1N1 strain (Day 1) | 20 Titers |
| cTIV\TIV (Elderly) | Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | B strain (Day 22) | 128 Titers |
| cTIV\TIV (Elderly) | Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | A/H1N1 strain (Day 22) | 61 Titers |
| cTIV\TIV (Elderly) | Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | A/H3N2 strain (Day 1) | 26 Titers |
| cTIV\TIV (Elderly) | Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | A/H3N2 strain (Day 22) | 197 Titers |
| TIV\TIV (Adults) | Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | B strain (Day 1) | 37 Titers |
| TIV\TIV (Adults) | Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | A/H1N1 strain (Day 22) | 72 Titers |
| TIV\TIV (Adults) | Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | B strain (Day 22) | 67 Titers |
| TIV\TIV (Adults) | Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | A/H1N1 strain (Day 1) | 35 Titers |
| TIV\TIV (Adults) | Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | A/H3N2 strain (Day 22) | 78 Titers |
| TIV\TIV (Adults) | Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | A/H3N2 strain (Day 1) | 19 Titers |
| TIV\cTIV (Adults) | Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | A/H3N2 strain (Day 22) | 170 Titers |
| TIV\cTIV (Adults) | Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | A/H1N1 strain (Day 1) | 36 Titers |
| TIV\cTIV (Adults) | Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | A/H1N1 strain (Day 22) | 104 Titers |
| TIV\cTIV (Adults) | Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | A/H3N2 strain (Day 1) | 21 Titers |
| TIV\cTIV (Adults) | Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | B strain (Day 1) | 35 Titers |
| TIV\cTIV (Adults) | Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | B strain (Day 22) | 104 Titers |
| TIV\TIV (Elderly) | Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | A/H3N2 strain (Day 22) | 125 Titers |
| TIV\TIV (Elderly) | Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | B strain (Day 22) | 68 Titers |
| TIV\TIV (Elderly) | Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | B strain (Day 1) | 26 Titers |
| TIV\TIV (Elderly) | Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | A/H3N2 strain (Day 1) | 19 Titers |
| TIV\TIV (Elderly) | Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | A/H1N1 strain (Day 22) | 61 Titers |
| TIV\TIV (Elderly) | Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | A/H1N1 strain (Day 1) | 24 Titers |
| TIV\cTIV (Elderly) | Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | A/H3N2 strain (Day 22) | 251 Titers |
| TIV\cTIV (Elderly) | Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | A/H3N2 strain (Day 1) | 20 Titers |
| TIV\cTIV (Elderly) | Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | A/H1N1 strain (Day 1) | 26 Titers |
| TIV\cTIV (Elderly) | Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | B strain (Day 1) | 37 Titers |
| TIV\cTIV (Elderly) | Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | B strain (Day 22) | 116 Titers |
| TIV\cTIV (Elderly) | Geometric Mean Titers (GMTs) After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult and Elderly Subjects | A/H1N1 strain (Day 22) | 80 Titers |
Secondary
Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine.
Immunogenicity was assessed in terms of percentages of adult and elderly subjects achieving HI titers≥40,after one dose of either the cTIV vaccine or the TIV vaccine. European (CHMP) criteria is met if the percentage of subjects achieving HI titers ≥ 40 is \> 70% for adults and \>60% for elderly.
Time frame: Day 22 postvaccination
Population: This analysis was done on immunogenicity subset.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| cTIV\cTIV (Adults) | Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine. | A/H3N2 strain (Day 1) | 25 Percentages of subjects |
| cTIV\cTIV (Adults) | Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine. | B strain (Day 22) | 80 Percentages of subjects |
| cTIV\cTIV (Adults) | Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine. | A/H1N1 strain (Day 1) | 57 Percentages of subjects |
| cTIV\cTIV (Adults) | Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine. | A/H1N1 strain (Day 22) | 85 Percentages of subjects |
| cTIV\cTIV (Adults) | Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine. | B strain (Day 1) | 50 Percentages of subjects |
| cTIV\cTIV (Adults) | Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine. | A/H3N2 strain (Day 22) | 92 Percentages of subjects |
| cTIV\TIV (Adults) | Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine. | A/H1N1 strain (Day 1) | 48 Percentages of subjects |
| cTIV\TIV (Adults) | Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine. | A/H3N2 strain (Day 22) | 95 Percentages of subjects |
| cTIV\TIV (Adults) | Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine. | B strain (Day 1) | 50 Percentages of subjects |
| cTIV\TIV (Adults) | Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine. | A/H1N1 strain (Day 22) | 80 Percentages of subjects |
| cTIV\TIV (Adults) | Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine. | B strain (Day 22) | 90 Percentages of subjects |
| cTIV\TIV (Adults) | Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine. | A/H3N2 strain (Day 1) | 27 Percentages of subjects |
| cTIV\cTIV (Elderly) | Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine. | A/H1N1 strain (Day 1) | 49 Percentages of subjects |
| cTIV\cTIV (Elderly) | Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine. | A/H3N2 strain (Day 1) | 30 Percentages of subjects |
| cTIV\cTIV (Elderly) | Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine. | B strain (Day 1) | 59 Percentages of subjects |
| cTIV\cTIV (Elderly) | Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine. | B strain (Day 22) | 84 Percentages of subjects |
| cTIV\cTIV (Elderly) | Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine. | A/H3N2 strain (Day 22) | 97 Percentages of subjects |
| cTIV\cTIV (Elderly) | Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine. | A/H1N1 strain (Day 22) | 77 Percentages of subjects |
| cTIV\TIV (Elderly) | Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine. | B strain (Day 1) | 61 Percentages of subjects |
| cTIV\TIV (Elderly) | Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine. | A/H1N1 strain (Day 1) | 36 Percentages of subjects |
| cTIV\TIV (Elderly) | Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine. | B strain (Day 22) | 92 Percentages of subjects |
| cTIV\TIV (Elderly) | Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine. | A/H1N1 strain (Day 22) | 74 Percentages of subjects |
| cTIV\TIV (Elderly) | Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine. | A/H3N2 strain (Day 1) | 39 Percentages of subjects |
| cTIV\TIV (Elderly) | Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine. | A/H3N2 strain (Day 22) | 95 Percentages of subjects |
| TIV\TIV (Adults) | Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine. | B strain (Day 1) | 54 Percentages of subjects |
| TIV\TIV (Adults) | Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine. | A/H1N1 strain (Day 22) | 80 Percentages of subjects |
| TIV\TIV (Adults) | Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine. | B strain (Day 22) | 85 Percentages of subjects |
| TIV\TIV (Adults) | Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine. | A/H1N1 strain (Day 1) | 54 Percentages of subjects |
| TIV\TIV (Adults) | Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine. | A/H3N2 strain (Day 22) | 86 Percentages of subjects |
| TIV\TIV (Adults) | Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine. | A/H3N2 strain (Day 1) | 32 Percentages of subjects |
| TIV\cTIV (Adults) | Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine. | A/H3N2 strain (Day 22) | 92 Percentages of subjects |
| TIV\cTIV (Adults) | Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine. | A/H1N1 strain (Day 1) | 57 Percentages of subjects |
| TIV\cTIV (Adults) | Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine. | A/H1N1 strain (Day 22) | 90 Percentages of subjects |
| TIV\cTIV (Adults) | Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine. | A/H3N2 strain (Day 1) | 33 Percentages of subjects |
| TIV\cTIV (Adults) | Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine. | B strain (Day 1) | 58 Percentages of subjects |
| TIV\cTIV (Adults) | Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine. | B strain (Day 22) | 87 Percentages of subjects |
| TIV\TIV (Elderly) | Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine. | A/H3N2 strain (Day 22) | 87 Percentages of subjects |
| TIV\TIV (Elderly) | Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine. | B strain (Day 22) | 84 Percentages of subjects |
| TIV\TIV (Elderly) | Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine. | B strain (Day 1) | 43 Percentages of subjects |
| TIV\TIV (Elderly) | Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine. | A/H3N2 strain (Day 1) | 26 Percentages of subjects |
| TIV\TIV (Elderly) | Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine. | A/H1N1 strain (Day 22) | 69 Percentages of subjects |
| TIV\TIV (Elderly) | Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine. | A/H1N1 strain (Day 1) | 36 Percentages of subjects |
| TIV\cTIV (Elderly) | Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine. | A/H3N2 strain (Day 22) | 92 Percentages of subjects |
| TIV\cTIV (Elderly) | Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine. | A/H3N2 strain (Day 1) | 34 Percentages of subjects |
| TIV\cTIV (Elderly) | Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine. | A/H1N1 strain (Day 1) | 48 Percentages of subjects |
| TIV\cTIV (Elderly) | Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine. | B strain (Day 1) | 62 Percentages of subjects |
| TIV\cTIV (Elderly) | Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine. | B strain (Day 22) | 90 Percentages of subjects |
| TIV\cTIV (Elderly) | Percentages of Adult and Elderly Subjects Achieving HI Titers ≥ 40 After One Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine. | A/H1N1 strain (Day 22) | 82 Percentages of subjects |
Secondary
Percentages of Adult and Elderly Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine.
Immunogenicity was assessed in terms of percentages of adult and elderly subjects showing seroconversion or significant increase in HI antibody titers after one dose of cell culture-derived or the egg-derived influenza vaccine. Seroconversion or significant increase as per European Licensure (CHMP) criteria is defined as percentage of subjects with a prevaccination HI titer \<10 to a postvaccination titer ≥ 40 for adults and ≥ 30 for elderly. Significant increase is defined as percentage of subjects with a prevaccination HI titer ≥ 10 and a ≥ 4-fold increase in postvaccination HI antibody titer.
Time frame: Day 22 postvaccination
Population: This analysis was done on the immunogenicity subset.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| cTIV\cTIV (Adults) | Percentages of Adult and Elderly Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | A/H1N1 strain | 22 Percentages of subjects |
| cTIV\cTIV (Adults) | Percentages of Adult and Elderly Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | B strain | 28 Percentages of subjects |
| cTIV\cTIV (Adults) | Percentages of Adult and Elderly Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | A/H3N2 strain | 82 Percentages of subjects |
| cTIV\TIV (Adults) | Percentages of Adult and Elderly Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | B strain | 33 Percentages of subjects |
| cTIV\TIV (Adults) | Percentages of Adult and Elderly Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | A/H3N2 strain | 85 Percentages of subjects |
| cTIV\TIV (Adults) | Percentages of Adult and Elderly Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | A/H1N1 strain | 32 Percentages of subjects |
| cTIV\cTIV (Elderly) | Percentages of Adult and Elderly Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | B strain | 28 Percentages of subjects |
| cTIV\cTIV (Elderly) | Percentages of Adult and Elderly Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | A/H1N1 strain | 30 Percentages of subjects |
| cTIV\cTIV (Elderly) | Percentages of Adult and Elderly Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | A/H3N2 strain | 84 Percentages of subjects |
| cTIV\TIV (Elderly) | Percentages of Adult and Elderly Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | A/H1N1 strain | 34 Percentages of subjects |
| cTIV\TIV (Elderly) | Percentages of Adult and Elderly Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | A/H3N2 strain | 80 Percentages of subjects |
| cTIV\TIV (Elderly) | Percentages of Adult and Elderly Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | B strain | 34 Percentages of subjects |
| TIV\TIV (Adults) | Percentages of Adult and Elderly Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | A/H3N2 strain | 61 Percentages of subjects |
| TIV\TIV (Adults) | Percentages of Adult and Elderly Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | A/H1N1 strain | 24 Percentages of subjects |
| TIV\TIV (Adults) | Percentages of Adult and Elderly Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | B strain | 27 Percentages of subjects |
| TIV\cTIV (Adults) | Percentages of Adult and Elderly Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | A/H3N2 strain | 80 Percentages of subjects |
| TIV\cTIV (Adults) | Percentages of Adult and Elderly Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | A/H1N1 strain | 30 Percentages of subjects |
| TIV\cTIV (Adults) | Percentages of Adult and Elderly Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | B strain | 40 Percentages of subjects |
| TIV\TIV (Elderly) | Percentages of Adult and Elderly Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | A/H3N2 strain | 77 Percentages of subjects |
| TIV\TIV (Elderly) | Percentages of Adult and Elderly Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | A/H1N1 strain | 30 Percentages of subjects |
| TIV\TIV (Elderly) | Percentages of Adult and Elderly Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | B strain | 31 Percentages of subjects |
| TIV\cTIV (Elderly) | Percentages of Adult and Elderly Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | A/H1N1 strain | 43 Percentages of subjects |
| TIV\cTIV (Elderly) | Percentages of Adult and Elderly Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | A/H3N2 strain | 82 Percentages of subjects |
| TIV\cTIV (Elderly) | Percentages of Adult and Elderly Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine. | B strain | 41 Percentages of subjects |
Secondary
Six-months Safety Data of Subjects After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine
To collect additional safety data for 6 months after vaccination with one dose of cell culture derived or egg-derived influenza vaccine in terms of serious adverse events (SAEs), adverse events (AEs) necessitating a physician's visit and/or resulting in premature subject's withdrawal from study.
Time frame: Up to 6 months postvaccination
Population: This analysis was done on the safety dataset.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| cTIV\cTIV (Adults) | Six-months Safety Data of Subjects After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine | Any AE | 50 Participants |
| cTIV\cTIV (Adults) | Six-months Safety Data of Subjects After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine | Any death | 1 Participants |
| cTIV\cTIV (Adults) | Six-months Safety Data of Subjects After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine | At least possibly related SAE | 0 Participants |
| cTIV\cTIV (Adults) | Six-months Safety Data of Subjects After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine | Any SAE | 5 Participants |
| cTIV\cTIV (Adults) | Six-months Safety Data of Subjects After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine | At least possibly related AE | 2 Participants |
| cTIV\TIV (Adults) | Six-months Safety Data of Subjects After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine | At least possibly related AE | 4 Participants |
| cTIV\TIV (Adults) | Six-months Safety Data of Subjects After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine | At least possibly related SAE | 0 Participants |
| cTIV\TIV (Adults) | Six-months Safety Data of Subjects After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine | Any death | 0 Participants |
| cTIV\TIV (Adults) | Six-months Safety Data of Subjects After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine | Any SAE | 4 Participants |
| cTIV\TIV (Adults) | Six-months Safety Data of Subjects After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine | Any AE | 38 Participants |
| cTIV\cTIV (Elderly) | Six-months Safety Data of Subjects After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine | At least possibly related AE | 2 Participants |
| cTIV\cTIV (Elderly) | Six-months Safety Data of Subjects After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine | Any death | 0 Participants |
| cTIV\cTIV (Elderly) | Six-months Safety Data of Subjects After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine | Any AE | 70 Participants |
| cTIV\cTIV (Elderly) | Six-months Safety Data of Subjects After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine | At least possibly related SAE | 0 Participants |
| cTIV\cTIV (Elderly) | Six-months Safety Data of Subjects After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine | Any SAE | 13 Participants |
| cTIV\TIV (Elderly) | Six-months Safety Data of Subjects After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine | Any SAE | 13 Participants |
| cTIV\TIV (Elderly) | Six-months Safety Data of Subjects After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine | Any death | 1 Participants |
| cTIV\TIV (Elderly) | Six-months Safety Data of Subjects After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine | Any AE | 58 Participants |
| cTIV\TIV (Elderly) | Six-months Safety Data of Subjects After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine | At least possibly related AE | 5 Participants |
| cTIV\TIV (Elderly) | Six-months Safety Data of Subjects After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine | At least possibly related SAE | 0 Participants |
| TIV\TIV (Adults) | Six-months Safety Data of Subjects After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine | Any SAE | 0 Participants |
| TIV\TIV (Adults) | Six-months Safety Data of Subjects After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine | Any AE | 35 Participants |
| TIV\TIV (Adults) | Six-months Safety Data of Subjects After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine | At least possibly related AE | 2 Participants |
| TIV\TIV (Adults) | Six-months Safety Data of Subjects After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine | At least possibly related SAE | 0 Participants |
| TIV\TIV (Adults) | Six-months Safety Data of Subjects After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine | Any death | 0 Participants |
| TIV\cTIV (Adults) | Six-months Safety Data of Subjects After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine | Any SAE | 4 Participants |
| TIV\cTIV (Adults) | Six-months Safety Data of Subjects After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine | At least possibly related SAE | 0 Participants |
| TIV\cTIV (Adults) | Six-months Safety Data of Subjects After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine | At least possibly related AE | 4 Participants |
| TIV\cTIV (Adults) | Six-months Safety Data of Subjects After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine | Any AE | 44 Participants |
| TIV\cTIV (Adults) | Six-months Safety Data of Subjects After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine | Any death | 0 Participants |
| TIV\TIV (Elderly) | Six-months Safety Data of Subjects After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine | Any SAE | 17 Participants |
| TIV\TIV (Elderly) | Six-months Safety Data of Subjects After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine | Any AE | 67 Participants |
| TIV\TIV (Elderly) | Six-months Safety Data of Subjects After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine | At least possibly related AE | 2 Participants |
| TIV\TIV (Elderly) | Six-months Safety Data of Subjects After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine | Any death | 1 Participants |
| TIV\TIV (Elderly) | Six-months Safety Data of Subjects After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine | At least possibly related SAE | 0 Participants |
| TIV\cTIV (Elderly) | Six-months Safety Data of Subjects After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine | Any death | 2 Participants |
| TIV\cTIV (Elderly) | Six-months Safety Data of Subjects After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine | At least possibly related SAE | 0 Participants |
| TIV\cTIV (Elderly) | Six-months Safety Data of Subjects After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine | Any AE | 76 Participants |
| TIV\cTIV (Elderly) | Six-months Safety Data of Subjects After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine | Any SAE | 10 Participants |
| TIV\cTIV (Elderly) | Six-months Safety Data of Subjects After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine | At least possibly related AE | 5 Participants |