Influenza
Conditions
Brief summary
The study primarily aims to evaluate immunogenicity and safety of influenza vaccines (cell culture derived seasonal trivalent influenza vaccine (cTIV) or influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV\_a)) when administered alone and when administered concomitantly with pneumococcal polysaccharide vaccine (PV) in elderly subjects. The study also aimed to evaluate safety and immunogenicity (subset) of annual vaccination with either cTIV or eTIV\_a in adults and elderly subjects.
Interventions
BIOLOGICALCell culture derived seasonal trivalent influenza vaccine (cTIV)
cell cultured trivalent influenza vaccine (cTIV) vaccine administered as 0.5 mL single dose in the deltoid muscle, preferably of the non-dominant arm.
BIOLOGICALInfluenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a).
egg based trivalent influenza vaccine (eTIV\_a) administered as 0.5 mL single dose in the deltoid muscle, preferably of the non-dominant arm.
BIOLOGICALcTIV or eTIV_a
0.5 mL, Single dose of either cell cultured trivalent influenza vaccine (cTIV) or egg based trivalent influenza vaccine eTIV\_a administered.
BIOLOGICALcTIV+PV OR eTIV_a+PV
0.5 mL, Single dose of either cell culture derived seasonal trivalent influenza vaccine (cTIV) or influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV\_a) administered concomitantly with 23-valent pneumococcal polysaccharide vaccine (PV).
Sponsors
Novartis Vaccines
Novartis
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
* participation in the V58P4 study * mentally competent to understand the nature, the scope and the consequences of the study * able and willing to give written informed consent prior to study entry * available for all the visits scheduled in the study
Exclusion criteria
* receipt of another investigational agent within 90 days prior to, or before completion of the safety follow-up period in another study, whichever is longer, prior to Visit 7 and unwilling to refuse participation in another clinical study through the end of the present study * history of any anaphylaxis, serious vaccine reactions, or allergy to any of the vaccine components * any acute respiratory disease or infections requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis was acceptable) or experienced fever (i.e., axillary temperature ≥ 38°C) within the 5 days prior to Visit 7 * pregnant/breast feeding women, or women of childbearing potential who refuse to use a reliable contraceptive method during the three weeks after vaccination
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Randomized Participants Reporting Local and Systemic Reactions. | One week postvaccination | Safety and tolerability evaluation of influenza vaccines, within one week of single intramuscular injection. Local reactions reported for Influenza Vaccine Injection site. |
| Immunogenicity Assessment by Geometric Mean Titers (GMT). | Three weeks postvaccination | Non-inferiority of the influenza vaccine FLU (cell-culture derived seasonal trivalent influenza vaccine (cTIV); and influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV\_a)) when administered alone versus administered concomitantly with pneumococcal vaccine (FLU + PV) is met if lower limit of the 2-sided 95% confidence interval (CI) of postvaccination (Day 22) Geometric Mean Titer ratio (FLU+PV/FLU) is greater than 0.5. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Unrandomized Participants Reporting Local and Systemic Reactions. | One week postvaccination | Safety and tolerability evaluation of influenza vaccines, within one week of single intramuscular injection. |
| Number of Randomized Participants Reporting Local and Systemic Reactions. | One week postvaccination | Safety and tolerability evaluation, within one week of single intramuscular injection of influenza vaccines (cell-culture derived seasonal trivalent influenza vaccine (cTIV) or influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV\_a) when administered alone or concomitantly with a pneumococcal vaccine (PV)). Local reactions reported for Influenza Vaccine Injection Site. |
| Number of Subjects With Antibody Response as Assessed by Hemagglutination Inhibition Assay. | Three weeks postvaccination | Immunogenicity (seroconversion or significant increase in antibody titer and HI titer ≥1:40) of cell cultured and egg based trivalent influenza vaccine three weeks after a single injection, by the measurement of strain-specific hemagglutination inhibition (HI) tests according to the Committee for Medicinal Products for Human Use (CHMP) criteria (CPMP/BWP/214/96). Seroconversion was defined as negative pre-vaccination titer (\<10)/postvaccination titer ≥40. Significant increase in antibody titer was defined as at least a fourfold increase from non-negative baseline (≥10). |
| Geometric Mean Ratio (GMR Day 22/Day1) After Single Dose of Influenza Vaccine. | Three weeks postvaccination | Immunogenicity (geometric mean titer ratio) of cell cultured and egg based trivalent influenza vaccine three weeks after a single injection, by the measurement of strain-specific hemagglutination inhibition (HI) tests according to the CHMP criteria (CPMP/BWP/214/96). CHMP Criteria fulfilled if the Geometric Mean titer Ratio (GMR) is \> 2.5. |
Countries
Poland
Participant flow
Recruitment details
Study was conducted during the period of October 2007 to June 2008 at five sites in Poland.
Pre-assignment details
All subjects enrolled were included in the trial. The data entered is for overall study.
Participants by arm
| Arm | Count |
|---|---|
| cTIV (Adults) Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in the parent (V58P4 \[NCT00492063\]) and the extension 1 (V58P4E1 \[NCT00306527\]) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine \[cTIV\] were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm). | 549 |
| eTIV_a (Adults) Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in parent (V58P4 \[NCT00492063\]) and Extension 1 (V58P4E1 \[NCT00306527\]) studies with influenza virus vaccine\[egg-derived seasonal trivalent, thiomersal free; eTIV\_a\] were allocated to receive eTIV\_a in the deltoid muscle, preferably of the non-dominant arm). | 169 |
| cTIV (Elderly) Revaccination unrandomized group (elderly subjects (\>= 61 years of age) who were pre-vaccinated in parent (V58P4 \[NCT00492063\]) and Extension 1 (V58P4E1 \[NCT00306527\]) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine \[cTIV\] were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm). | 391 |
| eTIV_a (Elderly) Revaccination unrandomized group (elderly subjects (\>= 61 years of age) who were pre-vaccinated in parent (V58P4 \[NCT00492063\]) and Extension 1 (V58P4E1 \[NCT00306527\]) study with influenza virus vaccine \[egg-derived seasonal trivalent, thiomersal free; eTIV\_a\] were allocated to receive eTIV\_a in the deltoid muscle, preferably of the non-dominant arm). | 144 |
| cTIV (Elderly; FLU Vaccination) Revaccination randomized group (elderly subjects (\>= 65 years of age) were revaccinated with cell-culture derived seasonal trivalent influenza vaccine \[cTIV\]; in the deltoid muscle, preferably of the non-dominant arm) irrespective of influenza vaccination received in parent (V58P4 \[NCT00492063\]) study or extension 1 (V58P4E1 \[NCT00306527\]) study. | 90 |
| cTIV+PV (Elderly; Concomitant Vaccination ) Revaccination randomized group (elderly subjects (\>= 65 years of age) were concomitantly revaccinated with cell-culture derived seasonal trivalent influenza vaccine \[cTIV; in the deltoid muscle, preferably of the non-dominant arm\] and pneumococcal vaccine \[PV; in opposite arm\] irrespective of influenza vaccination received in parent (V58P4 \[NCT00492063\]) study or extension 1 (V58P4E1 \[NCT00306527\]) study). | 78 |
| eTIV_a (Elderly; FLU Vaccination) Revaccination randomized group (elderly subjects (\>= 65 years of age) were revaccinated with influenza virus vaccine \[egg-derived seasonal trivalent, thiomersal free; eTIV\_a\] in the deltoid muscle, preferably of the non-dominant arm irrespective of influenza vaccination received in parent (V58P4 \[NCT00492063\]) study or extension 1 (V58P4E1 \[NCT00306527\]) study). | 57 |
| eTIV_a +PV (Elderly; Concomitant Vaccination) Revaccination randomized group (elderly subjects (\>= 65 years of age) were concomitantly revaccinated with influenza virus vaccine \[egg-derived seasonal trivalent, thiomersal free; eTIV\_a in the deltoid muscle, preferably of the non-dominant arm\] and pneumococcal vaccine \[PV; in opposite arm\] irrespective of influenza vaccination received in parent (V58P4 \[NCT00492063\]) study or extension 1 (V58P4E1 \[NCT00306527\]) study). | 44 |
| Total | 1,522 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Death | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Protocol Violation | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | cTIV (Adults) | eTIV_a (Adults) | cTIV (Elderly) | eTIV_a (Elderly) | cTIV (Elderly; FLU Vaccination) | cTIV+PV (Elderly; Concomitant Vaccination ) | eTIV_a (Elderly; FLU Vaccination) | eTIV_a +PV (Elderly; Concomitant Vaccination) | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous Randomized elderly | NA years | NA years | NA years | NA years | 71.6 years STANDARD_DEVIATION 5.9 | 71.5 years STANDARD_DEVIATION 5.5 | 71.2 years STANDARD_DEVIATION 4.9 | 71.1 years STANDARD_DEVIATION 5.2 | 71.4 years STANDARD_DEVIATION 5.5 |
| Age, Continuous Unrandomized adults | 44 years STANDARD_DEVIATION 12.3 | 43.3 years STANDARD_DEVIATION 12.4 | NA years | NA years | NA years | NA years | NA years | NA years | 43.9 years STANDARD_DEVIATION 12.3 |
| Age, Continuous Unrandomized elderly | NA years | NA years | 71.5 years STANDARD_DEVIATION 5.5 | 72.4 years STANDARD_DEVIATION 5.7 | NA years | NA years | NA years | NA years | 71.7 years STANDARD_DEVIATION 5.6 |
| Gender Female | 318 Participants | 102 Participants | 232 Participants | 90 Participants | 46 Participants | 40 Participants | 38 Participants | 25 Participants | 891 Participants |
| Gender Male | 231 Participants | 67 Participants | 159 Participants | 54 Participants | 44 Participants | 38 Participants | 19 Participants | 19 Participants | 631 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 219 / 550 | 73 / 168 | 119 / 391 | 40 / 144 | 25 / 83 | 48 / 84 | 23 / 52 | 21 / 50 |
| serious Total, serious adverse events | 17 / 550 | 5 / 168 | 23 / 391 | 6 / 144 | 3 / 83 | 5 / 84 | 1 / 52 | 6 / 50 |
Outcome results
Primary
Immunogenicity Assessment by Geometric Mean Titers (GMT).
Non-inferiority of the influenza vaccine FLU (cell-culture derived seasonal trivalent influenza vaccine (cTIV); and influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV\_a)) when administered alone versus administered concomitantly with pneumococcal vaccine (FLU + PV) is met if lower limit of the 2-sided 95% confidence interval (CI) of postvaccination (Day 22) Geometric Mean Titer ratio (FLU+PV/FLU) is greater than 0.5.
Time frame: Three weeks postvaccination
Population: Per protocol set: this population consisted of all subjects in the Intention To Treat population (ITT) who had no major protocol violation as defined prior to analysis (ITT=enrolled subjects who received single dose of influenza vaccine(or 2 vaccines if receiving the pneumococcal vaccine) and provided one serum sample before and one after baseline)
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| cTIV (Adults) | Immunogenicity Assessment by Geometric Mean Titers (GMT). | GMT Day 22 (H1N1) | 138 Titers |
| cTIV (Adults) | Immunogenicity Assessment by Geometric Mean Titers (GMT). | GMT Day 22 (H3N2) | 184 Titers |
| cTIV (Adults) | Immunogenicity Assessment by Geometric Mean Titers (GMT). | GMT Day 22 (B) | 36 Titers |
| eTIV_a (Adults) | Immunogenicity Assessment by Geometric Mean Titers (GMT). | GMT Day 22 (H1N1) | 198 Titers |
| eTIV_a (Adults) | Immunogenicity Assessment by Geometric Mean Titers (GMT). | GMT Day 22 (H3N2) | 228 Titers |
| eTIV_a (Adults) | Immunogenicity Assessment by Geometric Mean Titers (GMT). | GMT Day 22 (B) | 52 Titers |
Comparison: The non-inferiority null hypothesis stated that the FLU+PV vaccine group was non-inferior to the FLU alone group if the lower limit of the 95% CI of the ratio of GMTs between vaccines (FLU+PV/FLU alone) on day 22 was greater than 0.5 for all three vaccine strains.95% CI: [0.45, 0.98]
Comparison: The non-inferiority null hypothesis stated that the FLU+PV vaccine group was non-inferior to the FLU alone group if the lower limit of the 95% CI of the ratio of GMTs between vaccines (FLU+PV/FLU alone) on day 22 was greater than 0.5 for all three vaccine strains.95% CI: [0.55, 1.19]
Comparison: The non-inferiority null hypothesis stated that the FLU+PV vaccine group was non-inferior to the FLU alone group if the lower limit of the 95% CI of the ratio of GMTs between vaccines (FLU+PV/FLU alone) on day 22 was greater than 0.5 for all three vaccine strains.95% CI: [0.46, 1.02]
Primary
Number of Randomized Participants Reporting Local and Systemic Reactions.
Safety and tolerability evaluation of influenza vaccines, within one week of single intramuscular injection. Local reactions reported for Influenza Vaccine Injection site.
Time frame: One week postvaccination
Population: Safety set: this population consisted of all subjects who were vaccinated and who had some post-baseline safety data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| cTIV (Adults) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Swelling | 9 Subjects |
| cTIV (Adults) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Fatigue | 16 Subjects |
| cTIV (Adults) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Malaise | 20 Subjects |
| cTIV (Adults) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Fever (≥ 38°C) | 0 Subjects |
| cTIV (Adults) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Systemic Reaction | 32 Subjects |
| cTIV (Adults) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Analgesic and Antipyretics used | 11 Subjects |
| cTIV (Adults) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Myalgia | 14 Subjects |
| cTIV (Adults) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Stayed at Home Due to Vaccination Reaction | 2 Subjects |
| cTIV (Adults) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Arthralgia | 17 Subjects |
| cTIV (Adults) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Ecchymosis | 6 Subjects |
| cTIV (Adults) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Erythema | 24 Subjects |
| cTIV (Adults) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Headache | 15 Subjects |
| cTIV (Adults) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Induration | 15 Subjects |
| cTIV (Adults) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Chills | 5 Subjects |
| cTIV (Adults) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Sweating | 9 Subjects |
| cTIV (Adults) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Pain | 34 Subjects |
| cTIV (Adults) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Local Reactions | 52 Subjects |
| eTIV_a (Adults) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Myalgia | 3 Subjects |
| eTIV_a (Adults) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Swelling | 7 Subjects |
| eTIV_a (Adults) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Pain | 16 Subjects |
| eTIV_a (Adults) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Systemic Reaction | 16 Subjects |
| eTIV_a (Adults) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Chills | 6 Subjects |
| eTIV_a (Adults) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Malaise | 8 Subjects |
| eTIV_a (Adults) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Arthralgia | 6 Subjects |
| eTIV_a (Adults) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Headache | 6 Subjects |
| eTIV_a (Adults) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Sweating | 4 Subjects |
| eTIV_a (Adults) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Fatigue | 1 Subjects |
| eTIV_a (Adults) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Fever (≥ 38°C) | 0 Subjects |
| eTIV_a (Adults) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Analgesic and Antipyretics used | 5 Subjects |
| eTIV_a (Adults) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Stayed at Home Due to Vaccination Reaction | 0 Subjects |
| eTIV_a (Adults) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Local Reactions | 37 Subjects |
| eTIV_a (Adults) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Erythema | 19 Subjects |
| eTIV_a (Adults) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Induration | 8 Subjects |
| eTIV_a (Adults) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Ecchymosis | 9 Subjects |
Secondary
Geometric Mean Ratio (GMR Day 22/Day1) After Single Dose of Influenza Vaccine.
Immunogenicity (geometric mean titer ratio) of cell cultured and egg based trivalent influenza vaccine three weeks after a single injection, by the measurement of strain-specific hemagglutination inhibition (HI) tests according to the CHMP criteria (CPMP/BWP/214/96). CHMP Criteria fulfilled if the Geometric Mean titer Ratio (GMR) is \> 2.5.
Time frame: Three weeks postvaccination
Population: Per Protocol
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| cTIV (Adults) | Geometric Mean Ratio (GMR Day 22/Day1) After Single Dose of Influenza Vaccine. | GMR (H1N1; A/Solomon Islands/3/2006) | 5.6 Ratio |
| cTIV (Adults) | Geometric Mean Ratio (GMR Day 22/Day1) After Single Dose of Influenza Vaccine. | GMR (B; B/Malaysia/2506/2004) | 4.48 Ratio |
| cTIV (Adults) | Geometric Mean Ratio (GMR Day 22/Day1) After Single Dose of Influenza Vaccine. | GMR (H3N2; A/Wisconsin/67/2005) | 3.63 Ratio |
| eTIV_a (Adults) | Geometric Mean Ratio (GMR Day 22/Day1) After Single Dose of Influenza Vaccine. | GMR (H3N2; A/Wisconsin/67/2005) | 2.33 Ratio |
| eTIV_a (Adults) | Geometric Mean Ratio (GMR Day 22/Day1) After Single Dose of Influenza Vaccine. | GMR (B; B/Malaysia/2506/2004) | 2.33 Ratio |
| eTIV_a (Adults) | Geometric Mean Ratio (GMR Day 22/Day1) After Single Dose of Influenza Vaccine. | GMR (H1N1; A/Solomon Islands/3/2006) | 4.38 Ratio |
| cTIV (Elderly) | Geometric Mean Ratio (GMR Day 22/Day1) After Single Dose of Influenza Vaccine. | GMR (H1N1; A/Solomon Islands/3/2006) | 7.75 Ratio |
| cTIV (Elderly) | Geometric Mean Ratio (GMR Day 22/Day1) After Single Dose of Influenza Vaccine. | GMR (H3N2; A/Wisconsin/67/2005) | 2.65 Ratio |
| cTIV (Elderly) | Geometric Mean Ratio (GMR Day 22/Day1) After Single Dose of Influenza Vaccine. | GMR (B; B/Malaysia/2506/2004) | 2.51 Ratio |
| eTIV_a (Elderly) | Geometric Mean Ratio (GMR Day 22/Day1) After Single Dose of Influenza Vaccine. | GMR (B; B/Malaysia/2506/2004) | 2.97 Ratio |
| eTIV_a (Elderly) | Geometric Mean Ratio (GMR Day 22/Day1) After Single Dose of Influenza Vaccine. | GMR (H3N2; A/Wisconsin/67/2005) | 2.89 Ratio |
| eTIV_a (Elderly) | Geometric Mean Ratio (GMR Day 22/Day1) After Single Dose of Influenza Vaccine. | GMR (H1N1; A/Solomon Islands/3/2006) | 5.92 Ratio |
Secondary
Number of Randomized Participants Reporting Local and Systemic Reactions.
Safety and tolerability evaluation, within one week of single intramuscular injection of influenza vaccines (cell-culture derived seasonal trivalent influenza vaccine (cTIV) or influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV\_a) when administered alone or concomitantly with a pneumococcal vaccine (PV)). Local reactions reported for Influenza Vaccine Injection Site.
Time frame: One week postvaccination
Population: Safety Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| cTIV (Adults) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Chills | 6 Subjects |
| cTIV (Adults) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Systemic Reaction | 29 Subjects |
| cTIV (Adults) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Swelling | 6 Subjects |
| cTIV (Adults) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Sweating | 6 Subjects |
| cTIV (Adults) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Headache | 12 Subjects |
| cTIV (Adults) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Myalgia | 8 Subjects |
| cTIV (Adults) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Pain | 31 Subjects |
| cTIV (Adults) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Ecchymosis | 7 Subjects |
| cTIV (Adults) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Induration | 9 Subjects |
| cTIV (Adults) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Stayed at Home Due to Vaccination Reaction | 2 Subjects |
| cTIV (Adults) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Analgesic and Antipyretics used | 8 Subjects |
| cTIV (Adults) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Local Reactions | 49 Subjects |
| cTIV (Adults) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Erythema | 20 Subjects |
| cTIV (Adults) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Fever (≥ 38°C) | 0 Subjects |
| cTIV (Adults) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Fatigue | 10 Subjects |
| cTIV (Adults) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Arthralgia | 14 Subjects |
| cTIV (Adults) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Malaise | 19 Subjects |
| eTIV_a (Adults) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Fever (≥ 38°C) | 0 Subjects |
| eTIV_a (Adults) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Local Reactions | 40 Subjects |
| eTIV_a (Adults) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Ecchymosis | 8 Subjects |
| eTIV_a (Adults) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Swelling | 10 Subjects |
| eTIV_a (Adults) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Systemic Reaction | 19 Subjects |
| eTIV_a (Adults) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Chills | 5 Subjects |
| eTIV_a (Adults) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Malaise | 9 Subjects |
| eTIV_a (Adults) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Myalgia | 9 Subjects |
| eTIV_a (Adults) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Arthralgia | 9 Subjects |
| eTIV_a (Adults) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Sweating | 7 Subjects |
| eTIV_a (Adults) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Fatigue | 7 Subjects |
| eTIV_a (Adults) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Analgesic and Antipyretics used | 8 Subjects |
| eTIV_a (Adults) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Stayed at Home Due to Vaccination Reaction | 0 Subjects |
| eTIV_a (Adults) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Erythema | 23 Subjects |
| eTIV_a (Adults) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Induration | 14 Subjects |
| eTIV_a (Adults) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Pain | 19 Subjects |
| eTIV_a (Adults) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Headache | 9 Subjects |
| cTIV (Elderly) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Malaise | 6 Subjects |
| cTIV (Elderly) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Sweating | 4 Subjects |
| cTIV (Elderly) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Stayed at Home Due to Vaccination Reaction | 0 Subjects |
| cTIV (Elderly) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Myalgia | 6 Subjects |
| cTIV (Elderly) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Local Reactions | 20 Subjects |
| cTIV (Elderly) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Induration | 9 Subjects |
| cTIV (Elderly) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Ecchymosis | 3 Subjects |
| cTIV (Elderly) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Fatigue | 6 Subjects |
| cTIV (Elderly) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Arthralgia | 6 Subjects |
| cTIV (Elderly) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Analgesic and Antipyretics used | 5 Subjects |
| cTIV (Elderly) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Swelling | 6 Subjects |
| cTIV (Elderly) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Erythema | 12 Subjects |
| cTIV (Elderly) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Pain | 11 Subjects |
| cTIV (Elderly) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Fever (≥ 38°C) | 0 Subjects |
| cTIV (Elderly) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Chills | 2 Subjects |
| cTIV (Elderly) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Headache | 4 Subjects |
| cTIV (Elderly) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Systemic Reaction | 10 Subjects |
| eTIV_a (Elderly) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Swelling | 3 Subjects |
| eTIV_a (Elderly) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Analgesic and Antipyretics used | 6 Subjects |
| eTIV_a (Elderly) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Ecchymosis | 3 Subjects |
| eTIV_a (Elderly) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Stayed at Home Due to Vaccination Reaction | 2 Subjects |
| eTIV_a (Elderly) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Headache | 11 Subjects |
| eTIV_a (Elderly) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Induration | 6 Subjects |
| eTIV_a (Elderly) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Arthralgia | 11 Subjects |
| eTIV_a (Elderly) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Malaise | 14 Subjects |
| eTIV_a (Elderly) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Sweating | 5 Subjects |
| eTIV_a (Elderly) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Pain | 23 Subjects |
| eTIV_a (Elderly) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Erythema | 12 Subjects |
| eTIV_a (Elderly) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Local Reactions | 32 Subjects |
| eTIV_a (Elderly) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Fatigue | 10 Subjects |
| eTIV_a (Elderly) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Myalgia | 8 Subjects |
| eTIV_a (Elderly) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Fever (≥ 38°C) | 0 Subjects |
| eTIV_a (Elderly) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Chills | 3 Subjects |
| eTIV_a (Elderly) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Systemic Reaction | 22 Subjects |
| eTIV_a (Elderly; FLU Vaccination) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Myalgia | 3 Subjects |
| eTIV_a (Elderly; FLU Vaccination) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Chills | 3 Subjects |
| eTIV_a (Elderly; FLU Vaccination) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Malaise | 3 Subjects |
| eTIV_a (Elderly; FLU Vaccination) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Local Reactions | 20 Subjects |
| eTIV_a (Elderly; FLU Vaccination) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Arthralgia | 3 Subjects |
| eTIV_a (Elderly; FLU Vaccination) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Headache | 5 Subjects |
| eTIV_a (Elderly; FLU Vaccination) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Sweating | 3 Subjects |
| eTIV_a (Elderly; FLU Vaccination) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Fatigue | 1 Subjects |
| eTIV_a (Elderly; FLU Vaccination) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Fever (≥ 38°C) | 0 Subjects |
| eTIV_a (Elderly; FLU Vaccination) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Ecchymosis | 5 Subjects |
| eTIV_a (Elderly; FLU Vaccination) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Analgesic and Antipyretics used | 3 Subjects |
| eTIV_a (Elderly; FLU Vaccination) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Erythema | 11 Subjects |
| eTIV_a (Elderly; FLU Vaccination) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Swelling | 4 Subjects |
| eTIV_a (Elderly; FLU Vaccination) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Stayed at Home Due to Vaccination Reaction | 0 Subjects |
| eTIV_a (Elderly; FLU Vaccination) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Pain | 8 Subjects |
| eTIV_a (Elderly; FLU Vaccination) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Systemic Reaction | 9 Subjects |
| eTIV_a (Elderly; FLU Vaccination) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Induration | 5 Subjects |
| eTIV_a+PV (Elderly; Concomitant Vaccination) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Swelling | 3 Subjects |
| eTIV_a+PV (Elderly; Concomitant Vaccination) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Local Reactions | 17 Subjects |
| eTIV_a+PV (Elderly; Concomitant Vaccination) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Systemic Reaction | 7 Subjects |
| eTIV_a+PV (Elderly; Concomitant Vaccination) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Ecchymosis | 4 Subjects |
| eTIV_a+PV (Elderly; Concomitant Vaccination) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Fatigue | 0 Subjects |
| eTIV_a+PV (Elderly; Concomitant Vaccination) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Sweating | 1 Subjects |
| eTIV_a+PV (Elderly; Concomitant Vaccination) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Chills | 3 Subjects |
| eTIV_a+PV (Elderly; Concomitant Vaccination) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Pain | 8 Subjects |
| eTIV_a+PV (Elderly; Concomitant Vaccination) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Induration | 3 Subjects |
| eTIV_a+PV (Elderly; Concomitant Vaccination) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Arthralgia | 3 Subjects |
| eTIV_a+PV (Elderly; Concomitant Vaccination) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Headache | 1 Subjects |
| eTIV_a+PV (Elderly; Concomitant Vaccination) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Myalgia | 0 Subjects |
| eTIV_a+PV (Elderly; Concomitant Vaccination) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Erythema | 8 Subjects |
| eTIV_a+PV (Elderly; Concomitant Vaccination) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Analgesic and Antipyretics used | 2 Subjects |
| eTIV_a+PV (Elderly; Concomitant Vaccination) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Stayed at Home Due to Vaccination Reaction | 0 Subjects |
| eTIV_a+PV (Elderly; Concomitant Vaccination) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Fever (≥ 38°C) | 0 Subjects |
| eTIV_a+PV (Elderly; Concomitant Vaccination) | Number of Randomized Participants Reporting Local and Systemic Reactions. | Malaise | 5 Subjects |
Secondary
Number of Subjects With Antibody Response as Assessed by Hemagglutination Inhibition Assay.
Immunogenicity (seroconversion or significant increase in antibody titer and HI titer ≥1:40) of cell cultured and egg based trivalent influenza vaccine three weeks after a single injection, by the measurement of strain-specific hemagglutination inhibition (HI) tests according to the Committee for Medicinal Products for Human Use (CHMP) criteria (CPMP/BWP/214/96). Seroconversion was defined as negative pre-vaccination titer (\<10)/postvaccination titer ≥40. Significant increase in antibody titer was defined as at least a fourfold increase from non-negative baseline (≥10).
Time frame: Three weeks postvaccination
Population: Per Protocol Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| cTIV (Adults) | Number of Subjects With Antibody Response as Assessed by Hemagglutination Inhibition Assay. | HI titer ≥1:40 (H1N1) | 94 Subjects |
| cTIV (Adults) | Number of Subjects With Antibody Response as Assessed by Hemagglutination Inhibition Assay. | HI titer ≥1:40 (H3N2) | 92 Subjects |
| cTIV (Adults) | Number of Subjects With Antibody Response as Assessed by Hemagglutination Inhibition Assay. | HI titer ≥1:40 (B) | 57 Subjects |
| cTIV (Adults) | Number of Subjects With Antibody Response as Assessed by Hemagglutination Inhibition Assay. | seroconversion (H3N2) | 40 Subjects |
| cTIV (Adults) | Number of Subjects With Antibody Response as Assessed by Hemagglutination Inhibition Assay. | seroconversion (H1N1) | 57 Subjects |
| cTIV (Adults) | Number of Subjects With Antibody Response as Assessed by Hemagglutination Inhibition Assay. | seroconversion (B) | 39 Subjects |
| eTIV_a (Adults) | Number of Subjects With Antibody Response as Assessed by Hemagglutination Inhibition Assay. | seroconversion (H3N2) | 8 Subjects |
| eTIV_a (Adults) | Number of Subjects With Antibody Response as Assessed by Hemagglutination Inhibition Assay. | HI titer ≥1:40 (H1N1) | 23 Subjects |
| eTIV_a (Adults) | Number of Subjects With Antibody Response as Assessed by Hemagglutination Inhibition Assay. | seroconversion (H1N1) | 13 Subjects |
| eTIV_a (Adults) | Number of Subjects With Antibody Response as Assessed by Hemagglutination Inhibition Assay. | HI titer ≥1:40 (H3N2) | 22 Subjects |
| eTIV_a (Adults) | Number of Subjects With Antibody Response as Assessed by Hemagglutination Inhibition Assay. | HI titer ≥1:40 (B) | 16 Subjects |
| eTIV_a (Adults) | Number of Subjects With Antibody Response as Assessed by Hemagglutination Inhibition Assay. | seroconversion (B) | 8 Subjects |
| cTIV (Elderly) | Number of Subjects With Antibody Response as Assessed by Hemagglutination Inhibition Assay. | HI titer ≥1:40 (H3N2) | 86 Subjects |
| cTIV (Elderly) | Number of Subjects With Antibody Response as Assessed by Hemagglutination Inhibition Assay. | seroconversion (H3N2) | 32 Subjects |
| cTIV (Elderly) | Number of Subjects With Antibody Response as Assessed by Hemagglutination Inhibition Assay. | HI titer ≥1:40 (B) | 56 Subjects |
| cTIV (Elderly) | Number of Subjects With Antibody Response as Assessed by Hemagglutination Inhibition Assay. | HI titer ≥1:40 (H1N1) | 85 Subjects |
| cTIV (Elderly) | Number of Subjects With Antibody Response as Assessed by Hemagglutination Inhibition Assay. | seroconversion (B) | 23 Subjects |
| cTIV (Elderly) | Number of Subjects With Antibody Response as Assessed by Hemagglutination Inhibition Assay. | seroconversion (H1N1) | 62 Subjects |
| eTIV_a (Elderly) | Number of Subjects With Antibody Response as Assessed by Hemagglutination Inhibition Assay. | seroconversion (H1N1) | 41 Subjects |
| eTIV_a (Elderly) | Number of Subjects With Antibody Response as Assessed by Hemagglutination Inhibition Assay. | seroconversion (B) | 18 Subjects |
| eTIV_a (Elderly) | Number of Subjects With Antibody Response as Assessed by Hemagglutination Inhibition Assay. | HI titer ≥1:40 (H1N1) | 55 Subjects |
| eTIV_a (Elderly) | Number of Subjects With Antibody Response as Assessed by Hemagglutination Inhibition Assay. | seroconversion (H3N2) | 25 Subjects |
| eTIV_a (Elderly) | Number of Subjects With Antibody Response as Assessed by Hemagglutination Inhibition Assay. | HI titer ≥1:40 (H3N2) | 59 Subjects |
| eTIV_a (Elderly) | Number of Subjects With Antibody Response as Assessed by Hemagglutination Inhibition Assay. | HI titer ≥1:40 (B) | 33 Subjects |
Secondary
Number of Unrandomized Participants Reporting Local and Systemic Reactions.
Safety and tolerability evaluation of influenza vaccines, within one week of single intramuscular injection.
Time frame: One week postvaccination
Population: Safety set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| cTIV (Adults) | Number of Unrandomized Participants Reporting Local and Systemic Reactions. | Ecchymosis | 12 Subjects |
| cTIV (Adults) | Number of Unrandomized Participants Reporting Local and Systemic Reactions. | Erythema | 50 Subjects |
| cTIV (Adults) | Number of Unrandomized Participants Reporting Local and Systemic Reactions. | Induration | 38 Subjects |
| cTIV (Adults) | Number of Unrandomized Participants Reporting Local and Systemic Reactions. | Swelling | 23 Subjects |
| cTIV (Adults) | Number of Unrandomized Participants Reporting Local and Systemic Reactions. | Local Reactions | 185 Subjects |
| cTIV (Adults) | Number of Unrandomized Participants Reporting Local and Systemic Reactions. | Pain | 158 Subjects |
| cTIV (Adults) | Number of Unrandomized Participants Reporting Local and Systemic Reactions. | Sweating | 18 Subjects |
| cTIV (Adults) | Number of Unrandomized Participants Reporting Local and Systemic Reactions. | Fatigue | 35 Subjects |
| cTIV (Adults) | Number of Unrandomized Participants Reporting Local and Systemic Reactions. | Fever (≥ 38°C) | 2 Subjects |
| cTIV (Adults) | Number of Unrandomized Participants Reporting Local and Systemic Reactions. | Analgesic and Antipyretics used | 17 Subjects |
| cTIV (Adults) | Number of Unrandomized Participants Reporting Local and Systemic Reactions. | Stay at Home Due to Vaccination Reaction | 5 Subjects |
| cTIV (Adults) | Number of Unrandomized Participants Reporting Local and Systemic Reactions. | Systemic Reaction | 99 Subjects |
| cTIV (Adults) | Number of Unrandomized Participants Reporting Local and Systemic Reactions. | Chills | 15 Subjects |
| cTIV (Adults) | Number of Unrandomized Participants Reporting Local and Systemic Reactions. | Malaise | 52 Subjects |
| cTIV (Adults) | Number of Unrandomized Participants Reporting Local and Systemic Reactions. | Myalgia | 40 Subjects |
| cTIV (Adults) | Number of Unrandomized Participants Reporting Local and Systemic Reactions. | Arthralgia | 18 Subjects |
| cTIV (Adults) | Number of Unrandomized Participants Reporting Local and Systemic Reactions. | Headache | 39 Subjects |
| eTIV_a (Adults) | Number of Unrandomized Participants Reporting Local and Systemic Reactions. | Chills | 5 Subjects |
| eTIV_a (Adults) | Number of Unrandomized Participants Reporting Local and Systemic Reactions. | Analgesic and Antipyretics used | 11 Subjects |
| eTIV_a (Adults) | Number of Unrandomized Participants Reporting Local and Systemic Reactions. | Swelling | 7 Subjects |
| eTIV_a (Adults) | Number of Unrandomized Participants Reporting Local and Systemic Reactions. | Systemic Reaction | 28 Subjects |
| eTIV_a (Adults) | Number of Unrandomized Participants Reporting Local and Systemic Reactions. | Headache | 18 Subjects |
| eTIV_a (Adults) | Number of Unrandomized Participants Reporting Local and Systemic Reactions. | Stay at Home Due to Vaccination Reaction | 5 Subjects |
| eTIV_a (Adults) | Number of Unrandomized Participants Reporting Local and Systemic Reactions. | Induration | 14 Subjects |
| eTIV_a (Adults) | Number of Unrandomized Participants Reporting Local and Systemic Reactions. | Arthralgia | 5 Subjects |
| eTIV_a (Adults) | Number of Unrandomized Participants Reporting Local and Systemic Reactions. | Pain | 51 Subjects |
| eTIV_a (Adults) | Number of Unrandomized Participants Reporting Local and Systemic Reactions. | Myalgia | 8 Subjects |
| eTIV_a (Adults) | Number of Unrandomized Participants Reporting Local and Systemic Reactions. | Fatigue | 11 Subjects |
| eTIV_a (Adults) | Number of Unrandomized Participants Reporting Local and Systemic Reactions. | Malaise | 16 Subjects |
| eTIV_a (Adults) | Number of Unrandomized Participants Reporting Local and Systemic Reactions. | Erythema | 20 Subjects |
| eTIV_a (Adults) | Number of Unrandomized Participants Reporting Local and Systemic Reactions. | Ecchymosis | 1 Subjects |
| eTIV_a (Adults) | Number of Unrandomized Participants Reporting Local and Systemic Reactions. | Fever (≥ 38°C) | 2 Subjects |
| eTIV_a (Adults) | Number of Unrandomized Participants Reporting Local and Systemic Reactions. | Sweating | 8 Subjects |
| eTIV_a (Adults) | Number of Unrandomized Participants Reporting Local and Systemic Reactions. | Local Reactions | 60 Subjects |
| cTIV (Elderly) | Number of Unrandomized Participants Reporting Local and Systemic Reactions. | Malaise | 37 Subjects |
| cTIV (Elderly) | Number of Unrandomized Participants Reporting Local and Systemic Reactions. | Ecchymosis | 14 Subjects |
| cTIV (Elderly) | Number of Unrandomized Participants Reporting Local and Systemic Reactions. | Headache | 20 Subjects |
| cTIV (Elderly) | Number of Unrandomized Participants Reporting Local and Systemic Reactions. | Sweating | 13 Subjects |
| cTIV (Elderly) | Number of Unrandomized Participants Reporting Local and Systemic Reactions. | Fatigue | 23 Subjects |
| cTIV (Elderly) | Number of Unrandomized Participants Reporting Local and Systemic Reactions. | Myalgia | 25 Subjects |
| cTIV (Elderly) | Number of Unrandomized Participants Reporting Local and Systemic Reactions. | Fever (≥ 38°C) | 0 Subjects |
| cTIV (Elderly) | Number of Unrandomized Participants Reporting Local and Systemic Reactions. | Analgesic and Antipyretics used | 7 Subjects |
| cTIV (Elderly) | Number of Unrandomized Participants Reporting Local and Systemic Reactions. | Stay at Home Due to Vaccination Reaction | 6 Subjects |
| cTIV (Elderly) | Number of Unrandomized Participants Reporting Local and Systemic Reactions. | Pain | 64 Subjects |
| cTIV (Elderly) | Number of Unrandomized Participants Reporting Local and Systemic Reactions. | Systemic Reaction | 57 Subjects |
| cTIV (Elderly) | Number of Unrandomized Participants Reporting Local and Systemic Reactions. | Arthralgia | 16 Subjects |
| cTIV (Elderly) | Number of Unrandomized Participants Reporting Local and Systemic Reactions. | Chills | 5 Subjects |
| cTIV (Elderly) | Number of Unrandomized Participants Reporting Local and Systemic Reactions. | Local Reactions | 98 Subjects |
| cTIV (Elderly) | Number of Unrandomized Participants Reporting Local and Systemic Reactions. | Erythema | 36 Subjects |
| cTIV (Elderly) | Number of Unrandomized Participants Reporting Local and Systemic Reactions. | Induration | 26 Subjects |
| cTIV (Elderly) | Number of Unrandomized Participants Reporting Local and Systemic Reactions. | Swelling | 17 Subjects |
| eTIV_a (Elderly) | Number of Unrandomized Participants Reporting Local and Systemic Reactions. | Headache | 11 Subjects |
| eTIV_a (Elderly) | Number of Unrandomized Participants Reporting Local and Systemic Reactions. | Fever (≥ 38°C) | 0 Subjects |
| eTIV_a (Elderly) | Number of Unrandomized Participants Reporting Local and Systemic Reactions. | Malaise | 16 Subjects |
| eTIV_a (Elderly) | Number of Unrandomized Participants Reporting Local and Systemic Reactions. | Local Reactions | 26 Subjects |
| eTIV_a (Elderly) | Number of Unrandomized Participants Reporting Local and Systemic Reactions. | Chills | 4 Subjects |
| eTIV_a (Elderly) | Number of Unrandomized Participants Reporting Local and Systemic Reactions. | Fatigue | 11 Subjects |
| eTIV_a (Elderly) | Number of Unrandomized Participants Reporting Local and Systemic Reactions. | Ecchymosis | 2 Subjects |
| eTIV_a (Elderly) | Number of Unrandomized Participants Reporting Local and Systemic Reactions. | Erythema | 10 Subjects |
| eTIV_a (Elderly) | Number of Unrandomized Participants Reporting Local and Systemic Reactions. | Arthralgia | 6 Subjects |
| eTIV_a (Elderly) | Number of Unrandomized Participants Reporting Local and Systemic Reactions. | Sweating | 8 Subjects |
| eTIV_a (Elderly) | Number of Unrandomized Participants Reporting Local and Systemic Reactions. | Pain | 12 Subjects |
| eTIV_a (Elderly) | Number of Unrandomized Participants Reporting Local and Systemic Reactions. | Stay at Home Due to Vaccination Reaction | 3 Subjects |
| eTIV_a (Elderly) | Number of Unrandomized Participants Reporting Local and Systemic Reactions. | Analgesic and Antipyretics used | 6 Subjects |
| eTIV_a (Elderly) | Number of Unrandomized Participants Reporting Local and Systemic Reactions. | Swelling | 3 Subjects |
| eTIV_a (Elderly) | Number of Unrandomized Participants Reporting Local and Systemic Reactions. | Systemic Reaction | 25 Subjects |
| eTIV_a (Elderly) | Number of Unrandomized Participants Reporting Local and Systemic Reactions. | Induration | 3 Subjects |
| eTIV_a (Elderly) | Number of Unrandomized Participants Reporting Local and Systemic Reactions. | Myalgia | 8 Subjects |