Fever, Influenza
Conditions
Keywords
Influenza, children and adolescents, trivalent vaccine, cell culture, embryonated chicken eggs
Brief summary
Evaluate safety and tolerability of TIVa or TIVb vaccine in healthy children and adolescents 4 to 17 years of age.
Interventions
BIOLOGICALMammalian cell based flu vaccine
BIOLOGICALEgg based flu vaccine
Sponsors
Novartis Vaccines
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
4 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
\- Healthy subjects 4-17 years of age
Exclusion criteria
* Subjects who are not healthy, * Subjects who are pregnant or breast feeding, * Subjects with a history of severe allergic reaction or allergic to any of the vaccine components.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Day 1 to Day 7 after any vaccination | Safety was assessed as the number of subjects who reported solicited local and systemic adverse events and other indicators of reactogenicity following two doses of either mammalian cell culture-derived or egg-derived trivalent influenza vaccination in subjects aged ≥4 To ≤17 Years. |
| Number Of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. | Day 1 to Day49 for subjects aged ≥4 To ≤8 years not previously vaccinated. Day 1 to Day 38 for subjects aged ≥4 To ≤8 years previously vaccinated and all subjects aged ≥9 To ≤17 years. | Safety was assessed as the number of subjects who reported unsolicited adverse events following vaccination with either mammalian cell culture-derived or egg-derived trivalent influenza vaccination in subjects aged ≥4 To ≤17 Years. |
| Number Of Subjects Reporting Unsolicited Serious Adverse Events After Any Vaccination. | Day 1 to Day 183 for previously vaccinated subjects and Day 213 for not-previously vaccinated subjects | Safety was assessed as the number of subjects who reported serious adverse events (SAEs), medically attended AEs and new onset of chronic diseases (NOCD) in subjects aged ≥4 To ≤17 Years. |
Countries
Australia, New Zealand, Philippines, Thailand, United States
Participant flow
Recruitment details
Subjects were enrolled at a total of 34 centers in 5 countries: 18 sites in the US, 6 sites in Australia, 2 sites in New Zealand, 5 sites in the Philippines and 3 sites in Thailand.
Participants by arm
| Arm | Count |
|---|---|
| TIVc Subjects ≥4 to ≤17 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status. | 1,372 |
| TIVf Subjects ≥4 to ≤17 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status. | 683 |
| TOTAL Total of all reporting groups | 2,055 |
| Total | 4,110 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | ADMINISTRATIVE REASON | 0 | 1 |
| Overall Study | Lost to Follow-up | 9 | 6 |
| Overall Study | Unclassified | 3 | 3 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | TIVc | TIVf | TOTAL |
|---|---|---|---|
| Age, Continuous | 9.1 year STANDARD_DEVIATION 3.8 | 9.3 year STANDARD_DEVIATION 3.9 | 9.1 year STANDARD_DEVIATION 3.8 |
| Sex: Female, Male Female | 703 Participants | 349 Participants | 1052 Participants |
| Sex: Female, Male Male | 669 Participants | 334 Participants | 1003 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 | 545 / 688 | 267 / 341 | 489 / 682 | 220 / 341 |
| serious Total, serious adverse events | 17 / 688 | 7 / 341 | 7 / 682 | 9 / 341 |
Outcome results
Primary
Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination.
Safety was assessed as the number of subjects who reported solicited local and systemic adverse events and other indicators of reactogenicity following two doses of either mammalian cell culture-derived or egg-derived trivalent influenza vaccination in subjects aged ≥4 To ≤17 Years.
Time frame: Day 1 to Day 7 after any vaccination
Population: Analysis was done on the solicited safety dataset, i.e. the subjects in the exposed population who provided postvaccination solicited safety data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TIVc (≥4 to ≤8 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Sweating (AE) | 39 Subjects |
| TIVc (≥4 to ≤8 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Headache (AE) | 105 Subjects |
| TIVc (≥4 to ≤8 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Injection site Erythema (AE) | 148 Subjects |
| TIVc (≥4 to ≤8 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Malaise (AE) | 112 Subjects |
| TIVc (≥4 to ≤8 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Fatigue (AE) | 92 Subjects |
| TIVc (≥4 to ≤8 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Any Local | 422 Subjects |
| TIVc (≥4 to ≤8 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Loss of appetite (AE) | 68 Subjects |
| TIVc (≥4 to ≤8 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Injection site Induration (AE) | 109 Subjects |
| TIVc (≥4 to ≤8 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Prevention of pain and/or fever (Other Indicator) | 61 Subjects |
| TIVc (≥4 to ≤8 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Injection site Ecchymosis (AE) | 68 Subjects |
| TIVc (≥4 to ≤8 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | ≥40°C (Other Indicator) | 3 Subjects |
| TIVc (≥4 to ≤8 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Injection site Pain (AE) | 384 Subjects |
| TIVc (≥4 to ≤8 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Any Systemic | 252 Subjects |
| TIVc (≥4 to ≤8 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Treatment of pain and/or fever (Other Indicator) | 90 Subjects |
| TIVc (≥4 to ≤8 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Body Temperature (≥38°C) (AE) | 48 Subjects |
| TIVc (≥4 to ≤8 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Chills (AE) | 47 Subjects |
| TIVc (≥4 to ≤8 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Injection site Swelling (AE) | 87 Subjects |
| TIVc (≥4 to ≤8 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Nausea (AE) | 57 Subjects |
| TIVc (≥4 to ≤8 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Myalgia (AE) | 113 Subjects |
| TIVc (≥4 to ≤8 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Arthralgia (AE) | 39 Subjects |
| TIVf (≥4 to ≤8 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Sweating (AE) | 20 Subjects |
| TIVf (≥4 to ≤8 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Arthralgia (AE) | 16 Subjects |
| TIVf (≥4 to ≤8 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Prevention of pain and/or fever (Other Indicator) | 29 Subjects |
| TIVf (≥4 to ≤8 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Malaise (AE) | 43 Subjects |
| TIVf (≥4 to ≤8 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Injection site Pain (AE) | 186 Subjects |
| TIVf (≥4 to ≤8 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Headache (AE) | 42 Subjects |
| TIVf (≥4 to ≤8 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Any Local | 202 Subjects |
| TIVf (≥4 to ≤8 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Body Temperature (≥38°C) (AE) | 30 Subjects |
| TIVf (≥4 to ≤8 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Myalgia (AE) | 41 Subjects |
| TIVf (≥4 to ≤8 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Fatigue (AE) | 34 Subjects |
| TIVf (≥4 to ≤8 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Any Systemic | 110 Subjects |
| TIVf (≥4 to ≤8 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Loss of appetite (AE) | 25 Subjects |
| TIVf (≥4 to ≤8 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Nausea (AE) | 26 Subjects |
| TIVf (≥4 to ≤8 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Injection site Erythema (AE) | 57 Subjects |
| TIVf (≥4 to ≤8 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Injection site Swelling (AE) | 37 Subjects |
| TIVf (≥4 to ≤8 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | ≥40°C (Other Indicator) | 0 Subjects |
| TIVf (≥4 to ≤8 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Chills (AE) | 17 Subjects |
| TIVf (≥4 to ≤8 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Injection site Ecchymosis (AE) | 30 Subjects |
| TIVf (≥4 to ≤8 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Injection site Induration (AE) | 43 Subjects |
| TIVf (≥4 to ≤8 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Treatment of pain and/or fever (Other Indicator) | 40 Subjects |
| TIVc (≥9 to ≤17 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Fatigue (AE) | 109 Subjects |
| TIVc (≥9 to ≤17 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Any Local | 370 Subjects |
| TIVc (≥9 to ≤17 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Injection site Induration (AE) | 46 Subjects |
| TIVc (≥9 to ≤17 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Injection site Swelling (AE) | 36 Subjects |
| TIVc (≥9 to ≤17 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Injection site Erythema (AE) | 72 Subjects |
| TIVc (≥9 to ≤17 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Injection site Ecchymosis (AE) | 27 Subjects |
| TIVc (≥9 to ≤17 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Injection site Pain (AE) | 356 Subjects |
| TIVc (≥9 to ≤17 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Any Systemic | 267 Subjects |
| TIVc (≥9 to ≤17 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Chills (AE) | 39 Subjects |
| TIVc (≥9 to ≤17 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Nausea (AE) | 45 Subjects |
| TIVc (≥9 to ≤17 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Myalgia (AE) | 126 Subjects |
| TIVc (≥9 to ≤17 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Arthralgia (AE) | 54 Subjects |
| TIVc (≥9 to ≤17 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Headache (AE) | 128 Subjects |
| TIVc (≥9 to ≤17 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Loss of appetite (AE) | 50 Subjects |
| TIVc (≥9 to ≤17 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Malaise (AE) | 99 Subjects |
| TIVc (≥9 to ≤17 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Sweating (AE) | 52 Subjects |
| TIVc (≥9 to ≤17 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Body Temperature (≥38°C) (AE) | 12 Subjects |
| TIVc (≥9 to ≤17 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | ≥40°C (Other Indicator) | 0 Subjects |
| TIVc (≥9 to ≤17 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Prevention of pain and/or fever (Other Indicator) | 24 Subjects |
| TIVc (≥9 to ≤17 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Treatment of pain and/or fever (Other Indicator) | 39 Subjects |
| TIVf (≥9 to ≤17 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Myalgia (AE) | 44 Subjects |
| TIVf (≥9 to ≤17 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Nausea (AE) | 16 Subjects |
| TIVf (≥9 to ≤17 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Chills (AE) | 7 Subjects |
| TIVf (≥9 to ≤17 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Prevention of pain and/or fever (Other Indicator) | 10 Subjects |
| TIVf (≥9 to ≤17 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Sweating (AE) | 23 Subjects |
| TIVf (≥9 to ≤17 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Any Systemic | 113 Subjects |
| TIVf (≥9 to ≤17 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Injection site Pain (AE) | 142 Subjects |
| TIVf (≥9 to ≤17 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Injection site Induration (AE) | 33 Subjects |
| TIVf (≥9 to ≤17 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Body Temperature (≥38°C) (AE) | 5 Subjects |
| TIVf (≥9 to ≤17 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Injection site Ecchymosis (AE) | 11 Subjects |
| TIVf (≥9 to ≤17 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Any Local | 160 Subjects |
| TIVf (≥9 to ≤17 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | ≥40°C (Other Indicator) | 0 Subjects |
| TIVf (≥9 to ≤17 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Injection site Erythema (AE) | 37 Subjects |
| TIVf (≥9 to ≤17 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Fatigue (AE) | 56 Subjects |
| TIVf (≥9 to ≤17 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Injection site Swelling (AE) | 26 Subjects |
| TIVf (≥9 to ≤17 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Loss of appetite (AE) | 12 Subjects |
| TIVf (≥9 to ≤17 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Headache (AE) | 57 Subjects |
| TIVf (≥9 to ≤17 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Arthralgia (AE) | 14 Subjects |
| TIVf (≥9 to ≤17 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Treatment of pain and/or fever (Other Indicator) | 18 Subjects |
| TIVf (≥9 to ≤17 Years) | Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. | Malaise (AE) | 46 Subjects |
Primary
Number Of Subjects Reporting Unsolicited Adverse Events After Any Vaccination.
Safety was assessed as the number of subjects who reported unsolicited adverse events following vaccination with either mammalian cell culture-derived or egg-derived trivalent influenza vaccination in subjects aged ≥4 To ≤17 Years.
Time frame: Day 1 to Day49 for subjects aged ≥4 To ≤8 years not previously vaccinated. Day 1 to Day 38 for subjects aged ≥4 To ≤8 years previously vaccinated and all subjects aged ≥9 To ≤17 years.
Population: Analysis was done on the unsolicited safety dataset, i.e. the subjects in the exposed population who provided postvaccination unsolicited safety data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TIVc (≥4 to ≤8 Years) | Number Of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. | Any AE | 277 Subjects |
| TIVc (≥4 to ≤8 Years) | Number Of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. | At least possibly related AE | 50 Subjects |
| TIVf (≥4 to ≤8 Years) | Number Of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. | At least possibly related AE | 26 Subjects |
| TIVf (≥4 to ≤8 Years) | Number Of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. | Any AE | 139 Subjects |
| TIVc (≥9 to ≤17 Years) | Number Of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. | Any AE | 158 Subjects |
| TIVc (≥9 to ≤17 Years) | Number Of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. | At least possibly related AE | 32 Subjects |
| TIVf (≥9 to ≤17 Years) | Number Of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. | Any AE | 88 Subjects |
| TIVf (≥9 to ≤17 Years) | Number Of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. | At least possibly related AE | 22 Subjects |
Primary
Number Of Subjects Reporting Unsolicited Serious Adverse Events After Any Vaccination.
Safety was assessed as the number of subjects who reported serious adverse events (SAEs), medically attended AEs and new onset of chronic diseases (NOCD) in subjects aged ≥4 To ≤17 Years.
Time frame: Day 1 to Day 183 for previously vaccinated subjects and Day 213 for not-previously vaccinated subjects
Population: Analysis was done on the unsolicited safety dataset, i.e. the subjects in the exposed population who provided postvaccination unsolicited safety data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TIVc (≥4 to ≤8 Years) | Number Of Subjects Reporting Unsolicited Serious Adverse Events After Any Vaccination. | NOCD | 5 Subjects |
| TIVc (≥4 to ≤8 Years) | Number Of Subjects Reporting Unsolicited Serious Adverse Events After Any Vaccination. | Death | 0 Subjects |
| TIVc (≥4 to ≤8 Years) | Number Of Subjects Reporting Unsolicited Serious Adverse Events After Any Vaccination. | At least possibly related SAE | 0 Subjects |
| TIVc (≥4 to ≤8 Years) | Number Of Subjects Reporting Unsolicited Serious Adverse Events After Any Vaccination. | AE leading to withdrawal | 0 Subjects |
| TIVc (≥4 to ≤8 Years) | Number Of Subjects Reporting Unsolicited Serious Adverse Events After Any Vaccination. | SAE | 17 Subjects |
| TIVc (≥4 to ≤8 Years) | Number Of Subjects Reporting Unsolicited Serious Adverse Events After Any Vaccination. | Medically attended AE | 284 Subjects |
| TIVf (≥4 to ≤8 Years) | Number Of Subjects Reporting Unsolicited Serious Adverse Events After Any Vaccination. | At least possibly related SAE | 0 Subjects |
| TIVf (≥4 to ≤8 Years) | Number Of Subjects Reporting Unsolicited Serious Adverse Events After Any Vaccination. | Medically attended AE | 139 Subjects |
| TIVf (≥4 to ≤8 Years) | Number Of Subjects Reporting Unsolicited Serious Adverse Events After Any Vaccination. | AE leading to withdrawal | 0 Subjects |
| TIVf (≥4 to ≤8 Years) | Number Of Subjects Reporting Unsolicited Serious Adverse Events After Any Vaccination. | SAE | 7 Subjects |
| TIVf (≥4 to ≤8 Years) | Number Of Subjects Reporting Unsolicited Serious Adverse Events After Any Vaccination. | NOCD | 4 Subjects |
| TIVf (≥4 to ≤8 Years) | Number Of Subjects Reporting Unsolicited Serious Adverse Events After Any Vaccination. | Death | 0 Subjects |
| TIVc (≥9 to ≤17 Years) | Number Of Subjects Reporting Unsolicited Serious Adverse Events After Any Vaccination. | NOCD | 3 Subjects |
| TIVc (≥9 to ≤17 Years) | Number Of Subjects Reporting Unsolicited Serious Adverse Events After Any Vaccination. | At least possibly related SAE | 0 Subjects |
| TIVc (≥9 to ≤17 Years) | Number Of Subjects Reporting Unsolicited Serious Adverse Events After Any Vaccination. | SAE | 7 Subjects |
| TIVc (≥9 to ≤17 Years) | Number Of Subjects Reporting Unsolicited Serious Adverse Events After Any Vaccination. | Medically attended AE | 172 Subjects |
| TIVc (≥9 to ≤17 Years) | Number Of Subjects Reporting Unsolicited Serious Adverse Events After Any Vaccination. | Death | 0 Subjects |
| TIVc (≥9 to ≤17 Years) | Number Of Subjects Reporting Unsolicited Serious Adverse Events After Any Vaccination. | AE leading to withdrawal | 0 Subjects |
| TIVf (≥9 to ≤17 Years) | Number Of Subjects Reporting Unsolicited Serious Adverse Events After Any Vaccination. | Death | 0 Subjects |
| TIVf (≥9 to ≤17 Years) | Number Of Subjects Reporting Unsolicited Serious Adverse Events After Any Vaccination. | SAE | 9 Subjects |
| TIVf (≥9 to ≤17 Years) | Number Of Subjects Reporting Unsolicited Serious Adverse Events After Any Vaccination. | At least possibly related SAE | 0 Subjects |
| TIVf (≥9 to ≤17 Years) | Number Of Subjects Reporting Unsolicited Serious Adverse Events After Any Vaccination. | AE leading to withdrawal | 0 Subjects |
| TIVf (≥9 to ≤17 Years) | Number Of Subjects Reporting Unsolicited Serious Adverse Events After Any Vaccination. | Medically attended AE | 105 Subjects |
| TIVf (≥9 to ≤17 Years) | Number Of Subjects Reporting Unsolicited Serious Adverse Events After Any Vaccination. | NOCD | 1 Subjects |