Influenza
Conditions
Brief summary
A Phase IV, Open Label, Multi-Centre Study to Evaluate the Safety and Tolerability Profile of CSL Limited's Influenza Virus Vaccine in a Paediatric Population Aged \>= 6 Months to \< 18 Years
Interventions
BIOLOGICALCSL Limited Influenza Virus Vaccine
Single or two-vaccination regimen (0.25mL)
Sponsors
Seqirus
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 17 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy male or female participants aged ≥ 6 months to \< 18 years at the time of vaccination; 2. Written informed consent to participate in the study and adherence to all protocol requirements. Consent will be obtained from the participant, parent or guardian as appropriate according to the applicable Independent Ethics Committee (IEC) and local requirements. Participant assent will also be obtained if required by the applicable IEC; 3. Good health, as determined by medical history, and a targeted physical examination; 4. For participants aged \< 9 years, born after a normal gestation period (between 36 and 42 weeks); 5. Females of childbearing potential (defined as having experienced their first menstrual cycle) must be abstinent or be using adequate contraceptive precautions e.g. intrauterine contraceptive device, oral contraceptive, or equivalent hormonal contraception (e.g., progestogen-only implant, vaginal contraceptive ring, cutaneous hormonal patch or injectable contraceptives) for at least 2 months after vaccination. Females aged ≥ 9 years must also return a negative urine pregnancy test at enrolment.
Exclusion criteria
1. Known hypersensitivity to a previous dose of influenza vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of the Study Vaccine; 2. Clinical signs of significant active infection and/or an elevated temperature (≥ 38.0°C oral or ≥ 37.5°C axillary) at study entry; 3. Vaccination against influenza virus in the previous 6 months with a seasonal IVV; 4. Vaccination with an experimental IVV (e.g. a candidate pandemic IVV or a novel IVV) in the previous 6 months; 5. Females of child bearing potential, planning to become pregnant or planning to discontinue contraceptive precautions within 2 months of vaccination; 6. Pregnant or lactating females; 7. Clinically significant medical or psychiatric conditions, as follows: * For acute conditions (active or recent), the condition required hospitalisation within the last month; or * For chronic conditions: the Investigator feels that the chronic condition is unstable, such as illness exacerbations within the previous month: i. requiring hospitalisation; ii. with significant organ function deterioration; iii. with major changes to treatment dosages; iv. requiring major new treatments; or * The Investigator feels the participant has a clinical condition that may be adversely affected through study participation. 8. Confirmed or suspected immune deficiency (congenital or acquired, including cancer and human immunodeficiency virus infection); 9. History of seizures, with the exception of a past history of a single seizure event at any age more than two years previously; 10. Known history of Guillain-Barré Syndrome; 11. Current treatment with radiotherapy or cytotoxic drugs, or treatment within the 6 months prior to administration of the Study Vaccine; 12. Current (or within the 90 days prior to receiving the Study Vaccine) immunosuppressive or immunomodulative therapy, including systemic corticosteroids, as follows: • Chronic or long term corticosteroids: i. Age less than 9 years: ≥ 0.5 mg/kg/day of oral prednisolone or equivalent daily; ii. Age 9 years and above: ≥ 15 mg/day of oral prednisolone or equivalent daily; • Sporadic corticosteroids: i. Age less than 9 years: ≥ 1 mg/kg/day of oral prednisolone or equivalent for 2 or more short courses of \> 3 days in the 3 months preceding vaccination; ii. Age 9 years and above: ≥ 40 mg/day of oral prednisolone or equivalent for two or more short courses of \> 3 days in the 3 months preceding vaccination; Note: Use of topical or inhalant corticosteroids prior to administration of the Study Vaccine or throughout the Study is acceptable 13. Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the Study Vaccine or during the study; 14. Current treatment with warfarin or other anticoagulants; 15. Participation in a clinical trial or use of an investigational compound (i.e. a new chemical or biological entity not registered for clinical use) within 90 days prior to receiving the Study Vaccine or entry into such a study during the on study period; 16. Evidence, or history (within the previous 12 months) of drug or alcohol abuse; 17. If, in the Investigator's opinion, the participant should not take part in the clinical study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years) | 7 days post-vaccination | Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, and malaise. |
| Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) | 7 days post-vaccination | Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, and malaise. |
| Duration of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) | 7 days post-vaccination | Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, and malaise. |
| Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years) | 7 days post-vaccination | Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, and malaise. |
| Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) | 7 days post-vaccination | Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, loss of appetite, and irritability. |
| Duration of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) | 7 days post-vaccination | Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, loss of appetite, and irritability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency and Intensity of Unsolicited Adverse Events (UAEs) | 30 days after each study vaccination | UAE stands for Unsolicited Adverse Event. |
| Frequency of Serious Adverse Events | 180 days after the last study vaccination | — |
| Frequency of New Onsets of Chronic Illness | 180 days after the last study vaccination | — |
Countries
Australia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cohort A Participants aged 6 months to less than 3 years, who received one or two doses of the 2009 Southern Hemisphere formulation of CSL Limited Influenza Virus Vaccine. | 710 |
| Cohort B Participants aged 3 to less than 9 years, who received one or two doses of the 2009 Southern Hemisphere formulation of CSL Limited Influenza Virus Vaccine. | 880 |
| Cohort C Participants aged 9 to less than 18 years, who received one or two doses of the 2009 Southern Hemisphere formulation of CSL Limited Influenza Virus Vaccine. | 402 |
| Total | 1,992 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 9 | 6 | 3 |
| Overall Study | Move away from the study area | 1 | 0 | 0 |
| Overall Study | Physician Decision | 2 | 0 | 0 |
| Overall Study | Unable to attend the study visit | 5 | 2 | 0 |
| Overall Study | Withdrawal by Subject | 11 | 13 | 3 |
Baseline characteristics
| Characteristic | Cohort B | Cohort C | Cohort A | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 880 Participants | 402 Participants | 710 Participants | 1992 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 5.54 years STANDARD_DEVIATION 1.66 | 12.64 years STANDARD_DEVIATION 2.48 | 1.84 years STANDARD_DEVIATION 0.74 | 5.66 years STANDARD_DEVIATION 4.21 |
| Region of Enrollment Australia | 880 participants | 402 participants | 710 participants | 1992 participants |
| Sex: Female, Male Female | 439 Participants | 202 Participants | 325 Participants | 966 Participants |
| Sex: Female, Male Male | 441 Participants | 200 Participants | 385 Participants | 1026 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 531 / 703 | 467 / 875 | 97 / 398 |
| serious Total, serious adverse events | 19 / 703 | 5 / 875 | 2 / 398 |
Outcome results
Primary
Duration of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years)
Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, loss of appetite, and irritability.
Time frame: 7 days post-vaccination
Population: The Safety Population comprised all participants who received CSL's IVV and provided at least one safety assessment after vaccination. For the safety analysis of solicited AEs after the second vaccination, only those participants who received a second vaccination and provided safety follow-up after the second vaccination were included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| After First Vaccination, Cohort A | Duration of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) | Any myalgia | 1.54 Days | Standard Deviation 1.071 |
| After First Vaccination, Cohort A | Duration of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) | Any redness (> 0 mm) | 2.55 Days | Standard Deviation 1.93 |
| After First Vaccination, Cohort A | Duration of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) | Any fever (≥99.5°F axillary or ≥100.4 °F oral) | 1.54 Days | Standard Deviation 1.164 |
| After First Vaccination, Cohort A | Duration of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) | Any headache | 2.50 Days | Standard Deviation 4.492 |
| After First Vaccination, Cohort A | Duration of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) | Any diarrhea | 2.43 Days | Standard Deviation 3.473 |
| After First Vaccination, Cohort A | Duration of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) | Any nausea / vomiting | 1.87 Days | Standard Deviation 2.587 |
| After First Vaccination, Cohort A | Duration of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) | Any swelling / induration (> 0 mm) | 3.06 Days | Standard Deviation 4.011 |
| After First Vaccination, Cohort A | Duration of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) | Any loss of appetite | 2.53 Days | Standard Deviation 3.204 |
| After First Vaccination, Cohort A | Duration of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) | Any pain | 1.83 Days | Standard Deviation 1.264 |
| After First Vaccination, Cohort A | Duration of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) | Any irritability | 2.28 Days | Standard Deviation 2.503 |
| After Second Vaccination, Cohort A | Duration of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) | Any pain | 1.76 Days | Standard Deviation 1.315 |
| After Second Vaccination, Cohort A | Duration of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) | Any swelling / induration (> 0 mm) | 3.20 Days | Standard Deviation 3.301 |
| After Second Vaccination, Cohort A | Duration of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) | Any headache | 1.23 Days | Standard Deviation 0.439 |
| After Second Vaccination, Cohort A | Duration of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) | Any nausea / vomiting | 2.84 Days | Standard Deviation 4.919 |
| After Second Vaccination, Cohort A | Duration of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) | Any irritability | 2.42 Days | Standard Deviation 2.726 |
| After Second Vaccination, Cohort A | Duration of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) | Any redness (> 0 mm) | 2.74 Days | Standard Deviation 2.478 |
| After Second Vaccination, Cohort A | Duration of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) | Any fever (≥99.5°F axillary or ≥100.4 °F oral) | 1.67 Days | Standard Deviation 1.148 |
| After Second Vaccination, Cohort A | Duration of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) | Any myalgia | 1.70 Days | Standard Deviation 1.129 |
| After Second Vaccination, Cohort A | Duration of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) | Any diarrhea | 2.50 Days | Standard Deviation 2.573 |
| After Second Vaccination, Cohort A | Duration of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) | Any loss of appetite | 3.02 Days | Standard Deviation 4.325 |
Primary
Duration of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years)
Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, and malaise.
Time frame: 7 days post-vaccination
Population: The Safety Population comprised all participants who received CSL's IVV at Visit 1 and provided at least one safety assessment after vaccination. For the safety analysis of solicited AEs after the second vaccination, only those participants who received a second vaccination and provided safety follow-up after the second vaccination were included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| After First Vaccination, Cohort A | Duration of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) | Any headache | 1.79 Days | Standard Deviation 1.373 |
| After First Vaccination, Cohort A | Duration of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) | Any myalgia | 1.74 Days | Standard Deviation 1.264 |
| After First Vaccination, Cohort A | Duration of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) | Any redness (> 0 mm) | 2.45 Days | Standard Deviation 1.713 |
| After First Vaccination, Cohort A | Duration of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) | Any nausea / vomiting | 1.52 Days | Standard Deviation 1.305 |
| After First Vaccination, Cohort A | Duration of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) | Any fever (≥99.5°F axillary or ≥100.4 °F oral) | 1.40 Days | Standard Deviation 1.114 |
| After First Vaccination, Cohort A | Duration of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) | Any diarrhea | 2.00 Days | Standard Deviation 1.593 |
| After First Vaccination, Cohort A | Duration of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) | Any swelling / induration (> 0 mm) | 2.48 Days | Standard Deviation 1.688 |
| After First Vaccination, Cohort A | Duration of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) | Any malaise | 1.89 Days | Standard Deviation 1.763 |
| After First Vaccination, Cohort A | Duration of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) | Any pain | 1.89 Days | Standard Deviation 1.178 |
| After Second Vaccination, Cohort A | Duration of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) | Any malaise | 2.13 Days | Standard Deviation 1.584 |
| After Second Vaccination, Cohort A | Duration of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) | Any pain | 1.68 Days | Standard Deviation 1.03 |
| After Second Vaccination, Cohort A | Duration of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) | Any swelling / induration (> 0 mm) | 2.09 Days | Standard Deviation 1.696 |
| After Second Vaccination, Cohort A | Duration of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) | Any fever (≥99.5°F axillary or ≥100.4 °F oral) | 1.58 Days | Standard Deviation 1.117 |
| After Second Vaccination, Cohort A | Duration of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) | Any redness (> 0 mm) | 2.21 Days | Standard Deviation 1.316 |
| After Second Vaccination, Cohort A | Duration of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) | Any headache | 1.66 Days | Standard Deviation 1.311 |
| After Second Vaccination, Cohort A | Duration of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) | Any myalgia | 1.38 Days | Standard Deviation 0.59 |
| After Second Vaccination, Cohort A | Duration of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) | Any nausea / vomiting | 1.36 Days | Standard Deviation 0.757 |
| After Second Vaccination, Cohort A | Duration of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) | Any diarrhea | 2.00 Days | Standard Deviation 1.612 |
Primary
Duration of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years)
Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, and malaise.
Time frame: 7 days post-vaccination
Population: The Safety Population comprised all participants who received CSL's IVV at Visit 1 and provided at least one safety assessment after vaccination. For the safety analysis of solicited AEs after the second vaccination, only those participants who received a second vaccination and provided safety follow-up after the second vaccination were included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| After First Vaccination, Cohort A | Duration of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years) | Any pain | 2.02 Days | Standard Deviation 1.317 |
| After First Vaccination, Cohort A | Duration of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years) | Any redness (> 0 mm) | 2.52 Days | Standard Deviation 1.867 |
| After First Vaccination, Cohort A | Duration of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years) | Any swelling / induration (> 0 mm) | 2.81 Days | Standard Deviation 1.854 |
| After First Vaccination, Cohort A | Duration of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years) | Any fever (≥99.5°F axillary or ≥100.4 °F oral) | 1.21 Days | Standard Deviation 0.415 |
| After First Vaccination, Cohort A | Duration of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years) | Any headache | 1.97 Days | Standard Deviation 1.851 |
| After First Vaccination, Cohort A | Duration of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years) | Any myalgia | 2.20 Days | Standard Deviation 3.123 |
| After First Vaccination, Cohort A | Duration of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years) | Any nausea / vomiting | 1.65 Days | Standard Deviation 1.164 |
| After First Vaccination, Cohort A | Duration of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years) | Any diarrhea | 2.23 Days | Standard Deviation 1.771 |
| After First Vaccination, Cohort A | Duration of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years) | Any malaise | 2.56 Days | Standard Deviation 1.853 |
Primary
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years)
Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, loss of appetite, and irritability.
Time frame: 7 days post-vaccination
Population: The Safety Population comprised all participants who received CSL's IVV and provided at least one safety assessment after vaccination. For the safety analysis of solicited AEs after the second vaccination, only those participants who received a second vaccination and provided safety follow-up after the second vaccination were included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| After First Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) | Any irritability | 295 Participants |
| After First Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) | Any redness (> 0 mm) | 148 Participants |
| After First Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) | Grade 3 redness (> 30 mm) | 2 Participants |
| After First Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) | Any swelling / induration (> 0 mm) | 66 Participants |
| After First Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) | Grade 3 swelling / induration (> 30 mm) | 2 Participants |
| After First Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) | Any systemic solicited adverse event | 424 Participants |
| After First Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) | Any fever (≥99.5°F axillary or ≥100.4 °F oral) | 201 Participants |
| After First Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) | Any headache | 25 Participants |
| After First Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) | Any myalgia | 26 Participants |
| After First Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) | Any diarrhea | 100 Participants |
| After First Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) | Any loss of appetite | 141 Participants |
| After First Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) | Grade 3 irritability (prevent activities) | 24 Participants |
| After First Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) | Any local solicited adverse event | 254 Participants |
| After First Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) | Any pain | 160 Participants |
| After First Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) | Grade 3 pain | 1 Participants |
| After First Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) | Grade 3 fever (≥103.1 F°axillary or ≥104 °F oral) | 13 Participants |
| After First Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) | Grade 3 headache (prevent activities) | 1 Participants |
| After First Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) | Grade 3 myalgia (prevent activities) | 3 Participants |
| After First Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) | Any nausea / vomiting | 79 Participants |
| After First Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) | Grade 3 nausea / vomiting (prevent activities) | 12 Participants |
| After First Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) | Grade 3 diarrhea (prevent activities) | 4 Participants |
| After First Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) | Grade 3 loss of appetite (prevent activities) | 8 Participants |
| After Second Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) | Grade 3 loss of appetite (prevent activities) | 4 Participants |
| After Second Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) | Grade 3 pain | 2 Participants |
| After Second Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) | Any local solicited adverse event | 167 Participants |
| After Second Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) | Any redness (> 0 mm) | 109 Participants |
| After Second Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) | Grade 3 myalgia (prevent activities) | 1 Participants |
| After Second Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) | Any pain | 111 Participants |
| After Second Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) | Any swelling / induration (> 0 mm) | 64 Participants |
| After Second Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) | Grade 3 diarrhea (prevent activities) | 3 Participants |
| After Second Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) | Grade 3 swelling / induration (> 30 mm) | 0 Participants |
| After Second Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) | Any fever (≥99.5°F axillary or ≥100.4 °F oral) | 110 Participants |
| After Second Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) | Any systemic solicited adverse event | 261 Participants |
| After Second Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) | Any nausea / vomiting | 31 Participants |
| After Second Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) | Grade 3 fever (≥103.1 F°axillary or ≥104 °F oral) | 6 Participants |
| After Second Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) | Any headache | 12 Participants |
| After Second Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) | Grade 3 nausea / vomiting (prevent activities) | 4 Participants |
| After Second Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) | Grade 3 redness (> 30 mm) | 1 Participants |
| After Second Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) | Any diarrhea | 52 Participants |
| After Second Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) | Grade 3 headache (prevent activities) | 0 Participants |
| After Second Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) | Any loss of appetite | 82 Participants |
| After Second Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) | Any irritability | 175 Participants |
| After Second Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) | Any myalgia | 16 Participants |
| After Second Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) | Grade 3 irritability (prevent activities) | 7 Participants |
Primary
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years)
Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, and malaise.
Time frame: 7 days post-vaccination
Population: The Safety Population comprised all participants who received CSL's IVV and provided at least one safety assessment after vaccination. For the safety analysis of solicited AEs after the second vaccination, only those participants who received a second vaccination and provided safety follow-up after the second vaccination were included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| After First Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) | Any local solicited adverse event | 512 Participants |
| After First Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) | Any pain | 463 Participants |
| After First Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) | Any redness (> 0 mm) | 189 Participants |
| After First Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) | Grade 3 swelling / induration (> 30 mm) | 19 Participants |
| After First Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) | Any systemic solicited adverse event | 346 Participants |
| After First Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) | Any fever (≥99.5°F axillary or ≥100.4 °F oral) | 171 Participants |
| After First Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) | Grade 3 fever (≥103.1 F°axillary or ≥104 °F oral) | 7 Participants |
| After First Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) | Any headache | 136 Participants |
| After First Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) | Grade 3 headache (prevent activities) | 4 Participants |
| After First Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) | Grade 3 myalgia (prevent activities) | 3 Participants |
| After First Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) | Any nausea / vomiting | 75 Participants |
| After First Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) | Any diarrhea | 40 Participants |
| After First Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) | Grade 3 diarrhea (prevent activities) | 2 Participants |
| After First Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) | Grade 3 pain | 2 Participants |
| After First Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) | Grade 3 redness (> 30 mm) | 18 Participants |
| After First Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) | Any swelling / induration (> 0 mm) | 137 Participants |
| After First Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) | Any myalgia | 87 Participants |
| After First Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) | Grade 3 nausea / vomiting (prevent activities) | 6 Participants |
| After First Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) | Any malaise | 179 Participants |
| After First Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) | Grade 3 malaise (prevent activities) | 14 Participants |
| After Second Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) | Any diarrhea | 20 Participants |
| After Second Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) | Any myalgia | 34 Participants |
| After Second Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) | Grade 3 malaise (prevent activities) | 10 Participants |
| After Second Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) | Any redness (> 0 mm) | 109 Participants |
| After Second Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) | Any local solicited adverse event | 312 Participants |
| After Second Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) | Grade 3 swelling / induration (> 30 mm) | 8 Participants |
| After Second Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) | Any pain | 282 Participants |
| After Second Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) | Any systemic solicited adverse event | 157 Participants |
| After Second Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) | Any nausea / vomiting | 35 Participants |
| After Second Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) | Any fever (≥99.5°F axillary or ≥100.4 °F oral) | 63 Participants |
| After Second Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) | Grade 3 pain | 2 Participants |
| After Second Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) | Grade 3 fever (≥103.1 F°axillary or ≥104 °F oral) | 2 Participants |
| After Second Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) | Any malaise | 72 Participants |
| After Second Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) | Any headache | 38 Participants |
| After Second Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) | Grade 3 redness (> 30 mm) | 7 Participants |
| After Second Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) | Grade 3 headache (prevent activities) | 4 Participants |
| After Second Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) | Grade 3 nausea / vomiting (prevent activities) | 5 Participants |
| After Second Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) | Grade 3 myalgia (prevent activities) | 3 Participants |
| After Second Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) | Any swelling / induration (> 0 mm) | 77 Participants |
| After Second Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) | Grade 3 diarrhea (prevent activities) | 0 Participants |
Primary
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years)
Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, and malaise.
Time frame: 7 days post-vaccination
Population: The Safety Population comprised all participants who received CSL's IVV at Visit 1 and provided at least one safety assessment after vaccination. For the safety analysis of solicited AEs after the second vaccination, only those participants who received a second vaccination and provided safety follow-up after the second vaccination were included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| After First Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years) | Grade 3 fever (≥103.1 F°axillary or ≥104 °F oral) | 0 Participants |
| After First Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years) | Any headache | 107 Participants |
| After First Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years) | Grade 3 headache (prevent activities) | 2 Participants |
| After First Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years) | Any local solicited adverse event | 281 Participants |
| After First Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years) | Any pain | 271 Participants |
| After First Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years) | Grade 3 pain | 1 Participants |
| After First Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years) | Any redness (> 0 mm) | 66 Participants |
| After First Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years) | Grade 3 redness (> 30 mm) | 8 Participants |
| After First Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years) | Any swelling / induration (> 0 mm) | 52 Participants |
| After First Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years) | Grade 3 swelling / induration (> 30 mm) | 12 Participants |
| After First Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years) | Any systemic solicited adverse event | 170 Participants |
| After First Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years) | Any fever (≥99.5°F axillary or ≥100.4 °F oral) | 20 Participants |
| After First Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years) | Any myalgia | 80 Participants |
| After First Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years) | Grade 3 myalgia (prevent activities) | 0 Participants |
| After First Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years) | Any nausea / vomiting | 21 Participants |
| After First Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years) | Grade 3 nausea / vomiting (prevent activities) | 1 Participants |
| After First Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years) | Any diarrhea | 21 Participants |
| After First Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years) | Grade 3 diarrhea (prevent activities) | 1 Participants |
| After First Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years) | Any malaise | 66 Participants |
| After First Vaccination, Cohort A | Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years) | Grade 3 malaise (prevent activities) | 1 Participants |
Secondary
Frequency and Intensity of Unsolicited Adverse Events (UAEs)
UAE stands for Unsolicited Adverse Event.
Time frame: 30 days after each study vaccination
Population: The Safety Population comprised all participants who received CSL's IVV and provided at least one safety assessment after vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| After First Vaccination, Cohort A | Frequency and Intensity of Unsolicited Adverse Events (UAEs) | Number of participants with at least one UAE | 531 Participants |
| After First Vaccination, Cohort A | Frequency and Intensity of Unsolicited Adverse Events (UAEs) | Number of participants reported Grade 1 UAE | 115 Participants |
| After First Vaccination, Cohort A | Frequency and Intensity of Unsolicited Adverse Events (UAEs) | Number of participants reported Grade 2 UAE | 300 Participants |
| After First Vaccination, Cohort A | Frequency and Intensity of Unsolicited Adverse Events (UAEs) | Number of participants reported Grade 3 UAE | 116 Participants |
| After Second Vaccination, Cohort A | Frequency and Intensity of Unsolicited Adverse Events (UAEs) | Number of participants reported Grade 3 UAE | 87 Participants |
| After Second Vaccination, Cohort A | Frequency and Intensity of Unsolicited Adverse Events (UAEs) | Number of participants reported Grade 1 UAE | 183 Participants |
| After Second Vaccination, Cohort A | Frequency and Intensity of Unsolicited Adverse Events (UAEs) | Number of participants reported Grade 2 UAE | 251 Participants |
| After Second Vaccination, Cohort A | Frequency and Intensity of Unsolicited Adverse Events (UAEs) | Number of participants with at least one UAE | 521 Participants |
| Cohort C | Frequency and Intensity of Unsolicited Adverse Events (UAEs) | Number of participants reported Grade 2 UAE | 82 Participants |
| Cohort C | Frequency and Intensity of Unsolicited Adverse Events (UAEs) | Number of participants reported Grade 3 UAE | 22 Participants |
| Cohort C | Frequency and Intensity of Unsolicited Adverse Events (UAEs) | Number of participants with at least one UAE | 167 Participants |
| Cohort C | Frequency and Intensity of Unsolicited Adverse Events (UAEs) | Number of participants reported Grade 1 UAE | 63 Participants |
Secondary
Frequency of New Onsets of Chronic Illness
Time frame: 180 days after the last study vaccination
Population: The Safety Population comprised all participants who received CSL's IVV and provided at least one safety assessment after vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| After First Vaccination, Cohort A | Frequency of New Onsets of Chronic Illness | Number of participants with at least one NOCI | 10 Participants |
| After First Vaccination, Cohort A | Frequency of New Onsets of Chronic Illness | Number of participants with related NOCI | 2 Participants |
| After Second Vaccination, Cohort A | Frequency of New Onsets of Chronic Illness | Number of participants with at least one NOCI | 5 Participants |
| After Second Vaccination, Cohort A | Frequency of New Onsets of Chronic Illness | Number of participants with related NOCI | 0 Participants |
| Cohort C | Frequency of New Onsets of Chronic Illness | Number of participants with at least one NOCI | 2 Participants |
| Cohort C | Frequency of New Onsets of Chronic Illness | Number of participants with related NOCI | 0 Participants |
Secondary
Frequency of Serious Adverse Events
Time frame: 180 days after the last study vaccination
Population: The Safety Population comprised all participants who received CSL's IVV and provided at least one safety assessment after vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| After First Vaccination, Cohort A | Frequency of Serious Adverse Events | Number of participants with at least one SAE | 19 Participants |
| After First Vaccination, Cohort A | Frequency of Serious Adverse Events | Number of participants with related SAE | 0 Participants |
| After Second Vaccination, Cohort A | Frequency of Serious Adverse Events | Number of participants with at least one SAE | 5 Participants |
| After Second Vaccination, Cohort A | Frequency of Serious Adverse Events | Number of participants with related SAE | 0 Participants |
| Cohort C | Frequency of Serious Adverse Events | Number of participants with at least one SAE | 2 Participants |
| Cohort C | Frequency of Serious Adverse Events | Number of participants with related SAE | 0 Participants |