Influenza Caused by the Novel Influenza A (H1N1) Virus
Conditions
Brief summary
The purpose of this study is to determine whether CSL425 is a safe and effective vaccine for eliciting an immune response to H1N1 influenza in healthy children.
Interventions
BIOLOGICALCSL425
CSL's 2009 H1N1 Influenza Vaccine, thimerosal-free
Sponsors
Seqirus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 8 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female aged \>= 6 months to \< 9 years at the time of the first study vaccination. * For children \< 3 years of age at the time of first vaccination, born at or after 36 weeks of gestation.
Exclusion criteria
* Known hypersensitivity to a previous dose of influenza virus vaccine or allergy to eggs, chicken protein, thiomersal, neomycin, polymyxin, or any components of the Study Vaccine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More After the Second Vaccination | 21 days after the second vaccination | — |
| Haemagglutination Inhibition (HI) Antibody Titre Seroconversion Rate After the First Vaccination | Before and 21 days after the first vaccination | HI antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination HI antibody titre of 1:40 or more; or participants with a pre-vaccination HI titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre. |
| HI Antibody Titre Seroconversion Rate After the Second Vaccination | Before and 21 days after the second vaccination | HI antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination HI antibody titre of 1:40 or more; or participants with a pre-vaccination HI titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre. |
| Geometric Mean Fold Increase (GMFI) in the HI Antibody Titre After the First Vaccination | Before and 21 days after the first vaccination | GMFI in HI antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre. |
| GMFI in the HI Antibody Titre After the Second Vaccination | Before and 21 days after the second vaccination | GMFI in HI antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre. |
| Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More After the First Vaccination | 21 days after the first vaccination | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Solicited AEs After the First Vaccination | During the 7 days after the first vaccination and up to Day 20 after the first vaccination if AE is ongoing at Day 7. | Solicited AEs included AEs that were specifically sought for. |
| Duration of Solicited AEs After the Second Vaccination | During the 7 days after the second vaccination and up to Day 20 after the second vaccination if AE was ongoing at Day 7. | Solicited AEs included AEs that were specifically sought for. |
| Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs) | Up to 180 days after the last vaccination | An AESI was defined as an AE for which the association with seasonal influenza vaccine was unclear. A NOCI was defined as the diagnosis of a new medical condition that was chronic in nature, including those potentially controllable by medication (eg, diabetes, asthma). |
| Frequency and Intensity of Unsolicited Adverse Events After the First or Second Vaccination | During the 21 days after each vaccination; up to 180 days after the last vaccination for SAEs, AESIs, and NOCIs | Unsolicited AEs included AEs other than those specifically sought for. Grade 1 unsolicited AE definition: Easily tolerated and did not interfere with normal daily activities. Grade 2 unsolicited AE definition: Some interference with normal daily activities. Grade 3 unsolicited AE definition: Prevented normal daily activities. |
| Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | During the 7 days after each vaccination | Solicited AEs included AEs that were specifically sought for. Grade 3 solicited AE definitions: Cried when limb was moved/spontaneously painful (Cohort A) or prevented normal daily activities (Cohort B) for injection site pain; Size \> 100 mm for injection site redness and induration/swelling; Temperature \> 103.1°F (39.5°C) for fevers; Prevented normal daily activities or required medical intervention for all other systemic AEs. |
Countries
Australia
Participant flow
Pre-assignment details
One randomized participant withdrew consent prior to vaccine administration and was not included in the participant flow data or in any analysis population.
Participants by arm
| Arm | Count |
|---|---|
| CSL425 (15 mcg) Cohort A Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. | 82 |
| CSL425 (30 mcg) Cohort A Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. | 80 |
| CSL425 (15 mcg) Cohort B Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. | 103 |
| CSL425 (30 mcg) Cohort B Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. | 104 |
| Total | 369 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 4 | 0 | 2 |
| Overall Study | Declined further vaccination | 0 | 1 | 3 | 0 |
| Overall Study | Diagnosed with H1N1 | 0 | 0 | 0 | 1 |
| Overall Study | Dose 2 contraindicated | 1 | 1 | 0 | 1 |
| Overall Study | Refused - pyrexia after Dose 1 | 0 | 1 | 0 | 0 |
| Overall Study | Viral illness after Dose 1 | 0 | 1 | 0 | 0 |
| Overall Study | Withdrew Consent | 2 | 1 | 0 | 1 |
Baseline characteristics
| Characteristic | CSL425 (15 mcg) Cohort A | CSL425 (30 mcg) Cohort A | CSL425 (15 mcg) Cohort B | CSL425 (30 mcg) Cohort B | Total |
|---|---|---|---|---|---|
| Age, Continuous | 1.68 years STANDARD_DEVIATION 0.67 | 1.73 years STANDARD_DEVIATION 0.74 | 5.78 years STANDARD_DEVIATION 1.69 | 5.66 years STANDARD_DEVIATION 1.74 | 3.96 years STANDARD_DEVIATION 2.42 |
| Sex: Female, Male Female | 41 Participants | 41 Participants | 53 Participants | 49 Participants | 184 Participants |
| Sex: Female, Male Male | 41 Participants | 39 Participants | 50 Participants | 55 Participants | 185 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 | 81 / 82 | 78 / 80 | 91 / 103 | 96 / 104 |
| serious Total, serious adverse events | 4 / 82 | 1 / 80 | 1 / 103 | 1 / 104 |
Outcome results
Primary
Geometric Mean Fold Increase (GMFI) in the HI Antibody Titre After the First Vaccination
GMFI in HI antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre.
Time frame: Before and 21 days after the first vaccination
Population: The Evaluable Population (for the first vaccination) comprised all randomised participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| CSL425 (15 mcg) Cohort A | Geometric Mean Fold Increase (GMFI) in the HI Antibody Titre After the First Vaccination | 13.95 geometric mean fold increase |
| CSL425 (30 mcg) Cohort A | Geometric Mean Fold Increase (GMFI) in the HI Antibody Titre After the First Vaccination | 22.17 geometric mean fold increase |
| CSL425 (15 mcg) Cohort B | Geometric Mean Fold Increase (GMFI) in the HI Antibody Titre After the First Vaccination | 13.25 geometric mean fold increase |
| CSL425 (30 mcg) Cohort B | Geometric Mean Fold Increase (GMFI) in the HI Antibody Titre After the First Vaccination | 15.93 geometric mean fold increase |
Primary
GMFI in the HI Antibody Titre After the Second Vaccination
GMFI in HI antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre.
Time frame: Before and 21 days after the second vaccination
Population: The Evaluable Population (for the second vaccination) comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| CSL425 (15 mcg) Cohort A | GMFI in the HI Antibody Titre After the Second Vaccination | 57.64 geometric mean fold increase |
| CSL425 (30 mcg) Cohort A | GMFI in the HI Antibody Titre After the Second Vaccination | 72.93 geometric mean fold increase |
| CSL425 (15 mcg) Cohort B | GMFI in the HI Antibody Titre After the Second Vaccination | 37.48 geometric mean fold increase |
| CSL425 (30 mcg) Cohort B | GMFI in the HI Antibody Titre After the Second Vaccination | 37.06 geometric mean fold increase |
Primary
Haemagglutination Inhibition (HI) Antibody Titre Seroconversion Rate After the First Vaccination
HI antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination HI antibody titre of 1:40 or more; or participants with a pre-vaccination HI titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre.
Time frame: Before and 21 days after the first vaccination
Population: The Evaluable Population (for the first vaccination) comprised all randomised participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CSL425 (15 mcg) Cohort A | Haemagglutination Inhibition (HI) Antibody Titre Seroconversion Rate After the First Vaccination | 88.2 percentage of participants |
| CSL425 (30 mcg) Cohort A | Haemagglutination Inhibition (HI) Antibody Titre Seroconversion Rate After the First Vaccination | 97.3 percentage of participants |
| CSL425 (15 mcg) Cohort B | Haemagglutination Inhibition (HI) Antibody Titre Seroconversion Rate After the First Vaccination | 85.7 percentage of participants |
| CSL425 (30 mcg) Cohort B | Haemagglutination Inhibition (HI) Antibody Titre Seroconversion Rate After the First Vaccination | 91.9 percentage of participants |
Primary
HI Antibody Titre Seroconversion Rate After the Second Vaccination
HI antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination HI antibody titre of 1:40 or more; or participants with a pre-vaccination HI titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre.
Time frame: Before and 21 days after the second vaccination
Population: The Evaluable Population (for the second vaccination) comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CSL425 (15 mcg) Cohort A | HI Antibody Titre Seroconversion Rate After the Second Vaccination | 96.9 percentage of participants |
| CSL425 (30 mcg) Cohort A | HI Antibody Titre Seroconversion Rate After the Second Vaccination | 98.6 percentage of participants |
| CSL425 (15 mcg) Cohort B | HI Antibody Titre Seroconversion Rate After the Second Vaccination | 97.9 percentage of participants |
| CSL425 (30 mcg) Cohort B | HI Antibody Titre Seroconversion Rate After the Second Vaccination | 96.9 percentage of participants |
Primary
Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More After the First Vaccination
Time frame: 21 days after the first vaccination
Population: The Evaluable Population (for the first vaccination) comprised all randomised participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CSL425 (15 mcg) Cohort A | Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More After the First Vaccination | 92.1 percentage of participants |
| CSL425 (30 mcg) Cohort A | Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More After the First Vaccination | 100.0 percentage of participants |
| CSL425 (15 mcg) Cohort B | Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More After the First Vaccination | 92.9 percentage of participants |
| CSL425 (30 mcg) Cohort B | Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More After the First Vaccination | 96.0 percentage of participants |
Primary
Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More After the Second Vaccination
Time frame: 21 days after the second vaccination
Population: The Evaluable Population (for the second vaccination) comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CSL425 (15 mcg) Cohort A | Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More After the Second Vaccination | 100.0 percentage of participants |
| CSL425 (30 mcg) Cohort A | Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More After the Second Vaccination | 100.0 percentage of participants |
| CSL425 (15 mcg) Cohort B | Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More After the Second Vaccination | 100.0 percentage of participants |
| CSL425 (30 mcg) Cohort B | Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More After the Second Vaccination | 100.0 percentage of participants |
Secondary
Duration of Solicited AEs After the First Vaccination
Solicited AEs included AEs that were specifically sought for.
Time frame: During the 7 days after the first vaccination and up to Day 20 after the first vaccination if AE is ongoing at Day 7.
Population: The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CSL425 (15 mcg) Cohort A | Duration of Solicited AEs After the First Vaccination | Malaise | NA days | — |
| CSL425 (15 mcg) Cohort A | Duration of Solicited AEs After the First Vaccination | Swelling/induration at injection site | 1.88 days | Standard Deviation 0.957 |
| CSL425 (15 mcg) Cohort A | Duration of Solicited AEs After the First Vaccination | Fever | 1.77 days | Standard Deviation 1.547 |
| CSL425 (15 mcg) Cohort A | Duration of Solicited AEs After the First Vaccination | Pain at injection site | 1.48 days | Standard Deviation 0.677 |
| CSL425 (15 mcg) Cohort A | Duration of Solicited AEs After the First Vaccination | Irritability | 1.78 days | Standard Deviation 1.56 |
| CSL425 (15 mcg) Cohort A | Duration of Solicited AEs After the First Vaccination | Diarrhoea | 1.67 days | Standard Deviation 1.328 |
| CSL425 (15 mcg) Cohort A | Duration of Solicited AEs After the First Vaccination | Redness at injection site | 2.08 days | Standard Deviation 1.382 |
| CSL425 (15 mcg) Cohort A | Duration of Solicited AEs After the First Vaccination | Headache | NA days | — |
| CSL425 (15 mcg) Cohort A | Duration of Solicited AEs After the First Vaccination | Muscle ache | NA days | — |
| CSL425 (15 mcg) Cohort A | Duration of Solicited AEs After the First Vaccination | Loss of appetite | 2.32 days | Standard Deviation 1.906 |
| CSL425 (15 mcg) Cohort A | Duration of Solicited AEs After the First Vaccination | Nausea/vomiting | 1.33 days | Standard Deviation 0.5 |
| CSL425 (30 mcg) Cohort A | Duration of Solicited AEs After the First Vaccination | Loss of appetite | 1.97 days | Standard Deviation 1.447 |
| CSL425 (30 mcg) Cohort A | Duration of Solicited AEs After the First Vaccination | Headache | NA days | — |
| CSL425 (30 mcg) Cohort A | Duration of Solicited AEs After the First Vaccination | Irritability | 1.73 days | Standard Deviation 1.574 |
| CSL425 (30 mcg) Cohort A | Duration of Solicited AEs After the First Vaccination | Malaise | NA days | — |
| CSL425 (30 mcg) Cohort A | Duration of Solicited AEs After the First Vaccination | Fever | 1.52 days | Standard Deviation 1.079 |
| CSL425 (30 mcg) Cohort A | Duration of Solicited AEs After the First Vaccination | Redness at injection site | 2.23 days | Standard Deviation 1.602 |
| CSL425 (30 mcg) Cohort A | Duration of Solicited AEs After the First Vaccination | Swelling/induration at injection site | 1.64 days | Standard Deviation 0.745 |
| CSL425 (30 mcg) Cohort A | Duration of Solicited AEs After the First Vaccination | Muscle ache | NA days | — |
| CSL425 (30 mcg) Cohort A | Duration of Solicited AEs After the First Vaccination | Diarrhoea | 1.55 days | Standard Deviation 0.945 |
| CSL425 (30 mcg) Cohort A | Duration of Solicited AEs After the First Vaccination | Pain at injection site | 1.52 days | Standard Deviation 0.823 |
| CSL425 (30 mcg) Cohort A | Duration of Solicited AEs After the First Vaccination | Nausea/vomiting | 1.05 days | Standard Deviation 0.213 |
| CSL425 (15 mcg) Cohort B | Duration of Solicited AEs After the First Vaccination | Muscle ache | 1.45 days | Standard Deviation 0.688 |
| CSL425 (15 mcg) Cohort B | Duration of Solicited AEs After the First Vaccination | Nausea/vomiting | 1.18 days | Standard Deviation 0.405 |
| CSL425 (15 mcg) Cohort B | Duration of Solicited AEs After the First Vaccination | Pain at injection site | 1.91 days | Standard Deviation 1.221 |
| CSL425 (15 mcg) Cohort B | Duration of Solicited AEs After the First Vaccination | Redness at injection site | 2.26 days | Standard Deviation 1.347 |
| CSL425 (15 mcg) Cohort B | Duration of Solicited AEs After the First Vaccination | Swelling/induration at injection site | 1.60 days | Standard Deviation 0.737 |
| CSL425 (15 mcg) Cohort B | Duration of Solicited AEs After the First Vaccination | Diarrhoea | 1.11 days | Standard Deviation 0.333 |
| CSL425 (15 mcg) Cohort B | Duration of Solicited AEs After the First Vaccination | Loss of appetite | NA days | — |
| CSL425 (15 mcg) Cohort B | Duration of Solicited AEs After the First Vaccination | Irritability | NA days | — |
| CSL425 (15 mcg) Cohort B | Duration of Solicited AEs After the First Vaccination | Fever | 1.40 days | Standard Deviation 0.737 |
| CSL425 (15 mcg) Cohort B | Duration of Solicited AEs After the First Vaccination | Headache | 2.04 days | Standard Deviation 2.911 |
| CSL425 (15 mcg) Cohort B | Duration of Solicited AEs After the First Vaccination | Malaise | 1.60 days | Standard Deviation 0.91 |
| CSL425 (30 mcg) Cohort B | Duration of Solicited AEs After the First Vaccination | Loss of appetite | NA days | — |
| CSL425 (30 mcg) Cohort B | Duration of Solicited AEs After the First Vaccination | Malaise | 1.69 days | Standard Deviation 1.966 |
| CSL425 (30 mcg) Cohort B | Duration of Solicited AEs After the First Vaccination | Headache | 1.63 days | Standard Deviation 1.149 |
| CSL425 (30 mcg) Cohort B | Duration of Solicited AEs After the First Vaccination | Diarrhoea | 1.17 days | Standard Deviation 0.577 |
| CSL425 (30 mcg) Cohort B | Duration of Solicited AEs After the First Vaccination | Nausea/vomiting | 1.53 days | Standard Deviation 1.837 |
| CSL425 (30 mcg) Cohort B | Duration of Solicited AEs After the First Vaccination | Swelling/induration at injection site | 2.04 days | Standard Deviation 1.136 |
| CSL425 (30 mcg) Cohort B | Duration of Solicited AEs After the First Vaccination | Muscle ache | 1.86 days | Standard Deviation 2.175 |
| CSL425 (30 mcg) Cohort B | Duration of Solicited AEs After the First Vaccination | Redness at injection site | 2.00 days | Standard Deviation 1.134 |
| CSL425 (30 mcg) Cohort B | Duration of Solicited AEs After the First Vaccination | Pain at injection site | 1.80 days | Standard Deviation 1.016 |
| CSL425 (30 mcg) Cohort B | Duration of Solicited AEs After the First Vaccination | Fever | 1.54 days | Standard Deviation 1.319 |
| CSL425 (30 mcg) Cohort B | Duration of Solicited AEs After the First Vaccination | Irritability | NA days | — |
Secondary
Duration of Solicited AEs After the Second Vaccination
Solicited AEs included AEs that were specifically sought for.
Time frame: During the 7 days after the second vaccination and up to Day 20 after the second vaccination if AE was ongoing at Day 7.
Population: The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CSL425 (15 mcg) Cohort A | Duration of Solicited AEs After the Second Vaccination | Irritability | 2.57 days | Standard Deviation 2.41 |
| CSL425 (15 mcg) Cohort A | Duration of Solicited AEs After the Second Vaccination | Pain at injection site | 1.67 days | Standard Deviation 0.966 |
| CSL425 (15 mcg) Cohort A | Duration of Solicited AEs After the Second Vaccination | Fever | 2.14 days | Standard Deviation 3.005 |
| CSL425 (15 mcg) Cohort A | Duration of Solicited AEs After the Second Vaccination | Swelling/induration at injection site | 1.74 days | Standard Deviation 0.872 |
| CSL425 (15 mcg) Cohort A | Duration of Solicited AEs After the Second Vaccination | Loss of appetite | 3.15 days | Standard Deviation 4.475 |
| CSL425 (15 mcg) Cohort A | Duration of Solicited AEs After the Second Vaccination | Malaise | NA days | — |
| CSL425 (15 mcg) Cohort A | Duration of Solicited AEs After the Second Vaccination | Headache | NA days | — |
| CSL425 (15 mcg) Cohort A | Duration of Solicited AEs After the Second Vaccination | Nausea/vomiting | 5.00 days | Standard Deviation 8.832 |
| CSL425 (15 mcg) Cohort A | Duration of Solicited AEs After the Second Vaccination | Muscle ache | NA days | — |
| CSL425 (15 mcg) Cohort A | Duration of Solicited AEs After the Second Vaccination | Redness at injection site | 1.69 days | Standard Deviation 1.004 |
| CSL425 (15 mcg) Cohort A | Duration of Solicited AEs After the Second Vaccination | Diarrhoea | 3.40 days | Standard Deviation 3.777 |
| CSL425 (30 mcg) Cohort A | Duration of Solicited AEs After the Second Vaccination | Fever | 1.63 days | Standard Deviation 1.165 |
| CSL425 (30 mcg) Cohort A | Duration of Solicited AEs After the Second Vaccination | Diarrhoea | 1.25 days | Standard Deviation 0.452 |
| CSL425 (30 mcg) Cohort A | Duration of Solicited AEs After the Second Vaccination | Loss of appetite | 1.73 days | Standard Deviation 0.883 |
| CSL425 (30 mcg) Cohort A | Duration of Solicited AEs After the Second Vaccination | Irritability | 2.10 days | Standard Deviation 1.533 |
| CSL425 (30 mcg) Cohort A | Duration of Solicited AEs After the Second Vaccination | Pain at injection site | 1.64 days | Standard Deviation 1.002 |
| CSL425 (30 mcg) Cohort A | Duration of Solicited AEs After the Second Vaccination | Redness at injection site | 2.14 days | Standard Deviation 1.037 |
| CSL425 (30 mcg) Cohort A | Duration of Solicited AEs After the Second Vaccination | Malaise | NA days | — |
| CSL425 (30 mcg) Cohort A | Duration of Solicited AEs After the Second Vaccination | Headache | NA days | — |
| CSL425 (30 mcg) Cohort A | Duration of Solicited AEs After the Second Vaccination | Swelling/induration at injection site | 2.32 days | Standard Deviation 1.108 |
| CSL425 (30 mcg) Cohort A | Duration of Solicited AEs After the Second Vaccination | Nausea/vomiting | 1.00 days | Standard Deviation 0 |
| CSL425 (30 mcg) Cohort A | Duration of Solicited AEs After the Second Vaccination | Muscle ache | NA days | — |
| CSL425 (15 mcg) Cohort B | Duration of Solicited AEs After the Second Vaccination | Fever | 1.54 days | Standard Deviation 0.877 |
| CSL425 (15 mcg) Cohort B | Duration of Solicited AEs After the Second Vaccination | Malaise | 1.20 days | Standard Deviation 0.422 |
| CSL425 (15 mcg) Cohort B | Duration of Solicited AEs After the Second Vaccination | Pain at injection site | 1.90 days | Standard Deviation 1.179 |
| CSL425 (15 mcg) Cohort B | Duration of Solicited AEs After the Second Vaccination | Redness at injection site | 1.92 days | Standard Deviation 1.055 |
| CSL425 (15 mcg) Cohort B | Duration of Solicited AEs After the Second Vaccination | Swelling/induration at injection site | 2.24 days | Standard Deviation 1.348 |
| CSL425 (15 mcg) Cohort B | Duration of Solicited AEs After the Second Vaccination | Nausea/vomiting | 1.43 days | Standard Deviation 0.787 |
| CSL425 (15 mcg) Cohort B | Duration of Solicited AEs After the Second Vaccination | Loss of appetite | NA days | — |
| CSL425 (15 mcg) Cohort B | Duration of Solicited AEs After the Second Vaccination | Irritability | NA days | — |
| CSL425 (15 mcg) Cohort B | Duration of Solicited AEs After the Second Vaccination | Diarrhoea | 1.40 days | Standard Deviation 0.894 |
| CSL425 (15 mcg) Cohort B | Duration of Solicited AEs After the Second Vaccination | Headache | 1.33 days | Standard Deviation 0.686 |
| CSL425 (15 mcg) Cohort B | Duration of Solicited AEs After the Second Vaccination | Muscle ache | 1.60 days | Standard Deviation 0.516 |
| CSL425 (30 mcg) Cohort B | Duration of Solicited AEs After the Second Vaccination | Diarrhoea | 2.00 days | Standard Deviation 1 |
| CSL425 (30 mcg) Cohort B | Duration of Solicited AEs After the Second Vaccination | Fever | 1.67 days | Standard Deviation 1.414 |
| CSL425 (30 mcg) Cohort B | Duration of Solicited AEs After the Second Vaccination | Swelling/induration at injection site | 2.27 days | Standard Deviation 1.751 |
| CSL425 (30 mcg) Cohort B | Duration of Solicited AEs After the Second Vaccination | Redness at injection site | 1.70 days | Standard Deviation 0.822 |
| CSL425 (30 mcg) Cohort B | Duration of Solicited AEs After the Second Vaccination | Muscle ache | 1.29 days | Standard Deviation 0.756 |
| CSL425 (30 mcg) Cohort B | Duration of Solicited AEs After the Second Vaccination | Headache | 1.73 days | Standard Deviation 2.412 |
| CSL425 (30 mcg) Cohort B | Duration of Solicited AEs After the Second Vaccination | Pain at injection site | 1.80 days | Standard Deviation 1.04 |
| CSL425 (30 mcg) Cohort B | Duration of Solicited AEs After the Second Vaccination | Malaise | 2.00 days | Standard Deviation 1.826 |
| CSL425 (30 mcg) Cohort B | Duration of Solicited AEs After the Second Vaccination | Irritability | NA days | — |
| CSL425 (30 mcg) Cohort B | Duration of Solicited AEs After the Second Vaccination | Loss of appetite | NA days | — |
| CSL425 (30 mcg) Cohort B | Duration of Solicited AEs After the Second Vaccination | Nausea/vomiting | 1.11 days | Standard Deviation 0.333 |
Secondary
Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination
Solicited AEs included AEs that were specifically sought for. Grade 3 solicited AE definitions: Cried when limb was moved/spontaneously painful (Cohort A) or prevented normal daily activities (Cohort B) for injection site pain; Size \> 100 mm for injection site redness and induration/swelling; Temperature \> 103.1°F (39.5°C) for fevers; Prevented normal daily activities or required medical intervention for all other systemic AEs.
Time frame: During the 7 days after each vaccination
Population: The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Any swelling/induration at injection site | 30.5 percentage of participants |
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Any muscle ache | NA percentage of participants |
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Grade 3 diarrhoea | 1.2 percentage of participants |
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Any diarrhoea | 26.8 percentage of participants |
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Grade 3 swelling/induration at injection site | 0 percentage of participants |
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Grade 3 headache | NA percentage of participants |
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Grade 3 nausea/vomiting | 1.2 percentage of participants |
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Any nausea/vomiting | 13.4 percentage of participants |
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Any solicited systemic AE | 79.3 percentage of participants |
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Any pain at injection site | 48.8 percentage of participants |
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Grade 3 muscle ache | NA percentage of participants |
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Any headache | NA percentage of participants |
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Grade 3 fever | 1.2 percentage of participants |
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Grade 3 pain at injection site | 1.2 percentage of participants |
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Any malaise | NA percentage of participants |
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Any fever | 50.0 percentage of participants |
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Grade 3 irritability | 2.4 percentage of participants |
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Any redness at injection site | 53.7 percentage of participants |
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Any solicited local AE | 69.5 percentage of participants |
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Any irritability | 63.4 percentage of participants |
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Grade 3 loss of appetite | 1.2 percentage of participants |
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Grade 3 redness at injection site | 0 percentage of participants |
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Grade 3 malaise | NA percentage of participants |
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Any loss of appetite | 40.2 percentage of participants |
| CSL425 (30 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Grade 3 fever | 8.8 percentage of participants |
| CSL425 (30 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Grade 3 diarrhoea | 0 percentage of participants |
| CSL425 (30 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Any solicited local AE | 63.8 percentage of participants |
| CSL425 (30 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Any pain at injection site | 43.8 percentage of participants |
| CSL425 (30 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Grade 3 pain at injection site | 1.3 percentage of participants |
| CSL425 (30 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Any redness at injection site | 38.8 percentage of participants |
| CSL425 (30 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Grade 3 redness at injection site | 1.3 percentage of participants |
| CSL425 (30 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Any swelling/induration at injection site | 32.5 percentage of participants |
| CSL425 (30 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Grade 3 swelling/induration at injection site | 2.5 percentage of participants |
| CSL425 (30 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Any solicited systemic AE | 93.8 percentage of participants |
| CSL425 (30 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Any nausea/vomiting | 30.0 percentage of participants |
| CSL425 (30 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Grade 3 nausea/vomiting | 1.3 percentage of participants |
| CSL425 (30 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Any diarrhoea | 32.5 percentage of participants |
| CSL425 (30 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Any loss of appetite | 50.0 percentage of participants |
| CSL425 (30 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Grade 3 loss of appetite | 0 percentage of participants |
| CSL425 (30 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Any irritability | 72.5 percentage of participants |
| CSL425 (30 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Grade 3 irritability | 1.3 percentage of participants |
| CSL425 (30 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Any fever | 71.3 percentage of participants |
| CSL425 (30 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Any headache | NA percentage of participants |
| CSL425 (30 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Grade 3 headache | NA percentage of participants |
| CSL425 (30 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Any muscle ache | NA percentage of participants |
| CSL425 (30 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Grade 3 muscle ache | NA percentage of participants |
| CSL425 (30 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Any malaise | NA percentage of participants |
| CSL425 (30 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Grade 3 malaise | NA percentage of participants |
| CSL425 (15 mcg) Cohort B | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Any swelling/induration at injection site | 25.2 percentage of participants |
| CSL425 (15 mcg) Cohort B | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Grade 3 redness at injection site | 2.9 percentage of participants |
| CSL425 (15 mcg) Cohort B | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Any loss of appetite | NA percentage of participants |
| CSL425 (15 mcg) Cohort B | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Grade 3 loss of appetite | NA percentage of participants |
| CSL425 (15 mcg) Cohort B | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Any redness at injection site | 37.9 percentage of participants |
| CSL425 (15 mcg) Cohort B | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Grade 3 muscle ache | 0 percentage of participants |
| CSL425 (15 mcg) Cohort B | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Any irritability | NA percentage of participants |
| CSL425 (15 mcg) Cohort B | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Grade 3 irritability | NA percentage of participants |
| CSL425 (15 mcg) Cohort B | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Grade 3 pain at injection site | 0 percentage of participants |
| CSL425 (15 mcg) Cohort B | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Grade 3 malaise | 0 percentage of participants |
| CSL425 (15 mcg) Cohort B | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Any fever | 20.4 percentage of participants |
| CSL425 (15 mcg) Cohort B | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Grade 3 fever | 0 percentage of participants |
| CSL425 (15 mcg) Cohort B | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Any pain at injection site | 59.2 percentage of participants |
| CSL425 (15 mcg) Cohort B | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Any malaise | 19.4 percentage of participants |
| CSL425 (15 mcg) Cohort B | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Any headache | 27.2 percentage of participants |
| CSL425 (15 mcg) Cohort B | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Grade 3 headache | 0 percentage of participants |
| CSL425 (15 mcg) Cohort B | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Any solicited systemic AE | 54.4 percentage of participants |
| CSL425 (15 mcg) Cohort B | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Any solicited local AE | 68.0 percentage of participants |
| CSL425 (15 mcg) Cohort B | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Any nausea/vomiting | 15.5 percentage of participants |
| CSL425 (15 mcg) Cohort B | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Grade 3 swelling/induration at injection site | 0 percentage of participants |
| CSL425 (15 mcg) Cohort B | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Grade 3 diarrhoea | 0 percentage of participants |
| CSL425 (15 mcg) Cohort B | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Grade 3 nausea/vomiting | 0 percentage of participants |
| CSL425 (15 mcg) Cohort B | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Any muscle ache | 15.5 percentage of participants |
| CSL425 (15 mcg) Cohort B | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Any diarrhoea | 12.6 percentage of participants |
| CSL425 (30 mcg) Cohort B | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Any solicited systemic AE | 61.5 percentage of participants |
| CSL425 (30 mcg) Cohort B | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Grade 3 diarrhoea | 0 percentage of participants |
| CSL425 (30 mcg) Cohort B | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Grade 3 fever | 2.9 percentage of participants |
| CSL425 (30 mcg) Cohort B | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Any muscle ache | 22.1 percentage of participants |
| CSL425 (30 mcg) Cohort B | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Grade 3 swelling/induration at injection site | 4.8 percentage of participants |
| CSL425 (30 mcg) Cohort B | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Any loss of appetite | NA percentage of participants |
| CSL425 (30 mcg) Cohort B | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Any redness at injection site | 37.5 percentage of participants |
| CSL425 (30 mcg) Cohort B | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Grade 3 malaise | 1.9 percentage of participants |
| CSL425 (30 mcg) Cohort B | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Any swelling/induration at injection site | 26.9 percentage of participants |
| CSL425 (30 mcg) Cohort B | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Grade 3 loss of appetite | NA percentage of participants |
| CSL425 (30 mcg) Cohort B | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Any diarrhoea | 12.5 percentage of participants |
| CSL425 (30 mcg) Cohort B | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Any headache | 23.1 percentage of participants |
| CSL425 (30 mcg) Cohort B | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Any solicited local AE | 71.2 percentage of participants |
| CSL425 (30 mcg) Cohort B | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Any irritability | NA percentage of participants |
| CSL425 (30 mcg) Cohort B | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Grade 3 pain at injection site | 1.0 percentage of participants |
| CSL425 (30 mcg) Cohort B | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Grade 3 muscle ache | 1.0 percentage of participants |
| CSL425 (30 mcg) Cohort B | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Any malaise | 26.9 percentage of participants |
| CSL425 (30 mcg) Cohort B | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Grade 3 irritability | NA percentage of participants |
| CSL425 (30 mcg) Cohort B | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Any nausea/vomiting | 20.2 percentage of participants |
| CSL425 (30 mcg) Cohort B | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Grade 3 headache | 1.0 percentage of participants |
| CSL425 (30 mcg) Cohort B | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Grade 3 nausea/vomiting | 1.0 percentage of participants |
| CSL425 (30 mcg) Cohort B | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Any fever | 29.8 percentage of participants |
| CSL425 (30 mcg) Cohort B | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Any pain at injection site | 64.4 percentage of participants |
| CSL425 (30 mcg) Cohort B | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Grade 3 redness at injection site | 2.9 percentage of participants |
Secondary
Frequency and Intensity of Unsolicited Adverse Events After the First or Second Vaccination
Unsolicited AEs included AEs other than those specifically sought for. Grade 1 unsolicited AE definition: Easily tolerated and did not interfere with normal daily activities. Grade 2 unsolicited AE definition: Some interference with normal daily activities. Grade 3 unsolicited AE definition: Prevented normal daily activities.
Time frame: During the 21 days after each vaccination; up to 180 days after the last vaccination for SAEs, AESIs, and NOCIs
Population: The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Unsolicited Adverse Events After the First or Second Vaccination | At least one unsolicited AE | 78.0 percentage of participants |
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Unsolicited Adverse Events After the First or Second Vaccination | Grade 3 unsolicited AE | 9.8 percentage of participants |
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Unsolicited Adverse Events After the First or Second Vaccination | Grade 1 unsolicited AE | 26.8 percentage of participants |
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Unsolicited Adverse Events After the First or Second Vaccination | Grade 2 unsolicited AE | 41.5 percentage of participants |
| CSL425 (30 mcg) Cohort A | Frequency and Intensity of Unsolicited Adverse Events After the First or Second Vaccination | Grade 1 unsolicited AE | 33.8 percentage of participants |
| CSL425 (30 mcg) Cohort A | Frequency and Intensity of Unsolicited Adverse Events After the First or Second Vaccination | Grade 3 unsolicited AE | 7.5 percentage of participants |
| CSL425 (30 mcg) Cohort A | Frequency and Intensity of Unsolicited Adverse Events After the First or Second Vaccination | At least one unsolicited AE | 82.5 percentage of participants |
| CSL425 (30 mcg) Cohort A | Frequency and Intensity of Unsolicited Adverse Events After the First or Second Vaccination | Grade 2 unsolicited AE | 41.3 percentage of participants |
| CSL425 (15 mcg) Cohort B | Frequency and Intensity of Unsolicited Adverse Events After the First or Second Vaccination | At least one unsolicited AE | 67.0 percentage of participants |
| CSL425 (15 mcg) Cohort B | Frequency and Intensity of Unsolicited Adverse Events After the First or Second Vaccination | Grade 1 unsolicited AE | 27.2 percentage of participants |
| CSL425 (15 mcg) Cohort B | Frequency and Intensity of Unsolicited Adverse Events After the First or Second Vaccination | Grade 2 unsolicited AE | 37.9 percentage of participants |
| CSL425 (15 mcg) Cohort B | Frequency and Intensity of Unsolicited Adverse Events After the First or Second Vaccination | Grade 3 unsolicited AE | 1.9 percentage of participants |
| CSL425 (30 mcg) Cohort B | Frequency and Intensity of Unsolicited Adverse Events After the First or Second Vaccination | Grade 3 unsolicited AE | 11.5 percentage of participants |
| CSL425 (30 mcg) Cohort B | Frequency and Intensity of Unsolicited Adverse Events After the First or Second Vaccination | Grade 2 unsolicited AE | 26.9 percentage of participants |
| CSL425 (30 mcg) Cohort B | Frequency and Intensity of Unsolicited Adverse Events After the First or Second Vaccination | Grade 1 unsolicited AE | 37.5 percentage of participants |
| CSL425 (30 mcg) Cohort B | Frequency and Intensity of Unsolicited Adverse Events After the First or Second Vaccination | At least one unsolicited AE | 76.0 percentage of participants |
Secondary
Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs)
An AESI was defined as an AE for which the association with seasonal influenza vaccine was unclear. A NOCI was defined as the diagnosis of a new medical condition that was chronic in nature, including those potentially controllable by medication (eg, diabetes, asthma).
Time frame: Up to 180 days after the last vaccination
Population: The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CSL425 (15 mcg) Cohort A | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs) | At least one AESI | 2.4 percentage of participants |
| CSL425 (15 mcg) Cohort A | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs) | Related SAE | 0 percentage of participants |
| CSL425 (15 mcg) Cohort A | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs) | At least one NOCI | 1.2 percentage of participants |
| CSL425 (15 mcg) Cohort A | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs) | Related AESI | 0 percentage of participants |
| CSL425 (15 mcg) Cohort A | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs) | At least one SAE | 4.9 percentage of participants |
| CSL425 (15 mcg) Cohort A | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs) | Related NOCI | 0 percentage of participants |
| CSL425 (30 mcg) Cohort A | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs) | Related NOCI | 0 percentage of participants |
| CSL425 (30 mcg) Cohort A | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs) | At least one SAE | 1.3 percentage of participants |
| CSL425 (30 mcg) Cohort A | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs) | Related SAE | 0 percentage of participants |
| CSL425 (30 mcg) Cohort A | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs) | At least one AESI | 1.3 percentage of participants |
| CSL425 (30 mcg) Cohort A | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs) | Related AESI | 0 percentage of participants |
| CSL425 (30 mcg) Cohort A | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs) | At least one NOCI | 3.8 percentage of participants |
| CSL425 (15 mcg) Cohort B | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs) | At least one SAE | 1.0 percentage of participants |
| CSL425 (15 mcg) Cohort B | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs) | At least one AESI | 0 percentage of participants |
| CSL425 (15 mcg) Cohort B | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs) | Related NOCI | 0 percentage of participants |
| CSL425 (15 mcg) Cohort B | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs) | Related AESI | 0 percentage of participants |
| CSL425 (15 mcg) Cohort B | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs) | At least one NOCI | 1.9 percentage of participants |
| CSL425 (15 mcg) Cohort B | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs) | Related SAE | 0 percentage of participants |
| CSL425 (30 mcg) Cohort B | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs) | At least one SAE | 1.0 percentage of participants |
| CSL425 (30 mcg) Cohort B | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs) | At least one NOCI | 0 percentage of participants |
| CSL425 (30 mcg) Cohort B | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs) | Related SAE | 1.0 percentage of participants |
| CSL425 (30 mcg) Cohort B | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs) | At least one AESI | 0 percentage of participants |
| CSL425 (30 mcg) Cohort B | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs) | Related NOCI | 0 percentage of participants |
| CSL425 (30 mcg) Cohort B | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs) | Related AESI | 0 percentage of participants |