Influenza
Conditions
Brief summary
The purpose of this study is to evaluate the immunogenicity and safety profile of CSL425 (CSL's 2009 H1N1 influenza vaccine) in a healthy pediatric population.
Interventions
BIOLOGICALCSL's 2009 H1N1 Influenza Vaccine (CSL425)
0.5 mL intramuscular injection on Day 0 and Day 21
BIOLOGICALPlacebo
Placebo
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 9 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 gestation.
Exclusion criteria
* Known hypersensitivity to a previous dose of influenza virus vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of the Study Vaccine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seroconversion Rate 21 Days After First Study Vaccination | 21 days after the first study vaccination | Seroconversion rate: the percentage of participants achieving seroconversion in HI antibody titer. Seroconversion is defined as participants with a pre-vaccination titer of less than 1:10 achieving a post-vaccination HI antibody titer of 1:40 or more; or participants with a pre-vaccination HI titer of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titer. |
| Seroconversion Rate 21 Days After Second Study Vaccination | 21 days after the second study vaccination | Seroconversion rate: the percentage of participants achieving seroconversion in HI antibody titer. Seroconversion is defined as participants with a pre-vaccination titer of less than 1:10 achieving a post-vaccination HI antibody titer of 1:40 or more; or participants with a pre-vaccination HI titer of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titer. |
| Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After First Study Vaccination | 21 days after the first study vaccination | — |
| Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After Second Study Vaccination | 21 days after the second study vaccination | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination | During the 21 days after each vaccination | UAE grading: Grade 1: Symptoms were easily tolerated and did not interfere with daily activities. Grade 2: Enough discomfort to cause some interference with daily activities. Grade 3: Symptoms that prevented normal, everyday activities. |
| Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A | During the 7 days after each study vaccination | Grade 3 solicited AE definitions: Prevented normal daily activities or required medical intervention for systemic AEs; Cried when limb was moved/spontaneously painful (aged \< 3 years) for injection site pain; Size \> 30 mm for injection site redness and injection site induration/swelling; Oral temperature \> 104.0°F (40.0°C) or axillary temperature \> 103.1°F (39.5°C) for fevers. |
| Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset of Chronic Illness (NOCIs) | Up to 180 days after the last vaccination | A NOCI was defined as the diagnosis of a new medical condition that was chronic in nature, including those potentially controllable by medication (e.g., diabetes, asthma). |
| Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A | During the 7 days after each study vaccination | — |
| Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B | During the 7 days after each study vaccination | Grade 3 solicited AE definitions: Prevented normal daily activities or required medical intervention for systemic AEs; Prevented normal daily activities (aged \>= 3 years)for injection site pain; Size \> 30 mm for injection site redness and injection site induration/swelling; Oral temperature \> 104.0°F (40.0°C) or axillary temperature \> 103.1°F (39.5°C) for fevers. |
| Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B | During the 7 days after each study vaccination | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Cohort A Placebo, Aged 6 months to less than 3 years | 26 |
| CSL425 (7.5 mcg) Cohort A 7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years | 105 |
| CSL425 (15 mcg) Cohort A 15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years | 96 |
| Placebo Cohort B Placebo, Aged 3 years to less than 9 years | 28 |
| CSL425 (7.5 mcg) Cohort B 7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years | 109 |
| CSL425 (15 mcg) Cohort B 15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years | 109 |
| Total | 473 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 5 | 11 | 2 | 8 | 5 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 3 | 1 | 1 | 5 |
Baseline characteristics
| Characteristic | CSL425 (7.5 mcg) Cohort A | CSL425 (15 mcg) Cohort A | Placebo Cohort B | Placebo Cohort A | CSL425 (7.5 mcg) Cohort B | CSL425 (15 mcg) Cohort B | Total |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 105 Participants | 96 Participants | 28 Participants | 26 Participants | 109 Participants | 109 Participants | 473 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 1.73 years STANDARD_DEVIATION 0.72 | 1.85 years STANDARD_DEVIATION 0.66 | 5.90 years STANDARD_DEVIATION 1.71 | 1.87 years STANDARD_DEVIATION 0.77 | 5.94 years STANDARD_DEVIATION 1.71 | 5.91 years STANDARD_DEVIATION 1.7 | 3.93 years STANDARD_DEVIATION 2.45 |
| Region of Enrollment United States | 105 participants | 96 participants | 28 participants | 26 participants | 109 participants | 109 participants | 473 participants |
| Sex: Female, Male Female | 57 Participants | 44 Participants | 13 Participants | 11 Participants | 53 Participants | 50 Participants | 228 Participants |
| Sex: Female, Male Male | 48 Participants | 52 Participants | 15 Participants | 15 Participants | 56 Participants | 59 Participants | 245 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 25 / 26 | 58 / 105 | 82 / 96 | 22 / 28 | 70 / 107 | 49 / 109 |
| serious Total, serious adverse events | 0 / 26 | 2 / 105 | 3 / 96 | 0 / 28 | 0 / 107 | 0 / 109 |
Outcome results
Primary
Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After First Study Vaccination
Time frame: 21 days after the first study vaccination
Population: The Evaluable Population (for the first vaccination) comprised all randomized participants who received the first study vaccine; provided both pre- and post-vaccination blood samples; were not excluded from analyses (e.g., the use of a prohibited medication or a laboratory confirmed infection with 2009 H1N1 between Visit 1 and Visit 3).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Cohort A | Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After First Study Vaccination | 8.0 Percentage of participants |
| CSL425 (7.5 mcg) Cohort A | Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After First Study Vaccination | 90.2 Percentage of participants |
| CSL425 (15 mcg) Cohort A | Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After First Study Vaccination | 84.3 Percentage of participants |
| Placebo Cohort B | Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After First Study Vaccination | 25.9 Percentage of participants |
| CSL425 (7.5 mcg) Cohort B | Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After First Study Vaccination | 84.6 Percentage of participants |
| CSL425 (15 mcg) Cohort B | Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After First Study Vaccination | 89.2 Percentage of participants |
Primary
Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After Second Study Vaccination
Time frame: 21 days after the second study vaccination
Population: The Evaluable Population (for the second vaccination) comprised all randomized participants who received the second study vaccine; provided both pre- and post-vaccination blood samples; were not excluded from analyses (e.g., the use of a prohibited medication or a laboratory confirmed infection with 2009 H1N1 between Visit 1 and Visit 3).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Cohort A | Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After Second Study Vaccination | 28.6 Percentage of participants |
| CSL425 (7.5 mcg) Cohort A | Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After Second Study Vaccination | 98.9 Percentage of participants |
| CSL425 (15 mcg) Cohort A | Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After Second Study Vaccination | 100.0 Percentage of participants |
| Placebo Cohort B | Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After Second Study Vaccination | 34.6 Percentage of participants |
| CSL425 (7.5 mcg) Cohort B | Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After Second Study Vaccination | 98.0 Percentage of participants |
| CSL425 (15 mcg) Cohort B | Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After Second Study Vaccination | 100.0 Percentage of participants |
Primary
Seroconversion Rate 21 Days After First Study Vaccination
Seroconversion rate: the percentage of participants achieving seroconversion in HI antibody titer. Seroconversion is defined as participants with a pre-vaccination titer of less than 1:10 achieving a post-vaccination HI antibody titer of 1:40 or more; or participants with a pre-vaccination HI titer of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titer.
Time frame: 21 days after the first study vaccination
Population: The Evaluable Population (for the first vaccination) comprised all randomized participants who received the first study vaccine; provided both pre- and post-vaccination blood samples; were not excluded from analyses (e.g., the use of a prohibited medication or a laboratory confirmed infection with 2009 H1N1 between Visit 1 and Visit 3).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Cohort A | Seroconversion Rate 21 Days After First Study Vaccination | 4.0 Percentage of participants |
| CSL425 (7.5 mcg) Cohort A | Seroconversion Rate 21 Days After First Study Vaccination | 88.2 Percentage of participants |
| CSL425 (15 mcg) Cohort A | Seroconversion Rate 21 Days After First Study Vaccination | 83.1 Percentage of participants |
| Placebo Cohort B | Seroconversion Rate 21 Days After First Study Vaccination | 3.7 Percentage of participants |
| CSL425 (7.5 mcg) Cohort B | Seroconversion Rate 21 Days After First Study Vaccination | 84.6 Percentage of participants |
| CSL425 (15 mcg) Cohort B | Seroconversion Rate 21 Days After First Study Vaccination | 88.2 Percentage of participants |
Primary
Seroconversion Rate 21 Days After Second Study Vaccination
Seroconversion rate: the percentage of participants achieving seroconversion in HI antibody titer. Seroconversion is defined as participants with a pre-vaccination titer of less than 1:10 achieving a post-vaccination HI antibody titer of 1:40 or more; or participants with a pre-vaccination HI titer of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titer.
Time frame: 21 days after the second study vaccination
Population: The Evaluable Population (for the second vaccination) comprised all randomized participants who received the second study vaccine; provided both pre- and post-vaccination blood samples; were not excluded from analyses (e.g., the use of a prohibited medication or a laboratory confirmed infection with 2009 H1N1 between Visit 1 and Visit 3).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Cohort A | Seroconversion Rate 21 Days After Second Study Vaccination | 28.6 Percentage of participants |
| CSL425 (7.5 mcg) Cohort A | Seroconversion Rate 21 Days After Second Study Vaccination | 98.9 Percentage of participants |
| CSL425 (15 mcg) Cohort A | Seroconversion Rate 21 Days After Second Study Vaccination | 100.0 Percentage of participants |
| Placebo Cohort B | Seroconversion Rate 21 Days After Second Study Vaccination | 15.4 Percentage of participants |
| CSL425 (7.5 mcg) Cohort B | Seroconversion Rate 21 Days After Second Study Vaccination | 98.0 Percentage of participants |
| CSL425 (15 mcg) Cohort B | Seroconversion Rate 21 Days After Second Study Vaccination | 99.0 Percentage of participants |
Secondary
Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A
Time frame: During the 7 days after each study vaccination
Population: Safety Population comprised all randomized participants who received at least one dose of study vaccine and had provided follow-up safety data.In Cohort A, Safety Population after the first vaccination are placebo group 26, 7.5 mcg group 105 and 15 mcg group 96; and 25, 101 and 91 respectively after the second vaccination.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A | Any nausea / vomiting after first vaccination | 1.00 Days | Standard Deviation 0 |
| Placebo Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A | Any redness after first vaccination | 1.50 Days | Standard Deviation 0.577 |
| Placebo Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A | Any swelling / induration after first vaccination | 1.50 Days | Standard Deviation 0.707 |
| Placebo Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A | Any fever after first vaccination | 3.33 Days | Standard Deviation 3.215 |
| Placebo Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A | Any pain after first vaccination | 1.00 Days | Standard Deviation 0 |
| Placebo Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A | Any diarrhea after first vaccination | 1.67 Days | Standard Deviation 0.707 |
| Placebo Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A | Any loss of appetite after first vaccination | 2.00 Days | — |
| Placebo Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A | Any irritability after first vaccination | 6.00 Days | Standard Deviation 7.81 |
| Placebo Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A | Any pain after second vaccination | 1.43 Days | Standard Deviation 0.787 |
| Placebo Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A | Any redness after second vaccination | 2.40 Days | Standard Deviation 2.608 |
| Placebo Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A | Any swelling / induration after second vaccination | 3.00 Days | — |
| Placebo Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A | Any fever after second vaccination | 1.40 Days | Standard Deviation 0.894 |
| Placebo Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A | Any nausea / vomiting after second vaccination | NA Days | — |
| Placebo Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A | Any diarrhea after second vaccination | 8.00 Days | Standard Deviation 9.899 |
| Placebo Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A | Any loss of appetite after second vaccination | 1.50 Days | Standard Deviation 0.707 |
| Placebo Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A | Any irritability after second vaccination | 1.50 Days | Standard Deviation 0.577 |
| CSL425 (7.5 mcg) Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A | Any diarrhea after first vaccination | 2.38 Days | Standard Deviation 1.996 |
| CSL425 (7.5 mcg) Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A | Any loss of appetite after first vaccination | 3.13 Days | Standard Deviation 2.5 |
| CSL425 (7.5 mcg) Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A | Any irritability after first vaccination | 2.08 Days | Standard Deviation 1.412 |
| CSL425 (7.5 mcg) Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A | Any diarrhea after second vaccination | 1.92 Days | Standard Deviation 1.248 |
| CSL425 (7.5 mcg) Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A | Any pain after second vaccination | 1.57 Days | Standard Deviation 0.676 |
| CSL425 (7.5 mcg) Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A | Any redness after second vaccination | 2.00 Days | Standard Deviation 1.24 |
| CSL425 (7.5 mcg) Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A | Any irritability after second vaccination | 1.81 Days | Standard Deviation 1.001 |
| CSL425 (7.5 mcg) Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A | Any swelling / induration after second vaccination | 3.00 Days | Standard Deviation 2.098 |
| CSL425 (7.5 mcg) Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A | Any pain after first vaccination | 1.52 Days | Standard Deviation 0.677 |
| CSL425 (7.5 mcg) Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A | Any loss of appetite after second vaccination | 1.75 Days | Standard Deviation 1.183 |
| CSL425 (7.5 mcg) Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A | Any redness after first vaccination | 2.20 Days | Standard Deviation 1.323 |
| CSL425 (7.5 mcg) Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A | Any fever after second vaccination | 1.40 Days | Standard Deviation 0.894 |
| CSL425 (7.5 mcg) Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A | Any swelling / induration after first vaccination | 1.63 Days | Standard Deviation 0.957 |
| CSL425 (7.5 mcg) Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A | Any fever after first vaccination | 1.32 Days | Standard Deviation 0.557 |
| CSL425 (7.5 mcg) Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A | Any nausea / vomiting after first vaccination | 1.43 Days | Standard Deviation 0.535 |
| CSL425 (7.5 mcg) Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A | Any nausea / vomiting after second vaccination | 1.27 Days | Standard Deviation 0.647 |
| CSL425 (15 mcg) Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A | Any swelling / induration after second vaccination | 2.50 Days | Standard Deviation 0.707 |
| CSL425 (15 mcg) Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A | Any diarrhea after first vaccination | 3.95 Days | Standard Deviation 4.248 |
| CSL425 (15 mcg) Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A | Any nausea / vomiting after second vaccination | 1.50 Days | Standard Deviation 0.837 |
| CSL425 (15 mcg) Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A | Any swelling / induration after first vaccination | 2.00 Days | Standard Deviation 1.549 |
| CSL425 (15 mcg) Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A | Any loss of appetite after first vaccination | 2.07 Days | Standard Deviation 1.486 |
| CSL425 (15 mcg) Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A | Any irritability after second vaccination | 2.86 Days | Standard Deviation 4.597 |
| CSL425 (15 mcg) Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A | Any pain after first vaccination | 1.91 Days | Standard Deviation 1.743 |
| CSL425 (15 mcg) Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A | Any irritability after first vaccination | 1.97 Days | Standard Deviation 1.224 |
| CSL425 (15 mcg) Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A | Any fever after second vaccination | 2.19 Days | Standard Deviation 2.344 |
| CSL425 (15 mcg) Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A | Any nausea / vomiting after first vaccination | 1.11 Days | Standard Deviation 0.333 |
| CSL425 (15 mcg) Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A | Any pain after second vaccination | 1.23 Days | Standard Deviation 0.599 |
| CSL425 (15 mcg) Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A | Any diarrhea after second vaccination | 4.33 Days | Standard Deviation 6.754 |
| CSL425 (15 mcg) Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A | Any redness after first vaccination | 2.56 Days | Standard Deviation 1.459 |
| CSL425 (15 mcg) Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A | Any redness after second vaccination | 1.63 Days | Standard Deviation 0.916 |
| CSL425 (15 mcg) Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A | Any fever after first vaccination | 1.29 Days | Standard Deviation 0.893 |
| CSL425 (15 mcg) Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A | Any loss of appetite after second vaccination | 3.60 Days | Standard Deviation 5.168 |
Secondary
Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B
Time frame: During the 7 days after each study vaccination
Population: Safety Population comprised all randomized participants who received at least one dose of study vaccine and had provided follow-up safety data. In Cohort B, Safety Population after the first vaccination are placebo group 28, 7.5 mcg group 107 and 15 mcg group 109; and 27, 105 and 103 respectively after the second vaccination.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B | Any pain after first vaccination | 1.33 Days | Standard Deviation 0.516 |
| Placebo Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B | Any swelling / induration after second vaccination | 2.00 Days | — |
| Placebo Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B | Any malaise after first vaccination | 1.38 Days | Standard Deviation 0.744 |
| Placebo Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B | Any malaise after second vaccination | 1.50 Days | Standard Deviation 0.707 |
| Placebo Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B | Any redness after second vaccination | 2.00 Days | Standard Deviation 0 |
| Placebo Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B | Any myalgia after first vaccination | 1.60 Days | Standard Deviation 0.548 |
| Placebo Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B | Any swelling / induration after first vaccination | 2.00 Days | Standard Deviation 1.732 |
| Placebo Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B | Any pain after second vaccination | 1.25 Days | Standard Deviation 0.5 |
| Placebo Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B | Any headache after first vaccination | 1.40 Days | Standard Deviation 0.894 |
| Placebo Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B | Any headache after second vaccination | 1.50 Days | Standard Deviation 0.707 |
| Placebo Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B | Any diarrhea after second vaccination | 1 Days | — |
| Placebo Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B | Any fever after first vaccination | 1.20 Days | Standard Deviation 0.447 |
| Placebo Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B | Any myalgia after second vaccination | 1.00 Days | — |
| Placebo Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B | Any nausea / vomiting after second vaccination | 1.00 Days | — |
| Placebo Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B | Any nausea / vomiting after first vaccination | 1.00 Days | Standard Deviation 0 |
| Placebo Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B | Any redness after first vaccination | 2.29 Days | Standard Deviation 1.254 |
| Placebo Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B | Any fever after second vaccination | 1.00 Days | — |
| Placebo Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B | Any diarrhea after first vaccination | 1.13 Days | Standard Deviation 0.354 |
| CSL425 (7.5 mcg) Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B | Any redness after second vaccination | 1.67 Days | Standard Deviation 0.516 |
| CSL425 (7.5 mcg) Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B | Any pain after first vaccination | 1.63 Days | Standard Deviation 1.066 |
| CSL425 (7.5 mcg) Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B | Any redness after first vaccination | 2.17 Days | Standard Deviation 1.339 |
| CSL425 (7.5 mcg) Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B | Any swelling / induration after first vaccination | 1.80 Days | Standard Deviation 0.632 |
| CSL425 (7.5 mcg) Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B | Any fever after first vaccination | 1.12 Days | Standard Deviation 0.332 |
| CSL425 (7.5 mcg) Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B | Any nausea / vomiting after first vaccination | 1.25 Days | Standard Deviation 0.5 |
| CSL425 (7.5 mcg) Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B | Any diarrhea after first vaccination | 1.00 Days | Standard Deviation 0 |
| CSL425 (7.5 mcg) Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B | Any malaise after first vaccination | 1.47 Days | Standard Deviation 0.964 |
| CSL425 (7.5 mcg) Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B | Any myalgia after first vaccination | 1.42 Days | Standard Deviation 0.669 |
| CSL425 (7.5 mcg) Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B | Any headache after first vaccination | 1.15 Days | Standard Deviation 0.376 |
| CSL425 (7.5 mcg) Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B | Any pain after second vaccination | 1.56 Days | Standard Deviation 0.856 |
| CSL425 (7.5 mcg) Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B | Any headache after second vaccination | 1.38 Days | Standard Deviation 0.518 |
| CSL425 (7.5 mcg) Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B | Any swelling / induration after second vaccination | 1.17 Days | Standard Deviation 0.408 |
| CSL425 (7.5 mcg) Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B | Any fever after second vaccination | 1.40 Days | Standard Deviation 0.548 |
| CSL425 (7.5 mcg) Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B | Any nausea / vomiting after second vaccination | 1.25 Days | Standard Deviation 0.5 |
| CSL425 (7.5 mcg) Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B | Any diarrhea after second vaccination | 1.00 Days | Standard Deviation 0 |
| CSL425 (7.5 mcg) Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B | Any malaise after second vaccination | 1.75 Days | Standard Deviation 0.754 |
| CSL425 (7.5 mcg) Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B | Any myalgia after second vaccination | 1.38 Days | Standard Deviation 0.518 |
| CSL425 (15 mcg) Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B | Any myalgia after second vaccination | 1.42 Days | Standard Deviation 0.669 |
| CSL425 (15 mcg) Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B | Any swelling / induration after second vaccination | 1.63 Days | Standard Deviation 0.744 |
| CSL425 (15 mcg) Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B | Any nausea / vomiting after first vaccination | 1.00 Days | Standard Deviation 0 |
| CSL425 (15 mcg) Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B | Any malaise after second vaccination | 1.83 Days | Standard Deviation 1.467 |
| CSL425 (15 mcg) Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B | Any fever after second vaccination | 1.57 Days | Standard Deviation 1.134 |
| CSL425 (15 mcg) Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B | Any fever after first vaccination | 1.56 Days | Standard Deviation 0.856 |
| CSL425 (15 mcg) Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B | Any pain after first vaccination | 1.46 Days | Standard Deviation 0.691 |
| CSL425 (15 mcg) Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B | Any nausea / vomiting after second vaccination | 1.17 Days | Standard Deviation 0.408 |
| CSL425 (15 mcg) Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B | Any swelling / induration after first vaccination | 1.79 Days | Standard Deviation 0.975 |
| CSL425 (15 mcg) Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B | Any headache after second vaccination | 1.29 Days | Standard Deviation 0.488 |
| CSL425 (15 mcg) Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B | Any headache after first vaccination | 1.25 Days | Standard Deviation 0.645 |
| CSL425 (15 mcg) Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B | Any myalgia after first vaccination | 1.56 Days | Standard Deviation 0.984 |
| CSL425 (15 mcg) Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B | Any diarrhea after second vaccination | 1.00 Days | Standard Deviation 0 |
| CSL425 (15 mcg) Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B | Any pain after second vaccination | 1.33 Days | Standard Deviation 0.555 |
| CSL425 (15 mcg) Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B | Any malaise after first vaccination | 1.60 Days | Standard Deviation 0.995 |
| CSL425 (15 mcg) Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B | Any redness after first vaccination | 2.24 Days | Standard Deviation 1.809 |
| CSL425 (15 mcg) Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B | Any redness after second vaccination | 1.60 Days | Standard Deviation 0.699 |
| CSL425 (15 mcg) Cohort A | Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B | Any diarrhea after first vaccination | 1.22 Days | Standard Deviation 0.441 |
Secondary
Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A
Grade 3 solicited AE definitions: Prevented normal daily activities or required medical intervention for systemic AEs; Cried when limb was moved/spontaneously painful (aged \< 3 years) for injection site pain; Size \> 30 mm for injection site redness and injection site induration/swelling; Oral temperature \> 104.0°F (40.0°C) or axillary temperature \> 103.1°F (39.5°C) for fevers.
Time frame: During the 7 days after each study vaccination
Population: Safety Population comprised all randomized participants who received at least one dose of study vaccine and had provided follow-up safety data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A | Grade 3 loss of appetite | 0 Percentage of participants |
| Placebo Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A | Grade 3 swelling / induration | 0 Percentage of participants |
| Placebo Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A | Grade 3 diarrhea | 0 Percentage of participants |
| Placebo Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A | Any pain | 35 Percentage of participants |
| Placebo Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A | Any systemic solicited adverse event | 58 Percentage of participants |
| Placebo Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A | Any swelling / induration | 8 Percentage of participants |
| Placebo Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A | Any redness | 23 Percentage of participants |
| Placebo Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A | Any fever | 23 Percentage of participants |
| Placebo Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A | Any irritability | 23 Percentage of participants |
| Placebo Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A | Any loss of appetite | 12 Percentage of participants |
| Placebo Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A | Grade 3 fever | 0 Percentage of participants |
| Placebo Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A | Grade 3 redness | 0 Percentage of participants |
| Placebo Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A | Grade 3 irritability | 0 Percentage of participants |
| Placebo Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A | Any nausea / vomiting | 8 Percentage of participants |
| Placebo Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A | Any diarrhea | 39 Percentage of participants |
| Placebo Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A | Grade 3 pain | 0 Percentage of participants |
| Placebo Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A | Any local solicited adverse event | 42 Percentage of participants |
| Placebo Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A | Grade 3 nausea / vomiting | 0 Percentage of participants |
| CSL425 (7.5 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A | Grade 3 pain | 0 Percentage of participants |
| CSL425 (7.5 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A | Any diarrhea | 37 Percentage of participants |
| CSL425 (7.5 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A | Grade 3 diarrhea | 1 Percentage of participants |
| CSL425 (7.5 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A | Grade 3 redness | 0 Percentage of participants |
| CSL425 (7.5 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A | Any loss of appetite | 24 Percentage of participants |
| CSL425 (7.5 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A | Grade 3 loss of appetite | 0 Percentage of participants |
| CSL425 (7.5 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A | Any irritability | 48 Percentage of participants |
| CSL425 (7.5 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A | Any swelling / induration | 16 Percentage of participants |
| CSL425 (7.5 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A | Grade 3 irritability | 1 Percentage of participants |
| CSL425 (7.5 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A | Grade 3 nausea / vomiting | 0 Percentage of participants |
| CSL425 (7.5 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A | Grade 3 swelling / induration | 0 Percentage of participants |
| CSL425 (7.5 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A | Any systemic solicited adverse event | 70 Percentage of participants |
| CSL425 (7.5 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A | Any fever | 25 Percentage of participants |
| CSL425 (7.5 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A | Any pain | 33 Percentage of participants |
| CSL425 (7.5 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A | Grade 3 fever | 3 Percentage of participants |
| CSL425 (7.5 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A | Any redness | 27 Percentage of participants |
| CSL425 (7.5 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A | Any nausea / vomiting | 11 Percentage of participants |
| CSL425 (7.5 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A | Any local solicited adverse event | 44 Percentage of participants |
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A | Grade 3 irritability | 2 Percentage of participants |
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A | Any local solicited adverse event | 37 Percentage of participants |
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A | Any pain | 27 Percentage of participants |
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A | Grade 3 pain | 0 Percentage of participants |
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A | Grade 3 nausea / vomiting | 0 Percentage of participants |
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A | Any redness | 19 Percentage of participants |
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A | Grade 3 redness | 0 Percentage of participants |
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A | Any swelling / induration | 6 Percentage of participants |
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A | Grade 3 swelling / induration | 0 Percentage of participants |
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A | Any systemic solicited adverse event | 65 Percentage of participants |
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A | Any fever | 43 Percentage of participants |
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A | Grade 3 fever | 4 Percentage of participants |
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A | Any nausea / vomiting | 15 Percentage of participants |
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A | Any diarrhea | 38 Percentage of participants |
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A | Grade 3 diarrhea | 2 Percentage of participants |
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A | Any loss of appetite | 22 Percentage of participants |
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A | Grade 3 loss of appetite | 1 Percentage of participants |
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A | Any irritability | 34 Percentage of participants |
Secondary
Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B
Grade 3 solicited AE definitions: Prevented normal daily activities or required medical intervention for systemic AEs; Prevented normal daily activities (aged \>= 3 years)for injection site pain; Size \> 30 mm for injection site redness and injection site induration/swelling; Oral temperature \> 104.0°F (40.0°C) or axillary temperature \> 103.1°F (39.5°C) for fevers.
Time frame: During the 7 days after each study vaccination
Population: Safety Population comprised all randomized participants who received at least one dose of study vaccine and had provided follow-up safety data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo Cohort A | Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B | Any systemic solicited adverse event | 46 Percentage of participants |
| Placebo Cohort A | Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B | Any myalgia | 21 Percentage of participants |
| Placebo Cohort A | Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B | Any diarrhea | 21 Percentage of participants |
| Placebo Cohort A | Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B | Grade 3 redness | 0 Percentage of participants |
| Placebo Cohort A | Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B | Grade 3 malaise | 4 Percentage of participants |
| Placebo Cohort A | Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B | Grade 3 diarrhea | 0 Percentage of participants |
| Placebo Cohort A | Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B | Grade 3 pain | 0 Percentage of participants |
| Placebo Cohort A | Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B | Any malaise | 21 Percentage of participants |
| Placebo Cohort A | Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B | Any headache | 21 Percentage of participants |
| Placebo Cohort A | Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B | Any fever | 14 Percentage of participants |
| Placebo Cohort A | Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B | Grade 3 headache | 0 Percentage of participants |
| Placebo Cohort A | Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B | Grade 3 swelling / induration | 0 Percentage of participants |
| Placebo Cohort A | Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B | Any pain | 29 Percentage of participants |
| Placebo Cohort A | Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B | Grade 3 fever | 0 Percentage of participants |
| Placebo Cohort A | Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B | Any swelling / induration | 11 Percentage of participants |
| Placebo Cohort A | Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B | Any local solicited adverse event | 43 Percentage of participants |
| Placebo Cohort A | Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B | Any nausea / vomiting | 14 Percentage of participants |
| Placebo Cohort A | Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B | Any redness | 29 Percentage of participants |
| Placebo Cohort A | Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B | Grade 3 myalgia | 0 Percentage of participants |
| Placebo Cohort A | Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B | Grade 3 nausea / vomiting | 0 Percentage of participants |
| CSL425 (7.5 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B | Grade 3 redness | 0 Percentage of participants |
| CSL425 (7.5 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B | Any swelling / induration | 13 Percentage of participants |
| CSL425 (7.5 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B | Grade 3 swelling / induration | 0 Percentage of participants |
| CSL425 (7.5 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B | Any systemic solicited adverse event | 44 Percentage of participants |
| CSL425 (7.5 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B | Any fever | 19 Percentage of participants |
| CSL425 (7.5 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B | Grade 3 fever | 0 Percentage of participants |
| CSL425 (7.5 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B | Any nausea / vomiting | 8 Percentage of participants |
| CSL425 (7.5 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B | Grade 3 nausea / vomiting | 2 Percentage of participants |
| CSL425 (7.5 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B | Any diarrhea | 8 Percentage of participants |
| CSL425 (7.5 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B | Grade 3 diarrhea | 1 Percentage of participants |
| CSL425 (7.5 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B | Any headache | 17 Percentage of participants |
| CSL425 (7.5 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B | Grade 3 headache | 1 Percentage of participants |
| CSL425 (7.5 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B | Any malaise | 27 Percentage of participants |
| CSL425 (7.5 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B | Grade 3 myalgia | 0 Percentage of participants |
| CSL425 (7.5 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B | Grade 3 malaise | 0 Percentage of participants |
| CSL425 (7.5 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B | Any myalgia | 14 Percentage of participants |
| CSL425 (7.5 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B | Any local solicited adverse event | 38 Percentage of participants |
| CSL425 (7.5 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B | Any pain | 34 Percentage of participants |
| CSL425 (7.5 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B | Grade 3 pain | 0 Percentage of participants |
| CSL425 (7.5 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B | Any redness | 18 Percentage of participants |
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B | Grade 3 malaise | 0 Percentage of participants |
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B | Grade 3 nausea / vomiting | 1 Percentage of participants |
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B | Grade 3 swelling / induration | 0 Percentage of participants |
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B | Any myalgia | 22 Percentage of participants |
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B | Any nausea / vomiting | 13 Percentage of participants |
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B | Grade 3 myalgia | 0 Percentage of participants |
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B | Grade 3 fever | 0 Percentage of participants |
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B | Grade 3 redness | 0 Percentage of participants |
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B | Any local solicited adverse event | 49 Percentage of participants |
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B | Any fever | 20 Percentage of participants |
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B | Any redness | 26 Percentage of participants |
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B | Any headache | 25 Percentage of participants |
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B | Any pain | 40 Percentage of participants |
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B | Grade 3 headache | 0 Percentage of participants |
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B | Grade 3 diarrhea | 0 Percentage of participants |
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B | Any systemic solicited adverse event | 46 Percentage of participants |
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B | Any malaise | 20 Percentage of participants |
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B | Any diarrhea | 9 Percentage of participants |
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B | Any swelling / induration | 17 Percentage of participants |
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B | Grade 3 pain | 0 Percentage of participants |
Secondary
Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination
UAE grading: Grade 1: Symptoms were easily tolerated and did not interfere with daily activities. Grade 2: Enough discomfort to cause some interference with daily activities. Grade 3: Symptoms that prevented normal, everyday activities.
Time frame: During the 21 days after each vaccination
Population: Safety Population comprised all randomized participants who received at least one dose of study vaccine and had provided follow-up safety data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo Cohort A | Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination | Proportion of participants with at least one UAE | 69 Percentage of participants |
| Placebo Cohort A | Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination | Proportion of participants reported Grade 1 UAE | 31 Percentage of participants |
| Placebo Cohort A | Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination | Proportion of participants reported Grade 2 UAE | 39 Percentage of participants |
| Placebo Cohort A | Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination | Proportion of participants reported Grade 3 UAE | 0 Percentage of participants |
| CSL425 (7.5 mcg) Cohort A | Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination | Proportion of participants reported Grade 2 UAE | 22 Percentage of participants |
| CSL425 (7.5 mcg) Cohort A | Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination | Proportion of participants reported Grade 1 UAE | 26 Percentage of participants |
| CSL425 (7.5 mcg) Cohort A | Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination | Proportion of participants with at least one UAE | 52 Percentage of participants |
| CSL425 (7.5 mcg) Cohort A | Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination | Proportion of participants reported Grade 3 UAE | 5 Percentage of participants |
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination | Proportion of participants reported Grade 3 UAE | 6 Percentage of participants |
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination | Proportion of participants reported Grade 2 UAE | 27 Percentage of participants |
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination | Proportion of participants reported Grade 1 UAE | 22 Percentage of participants |
| CSL425 (15 mcg) Cohort A | Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination | Proportion of participants with at least one UAE | 55 Percentage of participants |
| Placebo Cohort B | Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination | Proportion of participants with at least one UAE | 50 Percentage of participants |
| Placebo Cohort B | Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination | Proportion of participants reported Grade 3 UAE | 11 Percentage of participants |
| Placebo Cohort B | Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination | Proportion of participants reported Grade 1 UAE | 14 Percentage of participants |
| Placebo Cohort B | Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination | Proportion of participants reported Grade 2 UAE | 25 Percentage of participants |
| CSL425 (7.5 mcg) Cohort B | Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination | Proportion of participants reported Grade 2 UAE | 21 Percentage of participants |
| CSL425 (7.5 mcg) Cohort B | Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination | Proportion of participants reported Grade 3 UAE | 5 Percentage of participants |
| CSL425 (7.5 mcg) Cohort B | Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination | Proportion of participants reported Grade 1 UAE | 23 Percentage of participants |
| CSL425 (7.5 mcg) Cohort B | Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination | Proportion of participants with at least one UAE | 49 Percentage of participants |
| CSL425 (15 mcg) Cohort B | Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination | Proportion of participants reported Grade 1 UAE | 19 Percentage of participants |
| CSL425 (15 mcg) Cohort B | Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination | Proportion of participants reported Grade 2 UAE | 17 Percentage of participants |
| CSL425 (15 mcg) Cohort B | Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination | Proportion of participants reported Grade 3 UAE | 6 Percentage of participants |
| CSL425 (15 mcg) Cohort B | Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination | Proportion of participants with at least one UAE | 41 Percentage of participants |
Secondary
Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset of Chronic Illness (NOCIs)
A NOCI was defined as the diagnosis of a new medical condition that was chronic in nature, including those potentially controllable by medication (e.g., diabetes, asthma).
Time frame: Up to 180 days after the last vaccination
Population: Safety Population comprised all randomized participants who received at least one dose of study vaccine and had provided follow-up safety data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo Cohort A | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset of Chronic Illness (NOCIs) | Proportion of participants with at least one SAE | 0 Percentage of participants |
| Placebo Cohort A | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset of Chronic Illness (NOCIs) | Proportion of participants with at least one AESI | 0 Percentage of participants |
| Placebo Cohort A | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset of Chronic Illness (NOCIs) | Proportion of participants with related NOCI | 0 Percentage of participants |
| Placebo Cohort A | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset of Chronic Illness (NOCIs) | Proportion of participants with at least one NOCI | 0 Percentage of participants |
| Placebo Cohort A | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset of Chronic Illness (NOCIs) | Proportion of participants with related SAE | 0 Percentage of participants |
| Placebo Cohort A | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset of Chronic Illness (NOCIs) | Proportion of participants with related AESI | 0 Percentage of participants |
| CSL425 (7.5 mcg) Cohort A | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset of Chronic Illness (NOCIs) | Proportion of participants with at least one SAE | 2 Percentage of participants |
| CSL425 (7.5 mcg) Cohort A | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset of Chronic Illness (NOCIs) | Proportion of participants with related AESI | 0 Percentage of participants |
| CSL425 (7.5 mcg) Cohort A | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset of Chronic Illness (NOCIs) | Proportion of participants with at least one AESI | 0 Percentage of participants |
| CSL425 (7.5 mcg) Cohort A | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset of Chronic Illness (NOCIs) | Proportion of participants with related SAE | 0 Percentage of participants |
| CSL425 (7.5 mcg) Cohort A | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset of Chronic Illness (NOCIs) | Proportion of participants with at least one NOCI | 0 Percentage of participants |
| CSL425 (7.5 mcg) Cohort A | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset of Chronic Illness (NOCIs) | Proportion of participants with related NOCI | 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 Illness (NOCIs) | Proportion of participants with at least one SAE | 3 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 Illness (NOCIs) | Proportion of participants with related NOCI | 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 Illness (NOCIs) | Proportion of participants with 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 Illness (NOCIs) | Proportion of participants with at least one 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 Illness (NOCIs) | Proportion of participants with 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 Illness (NOCIs) | Proportion of participants with at least one NOCI | 1 Percentage of participants |
| Placebo Cohort B | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset of Chronic Illness (NOCIs) | Proportion of participants with related AESI | 0 Percentage of participants |
| Placebo Cohort B | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset of Chronic Illness (NOCIs) | Proportion of participants with related SAE | 0 Percentage of participants |
| Placebo Cohort B | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset of Chronic Illness (NOCIs) | Proportion of participants with at least one SAE | 0 Percentage of participants |
| Placebo Cohort B | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset of Chronic Illness (NOCIs) | Proportion of participants with related NOCI | 0 Percentage of participants |
| Placebo Cohort B | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset of Chronic Illness (NOCIs) | Proportion of participants with at least one NOCI | 0 Percentage of participants |
| Placebo Cohort B | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset of Chronic Illness (NOCIs) | Proportion of participants with at least one AESI | 0 Percentage of participants |
| CSL425 (7.5 mcg) Cohort B | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset of Chronic Illness (NOCIs) | Proportion of participants with at least one AESI | 0 Percentage of participants |
| CSL425 (7.5 mcg) Cohort B | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset of Chronic Illness (NOCIs) | Proportion of participants with related SAE | 0 Percentage of participants |
| CSL425 (7.5 mcg) Cohort B | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset of Chronic Illness (NOCIs) | Proportion of participants with related NOCI | 0 Percentage of participants |
| CSL425 (7.5 mcg) Cohort B | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset of Chronic Illness (NOCIs) | Proportion of participants with at least one NOCI | 1 Percentage of participants |
| CSL425 (7.5 mcg) Cohort B | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset of Chronic Illness (NOCIs) | Proportion of participants with related AESI | 0 Percentage of participants |
| CSL425 (7.5 mcg) Cohort B | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset of Chronic Illness (NOCIs) | Proportion of participants with at least one SAE | 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 Illness (NOCIs) | Proportion of participants with 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 Illness (NOCIs) | Proportion of participants with related SAE | 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 Illness (NOCIs) | Proportion of participants with 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 Illness (NOCIs) | Proportion of participants with 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 Illness (NOCIs) | Proportion of participants with at least one 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 Illness (NOCIs) | Proportion of participants with at least one SAE | 0 Percentage of participants |