Influenza
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 adults
Interventions
BIOLOGICALCSL425
CSL's 2009 H1N1 Influenza Vaccine, thimerosal-free.
BIOLOGICALPlacebo
Vaccine diluent, thimerosal 0.01% (weight/volume).
Sponsors
Seqirus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Male or female aged 18 and older, inclusive, at the time of providing informed consent. * Females of child bearing potential (i.e., ovulating, pre-menopausal, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen for the duration of the study. Females of child bearing potential must return a negative urine pregnancy test result at enrolment and prior to each study vaccination.
Exclusion criteria
* Known hypersensitivity to a previous dose of influenza virus vaccine or allergy to eggs, chicken protein, thimerosal, neomycin, polymyxin, or any components of the Study Vaccine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving an HI Antibody Titer of 1:40 or More 21 Days After the Second Vaccination | 21 days after the second vaccination | — |
| Seroconversion Rate 21 Days After the First Vaccination | 21 days after the first vaccination | Seroconversion rate: the proportion of participants achieving seroconversion in hemagglutination inhibition (HI) antibody titer. Seroconversion is defined as participants with a baseline titer of less than 1:10 achieving a post-vaccination HI antibody titer of 1:40 or more; or participants with a baseline HI titer of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titer. |
| Seroconversion Rate 21 Days After the Second Vaccination | 21 days after the second 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 the First Vaccination | 21 days after the first vaccination | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency and Intensity of Solicited Adverse Events After the First Vaccination | During the 7 days after the first vaccination | Grade 3 solicited adverse event (AE) definitions: Prevented normal daily activities; Size \> 100 mm for injection site redness or induration/swelling; Temperature 102.2°F (39.0°C) or more for fevers. |
| Duration of Solicited Local Adverse Events After the First Vaccination | During the 7 days after the first vaccination, and day 7 - day 21 for ongoing AEs | — |
| Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI) | 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 (eg, diabetes, asthma). |
| Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination | Day 0 to Day 20 after each vaccination; up to Day 180 after the last vaccination for SAEs, AESI and NOCI | Unsolicited adverse event (UAE) grading: Grade 1 (mild): Symptoms were easily tolerated and did not interfere with daily activities. Grade 2 (moderate): Enough discomfort to cause some interference with daily activities. Grade 3 (severe): Symptoms that prevented normal, everyday activities. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo, Adults Vaccine diluent; Adults aged 18 to 64 years | 49 |
| CSL425 (7.5 mcg), Adults 7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years | 205 |
| CSL425 (15 Mcg), Adults 15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years | 201 |
| CSL425 (30 Mcg), Adults 30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years | 203 |
| Placebo, Older Adults Vaccine diluent; Older adults aged 65 years or older | 50 |
| CSL425 (7.5 Mcg), Older Adults 7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older | 203 |
| CSL425 (15 Mcg), Older Adults 15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older | 200 |
| CSL425 (30 Mcg), Older Adults 30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older | 202 |
| Total | 1,313 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 5 | 9 | 8 | 0 | 0 | 0 | 0 |
| Overall Study | Moved away from study area | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Other Reason | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 |
| Overall Study | Serious Adverse Event | 0 | 2 | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Sponsor/Investigator decision | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Placebo, Adults | CSL425 (7.5 mcg), Adults | CSL425 (15 Mcg), Adults | CSL425 (30 Mcg), Adults | Placebo, Older Adults | CSL425 (7.5 Mcg), Older Adults | CSL425 (15 Mcg), Older Adults | CSL425 (30 Mcg), Older Adults | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized >= 18 years to 64 years | 49 participants | 205 participants | 201 participants | 203 participants | 0 participants | 0 participants | 0 participants | 0 participants | 658 participants |
| Age, Customized >=65 years | 0 participants | 0 participants | 0 participants | 0 participants | 50 participants | 203 participants | 200 participants | 202 participants | 655 participants |
| Sex: Female, Male Female | 31 Participants | 123 Participants | 113 Participants | 113 Participants | 29 Participants | 120 Participants | 108 Participants | 112 Participants | 749 Participants |
| Sex: Female, Male Male | 18 Participants | 82 Participants | 88 Participants | 90 Participants | 21 Participants | 83 Participants | 92 Participants | 90 Participants | 564 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 12 / 49 | 27 / 204 | 25 / 201 | 27 / 203 | 5 / 50 | 20 / 203 | 23 / 200 | 18 / 202 |
| serious Total, serious adverse events | 0 / 49 | 6 / 204 | 4 / 201 | 3 / 203 | 3 / 50 | 9 / 203 | 6 / 200 | 9 / 202 |
Outcome results
Primary
Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After the First Vaccination
Time frame: 21 days after the first vaccination
Population: The Evaluable Population (for the first vaccination) comprised all randomized 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) |
|---|---|---|
| Placebo, Adults | Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After the First Vaccination | 22.9 percentage of participants |
| CSL425 (7.5 mcg), Adults | Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After the First Vaccination | 97.0 percentage of participants |
| CSL425 (15 Mcg), Adults | Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After the First Vaccination | 96.4 percentage of participants |
| CSL425 (30 Mcg), Adults | Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After the First Vaccination | 99.5 percentage of participants |
| Placebo, Older Adults | Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After the First Vaccination | 39.6 percentage of participants |
| CSL425 (7.5 Mcg), Older Adults | Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After the First Vaccination | 92.0 percentage of participants |
| CSL425 (15 Mcg), Older Adults | Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After the First Vaccination | 90.9 percentage of participants |
| CSL425 (30 Mcg), Older Adults | Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After the First Vaccination | 94.0 percentage of participants |
Primary
Percentage of Participants Achieving an HI Antibody Titer of 1:40 or More 21 Days After the Second Vaccination
Time frame: 21 days after the second vaccination
Population: The Evaluable Population (for the second vaccination) comprised all randomized 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) |
|---|---|---|
| Placebo, Adults | Percentage of Participants Achieving an HI Antibody Titer of 1:40 or More 21 Days After the Second Vaccination | 29.2 percentage of participants |
| CSL425 (7.5 mcg), Adults | Percentage of Participants Achieving an HI Antibody Titer of 1:40 or More 21 Days After the Second Vaccination | 98.5 percentage of participants |
| CSL425 (15 Mcg), Adults | Percentage of Participants Achieving an HI Antibody Titer of 1:40 or More 21 Days After the Second Vaccination | 99.5 percentage of participants |
| CSL425 (30 Mcg), Adults | Percentage of Participants Achieving an HI Antibody Titer of 1:40 or More 21 Days After the Second Vaccination | 99.5 percentage of participants |
| Placebo, Older Adults | Percentage of Participants Achieving an HI Antibody Titer of 1:40 or More 21 Days After the Second Vaccination | 35.4 percentage of participants |
| CSL425 (7.5 Mcg), Older Adults | Percentage of Participants Achieving an HI Antibody Titer of 1:40 or More 21 Days After the Second Vaccination | 96.0 percentage of participants |
| CSL425 (15 Mcg), Older Adults | Percentage of Participants Achieving an HI Antibody Titer of 1:40 or More 21 Days After the Second Vaccination | 93.4 percentage of participants |
| CSL425 (30 Mcg), Older Adults | Percentage of Participants Achieving an HI Antibody Titer of 1:40 or More 21 Days After the Second Vaccination | 94.9 percentage of participants |
Primary
Seroconversion Rate 21 Days After the First Vaccination
Seroconversion rate: the proportion of participants achieving seroconversion in hemagglutination inhibition (HI) antibody titer. Seroconversion is defined as participants with a baseline titer of less than 1:10 achieving a post-vaccination HI antibody titer of 1:40 or more; or participants with a baseline 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 vaccination
Population: The Evaluable Population (for the first vaccination) comprised all randomized 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) |
|---|---|---|
| Placebo, Adults | Seroconversion Rate 21 Days After the First Vaccination | 0 percentage of participants |
| CSL425 (7.5 mcg), Adults | Seroconversion Rate 21 Days After the First Vaccination | 82 percentage of participants |
| CSL425 (15 Mcg), Adults | Seroconversion Rate 21 Days After the First Vaccination | 88.2 percentage of participants |
| CSL425 (30 Mcg), Adults | Seroconversion Rate 21 Days After the First Vaccination | 94.5 percentage of participants |
| Placebo, Older Adults | Seroconversion Rate 21 Days After the First Vaccination | 2.1 percentage of participants |
| CSL425 (7.5 Mcg), Older Adults | Seroconversion Rate 21 Days After the First Vaccination | 51.2 percentage of participants |
| CSL425 (15 Mcg), Older Adults | Seroconversion Rate 21 Days After the First Vaccination | 58.9 percentage of participants |
| CSL425 (30 Mcg), Older Adults | Seroconversion Rate 21 Days After the First Vaccination | 73.0 percentage of participants |
Primary
Seroconversion Rate 21 Days After the Second 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 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 (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) |
|---|---|---|
| Placebo, Adults | Seroconversion Rate 21 Days After the Second Vaccination | 6.3 percentage of participants |
| CSL425 (7.5 mcg), Adults | Seroconversion Rate 21 Days After the Second Vaccination | 83.2 percentage of participants |
| CSL425 (15 Mcg), Adults | Seroconversion Rate 21 Days After the Second Vaccination | 91.1 percentage of participants |
| CSL425 (30 Mcg), Adults | Seroconversion Rate 21 Days After the Second Vaccination | 95.9 percentage of participants |
| Placebo, Older Adults | Seroconversion Rate 21 Days After the Second Vaccination | 8.3 percentage of participants |
| CSL425 (7.5 Mcg), Older Adults | Seroconversion Rate 21 Days After the Second Vaccination | 59.5 percentage of participants |
| CSL425 (15 Mcg), Older Adults | Seroconversion Rate 21 Days After the Second Vaccination | 67.3 percentage of participants |
| CSL425 (30 Mcg), Older Adults | Seroconversion Rate 21 Days After the Second Vaccination | 75.3 percentage of participants |
Secondary
Duration of Solicited Local Adverse Events After the First Vaccination
Time frame: During the 7 days after the first vaccination, and day 7 - day 21 for ongoing AEs
Population: The Safety Population (first vaccination) comprised all randomized participants who received the first vaccination and provided follow-up safety data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo, Adults | Duration of Solicited Local Adverse Events After the First Vaccination | Redness at injection site | NA days | — |
| Placebo, Adults | Duration of Solicited Local Adverse Events After the First Vaccination | Bruising at injection site | NA days | — |
| Placebo, Adults | Duration of Solicited Local Adverse Events After the First Vaccination | Pain at injection site | 1.14 days | Standard Deviation 0.378 |
| Placebo, Adults | Duration of Solicited Local Adverse Events After the First Vaccination | Swelling/induration at injection site | NA days | — |
| Placebo, Adults | Duration of Solicited Local Adverse Events After the First Vaccination | Tenderness at injection site | 2.1 days | Standard Deviation 1.912 |
| CSL425 (7.5 mcg), Adults | Duration of Solicited Local Adverse Events After the First Vaccination | Redness at injection site | 1.00 days | Standard Deviation 0 |
| CSL425 (7.5 mcg), Adults | Duration of Solicited Local Adverse Events After the First Vaccination | Bruising at injection site | 3.00 days | Standard Deviation 2.539 |
| CSL425 (7.5 mcg), Adults | Duration of Solicited Local Adverse Events After the First Vaccination | Pain at injection site | 1.87 days | Standard Deviation 2.705 |
| CSL425 (7.5 mcg), Adults | Duration of Solicited Local Adverse Events After the First Vaccination | Tenderness at injection site | 2.04 days | Standard Deviation 2.813 |
| CSL425 (7.5 mcg), Adults | Duration of Solicited Local Adverse Events After the First Vaccination | Swelling/induration at injection site | 1.56 days | Standard Deviation 0.726 |
| CSL425 (15 Mcg), Adults | Duration of Solicited Local Adverse Events After the First Vaccination | Redness at injection site | 1.00 days | — |
| CSL425 (15 Mcg), Adults | Duration of Solicited Local Adverse Events After the First Vaccination | Pain at injection site | 1.71 days | Standard Deviation 0.926 |
| CSL425 (15 Mcg), Adults | Duration of Solicited Local Adverse Events After the First Vaccination | Bruising at injection site | 2.25 days | Standard Deviation 1.669 |
| CSL425 (15 Mcg), Adults | Duration of Solicited Local Adverse Events After the First Vaccination | Tenderness at injection site | 1.85 days | Standard Deviation 0.966 |
| CSL425 (15 Mcg), Adults | Duration of Solicited Local Adverse Events After the First Vaccination | Swelling/induration at injection site | 1.2 days | Standard Deviation 0.447 |
| CSL425 (30 Mcg), Adults | Duration of Solicited Local Adverse Events After the First Vaccination | Swelling/induration at injection site | 3.38 days | Standard Deviation 2.615 |
| CSL425 (30 Mcg), Adults | Duration of Solicited Local Adverse Events After the First Vaccination | Bruising at injection site | 2.00 days | Standard Deviation 0 |
| CSL425 (30 Mcg), Adults | Duration of Solicited Local Adverse Events After the First Vaccination | Pain at injection site | 1.91 days | Standard Deviation 1.237 |
| CSL425 (30 Mcg), Adults | Duration of Solicited Local Adverse Events After the First Vaccination | Redness at injection site | 2.50 days | Standard Deviation 0.707 |
| CSL425 (30 Mcg), Adults | Duration of Solicited Local Adverse Events After the First Vaccination | Tenderness at injection site | 1.90 days | Standard Deviation 1.082 |
| Placebo, Older Adults | Duration of Solicited Local Adverse Events After the First Vaccination | Swelling/induration at injection site | NA days | — |
| Placebo, Older Adults | Duration of Solicited Local Adverse Events After the First Vaccination | Pain at injection site | 1.00 days | — |
| Placebo, Older Adults | Duration of Solicited Local Adverse Events After the First Vaccination | Redness at injection site | NA days | — |
| Placebo, Older Adults | Duration of Solicited Local Adverse Events After the First Vaccination | Tenderness at injection site | 1.5 days | Standard Deviation 0.707 |
| Placebo, Older Adults | Duration of Solicited Local Adverse Events After the First Vaccination | Bruising at injection site | NA days | — |
| CSL425 (7.5 Mcg), Older Adults | Duration of Solicited Local Adverse Events After the First Vaccination | Swelling/induration at injection site | 6.00 days | Standard Deviation 10 |
| CSL425 (7.5 Mcg), Older Adults | Duration of Solicited Local Adverse Events After the First Vaccination | Tenderness at injection site | 1.27 days | Standard Deviation 0.55 |
| CSL425 (7.5 Mcg), Older Adults | Duration of Solicited Local Adverse Events After the First Vaccination | Redness at injection site | 1.00 days | — |
| CSL425 (7.5 Mcg), Older Adults | Duration of Solicited Local Adverse Events After the First Vaccination | Pain at injection site | 1.75 days | Standard Deviation 0.957 |
| CSL425 (7.5 Mcg), Older Adults | Duration of Solicited Local Adverse Events After the First Vaccination | Bruising at injection site | 8.00 days | Standard Deviation 11.269 |
| CSL425 (15 Mcg), Older Adults | Duration of Solicited Local Adverse Events After the First Vaccination | Swelling/induration at injection site | 1.5 days | Standard Deviation 0.837 |
| CSL425 (15 Mcg), Older Adults | Duration of Solicited Local Adverse Events After the First Vaccination | Pain at injection site | 1.75 days | Standard Deviation 0.886 |
| CSL425 (15 Mcg), Older Adults | Duration of Solicited Local Adverse Events After the First Vaccination | Redness at injection site | 1.00 days | Standard Deviation 0 |
| CSL425 (15 Mcg), Older Adults | Duration of Solicited Local Adverse Events After the First Vaccination | Bruising at injection site | 4.33 days | Standard Deviation 2.503 |
| CSL425 (15 Mcg), Older Adults | Duration of Solicited Local Adverse Events After the First Vaccination | Tenderness at injection site | 1.71 days | Standard Deviation 0.955 |
| CSL425 (30 Mcg), Older Adults | Duration of Solicited Local Adverse Events After the First Vaccination | Bruising at injection site | 1.20 days | Standard Deviation 0.447 |
| CSL425 (30 Mcg), Older Adults | Duration of Solicited Local Adverse Events After the First Vaccination | Tenderness at injection site | 1.65 days | Standard Deviation 1.075 |
| CSL425 (30 Mcg), Older Adults | Duration of Solicited Local Adverse Events After the First Vaccination | Pain at injection site | 1.27 days | Standard Deviation 0.594 |
| CSL425 (30 Mcg), Older Adults | Duration of Solicited Local Adverse Events After the First Vaccination | Swelling/induration at injection site | 3.2 days | Standard Deviation 4.382 |
| CSL425 (30 Mcg), Older Adults | Duration of Solicited Local Adverse Events After the First Vaccination | Redness at injection site | NA days | — |
Secondary
Frequency and Intensity of Solicited Adverse Events After the First Vaccination
Grade 3 solicited adverse event (AE) definitions: Prevented normal daily activities; Size \> 100 mm for injection site redness or induration/swelling; Temperature 102.2°F (39.0°C) or more for fevers.
Time frame: During the 7 days after the first vaccination
Population: The Safety Population (first vaccination) comprised all randomized participants who received the first vaccination and provided follow-up safety data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo, Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any local solicited adverse event | 22.4 percentage of participants |
| Placebo, Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any nausea | 4.1 percentage of participants |
| Placebo, Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 chills | 0 percentage of participants |
| Placebo, Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 myalgia | 0 percentage of participants |
| Placebo, Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 pain at injection site | 0 percentage of participants |
| Placebo, Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any myalgia | 4.1 percentage of participants |
| Placebo, Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 redness at injection site | 0 percentage of participants |
| Placebo, Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any bruising at injection site | 0 percentage of participants |
| Placebo, Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 fever | 0 percentage of participants |
| Placebo, Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any tenderness at injection site | 18.4 percentage of participants |
| Placebo, Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 malaise | 0 percentage of participants |
| Placebo, Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 vomiting | 0 percentage of participants |
| Placebo, Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any malaise | 8.2 percentage of participants |
| Placebo, Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any chills | 2.0 percentage of participants |
| Placebo, Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any swelling/induration at injection site | 0 percentage of participants |
| Placebo, Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 tenderness at injection site | 0 percentage of participants |
| Placebo, Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 nausea | 0 percentage of participants |
| Placebo, Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 headache | 0 percentage of participants |
| Placebo, Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any vomiting | 0 percentage of participants |
| Placebo, Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any headache | 16.3 percentage of participants |
| Placebo, Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any redness at injection site | 0 percentage of participants |
| Placebo, Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any solicited systemic adverse event | 28.6 percentage of participants |
| Placebo, Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 swelling/induration at injection site | 0 percentage of participants |
| Placebo, Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any pain at injection site | 14.3 percentage of participants |
| Placebo, Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any fever | 2.0 percentage of participants |
| Placebo, Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 bruising at injection site | 0 percentage of participants |
| CSL425 (7.5 mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 bruising at injection site | 0 percentage of participants |
| CSL425 (7.5 mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any bruising at injection site | 4.4 percentage of participants |
| CSL425 (7.5 mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 tenderness at injection site | 0 percentage of participants |
| CSL425 (7.5 mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any tenderness at injection site | 23.5 percentage of participants |
| CSL425 (7.5 mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 vomiting | 0.5 percentage of participants |
| CSL425 (7.5 mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any pain at injection site | 14.7 percentage of participants |
| CSL425 (7.5 mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any local solicited adverse event | 28.9 percentage of participants |
| CSL425 (7.5 mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any vomiting | 2.9 percentage of participants |
| CSL425 (7.5 mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 chills | 0.5 percentage of participants |
| CSL425 (7.5 mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 pain at injection site | 0 percentage of participants |
| CSL425 (7.5 mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 fever | 0.5 percentage of participants |
| CSL425 (7.5 mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any chills | 3.9 percentage of participants |
| CSL425 (7.5 mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 nausea | 0.5 percentage of participants |
| CSL425 (7.5 mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any nausea | 6.4 percentage of participants |
| CSL425 (7.5 mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any redness at injection site | 1.0 percentage of participants |
| CSL425 (7.5 mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 myalgia | 0.5 percentage of participants |
| CSL425 (7.5 mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any myalgia | 14.7 percentage of participants |
| CSL425 (7.5 mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 redness at injection site | 0 percentage of participants |
| CSL425 (7.5 mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 malaise | 1.0 percentage of participants |
| CSL425 (7.5 mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any malaise | 10.8 percentage of participants |
| CSL425 (7.5 mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 headache | 1.0 percentage of participants |
| CSL425 (7.5 mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any swelling/induration at injection site | 3.9 percentage of participants |
| CSL425 (7.5 mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any fever | 3.4 percentage of participants |
| CSL425 (7.5 mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any headache | 19.6 percentage of participants |
| CSL425 (7.5 mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any solicited systemic adverse event | 35.3 percentage of participants |
| CSL425 (7.5 mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 swelling/induration at injection site | 0 percentage of participants |
| CSL425 (15 Mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any redness at injection site | 0.5 percentage of participants |
| CSL425 (15 Mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any local solicited adverse event | 35.8 percentage of participants |
| CSL425 (15 Mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any pain at injection site | 17.4 percentage of participants |
| CSL425 (15 Mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 pain at injection site | 0 percentage of participants |
| CSL425 (15 Mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 redness at injection site | 0 percentage of participants |
| CSL425 (15 Mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any swelling/induration at injection site | 2.5 percentage of participants |
| CSL425 (15 Mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 swelling/induration at injection site | 0 percentage of participants |
| CSL425 (15 Mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any tenderness at injection site | 32.8 percentage of participants |
| CSL425 (15 Mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 tenderness at injection site | 0 percentage of participants |
| CSL425 (15 Mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any bruising at injection site | 4.0 percentage of participants |
| CSL425 (15 Mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 bruising at injection site | 0 percentage of participants |
| CSL425 (15 Mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any solicited systemic adverse event | 34.8 percentage of participants |
| CSL425 (15 Mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any headache | 21.4 percentage of participants |
| CSL425 (15 Mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 headache | 1.0 percentage of participants |
| CSL425 (15 Mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any malaise | 16.4 percentage of participants |
| CSL425 (15 Mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 malaise | 1.0 percentage of participants |
| CSL425 (15 Mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any myalgia | 15.9 percentage of participants |
| CSL425 (15 Mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 myalgia | 0.5 percentage of participants |
| CSL425 (15 Mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any nausea | 8.0 percentage of participants |
| CSL425 (15 Mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 nausea | 0 percentage of participants |
| CSL425 (15 Mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any chills | 5.0 percentage of participants |
| CSL425 (15 Mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 chills | 0.5 percentage of participants |
| CSL425 (15 Mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any vomiting | 1.0 percentage of participants |
| CSL425 (15 Mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 vomiting | 0 percentage of participants |
| CSL425 (15 Mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any fever | 3.0 percentage of participants |
| CSL425 (15 Mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 fever | 1.0 percentage of participants |
| CSL425 (30 Mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any swelling/induration at injection site | 3.9 percentage of participants |
| CSL425 (30 Mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any redness at injection site | 1.0 percentage of participants |
| CSL425 (30 Mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any fever | 3.4 percentage of participants |
| CSL425 (30 Mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 headache | 0 percentage of participants |
| CSL425 (30 Mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any vomiting | 1.0 percentage of participants |
| CSL425 (30 Mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 swelling/induration at injection site | 0 percentage of participants |
| CSL425 (30 Mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any tenderness at injection site | 46.8 percentage of participants |
| CSL425 (30 Mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 tenderness at injection site | 0 percentage of participants |
| CSL425 (30 Mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 nausea | 0.5 percentage of participants |
| CSL425 (30 Mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any bruising at injection site | 1.0 percentage of participants |
| CSL425 (30 Mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 pain at injection site | 0.5 percentage of participants |
| CSL425 (30 Mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any malaise | 17.2 percentage of participants |
| CSL425 (30 Mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 fever | 0.5 percentage of participants |
| CSL425 (30 Mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 malaise | 0 percentage of participants |
| CSL425 (30 Mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 chills | 0 percentage of participants |
| CSL425 (30 Mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 redness at injection site | 0 percentage of participants |
| CSL425 (30 Mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any local solicited adverse event | 52.7 percentage of participants |
| CSL425 (30 Mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 vomiting | 0 percentage of participants |
| CSL425 (30 Mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 bruising at injection site | 0 percentage of participants |
| CSL425 (30 Mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any chills | 5.4 percentage of participants |
| CSL425 (30 Mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 myalgia | 0 percentage of participants |
| CSL425 (30 Mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any headache | 27.1 percentage of participants |
| CSL425 (30 Mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any pain at injection site | 31.0 percentage of participants |
| CSL425 (30 Mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any solicited systemic adverse event | 40.9 percentage of participants |
| CSL425 (30 Mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any nausea | 7.9 percentage of participants |
| CSL425 (30 Mcg), Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any myalgia | 17.7 percentage of participants |
| Placebo, Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any local solicited adverse event | 4.0 percentage of participants |
| Placebo, Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 pain at injection site | 0 percentage of participants |
| Placebo, Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any vomiting | 0 percentage of participants |
| Placebo, Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any chills | 0 percentage of participants |
| Placebo, Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 fever | 0 percentage of participants |
| Placebo, Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any swelling/induration at injection site | 0 percentage of participants |
| Placebo, Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 chills | 0 percentage of participants |
| Placebo, Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any pain at injection site | 2.0 percentage of participants |
| Placebo, Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any headache | 8.0 percentage of participants |
| Placebo, Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 bruising at injection site | 0 percentage of participants |
| Placebo, Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 tenderness at injection site | 0 percentage of participants |
| Placebo, Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 headache | 0 percentage of participants |
| Placebo, Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 swelling/induration at injection site | 0 percentage of participants |
| Placebo, Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any fever | 0 percentage of participants |
| Placebo, Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any malaise | 10.0 percentage of participants |
| Placebo, Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any bruising at injection site | 0 percentage of participants |
| Placebo, Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 redness at injection site | 0 percentage of participants |
| Placebo, Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 malaise | 0 percentage of participants |
| Placebo, Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any myalgia | 8.0 percentage of participants |
| Placebo, Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any tenderness at injection site | 4.0 percentage of participants |
| Placebo, Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any redness at injection site | 0 percentage of participants |
| Placebo, Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 vomiting | 0 percentage of participants |
| Placebo, Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 myalgia | 0 percentage of participants |
| Placebo, Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any solicited systemic adverse event | 18.0 percentage of participants |
| Placebo, Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 nausea | 0 percentage of participants |
| Placebo, Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any nausea | 2.0 percentage of participants |
| CSL425 (7.5 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any local solicited adverse event | 13.3 percentage of participants |
| CSL425 (7.5 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 tenderness at injection site | 0 percentage of participants |
| CSL425 (7.5 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 nausea | 0 percentage of participants |
| CSL425 (7.5 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any myalgia | 8.9 percentage of participants |
| CSL425 (7.5 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any headache | 9.4 percentage of participants |
| CSL425 (7.5 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any nausea | 1.0 percentage of participants |
| CSL425 (7.5 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any redness at injection site | 0.5 percentage of participants |
| CSL425 (7.5 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any solicited systemic adverse event | 16.7 percentage of participants |
| CSL425 (7.5 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any vomiting | 0 percentage of participants |
| CSL425 (7.5 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any pain at injection site | 2.0 percentage of participants |
| CSL425 (7.5 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any bruising at injection site | 1.5 percentage of participants |
| CSL425 (7.5 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 myalgia | 0 percentage of participants |
| CSL425 (7.5 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 pain at injection site | 0 percentage of participants |
| CSL425 (7.5 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 chills | 0 percentage of participants |
| CSL425 (7.5 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any swelling/induration at injection site | 2.0 percentage of participants |
| CSL425 (7.5 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 fever | 0 percentage of participants |
| CSL425 (7.5 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 swelling/induration at injection site | 0 percentage of participants |
| CSL425 (7.5 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 vomiting | 0 percentage of participants |
| CSL425 (7.5 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any fever | 0 percentage of participants |
| CSL425 (7.5 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any malaise | 5.4 percentage of participants |
| CSL425 (7.5 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any chills | 0.5 percentage of participants |
| CSL425 (7.5 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 malaise | 0 percentage of participants |
| CSL425 (7.5 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 redness at injection site | 0 percentage of participants |
| CSL425 (7.5 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 bruising at injection site | 0 percentage of participants |
| CSL425 (7.5 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any tenderness at injection site | 10.3 percentage of participants |
| CSL425 (7.5 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 headache | 0.5 percentage of participants |
| CSL425 (15 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 headache | 0 percentage of participants |
| CSL425 (15 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any local solicited adverse event | 23.5 percentage of participants |
| CSL425 (15 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 bruising at injection site | 0 percentage of participants |
| CSL425 (15 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any swelling/induration at injection site | 3.0 percentage of participants |
| CSL425 (15 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any solicited systemic adverse event | 24.0 percentage of participants |
| CSL425 (15 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 fever | 0 percentage of participants |
| CSL425 (15 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any headache | 10.5 percentage of participants |
| CSL425 (15 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any bruising at injection site | 3.0 percentage of participants |
| CSL425 (15 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 redness at injection site | 0 percentage of participants |
| CSL425 (15 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any malaise | 9.5 percentage of participants |
| CSL425 (15 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 malaise | 0 percentage of participants |
| CSL425 (15 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any redness at injection site | 1.0 percentage of participants |
| CSL425 (15 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any fever | 0.5 percentage of participants |
| CSL425 (15 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any myalgia | 13.0 percentage of participants |
| CSL425 (15 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 myalgia | 0 percentage of participants |
| CSL425 (15 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any nausea | 2.5 percentage of participants |
| CSL425 (15 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 pain at injection site | 0 percentage of participants |
| CSL425 (15 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 nausea | 0 percentage of participants |
| CSL425 (15 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any chills | 1.0 percentage of participants |
| CSL425 (15 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any pain at injection site | 4.0 percentage of participants |
| CSL425 (15 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 chills | 0 percentage of participants |
| CSL425 (15 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any vomiting | 0.5 percentage of participants |
| CSL425 (15 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any tenderness at injection site | 20.0 percentage of participants |
| CSL425 (15 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 tenderness at injection site | 0 percentage of participants |
| CSL425 (15 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 swelling/induration at injection site | 0 percentage of participants |
| CSL425 (15 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 vomiting | 0 percentage of participants |
| CSL425 (30 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 nausea | 0 percentage of participants |
| CSL425 (30 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any solicited systemic adverse event | 22.8 percentage of participants |
| CSL425 (30 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any vomiting | 0.5 percentage of participants |
| CSL425 (30 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any nausea | 3.5 percentage of participants |
| CSL425 (30 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any local solicited adverse event | 21.8 percentage of participants |
| CSL425 (30 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 pain at injection site | 0 percentage of participants |
| CSL425 (30 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 myalgia | 0 percentage of participants |
| CSL425 (30 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any fever | 0.5 percentage of participants |
| CSL425 (30 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any myalgia | 13.4 percentage of participants |
| CSL425 (30 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any redness at injection site | 0 percentage of participants |
| CSL425 (30 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any bruising at injection site | 1.5 percentage of participants |
| CSL425 (30 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any tenderness at injection site | 18.3 percentage of participants |
| CSL425 (30 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 malaise | 0 percentage of participants |
| CSL425 (30 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 swelling/induration at injection site | 0 percentage of participants |
| CSL425 (30 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any malaise | 11.9 percentage of participants |
| CSL425 (30 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 headache | 0.5 percentage of participants |
| CSL425 (30 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 redness at injection site | 0 percentage of participants |
| CSL425 (30 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any headache | 10.4 percentage of participants |
| CSL425 (30 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any swelling/induration at injection site | 2.5 percentage of participants |
| CSL425 (30 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 tenderness at injection site | 0 percentage of participants |
| CSL425 (30 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 bruising at injection site | 0 percentage of participants |
| CSL425 (30 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 chills | 0 percentage of participants |
| CSL425 (30 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any pain at injection site | 6.9 percentage of participants |
| CSL425 (30 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Any chills | 3.0 percentage of participants |
| CSL425 (30 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 vomiting | 0 percentage of participants |
| CSL425 (30 Mcg), Older Adults | Frequency and Intensity of Solicited Adverse Events After the First Vaccination | Grade 3 fever | 0 percentage of participants |
Secondary
Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination
Unsolicited adverse event (UAE) grading: Grade 1 (mild): Symptoms were easily tolerated and did not interfere with daily activities. Grade 2 (moderate): Enough discomfort to cause some interference with daily activities. Grade 3 (severe): Symptoms that prevented normal, everyday activities.
Time frame: Day 0 to Day 20 after each vaccination; up to Day 180 after the last vaccination for SAEs, AESI and NOCI
Population: The Safety Population comprised all randomized participants who received at least one dose of study vaccine and provided follow-up safety data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo, Adults | Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination | Percentage of participants with at least one UAE | 27.3 percentage of participants |
| Placebo, Adults | Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination | Percentage of participants reporting Grade 1 UAE | 7.1 percentage of participants |
| Placebo, Adults | Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination | Percentage of participants reporting Grade 2 UAE | 15.2 percentage of participants |
| Placebo, Adults | Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination | Percentage of participants reporting Grade 3 UAE | 5.1 percentage of participants |
| CSL425 (7.5 mcg), Adults | Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination | Percentage of participants reporting Grade 1 UAE | 12.8 percentage of participants |
| CSL425 (7.5 mcg), Adults | Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination | Percentage of participants reporting Grade 2 UAE | 8.8 percentage of participants |
| CSL425 (7.5 mcg), Adults | Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination | Percentage of participants reporting Grade 3 UAE | 5.9 percentage of participants |
| CSL425 (7.5 mcg), Adults | Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination | Percentage of participants with at least one UAE | 27.5 percentage of participants |
| CSL425 (15 Mcg), Adults | Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination | Percentage of participants reporting Grade 2 UAE | 14.0 percentage of participants |
| CSL425 (15 Mcg), Adults | Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination | Percentage of participants reporting Grade 1 UAE | 10.0 percentage of participants |
| CSL425 (15 Mcg), Adults | Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination | Percentage of participants reporting Grade 3 UAE | 6.2 percentage of participants |
| CSL425 (15 Mcg), Adults | Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination | Percentage of participants with at least one UAE | 30.2 percentage of participants |
| CSL425 (30 Mcg), Adults | Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination | Percentage of participants reporting Grade 3 UAE | 4.7 percentage of participants |
| CSL425 (30 Mcg), Adults | Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination | Percentage of participants reporting Grade 1 UAE | 12.8 percentage of participants |
| CSL425 (30 Mcg), Adults | Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination | Percentage of participants with at least one UAE | 27.9 percentage of participants |
| CSL425 (30 Mcg), Adults | Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination | Percentage of participants reporting Grade 2 UAE | 10.4 percentage of participants |
Secondary
Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI)
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 randomized participants who received at least one dose of study vaccine and provided follow-up safety data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo, Adults | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI) | Percentage of participants with related NOCI | 0 percentage of participants |
| Placebo, Adults | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI) | Percentage of participants with at least one SAE | 0 percentage of participants |
| Placebo, Adults | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI) | Percentage of participants with related SAE | 0 percentage of participants |
| Placebo, Adults | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI) | Percentage of participants with at least one AESI | 0 percentage of participants |
| Placebo, Adults | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI) | Percentage of participants with at least one NOCI | 4.1 percentage of participants |
| Placebo, Adults | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI) | Percentage of participants with related AESI | 0 percentage of participants |
| CSL425 (7.5 mcg), Adults | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI) | Percentage of participants with at least one AESI | 0 percentage of participants |
| CSL425 (7.5 mcg), Adults | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI) | Percentage of participants with at least one SAE | 2.9 percentage of participants |
| CSL425 (7.5 mcg), Adults | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI) | Percentage of participants with related AESI | 0 percentage of participants |
| CSL425 (7.5 mcg), Adults | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI) | Percentage of participants with related NOCI | 0 percentage of participants |
| CSL425 (7.5 mcg), Adults | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI) | Percentage of participants with related SAE | 0 percentage of participants |
| CSL425 (7.5 mcg), Adults | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI) | Percentage of participants with at least one NOCI | 0.5 percentage of participants |
| CSL425 (15 Mcg), Adults | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI) | Percentage of participants with at least one NOCI | 0.5 percentage of participants |
| CSL425 (15 Mcg), Adults | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI) | Percentage of participants with at least one AESI | 0 percentage of participants |
| CSL425 (15 Mcg), Adults | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI) | Percentage of participants with related SAE | 0 percentage of participants |
| CSL425 (15 Mcg), Adults | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI) | Percentage of participants with related AESI | 0 percentage of participants |
| CSL425 (15 Mcg), Adults | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI) | Percentage of participants with related NOCI | 0 percentage of participants |
| CSL425 (15 Mcg), Adults | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI) | Percentage of participants with at least one SAE | 2.0 percentage of participants |
| CSL425 (30 Mcg), Adults | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI) | Percentage of participants with at least one NOCI | 0.5 percentage of participants |
| CSL425 (30 Mcg), Adults | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI) | Percentage of participants with at least one SAE | 1.5 percentage of participants |
| CSL425 (30 Mcg), Adults | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI) | Percentage of participants with related SAE | 0 percentage of participants |
| CSL425 (30 Mcg), Adults | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI) | Percentage of participants with at least one AESI | 0 percentage of participants |
| CSL425 (30 Mcg), Adults | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI) | Percentage of participants with related AESI | 0 percentage of participants |
| CSL425 (30 Mcg), Adults | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI) | Percentage of participants with related NOCI | 0 percentage of participants |
| Placebo, Older Adults | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI) | Percentage of participants with at least one NOCI | 2.0 percentage of participants |
| Placebo, Older Adults | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI) | Percentage of participants with related SAE | 0 percentage of participants |
| Placebo, Older Adults | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI) | Percentage of participants with related NOCI | 0 percentage of participants |
| Placebo, Older Adults | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI) | Percentage of participants with at least one SAE | 6.0 percentage of participants |
| Placebo, Older Adults | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI) | Percentage of participants with related AESI | 0 percentage of participants |
| Placebo, Older Adults | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI) | Percentage of participants with at least one AESI | 0 percentage of participants |
| CSL425 (7.5 Mcg), Older Adults | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI) | Percentage of participants with at least one AESI | 0 percentage of participants |
| CSL425 (7.5 Mcg), Older Adults | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI) | Percentage of participants with related AESI | 0 percentage of participants |
| CSL425 (7.5 Mcg), Older Adults | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI) | Percentage of participants with related SAE | 0 percentage of participants |
| CSL425 (7.5 Mcg), Older Adults | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI) | Percentage of participants with at least one NOCI | 1.0 percentage of participants |
| CSL425 (7.5 Mcg), Older Adults | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI) | Percentage of participants with at least one SAE | 4.4 percentage of participants |
| CSL425 (7.5 Mcg), Older Adults | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI) | Percentage of participants with related NOCI | 0 percentage of participants |
| CSL425 (15 Mcg), Older Adults | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI) | Percentage of participants with related AESI | 0 percentage of participants |
| CSL425 (15 Mcg), Older Adults | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI) | Percentage of participants with at least one NOCI | 2.5 percentage of participants |
| CSL425 (15 Mcg), Older Adults | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI) | Percentage of participants with at least one SAE | 3.0 percentage of participants |
| CSL425 (15 Mcg), Older Adults | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI) | Percentage of participants with at least one AESI | 0 percentage of participants |
| CSL425 (15 Mcg), Older Adults | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI) | Percentage of participants with related NOCI | 0 percentage of participants |
| CSL425 (15 Mcg), Older Adults | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI) | Percentage of participants with related SAE | 0 percentage of participants |
| CSL425 (30 Mcg), Older Adults | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI) | Percentage of participants with related AESI | 0 percentage of participants |
| CSL425 (30 Mcg), Older Adults | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI) | Percentage of participants with at least one AESI | 0 percentage of participants |
| CSL425 (30 Mcg), Older Adults | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI) | Percentage of participants with related NOCI | 0 percentage of participants |
| CSL425 (30 Mcg), Older Adults | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI) | Percentage of participants with at least one NOCI | 2.0 percentage of participants |
| CSL425 (30 Mcg), Older Adults | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI) | Percentage of participants with at least one SAE | 4.5 percentage of participants |
| CSL425 (30 Mcg), Older Adults | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI) | Percentage of participants with related SAE | 0 percentage of participants |