Trial Outcomes & Findings for A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in a Healthy Pediatric Population in the USA (NCT NCT00958243)
NCT ID: NCT00958243
Last Updated: 2018-05-23
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
473 participants
Primary outcome timeframe
21 days after the first study vaccination
Results posted on
2018-05-23
Participant Flow
Participant milestones
| Measure |
Placebo Cohort A
Placebo, Aged 6 months to less than 3 years
|
CSL425 (7.5 mcg) Cohort A
7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
|
CSL425 (15 mcg) Cohort A
15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
|
Placebo Cohort B
Placebo, Aged 3 years to less than 9 years
|
CSL425 (7.5 mcg) Cohort B
7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
|
CSL425 (15 mcg) Cohort B
15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
26
|
105
|
96
|
28
|
109
|
109
|
|
Overall Study
COMPLETED
|
24
|
99
|
82
|
25
|
100
|
99
|
|
Overall Study
NOT COMPLETED
|
2
|
6
|
14
|
3
|
9
|
10
|
Reasons for withdrawal
| Measure |
Placebo Cohort A
Placebo, Aged 6 months to less than 3 years
|
CSL425 (7.5 mcg) Cohort A
7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
|
CSL425 (15 mcg) Cohort A
15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
|
Placebo Cohort B
Placebo, Aged 3 years to less than 9 years
|
CSL425 (7.5 mcg) Cohort B
7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
|
CSL425 (15 mcg) Cohort B
15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
3
|
1
|
1
|
5
|
|
Overall Study
Lost to Follow-up
|
2
|
5
|
11
|
2
|
8
|
5
|
Baseline Characteristics
A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in a Healthy Pediatric Population in the USA
Baseline characteristics by cohort
| Measure |
Placebo Cohort A
n=26 Participants
Placebo, Aged 6 months to less than 3 years
|
CSL425 (7.5 mcg) Cohort A
n=105 Participants
7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
|
CSL425 (15 mcg) Cohort A
n=96 Participants
15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
|
Placebo Cohort B
n=28 Participants
Placebo, Aged 3 years to less than 9 years
|
CSL425 (7.5 mcg) Cohort B
n=109 Participants
7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
|
CSL425 (15 mcg) Cohort B
n=109 Participants
15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
|
Total
n=473 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
26 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
109 Participants
n=21 Participants
|
109 Participants
n=10 Participants
|
473 Participants
n=115 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Age, Continuous
|
1.87 years
STANDARD_DEVIATION 0.77 • n=5 Participants
|
1.73 years
STANDARD_DEVIATION 0.72 • n=7 Participants
|
1.85 years
STANDARD_DEVIATION 0.66 • n=5 Participants
|
5.90 years
STANDARD_DEVIATION 1.71 • n=4 Participants
|
5.94 years
STANDARD_DEVIATION 1.71 • n=21 Participants
|
5.91 years
STANDARD_DEVIATION 1.70 • n=10 Participants
|
3.93 years
STANDARD_DEVIATION 2.45 • n=115 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
53 Participants
n=21 Participants
|
50 Participants
n=10 Participants
|
228 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
56 Participants
n=21 Participants
|
59 Participants
n=10 Participants
|
245 Participants
n=115 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
105 participants
n=7 Participants
|
96 participants
n=5 Participants
|
28 participants
n=4 Participants
|
109 participants
n=21 Participants
|
109 participants
n=10 Participants
|
473 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: 21 days after the first study vaccinationPopulation: 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).
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.
Outcome measures
| Measure |
Placebo Cohort A
n=25 Participants
Placebo, Aged 6 months to less than 3 years
|
CSL425 (7.5 mcg) Cohort A
n=102 Participants
7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
|
CSL425 (15 mcg) Cohort A
n=89 Participants
15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
|
Placebo Cohort B
n=27 Participants
Placebo, Aged 3 years to less than 9 years
|
CSL425 (7.5 mcg) Cohort B
n=104 Participants
7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
|
CSL425 (15 mcg) Cohort B
n=102 Participants
15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
|
|---|---|---|---|---|---|---|
|
Seroconversion Rate 21 Days After First Study Vaccination
|
4.0 Percentage of participants
Interval 0.1 to 20.4
|
88.2 Percentage of participants
Interval 80.4 to 93.8
|
83.1 Percentage of participants
Interval 73.7 to 90.2
|
3.7 Percentage of participants
Interval 0.1 to 19.0
|
84.6 Percentage of participants
Interval 76.2 to 90.9
|
88.2 Percentage of participants
Interval 80.4 to 93.8
|
PRIMARY outcome
Timeframe: 21 days after the second study vaccinationPopulation: 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).
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.
Outcome measures
| Measure |
Placebo Cohort A
n=21 Participants
Placebo, Aged 6 months to less than 3 years
|
CSL425 (7.5 mcg) Cohort A
n=90 Participants
7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
|
CSL425 (15 mcg) Cohort A
n=80 Participants
15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
|
Placebo Cohort B
n=26 Participants
Placebo, Aged 3 years to less than 9 years
|
CSL425 (7.5 mcg) Cohort B
n=98 Participants
7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
|
CSL425 (15 mcg) Cohort B
n=98 Participants
15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
|
|---|---|---|---|---|---|---|
|
Seroconversion Rate 21 Days After Second Study Vaccination
|
28.6 Percentage of participants
Interval 11.3 to 52.2
|
98.9 Percentage of participants
Interval 94.0 to 100.0
|
100.0 Percentage of participants
Interval 95.5 to 100.0
|
15.4 Percentage of participants
Interval 4.4 to 34.9
|
98.0 Percentage of participants
Interval 92.8 to 99.8
|
99.0 Percentage of participants
Interval 94.4 to 100.0
|
PRIMARY outcome
Timeframe: 21 days after the first study vaccinationPopulation: 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).
Outcome measures
| Measure |
Placebo Cohort A
n=25 Participants
Placebo, Aged 6 months to less than 3 years
|
CSL425 (7.5 mcg) Cohort A
n=102 Participants
7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
|
CSL425 (15 mcg) Cohort A
n=89 Participants
15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
|
Placebo Cohort B
n=27 Participants
Placebo, Aged 3 years to less than 9 years
|
CSL425 (7.5 mcg) Cohort B
n=104 Participants
7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
|
CSL425 (15 mcg) Cohort B
n=102 Participants
15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
|
|---|---|---|---|---|---|---|
|
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
Interval 1.0 to 26.0
|
90.2 Percentage of participants
Interval 82.7 to 95.2
|
84.3 Percentage of participants
Interval 75.0 to 91.1
|
25.9 Percentage of participants
Interval 11.1 to 46.3
|
84.6 Percentage of participants
Interval 76.2 to 90.9
|
89.2 Percentage of participants
Interval 81.5 to 94.5
|
PRIMARY outcome
Timeframe: 21 days after the second study vaccinationPopulation: 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).
Outcome measures
| Measure |
Placebo Cohort A
n=21 Participants
Placebo, Aged 6 months to less than 3 years
|
CSL425 (7.5 mcg) Cohort A
n=90 Participants
7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
|
CSL425 (15 mcg) Cohort A
n=80 Participants
15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
|
Placebo Cohort B
n=26 Participants
Placebo, Aged 3 years to less than 9 years
|
CSL425 (7.5 mcg) Cohort B
n=98 Participants
7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
|
CSL425 (15 mcg) Cohort B
n=98 Participants
15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
|
|---|---|---|---|---|---|---|
|
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
Interval 11.3 to 52.2
|
98.9 Percentage of participants
Interval 94.0 to 100.0
|
100.0 Percentage of participants
Interval 95.5 to 100.0
|
34.6 Percentage of participants
Interval 17.2 to 55.7
|
98.0 Percentage of participants
Interval 92.8 to 99.8
|
100.0 Percentage of participants
Interval 96.3 to 100.0
|
SECONDARY outcome
Timeframe: During the 7 days after each study vaccinationPopulation: Safety Population comprised all randomized participants who received at least one dose of study vaccine and had provided follow-up safety data.
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.
Outcome measures
| Measure |
Placebo Cohort A
n=26 Participants
Placebo, Aged 6 months to less than 3 years
|
CSL425 (7.5 mcg) Cohort A
n=105 Participants
7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
|
CSL425 (15 mcg) Cohort A
n=96 Participants
15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
|
Placebo Cohort B
Placebo, Aged 3 years to less than 9 years
|
CSL425 (7.5 mcg) Cohort B
7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
|
CSL425 (15 mcg) Cohort B
15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
|
|---|---|---|---|---|---|---|
|
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
|
44 Percentage of participants
|
37 Percentage of participants
|
—
|
—
|
—
|
|
Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A
Any pain
|
35 Percentage of participants
|
33 Percentage of participants
|
27 Percentage of participants
|
—
|
—
|
—
|
|
Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A
Grade 3 pain
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
|
Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A
Any redness
|
23 Percentage of participants
|
27 Percentage of participants
|
19 Percentage of participants
|
—
|
—
|
—
|
|
Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A
Grade 3 redness
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
|
Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A
Any swelling / induration
|
8 Percentage of participants
|
16 Percentage of participants
|
6 Percentage of participants
|
—
|
—
|
—
|
|
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
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
|
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
|
70 Percentage of participants
|
65 Percentage of participants
|
—
|
—
|
—
|
|
Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A
Any fever
|
23 Percentage of participants
|
25 Percentage of participants
|
43 Percentage of participants
|
—
|
—
|
—
|
|
Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A
Grade 3 fever
|
0 Percentage of participants
|
3 Percentage of participants
|
4 Percentage of participants
|
—
|
—
|
—
|
|
Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A
Any nausea / vomiting
|
8 Percentage of participants
|
11 Percentage of participants
|
15 Percentage of participants
|
—
|
—
|
—
|
|
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
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
|
Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A
Any diarrhea
|
39 Percentage of participants
|
37 Percentage of participants
|
38 Percentage of participants
|
—
|
—
|
—
|
|
Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A
Grade 3 diarrhea
|
0 Percentage of participants
|
1 Percentage of participants
|
2 Percentage of participants
|
—
|
—
|
—
|
|
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
|
24 Percentage of participants
|
22 Percentage of participants
|
—
|
—
|
—
|
|
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
|
0 Percentage of participants
|
1 Percentage of participants
|
—
|
—
|
—
|
|
Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A
Any irritability
|
23 Percentage of participants
|
48 Percentage of participants
|
34 Percentage of participants
|
—
|
—
|
—
|
|
Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A
Grade 3 irritability
|
0 Percentage of participants
|
1 Percentage of participants
|
2 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: During the 7 days after each study vaccinationPopulation: 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.
Outcome measures
| Measure |
Placebo Cohort A
n=26 Participants
Placebo, Aged 6 months to less than 3 years
|
CSL425 (7.5 mcg) Cohort A
n=105 Participants
7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
|
CSL425 (15 mcg) Cohort A
n=96 Participants
15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
|
Placebo Cohort B
Placebo, Aged 3 years to less than 9 years
|
CSL425 (7.5 mcg) Cohort B
7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
|
CSL425 (15 mcg) Cohort B
15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
|
|---|---|---|---|---|---|---|
|
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
|
1.75 Days
Standard Deviation 1.183
|
3.60 Days
Standard Deviation 5.168
|
—
|
—
|
—
|
|
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
|
1.81 Days
Standard Deviation 1.001
|
2.86 Days
Standard Deviation 4.597
|
—
|
—
|
—
|
|
Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A
Any pain after first vaccination
|
1.00 Days
Standard Deviation 0.000
|
1.52 Days
Standard Deviation 0.677
|
1.91 Days
Standard Deviation 1.743
|
—
|
—
|
—
|
|
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
|
2.20 Days
Standard Deviation 1.323
|
2.56 Days
Standard Deviation 1.459
|
—
|
—
|
—
|
|
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
|
1.63 Days
Standard Deviation 0.957
|
2.00 Days
Standard Deviation 1.549
|
—
|
—
|
—
|
|
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
|
1.32 Days
Standard Deviation 0.557
|
1.29 Days
Standard Deviation 0.893
|
—
|
—
|
—
|
|
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 0.000
|
1.43 Days
Standard Deviation 0.535
|
1.11 Days
Standard Deviation 0.333
|
—
|
—
|
—
|
|
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
|
2.38 Days
Standard Deviation 1.996
|
3.95 Days
Standard Deviation 4.248
|
—
|
—
|
—
|
|
Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A
Any loss of appetite after first vaccination
|
2.00 Days
Standard Deviation NA
Only one participant reported this AE after the first study vaccination in this group.
|
3.13 Days
Standard Deviation 2.500
|
2.07 Days
Standard Deviation 1.486
|
—
|
—
|
—
|
|
Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A
Any irritability after first vaccination
|
6.00 Days
Standard Deviation 7.810
|
2.08 Days
Standard Deviation 1.412
|
1.97 Days
Standard Deviation 1.224
|
—
|
—
|
—
|
|
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
|
1.57 Days
Standard Deviation 0.676
|
1.23 Days
Standard Deviation 0.599
|
—
|
—
|
—
|
|
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
|
2.00 Days
Standard Deviation 1.240
|
1.63 Days
Standard Deviation 0.916
|
—
|
—
|
—
|
|
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 NA
Only one participant reported this AE after the second study vaccination in this group.
|
3.00 Days
Standard Deviation 2.098
|
2.50 Days
Standard Deviation 0.707
|
—
|
—
|
—
|
|
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
|
1.40 Days
Standard Deviation 0.894
|
2.19 Days
Standard Deviation 2.344
|
—
|
—
|
—
|
|
Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A
Any nausea / vomiting after second vaccination
|
NA Days
Standard Deviation NA
No participants reported this AE after the second study vaccination in this group.
|
1.27 Days
Standard Deviation 0.647
|
1.50 Days
Standard Deviation 0.837
|
—
|
—
|
—
|
|
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
|
1.92 Days
Standard Deviation 1.248
|
4.33 Days
Standard Deviation 6.754
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: During the 7 days after each study vaccinationPopulation: Safety Population comprised all randomized participants who received at least one dose of study vaccine and had provided follow-up safety data.
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.
Outcome measures
| Measure |
Placebo Cohort A
n=28 Participants
Placebo, Aged 6 months to less than 3 years
|
CSL425 (7.5 mcg) Cohort A
n=107 Participants
7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
|
CSL425 (15 mcg) Cohort A
n=109 Participants
15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
|
Placebo Cohort B
Placebo, Aged 3 years to less than 9 years
|
CSL425 (7.5 mcg) Cohort B
7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
|
CSL425 (15 mcg) Cohort B
15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
|
|---|---|---|---|---|---|---|
|
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
|
38 Percentage of participants
|
49 Percentage of participants
|
—
|
—
|
—
|
|
Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B
Any pain
|
29 Percentage of participants
|
34 Percentage of participants
|
40 Percentage of participants
|
—
|
—
|
—
|
|
Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B
Grade 3 pain
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
|
Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B
Any redness
|
29 Percentage of participants
|
18 Percentage of participants
|
26 Percentage of participants
|
—
|
—
|
—
|
|
Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B
Grade 3 diarrhea
|
0 Percentage of participants
|
1 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
|
Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B
Grade 3 redness
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
|
Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B
Any swelling / induration
|
11 Percentage of participants
|
13 Percentage of participants
|
17 Percentage of participants
|
—
|
—
|
—
|
|
Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B
Grade 3 swelling / induration
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
|
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
|
44 Percentage of participants
|
46 Percentage of participants
|
—
|
—
|
—
|
|
Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B
Any fever
|
14 Percentage of participants
|
19 Percentage of participants
|
20 Percentage of participants
|
—
|
—
|
—
|
|
Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B
Grade 3 fever
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
|
Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B
Any nausea / vomiting
|
14 Percentage of participants
|
8 Percentage of participants
|
13 Percentage of participants
|
—
|
—
|
—
|
|
Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B
Grade 3 nausea / vomiting
|
0 Percentage of participants
|
2 Percentage of participants
|
1 Percentage of participants
|
—
|
—
|
—
|
|
Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B
Any diarrhea
|
21 Percentage of participants
|
8 Percentage of participants
|
9 Percentage of participants
|
—
|
—
|
—
|
|
Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B
Any headache
|
21 Percentage of participants
|
17 Percentage of participants
|
25 Percentage of participants
|
—
|
—
|
—
|
|
Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B
Grade 3 headache
|
0 Percentage of participants
|
1 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
|
Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B
Any malaise
|
21 Percentage of participants
|
27 Percentage of participants
|
20 Percentage of participants
|
—
|
—
|
—
|
|
Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B
Grade 3 malaise
|
4 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
|
Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B
Any myalgia
|
21 Percentage of participants
|
14 Percentage of participants
|
22 Percentage of participants
|
—
|
—
|
—
|
|
Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B
Grade 3 myalgia
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: During the 7 days after each study vaccinationPopulation: 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.
Outcome measures
| Measure |
Placebo Cohort A
n=28 Participants
Placebo, Aged 6 months to less than 3 years
|
CSL425 (7.5 mcg) Cohort A
n=107 Participants
7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
|
CSL425 (15 mcg) Cohort A
n=109 Participants
15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
|
Placebo Cohort B
Placebo, Aged 3 years to less than 9 years
|
CSL425 (7.5 mcg) Cohort B
7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
|
CSL425 (15 mcg) Cohort B
15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
|
|---|---|---|---|---|---|---|
|
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
|
1.63 Days
Standard Deviation 1.066
|
1.46 Days
Standard Deviation 0.691
|
—
|
—
|
—
|
|
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
|
2.17 Days
Standard Deviation 1.339
|
2.24 Days
Standard Deviation 1.809
|
—
|
—
|
—
|
|
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
|
1.80 Days
Standard Deviation 0.632
|
1.79 Days
Standard Deviation 0.975
|
—
|
—
|
—
|
|
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
|
1.12 Days
Standard Deviation 0.332
|
1.56 Days
Standard Deviation 0.856
|
—
|
—
|
—
|
|
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 0.000
|
1.25 Days
Standard Deviation 0.500
|
1.00 Days
Standard Deviation 0.000
|
—
|
—
|
—
|
|
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
|
1.00 Days
Standard Deviation 0.000
|
1.22 Days
Standard Deviation 0.441
|
—
|
—
|
—
|
|
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
|
1.47 Days
Standard Deviation 0.964
|
1.60 Days
Standard Deviation 0.995
|
—
|
—
|
—
|
|
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
|
1.42 Days
Standard Deviation 0.669
|
1.56 Days
Standard Deviation 0.984
|
—
|
—
|
—
|
|
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
|
1.15 Days
Standard Deviation 0.376
|
1.25 Days
Standard Deviation 0.645
|
—
|
—
|
—
|
|
Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B
Any pain after second vaccination
|
1.25 Days
Standard Deviation 0.500
|
1.56 Days
Standard Deviation 0.856
|
1.33 Days
Standard Deviation 0.555
|
—
|
—
|
—
|
|
Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B
Any redness after second vaccination
|
2.00 Days
Standard Deviation 0.000
|
1.67 Days
Standard Deviation 0.516
|
1.60 Days
Standard Deviation 0.699
|
—
|
—
|
—
|
|
Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B
Any swelling / induration after second vaccination
|
2.00 Days
Standard Deviation NA
Only one participant reported this AE after the second study vaccination in this group.
|
1.17 Days
Standard Deviation 0.408
|
1.63 Days
Standard Deviation 0.744
|
—
|
—
|
—
|
|
Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B
Any fever after second vaccination
|
1.00 Days
Standard Deviation NA
Only one participant reported this AE after the second study vaccination in this group.
|
1.40 Days
Standard Deviation 0.548
|
1.57 Days
Standard Deviation 1.134
|
—
|
—
|
—
|
|
Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B
Any nausea / vomiting after second vaccination
|
1.00 Days
Standard Deviation NA
Only one participant reported this AE after the second study vaccination in this group.
|
1.25 Days
Standard Deviation 0.500
|
1.17 Days
Standard Deviation 0.408
|
—
|
—
|
—
|
|
Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B
Any diarrhea after second vaccination
|
1 Days
Standard Deviation NA
Only one participant reported this AE after the second study vaccination in this group.
|
1.00 Days
Standard Deviation 0.000
|
1.00 Days
Standard Deviation 0.000
|
—
|
—
|
—
|
|
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
|
1.75 Days
Standard Deviation 0.754
|
1.83 Days
Standard Deviation 1.467
|
—
|
—
|
—
|
|
Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B
Any myalgia after second vaccination
|
1.00 Days
Standard Deviation NA
Only one participant reported this AE after the second study vaccination in this group.
|
1.38 Days
Standard Deviation 0.518
|
1.42 Days
Standard Deviation 0.669
|
—
|
—
|
—
|
|
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
|
1.38 Days
Standard Deviation 0.518
|
1.29 Days
Standard Deviation 0.488
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: During the 21 days after each vaccinationPopulation: Safety Population comprised all randomized participants who received at least one dose of study vaccine and had provided follow-up safety data.
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.
Outcome measures
| Measure |
Placebo Cohort A
n=26 Participants
Placebo, Aged 6 months to less than 3 years
|
CSL425 (7.5 mcg) Cohort A
n=105 Participants
7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
|
CSL425 (15 mcg) Cohort A
n=96 Participants
15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
|
Placebo Cohort B
n=28 Participants
Placebo, Aged 3 years to less than 9 years
|
CSL425 (7.5 mcg) Cohort B
n=107 Participants
7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
|
CSL425 (15 mcg) Cohort B
n=109 Participants
15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
|
|---|---|---|---|---|---|---|
|
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
|
52 Percentage of participants
|
55 Percentage of participants
|
50 Percentage of participants
|
49 Percentage of participants
|
41 Percentage of participants
|
|
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
|
26 Percentage of participants
|
22 Percentage of participants
|
14 Percentage of participants
|
23 Percentage of participants
|
19 Percentage of participants
|
|
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
|
22 Percentage of participants
|
27 Percentage of participants
|
25 Percentage of participants
|
21 Percentage of participants
|
17 Percentage of participants
|
|
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
|
5 Percentage of participants
|
6 Percentage of participants
|
11 Percentage of participants
|
5 Percentage of participants
|
6 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 180 days after the last vaccinationPopulation: Safety Population comprised all randomized participants who received at least one dose of study vaccine and had provided follow-up safety data.
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).
Outcome measures
| Measure |
Placebo Cohort A
n=26 Participants
Placebo, Aged 6 months to less than 3 years
|
CSL425 (7.5 mcg) Cohort A
n=105 Participants
7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
|
CSL425 (15 mcg) Cohort A
n=96 Participants
15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
|
Placebo Cohort B
n=28 Participants
Placebo, Aged 3 years to less than 9 years
|
CSL425 (7.5 mcg) Cohort B
n=107 Participants
7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
|
CSL425 (15 mcg) Cohort B
n=109 Participants
15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
|
|---|---|---|---|---|---|---|
|
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
|
2 Percentage of participants
|
3 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
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
|
0 Percentage of participants
|
1 Percentage of participants
|
0 Percentage of participants
|
1 Percentage of participants
|
0 Percentage of participants
|
|
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
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
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
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
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
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
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
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
Adverse Events
Placebo Cohort A
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
CSL425 (7.5 mcg) Cohort A
Serious events: 2 serious events
Other events: 58 other events
Deaths: 0 deaths
CSL425 (15 mcg) Cohort A
Serious events: 3 serious events
Other events: 82 other events
Deaths: 0 deaths
Placebo Cohort B
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
CSL425 (7.5 mcg) Cohort B
Serious events: 0 serious events
Other events: 70 other events
Deaths: 0 deaths
CSL425 (15 mcg) Cohort B
Serious events: 0 serious events
Other events: 49 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo Cohort A
n=26 participants at risk
Placebo, Aged 6 months to less than 3 years
|
CSL425 (7.5 mcg) Cohort A
n=105 participants at risk
7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
|
CSL425 (15 mcg) Cohort A
n=96 participants at risk
15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
|
Placebo Cohort B
n=28 participants at risk
Placebo, Aged 3 years to less than 9 years
|
CSL425 (7.5 mcg) Cohort B
n=107 participants at risk
7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
|
CSL425 (15 mcg) Cohort B
n=109 participants at risk
15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/26 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
0.00%
0/105 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
1.0%
1/96 • Number of events 1 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
0.00%
0/28 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
0.00%
0/107 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
0.00%
0/109 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
|
Infections and infestations
Influenza
|
0.00%
0/26 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
0.00%
0/105 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
1.0%
1/96 • Number of events 1 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
0.00%
0/28 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
0.00%
0/107 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
0.00%
0/109 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/26 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
0.00%
0/105 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
1.0%
1/96 • Number of events 1 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
0.00%
0/28 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
0.00%
0/107 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
0.00%
0/109 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/26 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
0.00%
0/105 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
1.0%
1/96 • Number of events 1 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
0.00%
0/28 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
0.00%
0/107 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
0.00%
0/109 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/26 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
0.95%
1/105 • Number of events 1 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
0.00%
0/96 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
0.00%
0/28 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
0.00%
0/107 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
0.00%
0/109 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/26 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
0.00%
0/105 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
1.0%
1/96 • Number of events 1 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
0.00%
0/28 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
0.00%
0/107 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
0.00%
0/109 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/26 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
0.95%
1/105 • Number of events 1 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
0.00%
0/96 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
0.00%
0/28 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
0.00%
0/107 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
0.00%
0/109 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
Other adverse events
| Measure |
Placebo Cohort A
n=26 participants at risk
Placebo, Aged 6 months to less than 3 years
|
CSL425 (7.5 mcg) Cohort A
n=105 participants at risk
7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
|
CSL425 (15 mcg) Cohort A
n=96 participants at risk
15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
|
Placebo Cohort B
n=28 participants at risk
Placebo, Aged 3 years to less than 9 years
|
CSL425 (7.5 mcg) Cohort B
n=107 participants at risk
7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
|
CSL425 (15 mcg) Cohort B
n=109 participants at risk
15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Ear infection
|
7.7%
2/26 • Number of events 2 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
1.9%
2/105 • Number of events 2 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
1.0%
1/96 • Number of events 1 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
3.6%
1/28 • Number of events 1 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
0.00%
0/107 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
0.00%
0/109 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
38.5%
10/26 • Number of events 13 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
16.2%
17/105 • Number of events 19 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
14.6%
14/96 • Number of events 17 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
10.7%
3/28 • Number of events 3 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
5.6%
6/107 • Number of events 8 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
6.4%
7/109 • Number of events 7 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.4%
4/26 • Number of events 6 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
8.6%
9/105 • Number of events 11 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
17.7%
17/96 • Number of events 21 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
10.7%
3/28 • Number of events 3 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
19.6%
21/107 • Number of events 22 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
13.8%
15/109 • Number of events 17 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.8%
1/26 • Number of events 1 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
3.8%
4/105 • Number of events 5 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
11.5%
11/96 • Number of events 12 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
3.6%
1/28 • Number of events 1 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
2.8%
3/107 • Number of events 3 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
4.6%
5/109 • Number of events 5 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
|
Gastrointestinal disorders
Diarrhea
|
3.8%
1/26 • Number of events 1 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
4.8%
5/105 • Number of events 5 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
5.2%
5/96 • Number of events 7 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
0.00%
0/28 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
6.5%
7/107 • Number of events 7 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
1.8%
2/109 • Number of events 2 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
|
Gastrointestinal disorders
Teething
|
3.8%
1/26 • Number of events 1 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
4.8%
5/105 • Number of events 7 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
7.3%
7/96 • Number of events 10 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
0.00%
0/28 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
0.00%
0/107 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
0.00%
0/109 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/26 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
3.8%
4/105 • Number of events 4 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
4.2%
4/96 • Number of events 5 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
7.1%
2/28 • Number of events 2 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
6.5%
7/107 • Number of events 7 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
1.8%
2/109 • Number of events 2 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
|
General disorders
Pyrexia
|
19.2%
5/26 • Number of events 6 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
7.6%
8/105 • Number of events 8 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
14.6%
14/96 • Number of events 15 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
21.4%
6/28 • Number of events 9 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
14.0%
15/107 • Number of events 17 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
9.2%
10/109 • Number of events 11 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
|
General disorders
Irritability
|
0.00%
0/26 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
1.9%
2/105 • Number of events 2 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
7.3%
7/96 • Number of events 7 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
0.00%
0/28 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
0.00%
0/107 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
2.8%
3/109 • Number of events 5 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
|
General disorders
Malaise
|
3.8%
1/26 • Number of events 1 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
1.9%
2/105 • Number of events 3 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
1.0%
1/96 • Number of events 1 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
7.1%
2/28 • Number of events 2 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
2.8%
3/107 • Number of events 3 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
0.92%
1/109 • Number of events 1 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
|
Nervous system disorders
Headache
|
0.00%
0/26 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
0.00%
0/105 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
1.0%
1/96 • Number of events 1 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
14.3%
4/28 • Number of events 5 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
7.5%
8/107 • Number of events 8 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
3.7%
4/109 • Number of events 4 • 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.
Other adverse events presented are unsolicited adverse events 21 days after either study vaccination.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60