Trial Outcomes & Findings for A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Adults (NCT NCT00938639)
NCT ID: NCT00938639
Last Updated: 2018-06-28
Results Overview
Antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination antibody titre of 1:40 or more; or participants with a pre-vaccination titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
240 participants
Primary outcome timeframe
Before and 21 days after the first vaccination
Results posted on
2018-06-28
Participant Flow
Participant milestones
| Measure |
CSL425 (15 mcg)
15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg)
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
|---|---|---|
|
Overall Study
STARTED
|
120
|
120
|
|
Overall Study
COMPLETED
|
117
|
116
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
| Measure |
CSL425 (15 mcg)
15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg)
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
|---|---|---|
|
Overall Study
Moved away from study area
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Family issues
|
1
|
1
|
|
Overall Study
Participant noncompliance
|
1
|
0
|
Baseline Characteristics
A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Adults
Baseline characteristics by cohort
| Measure |
CSL425 (15 mcg)
n=120 Participants
15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg)
n=120 Participants
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
Total
n=240 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.6 years
STANDARD_DEVIATION 15.12 • n=99 Participants
|
42.9 years
STANDARD_DEVIATION 15.39 • n=107 Participants
|
43.7 years
STANDARD_DEVIATION 15.25 • n=206 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=99 Participants
|
67 Participants
n=107 Participants
|
134 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
106 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Before and 21 days after the first vaccinationPopulation: The Evaluable Population (for the first vaccination) comprised all randomised participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).
Antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination antibody titre of 1:40 or more; or participants with a pre-vaccination titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre.
Outcome measures
| Measure |
CSL425 (15 mcg)
n=120 Participants
15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg)
n=119 Participants
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg), Adult
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg), Older Adult
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
|---|---|---|---|---|
|
Haemagglutination Inhibition (HI) and Microneutralisation (MN) Antibody Titre Seroconversion Rate After the First Vaccination
Seroconversion rate - MN
|
77.5 percentage of participants
Interval 69.0 to 84.6
|
75.6 percentage of participants
Interval 66.9 to 83.0
|
—
|
—
|
|
Haemagglutination Inhibition (HI) and Microneutralisation (MN) Antibody Titre Seroconversion Rate After the First Vaccination
Seroconversion rate - HI
|
74.2 percentage of participants
Interval 65.4 to 81.7
|
81.5 percentage of participants
Interval 73.4 to 88.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Before and 21 days after the second vaccinationPopulation: The Evaluable Population (for the second vaccination) comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).
Antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination antibody titre of 1:40 or more; or participants with a pre-vaccination titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre.
Outcome measures
| Measure |
CSL425 (15 mcg)
n=117 Participants
15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg)
n=115 Participants
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg), Adult
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg), Older Adult
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
|---|---|---|---|---|
|
HI and MN Antibody Titre Seroconversion Rate After the Second Vaccination
Seroconversion rate - HI
|
82.1 percentage of participants
Interval 73.9 to 88.5
|
89.6 percentage of participants
Interval 82.5 to 94.5
|
—
|
—
|
|
HI and MN Antibody Titre Seroconversion Rate After the Second Vaccination
Seroconversion rate - MN
|
87.2 percentage of participants
Interval 79.7 to 92.6
|
83.5 percentage of participants
Interval 75.4 to 89.7
|
—
|
—
|
PRIMARY outcome
Timeframe: Before and 21 days after the first vaccinationPopulation: The Evaluable Population (for the first vaccination) comprised all randomised participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).
GMFI in antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre.
Outcome measures
| Measure |
CSL425 (15 mcg)
n=120 Participants
15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg)
n=119 Participants
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg), Adult
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg), Older Adult
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
|---|---|---|---|---|
|
Geometric Mean Fold Increase (GMFI) in the HI and MN Antibody Titre After the First Vaccination
GMFI - HI
|
11.83 geometric mean fold increase
Interval 8.91 to 15.7
|
19.54 geometric mean fold increase
Interval 14.58 to 26.2
|
—
|
—
|
|
Geometric Mean Fold Increase (GMFI) in the HI and MN Antibody Titre After the First Vaccination
GMFI - MN
|
24.83 geometric mean fold increase
Interval 17.56 to 35.11
|
39.70 geometric mean fold increase
Interval 26.68 to 59.06
|
—
|
—
|
PRIMARY outcome
Timeframe: Before and 21 days after the second vaccinationPopulation: The Evaluable Population (for the second vaccination) comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).
GMFI in antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre.
Outcome measures
| Measure |
CSL425 (15 mcg)
n=117 Participants
15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg)
n=115 Participants
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg), Adult
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg), Older Adult
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
|---|---|---|---|---|
|
GMFI in the HI and MN Antibody Titer After the Second Vaccination
GMFI - MN
|
32.30 geometric mean fold increase
Interval 23.96 to 43.54
|
46.50 geometric mean fold increase
Interval 32.83 to 65.87
|
—
|
—
|
|
GMFI in the HI and MN Antibody Titer After the Second Vaccination
GMFI - HI
|
16.00 geometric mean fold increase
Interval 12.36 to 20.71
|
23.30 geometric mean fold increase
Interval 17.92 to 30.29
|
—
|
—
|
PRIMARY outcome
Timeframe: 21 days after the first vaccinationPopulation: The Evaluable Population (for the first vaccination) comprised all randomised participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).
Outcome measures
| Measure |
CSL425 (15 mcg)
n=120 Participants
15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg)
n=119 Participants
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg), Adult
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg), Older Adult
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
|---|---|---|---|---|
|
Percentage of Participants Achieving a HI or MN Antibody Titre of 1:40 or More After the First Vaccination
Participants with HI titer ≥ 1:40
|
95.0 percentage of participants
Interval 89.4 to 98.1
|
89.1 percentage of participants
Interval 82.0 to 94.1
|
—
|
—
|
|
Percentage of Participants Achieving a HI or MN Antibody Titre of 1:40 or More After the First Vaccination
Participants with MN titer ≥ 1:40
|
88.3 percentage of participants
Interval 81.2 to 93.5
|
83.2 percentage of participants
Interval 75.2 to 89.4
|
—
|
—
|
PRIMARY outcome
Timeframe: 21 days after the second vaccinationPopulation: The Evaluable Population (for the second vaccination) comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).
Outcome measures
| Measure |
CSL425 (15 mcg)
n=117 Participants
15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg)
n=115 Participants
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg), Adult
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg), Older Adult
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
|---|---|---|---|---|
|
Percentage of Participants Achieving a HI or MN Antibody Titre of 1:40 or More After the Second Vaccination
Participants with HI titer ≥ 1:40
|
98.3 percentage of participants
Interval 94.0 to 99.8
|
96.5 percentage of participants
Interval 91.3 to 99.0
|
—
|
—
|
|
Percentage of Participants Achieving a HI or MN Antibody Titre of 1:40 or More After the Second Vaccination
Participants with MN titer ≥ 1:40
|
95.7 percentage of participants
Interval 90.3 to 98.6
|
92.2 percentage of participants
Interval 85.7 to 96.4
|
—
|
—
|
SECONDARY outcome
Timeframe: Before and 21 days after the first vaccinationPopulation: The Evaluable Population (for the first vaccination) comprised all randomised participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).
Antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination antibody titre of 1:40 or more; or participants with a pre-vaccination titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre. Adults were aged from 18 to 49 years; Older adults were aged from 50 to 64 years.
Outcome measures
| Measure |
CSL425 (15 mcg)
n=58 Participants
15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg)
n=62 Participants
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg), Adult
n=61 Participants
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg), Older Adult
n=58 Participants
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
|---|---|---|---|---|
|
HI and MN Antibody Titre Seroconversion Rate After the First Vaccination by Age Group
Seroconversion rate - HI
|
77.6 percentage of participants
Interval 64.7 to 87.5
|
71.0 percentage of participants
Interval 58.1 to 81.8
|
85.2 percentage of participants
Interval 73.8 to 93.0
|
77.6 percentage of participants
Interval 64.7 to 87.5
|
|
HI and MN Antibody Titre Seroconversion Rate After the First Vaccination by Age Group
Seroconversion rate - MN
|
82.8 percentage of participants
Interval 70.6 to 91.4
|
72.6 percentage of participants
Interval 59.8 to 83.1
|
83.6 percentage of participants
Interval 71.9 to 91.8
|
67.2 percentage of participants
Interval 53.7 to 79.0
|
SECONDARY outcome
Timeframe: Before and 21 days after the second vaccinationPopulation: The Evaluable Population (for the second vaccination) comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).
Antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination antibody titre of 1:40 or more; or participants with a pre-vaccination titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre. Adults were aged from 18 to 49 years; Older adults were aged from 50 to 64 years.
Outcome measures
| Measure |
CSL425 (15 mcg)
n=55 Participants
15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg)
n=62 Participants
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg), Adult
n=58 Participants
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg), Older Adult
n=57 Participants
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
|---|---|---|---|---|
|
HI and MN Antibody Titre Seroconversion Rate After the Second Vaccination by Age Group
Seroconversion rate - HI
|
83.6 percentage of participants
Interval 71.2 to 92.2
|
80.6 percentage of participants
Interval 68.6 to 89.6
|
87.9 percentage of participants
Interval 76.7 to 95.0
|
91.2 percentage of participants
Interval 80.7 to 97.1
|
|
HI and MN Antibody Titre Seroconversion Rate After the Second Vaccination by Age Group
Seroconversion rate - MN
|
89.1 percentage of participants
Interval 77.8 to 95.9
|
85.5 percentage of participants
Interval 74.2 to 93.1
|
86.2 percentage of participants
Interval 74.6 to 93.9
|
80.7 percentage of participants
Interval 68.1 to 90.0
|
SECONDARY outcome
Timeframe: Before and 21 days after the first vaccinationPopulation: The Evaluable Population (for the first vaccination) comprised all randomised participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).
GMFI in antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre. Adults were aged from 18 to 49 years; Older adults were aged from 50 to 64 years.
Outcome measures
| Measure |
CSL425 (15 mcg)
n=58 Participants
15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg)
n=62 Participants
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg), Adult
n=61 Participants
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg), Older Adult
n=58 Participants
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
|---|---|---|---|---|
|
GMFI in the HI and MN Antibody Titre After the First Vaccination by Age Group
GMFI - HI
|
15.13 geometric mean fold increase
Interval 9.97 to 22.96
|
9.39 geometric mean fold increase
Interval 6.37 to 13.84
|
25.79 geometric mean fold increase
Interval 17.0 to 39.11
|
14.60 geometric mean fold increase
Interval 9.68 to 22.02
|
|
GMFI in the HI and MN Antibody Titre After the First Vaccination by Age Group
GMFI - MN
|
36.73 geometric mean fold increase
Interval 22.23 to 60.68
|
17.21 geometric mean fold increase
Interval 10.72 to 27.64
|
54.91 geometric mean fold increase
Interval 31.75 to 94.96
|
28.22 geometric mean fold increase
Interval 15.8 to 50.41
|
SECONDARY outcome
Timeframe: Before and 21 days after the second vaccinationPopulation: The Evaluable Population (for the second vaccination) comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).
GMFI in antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre. Adults were aged from 18 to 49 years; Older adults were aged from 50 to 64 years.
Outcome measures
| Measure |
CSL425 (15 mcg)
n=55 Participants
15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg)
n=62 Participants
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg), Adult
n=58 Participants
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg), Older Adult
n=57 Participants
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
|---|---|---|---|---|
|
GMFI in the HI and MN Antibody Titre After the Second Vaccination by Age Group
GMFI - HI
|
18.00 geometric mean fold increase
Interval 12.17 to 26.62
|
14.41 geometric mean fold increase
Interval 10.16 to 20.45
|
26.01 geometric mean fold increase
Interval 17.69 to 38.25
|
20.82 geometric mean fold increase
Interval 14.44 to 30.02
|
|
GMFI in the HI and MN Antibody Titre After the Second Vaccination by Age Group
GMFI - MN
|
37.95 geometric mean fold increase
Interval 23.39 to 61.58
|
28.00 geometric mean fold increase
Interval 19.26 to 40.7
|
55.79 geometric mean fold increase
Interval 33.51 to 92.9
|
38.63 geometric mean fold increase
Interval 23.79 to 62.73
|
SECONDARY outcome
Timeframe: 21 days after the first vaccinationPopulation: The Evaluable Population (for the first vaccination) comprised all randomised participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).
Adults were aged from 18 to 49 years; Older adults were aged from 50 to 64 years.
Outcome measures
| Measure |
CSL425 (15 mcg)
n=58 Participants
15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg)
n=62 Participants
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg), Adult
n=61 Participants
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg), Older Adult
n=58 Participants
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
|---|---|---|---|---|
|
Percentage of Participants Achieving a HI or MN Antibody Titre of 1:40 or More After the First Vaccination by Age Group
Participants with HI titer ≥ 1:40
|
96.6 percentage of participants
Interval 88.1 to 99.6
|
93.5 percentage of participants
Interval 84.3 to 98.2
|
98.4 percentage of participants
Interval 91.2 to 100.0
|
79.3 percentage of participants
Interval 66.6 to 88.8
|
|
Percentage of Participants Achieving a HI or MN Antibody Titre of 1:40 or More After the First Vaccination by Age Group
Participants with MN titer ≥ 1:40
|
94.8 percentage of participants
Interval 85.6 to 98.9
|
82.3 percentage of participants
Interval 70.5 to 90.8
|
95.1 percentage of participants
Interval 86.3 to 99.0
|
70.7 percentage of participants
Interval 57.3 to 81.9
|
SECONDARY outcome
Timeframe: 21 days after the second vaccinationPopulation: The Evaluable Population (for the second vaccination) comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).
Adults were aged from 18 to 49 years; Older adults were aged from 50 to 64 years.
Outcome measures
| Measure |
CSL425 (15 mcg)
n=55 Participants
15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg)
n=62 Participants
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg), Adult
n=58 Participants
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg), Older Adult
n=57 Participants
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
|---|---|---|---|---|
|
Percentage of Participants Achieving a HI or MN Antibody Titre of 1:40 or More After the Second Vaccination by Age Group
Participants with HI titer ≥ 1:40
|
98.2 percentage of participants
Interval 90.3 to 100.0
|
98.4 percentage of participants
Interval 91.3 to 100.0
|
100.0 percentage of participants
Interval 93.8 to 100.0
|
93.0 percentage of participants
Interval 83.0 to 98.1
|
|
Percentage of Participants Achieving a HI or MN Antibody Titre of 1:40 or More After the Second Vaccination by Age Group
Participants with MN titer ≥ 1:40
|
100.0 percentage of participants
Interval 93.5 to 100.0
|
91.9 percentage of participants
Interval 82.2 to 97.3
|
100.0 percentage of participants
Interval 93.8 to 100.0
|
84.2 percentage of participants
Interval 72.1 to 92.5
|
SECONDARY outcome
Timeframe: Before and 21 days after each vaccinationPopulation: The Evaluable Population comprised all randomised participants who received the first (or second, as appropriate) 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).
The number of participants with a baseline titre less than 1:10 differed according to antibody assay (HI or MN) and is shown in the category titles accordingly. The total number of participants analysed includes all evaluable participants; however, the analysis is stratified by baseline titre and those participants with a baseline titre less than 1:10 are presented in this outcome measure while those with a baseline titre of 1:10 or more are presented in a separate outcome measure. Antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination titre of 1:40 or more; or participants with a pre-vaccination titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre.
Outcome measures
| Measure |
CSL425 (15 mcg)
n=120 Participants
15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg)
n=119 Participants
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg), Adult
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg), Older Adult
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
|---|---|---|---|---|
|
Percentage of Participants With a Baseline Titre Less Than 1:10 Achieving Seroconversion After Vaccination
After the first vaccination - HI (N = 42, 49)
|
92.9 percentage of participants
Interval 80.5 to 98.5
|
83.7 percentage of participants
Interval 70.3 to 92.7
|
—
|
—
|
|
Percentage of Participants With a Baseline Titre Less Than 1:10 Achieving Seroconversion After Vaccination
After the second vaccination - HI (N = 42, 47)
|
95.2 percentage of participants
Interval 83.8 to 99.4
|
93.6 percentage of participants
Interval 82.5 to 98.7
|
—
|
—
|
|
Percentage of Participants With a Baseline Titre Less Than 1:10 Achieving Seroconversion After Vaccination
After the first vaccination - MN (N = 62, 73)
|
77.4 percentage of participants
Interval 65.0 to 87.1
|
74.0 percentage of participants
Interval 62.4 to 83.5
|
—
|
—
|
|
Percentage of Participants With a Baseline Titre Less Than 1:10 Achieving Seroconversion After Vaccination
After the second vaccination - MN (N = 60, 71)
|
91.7 percentage of participants
Interval 81.6 to 97.2
|
87.3 percentage of participants
Interval 77.3 to 94.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Before and 21 days after each vaccinationPopulation: The Evaluable Population comprised all randomised participants who received the 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).
The number of participants with a baseline titre greater than or equal to 1:10 differed according to antibody assay (HI or MN) and is shown in the category titles accordingly. The total number of participants analysed includes all evaluable participants; however, the analysis is stratified by baseline titre and those participants with a baseline titre of 1:10 or more are presented in this outcome measure while those with a baseline titre less than 1:10 are presented in a separate outcome measure. Antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination titre of 1:40 or more; or participants with a pre-vaccination titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre (ie, a significant increase in antibody titre after vaccination).
Outcome measures
| Measure |
CSL425 (15 mcg)
n=120 Participants
15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg)
n=119 Participants
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg), Adult
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg), Older Adult
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
|---|---|---|---|---|
|
Percentage of Participants With a Baseline Titre Greater Than or Equal to 1:10 Achieving Seroconversion After Vaccination
After the first vaccination - HI (N = 78, 70)
|
64.1 percentage of participants
Interval 52.4 to 74.7
|
80.0 percentage of participants
Interval 68.7 to 88.6
|
—
|
—
|
|
Percentage of Participants With a Baseline Titre Greater Than or Equal to 1:10 Achieving Seroconversion After Vaccination
After the second vaccination - HI (N = 75, 68)
|
74.7 percentage of participants
Interval 63.3 to 84.0
|
86.8 percentage of participants
Interval 76.4 to 93.8
|
—
|
—
|
|
Percentage of Participants With a Baseline Titre Greater Than or Equal to 1:10 Achieving Seroconversion After Vaccination
After the first vaccination - MN (N = 58, 46)
|
77.6 percentage of participants
Interval 64.7 to 87.5
|
78.3 percentage of participants
Interval 63.6 to 89.1
|
—
|
—
|
|
Percentage of Participants With a Baseline Titre Greater Than or Equal to 1:10 Achieving Seroconversion After Vaccination
After the second vaccination - MN (N = 57, 44)
|
82.5 percentage of participants
Interval 70.1 to 91.3
|
77.3 percentage of participants
Interval 62.2 to 88.5
|
—
|
—
|
SECONDARY outcome
Timeframe: 21 days and 180 days after the second vaccinationPopulation: The Evaluable Population comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).
The GMFI in antibody titre was calculated by taking the anti-logs of the means of the log transformed fold-increases in the antibody titre 180 days after the second vaccination over the antibody titre 21 days after the second vaccination.
Outcome measures
| Measure |
CSL425 (15 mcg)
n=115 Participants
15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg)
n=111 Participants
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg), Adult
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg), Older Adult
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
|---|---|---|---|---|
|
GMFI in the HI Antibody Titre 180 Days After the Second Vaccination
|
0.49 geometric mean fold increase
Interval 0.44 to 0.55
|
0.42 geometric mean fold increase
Interval 0.38 to 0.47
|
—
|
—
|
SECONDARY outcome
Timeframe: 180 days after the second vaccinationPopulation: The Evaluable Population comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).
Outcome measures
| Measure |
CSL425 (15 mcg)
n=115 Participants
15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg)
n=111 Participants
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg), Adult
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg), Older Adult
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
|---|---|---|---|---|
|
Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More 180 Days After the Second Vaccination
|
95.7 percentage of participants
Interval 90.1 to 98.6
|
91.9 percentage of participants
Interval 85.2 to 96.2
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 0 to Day 6 after the first vaccinationPopulation: The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.
Solicited AEs included AEs that were specifically sought for. Grade 3 solicited AE definitions: Prevented normal daily activities; Size \> 100 mm for injection site redness, induration/swelling, and bruising.
Outcome measures
| Measure |
CSL425 (15 mcg)
n=120 Participants
15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg)
n=120 Participants
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg), Adult
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg), Older Adult
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
|---|---|---|---|---|
|
Frequency and Intensity of Solicited Local Adverse Events (AEs) After the First Vaccination
Any local solicited AE
|
40.0 percentage of participants
|
49.2 percentage of participants
|
—
|
—
|
|
Frequency and Intensity of Solicited Local Adverse Events (AEs) After the First Vaccination
Any pain at injection site
|
20.8 percentage of participants
|
22.5 percentage of participants
|
—
|
—
|
|
Frequency and Intensity of Solicited Local Adverse Events (AEs) After the First Vaccination
Grade 3 pain at injection site
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Frequency and Intensity of Solicited Local Adverse Events (AEs) After the First Vaccination
Any redness at injection site
|
0.8 percentage of participants
|
0.8 percentage of participants
|
—
|
—
|
|
Frequency and Intensity of Solicited Local Adverse Events (AEs) After the First Vaccination
Grade 3 redness at injection site
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Frequency and Intensity of Solicited Local Adverse Events (AEs) After the First Vaccination
Any swelling/induration at injection site
|
9.2 percentage of participants
|
8.3 percentage of participants
|
—
|
—
|
|
Frequency and Intensity of Solicited Local Adverse Events (AEs) After the First Vaccination
Grade 3 swelling/induration at injection site
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Frequency and Intensity of Solicited Local Adverse Events (AEs) After the First Vaccination
Any tenderness at injection site
|
30.8 percentage of participants
|
42.5 percentage of participants
|
—
|
—
|
|
Frequency and Intensity of Solicited Local Adverse Events (AEs) After the First Vaccination
Grade 3 tenderness at injection site
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Frequency and Intensity of Solicited Local Adverse Events (AEs) After the First Vaccination
Any bruising at injection site
|
5.0 percentage of participants
|
4.2 percentage of participants
|
—
|
—
|
|
Frequency and Intensity of Solicited Local Adverse Events (AEs) After the First Vaccination
Grade 3 bruising at injection site
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 0 to Day 6 after the first vaccination and up to Day 20 after the first vaccination if AE is ongoing at Day 7Population: The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.
Solicited AEs included AEs that were specifically sought for.
Outcome measures
| Measure |
CSL425 (15 mcg)
n=120 Participants
15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg)
n=120 Participants
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg), Adult
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg), Older Adult
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
|---|---|---|---|---|
|
Duration of Solicited Local AEs After the First Vaccination
Pain at injection site
|
1.96 days
Standard Deviation 2.423
|
1.67 days
Standard Deviation 1.240
|
—
|
—
|
|
Duration of Solicited Local AEs After the First Vaccination
Redness at injection site
|
1.00 days
Standard Deviation NA
Only one participant experienced redness at the injection site so the standard deviation cannot be derived
|
1.00 days
Standard Deviation NA
Only one participant experienced redness at the injection site so the standard deviation cannot be derived
|
—
|
—
|
|
Duration of Solicited Local AEs After the First Vaccination
Swelling/induration at injection site
|
1.64 days
Standard Deviation 0.809
|
2.70 days
Standard Deviation 2.263
|
—
|
—
|
|
Duration of Solicited Local AEs After the First Vaccination
Tenderness at injection site
|
2.24 days
Standard Deviation 1.862
|
1.88 days
Standard Deviation 1.078
|
—
|
—
|
|
Duration of Solicited Local AEs After the First Vaccination
Bruising at injection site
|
5.83 days
Standard Deviation 6.113
|
4.40 days
Standard Deviation 7.057
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 0 to Day 6 after the second vaccinationPopulation: The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.
Solicited AEs included AEs that were specifically sought for. Grade 3 solicited AE definitions: Prevented normal daily activities; Size \> 100 mm for injection site redness, induration/swelling, and bruising.
Outcome measures
| Measure |
CSL425 (15 mcg)
n=119 Participants
15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg)
n=119 Participants
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg), Adult
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg), Older Adult
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
|---|---|---|---|---|
|
Frequency and Intensity of Solicited Local AEs After the Second Vaccination
Any pain at injection site
|
11.8 percentage of participants
|
16.8 percentage of participants
|
—
|
—
|
|
Frequency and Intensity of Solicited Local AEs After the Second Vaccination
Any tenderness at injection site
|
21.8 percentage of participants
|
39.5 percentage of participants
|
—
|
—
|
|
Frequency and Intensity of Solicited Local AEs After the Second Vaccination
Grade 3 bruising at injection site
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Frequency and Intensity of Solicited Local AEs After the Second Vaccination
Any local solicited AE
|
28.6 percentage of participants
|
42.9 percentage of participants
|
—
|
—
|
|
Frequency and Intensity of Solicited Local AEs After the Second Vaccination
Grade 3 pain at injection site
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Frequency and Intensity of Solicited Local AEs After the Second Vaccination
Any redness at injection site
|
1.7 percentage of participants
|
2.5 percentage of participants
|
—
|
—
|
|
Frequency and Intensity of Solicited Local AEs After the Second Vaccination
Grade 3 redness at injection site
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Frequency and Intensity of Solicited Local AEs After the Second Vaccination
Any swelling/induration at injection site
|
3.4 percentage of participants
|
5.9 percentage of participants
|
—
|
—
|
|
Frequency and Intensity of Solicited Local AEs After the Second Vaccination
Grade 3 swelling/induration at injection site
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Frequency and Intensity of Solicited Local AEs After the Second Vaccination
Grade 3 tenderness at injection site
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Frequency and Intensity of Solicited Local AEs After the Second Vaccination
Any bruising at injection site
|
2.5 percentage of participants
|
3.4 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 0 to Day 6 after the second vaccination and up to Day 20 after the second vaccination if AE is ongoing at Day 7Population: The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.
Solicited AEs included AEs that were specifically sought for.
Outcome measures
| Measure |
CSL425 (15 mcg)
n=119 Participants
15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg)
n=119 Participants
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg), Adult
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg), Older Adult
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
|---|---|---|---|---|
|
Duration of Solicited Local AEs After the Second Vaccination
Pain at injection site
|
1.50 days
Standard Deviation 0.519
|
2.40 days
Standard Deviation 4.430
|
—
|
—
|
|
Duration of Solicited Local AEs After the Second Vaccination
Redness at injection site
|
6.00 days
Standard Deviation 5.657
|
1.67 days
Standard Deviation 1.155
|
—
|
—
|
|
Duration of Solicited Local AEs After the Second Vaccination
Swelling/induration at injection site
|
1.75 days
Standard Deviation 0.500
|
1.43 days
Standard Deviation 0.787
|
—
|
—
|
|
Duration of Solicited Local AEs After the Second Vaccination
Tenderness at injection site
|
1.62 days
Standard Deviation 0.852
|
2.11 days
Standard Deviation 1.521
|
—
|
—
|
|
Duration of Solicited Local AEs After the Second Vaccination
Bruising at injection site
|
8.00 days
Standard Deviation 5.196
|
2.00 days
Standard Deviation 0.707
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 0 to Day 6 after the first vaccinationPopulation: The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.
Solicited AEs included AEs that were specifically sought for. Grade 3 solicited AE definitions: Prevented normal daily activities; Temperature 102.2°F (39.0°C) or more for fevers.
Outcome measures
| Measure |
CSL425 (15 mcg)
n=120 Participants
15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg)
n=120 Participants
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg), Adult
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg), Older Adult
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
|---|---|---|---|---|
|
Frequency and Intensity of Solicited Systemic AEs After the First Vaccination
Any nausea
|
5.8 percentage of participants
|
8.3 percentage of participants
|
—
|
—
|
|
Frequency and Intensity of Solicited Systemic AEs After the First Vaccination
Grade 3 nausea
|
0.8 percentage of participants
|
0.8 percentage of participants
|
—
|
—
|
|
Frequency and Intensity of Solicited Systemic AEs After the First Vaccination
Any solicited AE
|
37.5 percentage of participants
|
53.3 percentage of participants
|
—
|
—
|
|
Frequency and Intensity of Solicited Systemic AEs After the First Vaccination
Any headache
|
26.7 percentage of participants
|
37.5 percentage of participants
|
—
|
—
|
|
Frequency and Intensity of Solicited Systemic AEs After the First Vaccination
Grade 3 headache
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Frequency and Intensity of Solicited Systemic AEs After the First Vaccination
Any malaise/feeling generally unwell
|
11.7 percentage of participants
|
22.5 percentage of participants
|
—
|
—
|
|
Frequency and Intensity of Solicited Systemic AEs After the First Vaccination
Grade 3 Malaise/feeling generally unwell
|
0.8 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Frequency and Intensity of Solicited Systemic AEs After the First Vaccination
Any muscle ache (myalgia)
|
15.8 percentage of participants
|
19.2 percentage of participants
|
—
|
—
|
|
Frequency and Intensity of Solicited Systemic AEs After the First Vaccination
Grade 3 muscle ache (myalgia)
|
0.8 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Frequency and Intensity of Solicited Systemic AEs After the First Vaccination
Any chills
|
0.8 percentage of participants
|
12.5 percentage of participants
|
—
|
—
|
|
Frequency and Intensity of Solicited Systemic AEs After the First Vaccination
Grade 3 chills
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Frequency and Intensity of Solicited Systemic AEs After the First Vaccination
Any vomiting
|
0 percentage of participants
|
1.7 percentage of participants
|
—
|
—
|
|
Frequency and Intensity of Solicited Systemic AEs After the First Vaccination
Grade 3 vomiting
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Frequency and Intensity of Solicited Systemic AEs After the First Vaccination
Any fever
|
5.0 percentage of participants
|
3.3 percentage of participants
|
—
|
—
|
|
Frequency and Intensity of Solicited Systemic AEs After the First Vaccination
Grade 3 fever
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 0 to Day 6 after the first vaccination and up to Day 20 after the first vaccination if AE is ongoing at Day 7Population: The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.
Solicited AEs included AEs that were specifically sought for.
Outcome measures
| Measure |
CSL425 (15 mcg)
n=120 Participants
15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg)
n=120 Participants
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg), Adult
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg), Older Adult
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
|---|---|---|---|---|
|
Duration of Solicited Systemic AEs After the First Vaccination
Headache
|
1.15 days
Standard Deviation 0.432
|
1.64 days
Standard Deviation 1.419
|
—
|
—
|
|
Duration of Solicited Systemic AEs After the First Vaccination
Muscle ache (myalgia)
|
2.24 days
Standard Deviation 1.729
|
1.67 days
Standard Deviation 1.240
|
—
|
—
|
|
Duration of Solicited Systemic AEs After the First Vaccination
Fever
|
1.14 days
Standard Deviation 0.378
|
1.00 days
Standard Deviation 0.000
|
—
|
—
|
|
Duration of Solicited Systemic AEs After the First Vaccination
Malaise/feeling generally unwell
|
2.00 days
Standard Deviation 1.328
|
1.47 days
Standard Deviation 1.134
|
—
|
—
|
|
Duration of Solicited Systemic AEs After the First Vaccination
Nausea
|
1.25 days
Standard Deviation 0.707
|
1.64 days
Standard Deviation 1.286
|
—
|
—
|
|
Duration of Solicited Systemic AEs After the First Vaccination
Chills
|
3.00 days
Standard Deviation NA
Only 1 participant experienced chills so the standard deviation cannot be derived.
|
1.38 days
Standard Deviation 0.885
|
—
|
—
|
|
Duration of Solicited Systemic AEs After the First Vaccination
Vomiting
|
NA days
Standard Deviation NA
No participants in the CSL425 (15 mcg) group experienced vomiting after the first vaccination.
|
2.00 days
Standard Deviation 1.414
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 0 to Day 6 after the second vaccinationPopulation: The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.
Solicited AEs included AEs that were specifically sought for. Grade 3 solicited AE definitions: Prevented normal daily activities; Temperature 102.2°F (39.0°C) or more for fevers.
Outcome measures
| Measure |
CSL425 (15 mcg)
n=119 Participants
15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg)
n=119 Participants
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg), Adult
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg), Older Adult
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
|---|---|---|---|---|
|
Frequency and Intensity of Solicited Systemic AEs After the Second Vaccination
Any solicited AE
|
19.3 percentage of participants
|
32.8 percentage of participants
|
—
|
—
|
|
Frequency and Intensity of Solicited Systemic AEs After the Second Vaccination
Any headache
|
12.6 percentage of participants
|
21.8 percentage of participants
|
—
|
—
|
|
Frequency and Intensity of Solicited Systemic AEs After the Second Vaccination
Grade 3 headache
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Frequency and Intensity of Solicited Systemic AEs After the Second Vaccination
Any malaise/feeling generally unwell
|
9.2 percentage of participants
|
15.1 percentage of participants
|
—
|
—
|
|
Frequency and Intensity of Solicited Systemic AEs After the Second Vaccination
Grade 3 Malaise/feeling generally unwell
|
0.8 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Frequency and Intensity of Solicited Systemic AEs After the Second Vaccination
Any muscle ache (myalgia)
|
9.2 percentage of participants
|
11.8 percentage of participants
|
—
|
—
|
|
Frequency and Intensity of Solicited Systemic AEs After the Second Vaccination
Grade 3 muscle ache (myalgia)
|
0 percentage of participants
|
0.8 percentage of participants
|
—
|
—
|
|
Frequency and Intensity of Solicited Systemic AEs After the Second Vaccination
Any nausea
|
1.7 percentage of participants
|
4.2 percentage of participants
|
—
|
—
|
|
Frequency and Intensity of Solicited Systemic AEs After the Second Vaccination
Grade 3 nausea
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Frequency and Intensity of Solicited Systemic AEs After the Second Vaccination
Any chills
|
0.8 percentage of participants
|
1.7 percentage of participants
|
—
|
—
|
|
Frequency and Intensity of Solicited Systemic AEs After the Second Vaccination
Grade 3 chills
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Frequency and Intensity of Solicited Systemic AEs After the Second Vaccination
Any vomiting
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Frequency and Intensity of Solicited Systemic AEs After the Second Vaccination
Grade 3 vomiting
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Frequency and Intensity of Solicited Systemic AEs After the Second Vaccination
Any fever
|
0 percentage of participants
|
2.5 percentage of participants
|
—
|
—
|
|
Frequency and Intensity of Solicited Systemic AEs After the Second Vaccination
Grade 3 fever
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 0 to Day 6 after the second vaccination and up to Day 20 after the second vaccination if AE is ongoing at Day 7Population: The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.
Solicited AEs included AEs that were specifically sought for.
Outcome measures
| Measure |
CSL425 (15 mcg)
n=119 Participants
15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg)
n=119 Participants
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg), Adult
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg), Older Adult
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
|---|---|---|---|---|
|
Duration of Solicited Systemic AEs After the Second Vaccination
Headache
|
1.19 days
Standard Deviation 0.403
|
1.58 days
Standard Deviation 1.173
|
—
|
—
|
|
Duration of Solicited Systemic AEs After the Second Vaccination
Malaise/feeling generally unwell
|
1.64 days
Standard Deviation 0.929
|
2.10 days
Standard Deviation 1.841
|
—
|
—
|
|
Duration of Solicited Systemic AEs After the Second Vaccination
Muscle ache (myalgia)
|
2.08 days
Standard Deviation 2.275
|
2.06 days
Standard Deviation 1.611
|
—
|
—
|
|
Duration of Solicited Systemic AEs After the Second Vaccination
Nausea
|
2.00 days
Standard Deviation 1.414
|
1.29 days
Standard Deviation 0.488
|
—
|
—
|
|
Duration of Solicited Systemic AEs After the Second Vaccination
Chills
|
2.00 days
Standard Deviation NA
Only 1 participant experienced chills so the standard deviation cannot be derived.
|
1.25 days
Standard Deviation 0.500
|
—
|
—
|
|
Duration of Solicited Systemic AEs After the Second Vaccination
Vomiting
|
NA days
Standard Deviation NA
No participants in the CSL425 (15 mcg) group experienced vomiting after the second vaccination.
|
NA days
Standard Deviation NA
No participants in the CSL425 (30 mcg) group experienced vomiting after the second vaccination.
|
—
|
—
|
|
Duration of Solicited Systemic AEs After the Second Vaccination
Fever
|
NA days
Standard Deviation NA
No participants in the CSL425 (15 mcg) group experienced fever after the second vaccination.
|
1.33 days
Standard Deviation 0.577
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 180 days after the last vaccinationPopulation: The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.
An AESI was defined as an AE for which the association with seasonal influenza vaccine was unclear. A NOCI was defined as the diagnosis of a new medical condition that was chronic in nature, including those potentially controllable by medication (eg, diabetes, asthma).
Outcome measures
| Measure |
CSL425 (15 mcg)
n=120 Participants
15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg)
n=120 Participants
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg), Adult
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg), Older Adult
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
|---|---|---|---|---|
|
Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs)
Related SAE
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs)
At least one AESI
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs)
At least one NOCI
|
2.5 percentage of participants
|
2.5 percentage of participants
|
—
|
—
|
|
Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs)
Related NOCI
|
0.8 percentage of participants
|
1.7 percentage of participants
|
—
|
—
|
|
Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs)
At least one SAE
|
0.8 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs)
Related AESI
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 0 to Day 20 after vaccination; up to 180 days after the last vaccination for SAEs, AESIs, and NOCIsPopulation: The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.
Unsolicited AEs included AEs other than those specifically sought for. The grading definitions were: Mild (Grade 1): Symptoms were easily tolerated and did not interfere with daily activities. Moderate (Grade 2): Enough discomfort to cause some interference with daily activities. Severe (Grade 3): Incapacitating, with inability to work or do usual activities.
Outcome measures
| Measure |
CSL425 (15 mcg)
n=120 Participants
15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg)
n=120 Participants
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg), Adult
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg), Older Adult
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
|---|---|---|---|---|
|
Frequency and Intensity of Unsolicited AEs
Total unsolicited AEs after doses 1 & 2
|
44.2 percentage of participants
|
45.8 percentage of participants
|
—
|
—
|
|
Frequency and Intensity of Unsolicited AEs
All unsolicited AEs after the first dose
|
40.0 percentage of participants
|
35.0 percentage of participants
|
—
|
—
|
|
Frequency and Intensity of Unsolicited AEs
Grade 1 unsolicited AEs after the first dose
|
24.2 percentage of participants
|
15.8 percentage of participants
|
—
|
—
|
|
Frequency and Intensity of Unsolicited AEs
Grade 2 unsolicited AEs after the first dose
|
15.0 percentage of participants
|
15.0 percentage of participants
|
—
|
—
|
|
Frequency and Intensity of Unsolicited AEs
Grade 3 unsolicited AEs after the first dose
|
0.8 percentage of participants
|
4.2 percentage of participants
|
—
|
—
|
|
Frequency and Intensity of Unsolicited AEs
All unsolicited AEs after the second dose (n=119)
|
25.2 percentage of participants
|
28.6 percentage of participants
|
—
|
—
|
|
Frequency and Intensity of Unsolicited AEs
Total grade 1 unsolicited AEs after doses 1 & 2
|
25.0 percentage of participants
|
20.8 percentage of participants
|
—
|
—
|
|
Frequency and Intensity of Unsolicited AEs
Total grade 2 unsolicited AEs after doses 1 & 2
|
17.5 percentage of participants
|
20.0 percentage of participants
|
—
|
—
|
|
Frequency and Intensity of Unsolicited AEs
Total grade 3 unsolicited AEs after doses 1 & 2
|
1.7 percentage of participants
|
5.0 percentage of participants
|
—
|
—
|
Adverse Events
CSL425 (15 mcg)
Serious events: 1 serious events
Other events: 97 other events
Deaths: 0 deaths
CSL425 (30 mcg)
Serious events: 0 serious events
Other events: 99 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CSL425 (15 mcg)
n=120 participants at risk
15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg)
n=120 participants at risk
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
|---|---|---|
|
Nervous system disorders
Tension headache
|
0.83%
1/120 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
0.00%
0/120 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
Other adverse events
| Measure |
CSL425 (15 mcg)
n=120 participants at risk
15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
CSL425 (30 mcg)
n=120 participants at risk
30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
4.2%
5/120 • Number of events 5 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
3.3%
4/120 • Number of events 4 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
|
Infections and infestations
Nasopharyngitis
|
2.5%
3/120 • Number of events 3 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
1.7%
2/120 • Number of events 2 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
|
Infections and infestations
Cystitis
|
0.00%
0/120 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
1.7%
2/120 • Number of events 2 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
|
Immune system disorders
Seasonal allergy
|
3.3%
4/120 • Number of events 8 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
0.83%
1/120 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
|
Endocrine disorders
Hypothyroidism
|
1.7%
2/120 • Number of events 2 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
0.83%
1/120 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
|
Nervous system disorders
Headache
|
16.7%
20/120 • Number of events 35 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
20.8%
25/120 • Number of events 44 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.2%
5/120 • Number of events 5 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
7.5%
9/120 • Number of events 10 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.5%
3/120 • Number of events 3 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
5.0%
6/120 • Number of events 7 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.83%
1/120 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
4.2%
5/120 • Number of events 5 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.3%
4/120 • Number of events 4 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
0.83%
1/120 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
1.7%
2/120 • Number of events 2 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
0.83%
1/120 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.2%
5/120 • Number of events 5 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
1.7%
2/120 • Number of events 3 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
|
Gastrointestinal disorders
Toothache
|
2.5%
3/120 • Number of events 5 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
0.00%
0/120 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.7%
2/120 • Number of events 6 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
0.00%
0/120 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.8%
7/120 • Number of events 8 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
1.7%
2/120 • Number of events 2 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.5%
3/120 • Number of events 5 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
2.5%
3/120 • Number of events 5 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/120 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
2.5%
3/120 • Number of events 3 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.7%
2/120 • Number of events 2 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
1.7%
2/120 • Number of events 3 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/120 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
5.8%
7/120 • Number of events 9 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
|
General disorders
Fatigue
|
1.7%
2/120 • Number of events 2 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
2.5%
3/120 • Number of events 3 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
|
General disorders
Pyrexia
|
3.3%
4/120 • Number of events 5 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
0.83%
1/120 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
|
General disorders
Malaise
|
0.00%
0/120 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
1.7%
2/120 • Number of events 2 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/120 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
1.7%
2/120 • Number of events 2 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
|
General disorders
Pain at injection site
|
25.8%
31/120 • Number of events 39 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
30.0%
36/120 • Number of events 47 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
|
General disorders
Redness at injection site
|
2.5%
3/120 • Number of events 3 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
3.3%
4/120 • Number of events 4 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
|
General disorders
Swelling/Induration at injection site
|
10.8%
13/120 • Number of events 15 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
12.5%
15/120 • Number of events 17 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
|
General disorders
Tenderness at injection site
|
39.2%
47/120 • Number of events 63 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
55.0%
66/120 • Number of events 99 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
|
General disorders
Bruising at injection site
|
6.7%
8/120 • Number of events 9 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
7.5%
9/120 • Number of events 10 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
|
General disorders
Headache
|
35.0%
42/120 • Number of events 55 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
43.3%
52/120 • Number of events 87 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
|
General disorders
Malaise/feeling generally unwell
|
18.3%
22/120 • Number of events 32 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
30.8%
37/120 • Number of events 55 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
|
General disorders
Muscle ache (myalgia)
|
21.7%
26/120 • Number of events 33 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
24.2%
29/120 • Number of events 43 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
|
General disorders
Nausea
|
7.5%
9/120 • Number of events 10 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
10.0%
12/120 • Number of events 18 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
|
General disorders
Chills
|
1.7%
2/120 • Number of events 2 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
13.3%
16/120 • Number of events 20 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
|
General disorders
Vomiting
|
0.00%
0/120 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
1.7%
2/120 • Number of events 2 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
|
General disorders
Fever
|
5.0%
6/120 • Number of events 7 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
5.0%
6/120 • Number of events 7 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
|
Infections and infestations
Tooth infection
|
1.7%
2/120 • Number of events 2 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
0.00%
0/120 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/120 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
1.7%
2/120 • Number of events 2 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
|
Ear and labyrinth disorders
Motion sickness
|
0.00%
0/120 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
1.7%
2/120 • Number of events 2 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
1.7%
2/120 • Number of events 2 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
2.5%
3/120 • Number of events 4 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: from Day 0 to Day 6 after each vaccination; unsolicited AEs: from Day 0 to Day 20 after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA 12.1", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee CSL agreements and restrictions on publishing may vary with individual investigators; however, CSL will not prohibit any investigator from publishing. CSL supports the publication of results from all centers of a multi-center trial and generally requires that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER