Trial Outcomes & Findings for A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Children (NCT NCT00940108)
NCT ID: NCT00940108
Last Updated: 2018-06-28
Results Overview
HI antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination HI antibody titre of 1:40 or more; or participants with a pre-vaccination HI titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
370 participants
Primary outcome timeframe
Before and 21 days after the first vaccination
Results posted on
2018-06-28
Participant Flow
One randomized participant withdrew consent prior to vaccine administration and was not included in the participant flow data or in any analysis population.
Participant milestones
| Measure |
CSL425 (15 mcg) Cohort A
Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
|
CSL425 (30 mcg) Cohort A
Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
|
CSL425 (15 mcg) Cohort B
Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
|
CSL425 (30 mcg) Cohort B
Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
82
|
80
|
103
|
104
|
|
Overall Study
COMPLETED
|
77
|
71
|
100
|
99
|
|
Overall Study
NOT COMPLETED
|
5
|
9
|
3
|
5
|
Reasons for withdrawal
| Measure |
CSL425 (15 mcg) Cohort A
Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
|
CSL425 (30 mcg) Cohort A
Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
|
CSL425 (15 mcg) Cohort B
Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
|
CSL425 (30 mcg) Cohort B
Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
4
|
0
|
2
|
|
Overall Study
Withdrew Consent
|
2
|
1
|
0
|
1
|
|
Overall Study
Dose 2 contraindicated
|
1
|
1
|
0
|
1
|
|
Overall Study
Declined further vaccination
|
0
|
1
|
3
|
0
|
|
Overall Study
Refused - pyrexia after Dose 1
|
0
|
1
|
0
|
0
|
|
Overall Study
Viral illness after Dose 1
|
0
|
1
|
0
|
0
|
|
Overall Study
Diagnosed with H1N1
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Children
Baseline characteristics by cohort
| Measure |
CSL425 (15 mcg) Cohort A
n=82 Participants
Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
|
CSL425 (30 mcg) Cohort A
n=80 Participants
Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
|
CSL425 (15 mcg) Cohort B
n=103 Participants
Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
|
CSL425 (30 mcg) Cohort B
n=104 Participants
Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
|
Total
n=369 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
1.68 years
STANDARD_DEVIATION 0.67 • n=93 Participants
|
1.73 years
STANDARD_DEVIATION 0.74 • n=4 Participants
|
5.78 years
STANDARD_DEVIATION 1.69 • n=27 Participants
|
5.66 years
STANDARD_DEVIATION 1.74 • n=483 Participants
|
3.96 years
STANDARD_DEVIATION 2.42 • n=36 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=93 Participants
|
41 Participants
n=4 Participants
|
53 Participants
n=27 Participants
|
49 Participants
n=483 Participants
|
184 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=93 Participants
|
39 Participants
n=4 Participants
|
50 Participants
n=27 Participants
|
55 Participants
n=483 Participants
|
185 Participants
n=36 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).
HI antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination HI antibody titre of 1:40 or more; or participants with a pre-vaccination HI titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre.
Outcome measures
| Measure |
CSL425 (15 mcg) Cohort A
n=76 Participants
Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
|
CSL425 (30 mcg) Cohort A
n=73 Participants
Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
|
CSL425 (15 mcg) Cohort B
n=98 Participants
Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
|
CSL425 (30 mcg) Cohort B
n=99 Participants
Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
|
|---|---|---|---|---|
|
Haemagglutination Inhibition (HI) Antibody Titre Seroconversion Rate After the First Vaccination
|
88.2 percentage of participants
Interval 78.7 to 94.4
|
97.3 percentage of participants
Interval 90.5 to 99.7
|
85.7 percentage of participants
Interval 77.2 to 92.0
|
91.9 percentage of participants
Interval 84.7 to 96.4
|
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).
HI antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination HI antibody titre of 1:40 or more; or participants with a pre-vaccination HI titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre.
Outcome measures
| Measure |
CSL425 (15 mcg) Cohort A
n=64 Participants
Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
|
CSL425 (30 mcg) Cohort A
n=69 Participants
Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
|
CSL425 (15 mcg) Cohort B
n=95 Participants
Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
|
CSL425 (30 mcg) Cohort B
n=96 Participants
Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
|
|---|---|---|---|---|
|
HI Antibody Titre Seroconversion Rate After the Second Vaccination
|
96.9 percentage of participants
Interval 89.2 to 99.6
|
98.6 percentage of participants
Interval 92.2 to 100.0
|
97.9 percentage of participants
Interval 92.6 to 99.7
|
96.9 percentage of participants
Interval 91.1 to 99.4
|
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 HI antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre.
Outcome measures
| Measure |
CSL425 (15 mcg) Cohort A
n=76 Participants
Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
|
CSL425 (30 mcg) Cohort A
n=73 Participants
Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
|
CSL425 (15 mcg) Cohort B
n=98 Participants
Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
|
CSL425 (30 mcg) Cohort B
n=99 Participants
Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
|
|---|---|---|---|---|
|
Geometric Mean Fold Increase (GMFI) in the HI Antibody Titre After the First Vaccination
|
13.95 geometric mean fold increase
Interval 11.39 to 17.09
|
22.17 geometric mean fold increase
Interval 17.87 to 27.49
|
13.25 geometric mean fold increase
Interval 10.84 to 16.19
|
15.93 geometric mean fold increase
Interval 12.87 to 19.71
|
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 HI antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre.
Outcome measures
| Measure |
CSL425 (15 mcg) Cohort A
n=64 Participants
Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
|
CSL425 (30 mcg) Cohort A
n=69 Participants
Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
|
CSL425 (15 mcg) Cohort B
n=95 Participants
Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
|
CSL425 (30 mcg) Cohort B
n=96 Participants
Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
|
|---|---|---|---|---|
|
GMFI in the HI Antibody Titre After the Second Vaccination
|
57.64 geometric mean fold increase
Interval 42.87 to 77.5
|
72.93 geometric mean fold increase
Interval 56.1 to 94.8
|
37.48 geometric mean fold increase
Interval 28.33 to 49.58
|
37.06 geometric mean fold increase
Interval 28.77 to 47.75
|
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) Cohort A
n=76 Participants
Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
|
CSL425 (30 mcg) Cohort A
n=73 Participants
Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
|
CSL425 (15 mcg) Cohort B
n=98 Participants
Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
|
CSL425 (30 mcg) Cohort B
n=99 Participants
Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More After the First Vaccination
|
92.1 percentage of participants
Interval 83.6 to 97.0
|
100.0 percentage of participants
Interval 95.1 to 100.0
|
92.9 percentage of participants
Interval 85.8 to 97.1
|
96.0 percentage of participants
Interval 90.0 to 98.9
|
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) Cohort A
n=64 Participants
Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
|
CSL425 (30 mcg) Cohort A
n=69 Participants
Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
|
CSL425 (15 mcg) Cohort B
n=95 Participants
Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
|
CSL425 (30 mcg) Cohort B
n=96 Participants
Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More After the Second Vaccination
|
100.0 percentage of participants
Interval 94.4 to 100.0
|
100.0 percentage of participants
Interval 94.8 to 100.0
|
100.0 percentage of participants
Interval 96.2 to 100.0
|
100.0 percentage of participants
Interval 96.2 to 100.0
|
SECONDARY outcome
Timeframe: During the 7 days after each 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: Cried when limb was moved/spontaneously painful (Cohort A) or prevented normal daily activities (Cohort B) for injection site pain; Size \> 100 mm for injection site redness and induration/swelling; Temperature \> 103.1°F (39.5°C) for fevers; Prevented normal daily activities or required medical intervention for all other systemic AEs.
Outcome measures
| Measure |
CSL425 (15 mcg) Cohort A
n=82 Participants
Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
|
CSL425 (30 mcg) Cohort A
n=80 Participants
Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
|
CSL425 (15 mcg) Cohort B
n=103 Participants
Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
|
CSL425 (30 mcg) Cohort B
n=104 Participants
Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
|
|---|---|---|---|---|
|
Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination
Any solicited local AE
|
69.5 percentage of participants
|
63.8 percentage of participants
|
68.0 percentage of participants
|
71.2 percentage of participants
|
|
Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination
Any pain at injection site
|
48.8 percentage of participants
|
43.8 percentage of participants
|
59.2 percentage of participants
|
64.4 percentage of participants
|
|
Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination
Grade 3 pain at injection site
|
1.2 percentage of participants
|
1.3 percentage of participants
|
0 percentage of participants
|
1.0 percentage of participants
|
|
Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination
Any redness at injection site
|
53.7 percentage of participants
|
38.8 percentage of participants
|
37.9 percentage of participants
|
37.5 percentage of participants
|
|
Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination
Grade 3 redness at injection site
|
0 percentage of participants
|
1.3 percentage of participants
|
2.9 percentage of participants
|
2.9 percentage of participants
|
|
Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination
Any swelling/induration at injection site
|
30.5 percentage of participants
|
32.5 percentage of participants
|
25.2 percentage of participants
|
26.9 percentage of participants
|
|
Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination
Grade 3 swelling/induration at injection site
|
0 percentage of participants
|
2.5 percentage of participants
|
0 percentage of participants
|
4.8 percentage of participants
|
|
Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination
Any solicited systemic AE
|
79.3 percentage of participants
|
93.8 percentage of participants
|
54.4 percentage of participants
|
61.5 percentage of participants
|
|
Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination
Any nausea/vomiting
|
13.4 percentage of participants
|
30.0 percentage of participants
|
15.5 percentage of participants
|
20.2 percentage of participants
|
|
Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination
Grade 3 nausea/vomiting
|
1.2 percentage of participants
|
1.3 percentage of participants
|
0 percentage of participants
|
1.0 percentage of participants
|
|
Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination
Any diarrhoea
|
26.8 percentage of participants
|
32.5 percentage of participants
|
12.6 percentage of participants
|
12.5 percentage of participants
|
|
Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination
Grade 3 diarrhoea
|
1.2 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination
Any loss of appetite
|
40.2 percentage of participants
|
50.0 percentage of participants
|
NA percentage of participants
Not solicited for in Cohort B
|
NA percentage of participants
Not solicited for in Cohort B
|
|
Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination
Grade 3 loss of appetite
|
1.2 percentage of participants
|
0 percentage of participants
|
NA percentage of participants
Not solicited for in Cohort B
|
NA percentage of participants
Not solicited for in Cohort B
|
|
Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination
Any irritability
|
63.4 percentage of participants
|
72.5 percentage of participants
|
NA percentage of participants
Not solicited for in Cohort B
|
NA percentage of participants
Not solicited for in Cohort B
|
|
Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination
Grade 3 irritability
|
2.4 percentage of participants
|
1.3 percentage of participants
|
NA percentage of participants
Not solicited for in Cohort B
|
NA percentage of participants
Not solicited for in Cohort B
|
|
Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination
Any fever
|
50.0 percentage of participants
|
71.3 percentage of participants
|
20.4 percentage of participants
|
29.8 percentage of participants
|
|
Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination
Grade 3 fever
|
1.2 percentage of participants
|
8.8 percentage of participants
|
0 percentage of participants
|
2.9 percentage of participants
|
|
Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination
Any headache
|
NA percentage of participants
Not solicited for in Cohort A
|
NA percentage of participants
Not solicited for in Cohort A
|
27.2 percentage of participants
|
23.1 percentage of participants
|
|
Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination
Grade 3 headache
|
NA percentage of participants
Not solicited for in Cohort A
|
NA percentage of participants
Not solicited for in Cohort A
|
0 percentage of participants
|
1.0 percentage of participants
|
|
Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination
Any muscle ache
|
NA percentage of participants
Not solicited for in Cohort A
|
NA percentage of participants
Not solicited for in Cohort A
|
15.5 percentage of participants
|
22.1 percentage of participants
|
|
Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination
Grade 3 muscle ache
|
NA percentage of participants
Not solicited for in Cohort A
|
NA percentage of participants
Not solicited for in Cohort A
|
0 percentage of participants
|
1.0 percentage of participants
|
|
Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination
Any malaise
|
NA percentage of participants
Not solicited for in Cohort A
|
NA percentage of participants
Not solicited for in Cohort A
|
19.4 percentage of participants
|
26.9 percentage of participants
|
|
Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination
Grade 3 malaise
|
NA percentage of participants
Not solicited for in Cohort A
|
NA percentage of participants
Not solicited for in Cohort A
|
0 percentage of participants
|
1.9 percentage of participants
|
SECONDARY outcome
Timeframe: During the 7 days after the first vaccination and up to Day 20 after the first vaccination if AE is ongoing at Day 7.Population: The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.
Solicited AEs included AEs that were specifically sought for.
Outcome measures
| Measure |
CSL425 (15 mcg) Cohort A
n=82 Participants
Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
|
CSL425 (30 mcg) Cohort A
n=80 Participants
Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
|
CSL425 (15 mcg) Cohort B
n=103 Participants
Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
|
CSL425 (30 mcg) Cohort B
n=104 Participants
Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
|
|---|---|---|---|---|
|
Duration of Solicited AEs After the First Vaccination
Pain at injection site
|
1.48 days
Standard Deviation 0.677
|
1.52 days
Standard Deviation 0.823
|
1.91 days
Standard Deviation 1.221
|
1.80 days
Standard Deviation 1.016
|
|
Duration of Solicited AEs After the First Vaccination
Redness at injection site
|
2.08 days
Standard Deviation 1.382
|
2.23 days
Standard Deviation 1.602
|
2.26 days
Standard Deviation 1.347
|
2.00 days
Standard Deviation 1.134
|
|
Duration of Solicited AEs After the First Vaccination
Swelling/induration at injection site
|
1.88 days
Standard Deviation 0.957
|
1.64 days
Standard Deviation 0.745
|
1.60 days
Standard Deviation 0.737
|
2.04 days
Standard Deviation 1.136
|
|
Duration of Solicited AEs After the First Vaccination
Nausea/vomiting
|
1.33 days
Standard Deviation 0.500
|
1.05 days
Standard Deviation 0.213
|
1.18 days
Standard Deviation 0.405
|
1.53 days
Standard Deviation 1.837
|
|
Duration of Solicited AEs After the First Vaccination
Diarrhoea
|
1.67 days
Standard Deviation 1.328
|
1.55 days
Standard Deviation 0.945
|
1.11 days
Standard Deviation 0.333
|
1.17 days
Standard Deviation 0.577
|
|
Duration of Solicited AEs After the First Vaccination
Loss of appetite
|
2.32 days
Standard Deviation 1.906
|
1.97 days
Standard Deviation 1.447
|
NA days
Standard Deviation NA
Not solicited for in Cohort B
|
NA days
Standard Deviation NA
Not solicited for in Cohort B
|
|
Duration of Solicited AEs After the First Vaccination
Irritability
|
1.78 days
Standard Deviation 1.560
|
1.73 days
Standard Deviation 1.574
|
NA days
Standard Deviation NA
Not solicited for in Cohort B
|
NA days
Standard Deviation NA
Not solicited for in Cohort B
|
|
Duration of Solicited AEs After the First Vaccination
Fever
|
1.77 days
Standard Deviation 1.547
|
1.52 days
Standard Deviation 1.079
|
1.40 days
Standard Deviation 0.737
|
1.54 days
Standard Deviation 1.319
|
|
Duration of Solicited AEs After the First Vaccination
Headache
|
NA days
Standard Deviation NA
Not solicited for in Cohort A
|
NA days
Standard Deviation NA
Not solicited for in Cohort A
|
2.04 days
Standard Deviation 2.911
|
1.63 days
Standard Deviation 1.149
|
|
Duration of Solicited AEs After the First Vaccination
Muscle ache
|
NA days
Standard Deviation NA
Not solicited for in Cohort A
|
NA days
Standard Deviation NA
Not solicited for in Cohort A
|
1.45 days
Standard Deviation 0.688
|
1.86 days
Standard Deviation 2.175
|
|
Duration of Solicited AEs After the First Vaccination
Malaise
|
NA days
Standard Deviation NA
Not solicited for in Cohort A
|
NA days
Standard Deviation NA
Not solicited for in Cohort A
|
1.60 days
Standard Deviation 0.910
|
1.69 days
Standard Deviation 1.966
|
SECONDARY outcome
Timeframe: During the 7 days after the second vaccination and up to Day 20 after the second vaccination if AE was ongoing at Day 7.Population: The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.
Solicited AEs included AEs that were specifically sought for.
Outcome measures
| Measure |
CSL425 (15 mcg) Cohort A
n=77 Participants
Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
|
CSL425 (30 mcg) Cohort A
n=71 Participants
Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
|
CSL425 (15 mcg) Cohort B
n=100 Participants
Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
|
CSL425 (30 mcg) Cohort B
n=99 Participants
Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
|
|---|---|---|---|---|
|
Duration of Solicited AEs After the Second Vaccination
Muscle ache
|
NA days
Standard Deviation NA
Not solicited for in Cohort A
|
NA days
Standard Deviation NA
Not solicited for in Cohort A
|
1.60 days
Standard Deviation 0.516
|
1.29 days
Standard Deviation 0.756
|
|
Duration of Solicited AEs After the Second Vaccination
Malaise
|
NA days
Standard Deviation NA
Not solicited for in Cohort A
|
NA days
Standard Deviation NA
Not solicited for in Cohort A
|
1.20 days
Standard Deviation 0.422
|
2.00 days
Standard Deviation 1.826
|
|
Duration of Solicited AEs After the Second Vaccination
Pain at injection site
|
1.67 days
Standard Deviation 0.966
|
1.64 days
Standard Deviation 1.002
|
1.90 days
Standard Deviation 1.179
|
1.80 days
Standard Deviation 1.040
|
|
Duration of Solicited AEs After the Second Vaccination
Redness at injection site
|
1.69 days
Standard Deviation 1.004
|
2.14 days
Standard Deviation 1.037
|
1.92 days
Standard Deviation 1.055
|
1.70 days
Standard Deviation 0.822
|
|
Duration of Solicited AEs After the Second Vaccination
Swelling/induration at injection site
|
1.74 days
Standard Deviation 0.872
|
2.32 days
Standard Deviation 1.108
|
2.24 days
Standard Deviation 1.348
|
2.27 days
Standard Deviation 1.751
|
|
Duration of Solicited AEs After the Second Vaccination
Nausea/vomiting
|
5.00 days
Standard Deviation 8.832
|
1.00 days
Standard Deviation 0.000
|
1.43 days
Standard Deviation 0.787
|
1.11 days
Standard Deviation 0.333
|
|
Duration of Solicited AEs After the Second Vaccination
Diarrhoea
|
3.40 days
Standard Deviation 3.777
|
1.25 days
Standard Deviation 0.452
|
1.40 days
Standard Deviation 0.894
|
2.00 days
Standard Deviation 1.000
|
|
Duration of Solicited AEs After the Second Vaccination
Loss of appetite
|
3.15 days
Standard Deviation 4.475
|
1.73 days
Standard Deviation 0.883
|
NA days
Standard Deviation NA
Not solicited for in Cohort B
|
NA days
Standard Deviation NA
Not solicited for in Cohort B
|
|
Duration of Solicited AEs After the Second Vaccination
Irritability
|
2.57 days
Standard Deviation 2.410
|
2.10 days
Standard Deviation 1.533
|
NA days
Standard Deviation NA
Not solicited for in Cohort B
|
NA days
Standard Deviation NA
Not solicited for in Cohort B
|
|
Duration of Solicited AEs After the Second Vaccination
Fever
|
2.14 days
Standard Deviation 3.005
|
1.63 days
Standard Deviation 1.165
|
1.54 days
Standard Deviation 0.877
|
1.67 days
Standard Deviation 1.414
|
|
Duration of Solicited AEs After the Second Vaccination
Headache
|
NA days
Standard Deviation NA
Not solicited for in Cohort A
|
NA days
Standard Deviation NA
Not solicited for in Cohort A
|
1.33 days
Standard Deviation 0.686
|
1.73 days
Standard Deviation 2.412
|
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) Cohort A
n=82 Participants
Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
|
CSL425 (30 mcg) Cohort A
n=80 Participants
Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
|
CSL425 (15 mcg) Cohort B
n=103 Participants
Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
|
CSL425 (30 mcg) Cohort B
n=104 Participants
Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
|
|---|---|---|---|---|
|
Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs)
At least one AESI
|
2.4 percentage of participants
|
1.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs)
At least one SAE
|
4.9 percentage of participants
|
1.3 percentage of participants
|
1.0 percentage of participants
|
1.0 percentage of participants
|
|
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
|
0 percentage of participants
|
1.0 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
|
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
|
1.2 percentage of participants
|
3.8 percentage of participants
|
1.9 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 NOCI
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: During the 21 days after each 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. Grade 1 unsolicited AE definition: Easily tolerated and did not interfere with normal daily activities. Grade 2 unsolicited AE definition: Some interference with normal daily activities. Grade 3 unsolicited AE definition: Prevented normal daily activities.
Outcome measures
| Measure |
CSL425 (15 mcg) Cohort A
n=82 Participants
Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
|
CSL425 (30 mcg) Cohort A
n=80 Participants
Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
|
CSL425 (15 mcg) Cohort B
n=103 Participants
Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
|
CSL425 (30 mcg) Cohort B
n=104 Participants
Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
|
|---|---|---|---|---|
|
Frequency and Intensity of Unsolicited Adverse Events After the First or Second Vaccination
At least one unsolicited AE
|
78.0 percentage of participants
|
82.5 percentage of participants
|
67.0 percentage of participants
|
76.0 percentage of participants
|
|
Frequency and Intensity of Unsolicited Adverse Events After the First or Second Vaccination
Grade 1 unsolicited AE
|
26.8 percentage of participants
|
33.8 percentage of participants
|
27.2 percentage of participants
|
37.5 percentage of participants
|
|
Frequency and Intensity of Unsolicited Adverse Events After the First or Second Vaccination
Grade 2 unsolicited AE
|
41.5 percentage of participants
|
41.3 percentage of participants
|
37.9 percentage of participants
|
26.9 percentage of participants
|
|
Frequency and Intensity of Unsolicited Adverse Events After the First or Second Vaccination
Grade 3 unsolicited AE
|
9.8 percentage of participants
|
7.5 percentage of participants
|
1.9 percentage of participants
|
11.5 percentage of participants
|
Adverse Events
CSL425 (15 mcg) Cohort A
Serious events: 4 serious events
Other events: 81 other events
Deaths: 0 deaths
CSL425 (30 mcg) Cohort A
Serious events: 1 serious events
Other events: 78 other events
Deaths: 0 deaths
CSL425 (15 mcg) Cohort B
Serious events: 1 serious events
Other events: 91 other events
Deaths: 0 deaths
CSL425 (30 mcg) Cohort B
Serious events: 1 serious events
Other events: 96 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CSL425 (15 mcg) Cohort A
n=82 participants at risk
Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
|
CSL425 (30 mcg) Cohort A
n=80 participants at risk
Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
|
CSL425 (15 mcg) Cohort B
n=103 participants at risk
Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
|
CSL425 (30 mcg) Cohort B
n=104 participants at risk
Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
|
|---|---|---|---|---|
|
Infections and infestations
Gastroenteritis viral
|
1.2%
1/82 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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%
0/80 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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%
0/103 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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%
0/104 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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
Convulsion
|
2.4%
2/82 • Number of events 2 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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%
0/80 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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%
0/103 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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%
0/104 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
|
Vascular disorders
Kawasaki's disease
|
0.00%
0/82 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
1.2%
1/80 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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%
0/103 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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%
0/104 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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
Asthma
|
1.2%
1/82 • Number of events 2 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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%
0/80 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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%
0/103 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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%
0/104 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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
Lobar pneumonia
|
0.00%
0/82 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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%
0/80 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
0.97%
1/103 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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%
0/104 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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
|
0.00%
0/82 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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%
0/80 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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%
0/103 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
0.96%
1/104 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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) Cohort A
n=82 participants at risk
Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
|
CSL425 (30 mcg) Cohort A
n=80 participants at risk
Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
|
CSL425 (15 mcg) Cohort B
n=103 participants at risk
Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
|
CSL425 (30 mcg) Cohort B
n=104 participants at risk
Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
|
|---|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
26.8%
22/82 • Number of events 28 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
35.0%
28/80 • Number of events 31 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
21.4%
22/103 • Number of events 26 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
23.1%
24/104 • Number of events 26 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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
Viral infection
|
4.9%
4/82 • Number of events 4 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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%
0/80 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
2.9%
3/103 • Number of events 4 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
8.7%
9/104 • Number of events 9 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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
Croup infectious
|
3.7%
3/82 • Number of events 3 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
1.2%
1/80 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
3.9%
4/103 • Number of events 4 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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%
0/104 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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
Tonsillitis
|
1.2%
1/82 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
1.2%
1/80 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
0.97%
1/103 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
2.9%
3/104 • Number of events 3 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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
|
1.2%
1/82 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
1.2%
1/80 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
2.9%
3/103 • Number of events 3 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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%
0/104 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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
Otitis media
|
4.9%
4/82 • Number of events 5 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
1.2%
1/80 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
2.9%
3/103 • Number of events 3 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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%
0/104 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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
|
1.2%
1/82 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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%
0/80 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
2.9%
3/103 • Number of events 3 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
2.9%
3/104 • Number of events 3 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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
|
1.2%
1/82 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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%
2/80 • Number of events 2 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
3.9%
4/103 • Number of events 4 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
3.8%
4/104 • Number of events 4 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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
Ear pain
|
0.00%
0/82 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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%
2/80 • Number of events 2 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
7.8%
8/103 • Number of events 8 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
3.8%
4/104 • Number of events 5 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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
|
7.3%
6/82 • Number of events 6 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
13.8%
11/80 • Number of events 12 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
12.6%
13/103 • Number of events 13 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
10.6%
11/104 • Number of events 12 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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
Rhinorrhea
|
9.8%
8/82 • Number of events 8 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
21.2%
17/80 • Number of events 17 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
3.9%
4/103 • Number of events 4 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
7.7%
8/104 • Number of events 10 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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
|
2.4%
2/82 • Number of events 2 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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%
0/80 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
3.9%
4/103 • Number of events 6 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
3.8%
4/104 • Number of events 4 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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
Asthma
|
2.4%
2/82 • Number of events 2 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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%
4/80 • Number of events 4 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
2.9%
3/103 • Number of events 4 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
2.9%
3/104 • Number of events 4 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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
Abdominal pain
|
1.2%
1/82 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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%
0/80 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
3.9%
4/103 • Number of events 4 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
0.96%
1/104 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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
|
3.7%
3/82 • Number of events 3 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
3.8%
3/80 • Number of events 3 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
2.9%
3/103 • Number of events 3 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
1.9%
2/104 • Number of events 2 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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
Abdominal pain upper
|
0.00%
0/82 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
1.2%
1/80 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
0.97%
1/103 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
2.9%
3/104 • Number of events 3 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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
|
0.00%
0/82 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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%
0/80 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
2.9%
3/103 • Number of events 3 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
0.96%
1/104 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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
Influenza-like illness
|
14.6%
12/82 • Number of events 14 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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%
10/80 • Number of events 10 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
6.8%
7/103 • Number of events 8 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
8.7%
9/104 • Number of events 9 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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
|
12.2%
10/82 • Number of events 10 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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%
4/80 • Number of events 4 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
2.9%
3/103 • Number of events 4 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
1.9%
2/104 • Number of events 2 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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
|
—
0/0 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
—
0/0 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
19.4%
20/103 • Number of events 25 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
26.9%
28/104 • Number of events 39 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
|
Injury, poisoning and procedural complications
Fall
|
3.7%
3/82 • Number of events 3 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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%
6/80 • Number of events 6 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
3.9%
4/103 • Number of events 5 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
6.7%
7/104 • Number of events 7 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
|
Injury, poisoning and procedural complications
Excoriation
|
2.4%
2/82 • Number of events 2 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
1.2%
1/80 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
2.9%
3/103 • Number of events 3 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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%
6/104 • Number of events 8 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
|
Injury, poisoning and procedural complications
Contusion
|
1.2%
1/82 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
1.2%
1/80 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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%
0/103 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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%
6/104 • Number of events 6 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
|
Injury, poisoning and procedural complications
Injury
|
1.2%
1/82 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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%
0/80 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
0.97%
1/103 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
3.8%
4/104 • Number of events 5 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
|
Injury, poisoning and procedural complications
Accident
|
1.2%
1/82 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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%
0/80 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
0.97%
1/103 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
2.9%
3/104 • Number of events 4 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/82 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
3.8%
3/80 • Number of events 5 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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%
0/103 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
3.8%
4/104 • Number of events 5 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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
Hand-foot-and-mouth disease
|
4.9%
4/82 • Number of events 4 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
3.8%
3/80 • Number of events 3 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
0.97%
1/103 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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%
0/104 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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
Gastroenteritis
|
2.4%
2/82 • Number of events 2 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
3.8%
3/80 • Number of events 3 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
0.97%
1/103 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
1.9%
2/104 • Number of events 2 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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
Viral upper respiratory tract infection
|
1.2%
1/82 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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%
2/80 • Number of events 2 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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%
0/103 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
1.9%
2/104 • Number of events 2 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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
Ear infection
|
2.4%
2/82 • Number of events 2 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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%
0/80 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
0.97%
1/103 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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%
0/104 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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
Lower respiratory tract infection
|
0.00%
0/82 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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%
2/80 • Number of events 2 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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%
0/103 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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%
0/104 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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
Rhinitis
|
2.4%
2/82 • Number of events 2 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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%
0/80 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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%
0/103 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
0.96%
1/104 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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
Lethargy
|
1.2%
1/82 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
3.8%
3/80 • Number of events 3 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
0.97%
1/103 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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%
0/104 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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
|
0.00%
0/82 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
3.8%
3/80 • Number of events 4 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
1.9%
2/103 • Number of events 4 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
1.9%
2/104 • Number of events 2 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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
Teething
|
17.1%
14/82 • Number of events 18 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
15.0%
12/80 • Number of events 19 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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%
0/103 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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%
0/104 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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%
0/82 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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%
4/80 • Number of events 4 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
1.9%
2/103 • Number of events 2 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
1.9%
2/104 • Number of events 2 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.5%
7/82 • Number of events 7 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
3.8%
3/80 • Number of events 3 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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%
0/103 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
1.9%
2/104 • Number of events 2 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
8.5%
7/82 • Number of events 7 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
1.2%
1/80 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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%
0/103 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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%
0/104 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
1.2%
1/82 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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%
2/80 • Number of events 2 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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%
0/103 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
1.9%
2/104 • Number of events 3 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.2%
1/82 • Number of events 1 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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%
2/80 • Number of events 3 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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%
0/103 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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%
0/104 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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
|
0.00%
0/82 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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%
2/80 • Number of events 2 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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%
0/103 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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%
0/104 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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
|
48.8%
40/82 • Number of events 52 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
43.8%
35/80 • Number of events 47 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
59.2%
61/103 • Number of events 96 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
64.4%
67/104 • Number of events 105 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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
|
53.7%
44/82 • Number of events 66 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
38.8%
31/80 • Number of events 44 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
37.9%
39/103 • Number of events 53 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
37.5%
39/104 • Number of events 52 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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
|
30.5%
25/82 • Number of events 35 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
32.5%
26/80 • Number of events 33 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
25.2%
26/103 • Number of events 32 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
26.9%
28/104 • Number of events 40 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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/Vomiting
|
13.4%
11/82 • Number of events 15 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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%
24/80 • Number of events 26 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
15.5%
16/103 • Number of events 18 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
20.2%
21/104 • Number of events 28 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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
Diarrhoea
|
26.8%
22/82 • Number of events 28 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
32.5%
26/80 • Number of events 32 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
12.6%
13/103 • Number of events 14 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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%
13/104 • Number of events 15 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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
Loss of Appetite
|
40.2%
33/82 • Number of events 48 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
50.0%
40/80 • Number of events 55 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
—
0/0 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
—
0/0 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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
Irritability
|
63.4%
52/82 • Number of events 92 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
72.5%
58/80 • Number of events 99 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
—
0/0 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
—
0/0 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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
|
50.0%
41/82 • Number of events 51 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
71.2%
57/80 • Number of events 75 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
20.4%
21/103 • Number of events 28 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
29.8%
31/104 • Number of events 37 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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
|
—
0/0 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
—
0/0 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
27.2%
28/103 • Number of events 42 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
23.1%
24/104 • Number of events 38 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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)
|
—
0/0 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
—
0/0 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
15.5%
16/103 • Number of events 21 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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.
|
22.1%
23/104 • Number of events 28 • For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days 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 V13.0", 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