Trial Outcomes & Findings for Enhanced Safety Surveillance of GlaxoSmithKline's (GSK's) Quadrivalent Seasonal Influenza Vaccines During the 2018/19 Influenza Season (NCT NCT03688620)
NCT ID: NCT03688620
Last Updated: 2024-01-05
Results Overview
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between Intenational Organization for Standardization (ISO) weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
1060 participants
Primary outcome timeframe
Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days
Results posted on
2024-01-05
Participant Flow
GSK's quadrivalent seasonal influenza vaccine (AlphaRix Tetra in Belgium; Influsplit Tetra in Germany, Fluarix Tetra in Spain) was administered to subjects in this study
Subjects aged \<9 years in Vaccinated\_Fluarix Tetra Group (Spain) who were not vaccinated against influenza in preceding seasons received 2 doses of quadrivalent seasonal influenza vaccine in this study. Subjects from other groups received only 1 dose of the vaccine. Dose 2 results correspond to only some subjects in Vaccinated\_Fluarix Tetra Group.
Participant milestones
| Measure |
Vaccinated_AlphaRix Tetra Group
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between
01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between
01 October and 31 December 2018.
|
|---|---|---|---|
|
Overall Study
STARTED
|
329
|
278
|
453
|
|
Overall Study
COMPLETED
|
313
|
277
|
445
|
|
Overall Study
NOT COMPLETED
|
16
|
1
|
8
|
Reasons for withdrawal
| Measure |
Vaccinated_AlphaRix Tetra Group
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between
01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between
01 October and 31 December 2018.
|
|---|---|---|---|
|
Overall Study
Other
|
0
|
0
|
1
|
|
Overall Study
Unwilling to attend the scheduled visit
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
16
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
6
|
Baseline Characteristics
Enhanced Safety Surveillance of GlaxoSmithKline's (GSK's) Quadrivalent Seasonal Influenza Vaccines During the 2018/19 Influenza Season
Baseline characteristics by cohort
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between
01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between
01 October and 31 December 2018.
|
Total
n=1060 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
61.3 Years
STANDARD_DEVIATION 18.2 • n=5 Participants
|
65.0 Years
STANDARD_DEVIATION 15.1 • n=7 Participants
|
15.7 Years
STANDARD_DEVIATION 18.7 • n=5 Participants
|
42.8 Years
STANDARD_DEVIATION 29.4 • n=4 Participants
|
|
Sex: Female, Male
Female
|
147 Participants
n=5 Participants
|
166 Participants
n=7 Participants
|
231 Participants
n=5 Participants
|
544 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
182 Participants
n=5 Participants
|
112 Participants
n=7 Participants
|
222 Participants
n=5 Participants
|
516 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or african american
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian - central / south asian heritage
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian - east asian heritage
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian - south east asian heritage
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White - arabic / north african heritage
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White - caucasian / european heritage
|
321 Participants
n=5 Participants
|
274 Participants
n=7 Participants
|
444 Participants
n=5 Participants
|
1039 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other, Not specified
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between Intenational Organization for Standardization (ISO) weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Any Adverse Events of Interest (AEIs) and/or Adverse Events (AEs) Using Adverse Drug Reaction (ADR) Card, Post Dose 1 by Vaccine Group and Overall
Week 40-40
|
—
|
32.86 Percentage of subjects
Interval 12.23 to 59.9
|
—
|
32.86 Percentage of subjects
Interval 12.23 to 59.9
|
|
Cumulative Percentage of Subjects Reporting Any Adverse Events of Interest (AEIs) and/or Adverse Events (AEs) Using Adverse Drug Reaction (ADR) Card, Post Dose 1 by Vaccine Group and Overall
Week 40-41
|
—
|
34.78 Percentage of subjects
Interval 7.27 to 73.22
|
—
|
34.78 Percentage of subjects
Interval 7.27 to 73.22
|
|
Cumulative Percentage of Subjects Reporting Any Adverse Events of Interest (AEIs) and/or Adverse Events (AEs) Using Adverse Drug Reaction (ADR) Card, Post Dose 1 by Vaccine Group and Overall
Week 40-42
|
45.39 Percentage of subjects
Interval 36.99 to 53.98
|
34.31 Percentage of subjects
Interval 11.18 to 64.77
|
44.23 Percentage of subjects
Interval 0.11 to 99.54
|
39.55 Percentage of subjects
Interval 30.15 to 49.55
|
|
Cumulative Percentage of Subjects Reporting Any Adverse Events of Interest (AEIs) and/or Adverse Events (AEs) Using Adverse Drug Reaction (ADR) Card, Post Dose 1 by Vaccine Group and Overall
Week 40-43
|
45.35 Percentage of subjects
Interval 37.76 to 53.1
|
34.56 Percentage of subjects
Interval 12.27 to 63.37
|
46.15 Percentage of subjects
Interval 14.72 to 80.1
|
41.04 Percentage of subjects
Interval 33.11 to 49.33
|
|
Cumulative Percentage of Subjects Reporting Any Adverse Events of Interest (AEIs) and/or Adverse Events (AEs) Using Adverse Drug Reaction (ADR) Card, Post Dose 1 by Vaccine Group and Overall
Week 40-44
|
47.12 Percentage of subjects
Interval 35.4 to 59.06
|
33.62 Percentage of subjects
Interval 13.15 to 59.93
|
42.56 Percentage of subjects
Interval 35.53 to 49.83
|
40.79 Percentage of subjects
Interval 34.98 to 46.79
|
|
Cumulative Percentage of Subjects Reporting Any Adverse Events of Interest (AEIs) and/or Adverse Events (AEs) Using Adverse Drug Reaction (ADR) Card, Post Dose 1 by Vaccine Group and Overall
Week 40-45
|
43.97 Percentage of subjects
Interval 26.4 to 62.73
|
36.00 Percentage of subjects
Interval 14.36 to 62.87
|
46.29 Percentage of subjects
Interval 24.41 to 69.27
|
42.63 Percentage of subjects
Interval 37.13 to 48.27
|
|
Cumulative Percentage of Subjects Reporting Any Adverse Events of Interest (AEIs) and/or Adverse Events (AEs) Using Adverse Drug Reaction (ADR) Card, Post Dose 1 by Vaccine Group and Overall
Week 40-46
|
42.53 Percentage of subjects
Interval 22.1 to 65.02
|
36.59 Percentage of subjects
Interval 15.78 to 61.9
|
45.08 Percentage of subjects
Interval 28.25 to 62.79
|
41.96 Percentage of subjects
Interval 36.86 to 47.19
|
|
Cumulative Percentage of Subjects Reporting Any Adverse Events of Interest (AEIs) and/or Adverse Events (AEs) Using Adverse Drug Reaction (ADR) Card, Post Dose 1 by Vaccine Group and Overall
Week 40-47
|
42.25 Percentage of subjects
Interval 22.24 to 64.31
|
36.69 Percentage of subjects
Interval 15.84 to 62.0
|
46.22 Percentage of subjects
Interval 25.61 to 67.83
|
42.43 Percentage of subjects
Interval 36.88 to 48.13
|
|
Cumulative Percentage of Subjects Reporting Any Adverse Events of Interest (AEIs) and/or Adverse Events (AEs) Using Adverse Drug Reaction (ADR) Card, Post Dose 1 by Vaccine Group and Overall
Week 40-48
|
42.25 Percentage of subjects
Interval 22.24 to 64.31
|
36.69 Percentage of subjects
Interval 15.84 to 62.0
|
47.46 Percentage of subjects
Interval 23.2 to 72.64
|
43.02 Percentage of subjects
Interval 36.81 to 49.39
|
|
Cumulative Percentage of Subjects Reporting Any Adverse Events of Interest (AEIs) and/or Adverse Events (AEs) Using Adverse Drug Reaction (ADR) Card, Post Dose 1 by Vaccine Group and Overall
Week 40-49
|
42.25 Percentage of subjects
Interval 22.24 to 64.31
|
36.69 Percentage of subjects
Interval 15.84 to 62.0
|
47.46 Percentage of subjects
Interval 23.2 to 72.64
|
43.02 Percentage of subjects
Interval 36.81 to 49.39
|
|
Cumulative Percentage of Subjects Reporting Any Adverse Events of Interest (AEIs) and/or Adverse Events (AEs) Using Adverse Drug Reaction (ADR) Card, Post Dose 1 by Vaccine Group and Overall
Week 40-50
|
42.25 Percentage of subjects
Interval 22.24 to 64.31
|
36.69 Percentage of subjects
Interval 15.84 to 62.0
|
47.46 Percentage of subjects
Interval 23.2 to 72.64
|
43.02 Percentage of subjects
Interval 36.81 to 49.39
|
|
Cumulative Percentage of Subjects Reporting Any Adverse Events of Interest (AEIs) and/or Adverse Events (AEs) Using Adverse Drug Reaction (ADR) Card, Post Dose 1 by Vaccine Group and Overall
Week 40-51
|
42.25 Percentage of subjects
Interval 22.24 to 64.31
|
36.69 Percentage of subjects
Interval 15.84 to 62.0
|
47.46 Percentage of subjects
Interval 23.2 to 72.64
|
43.02 Percentage of subjects
Interval 36.81 to 49.39
|
|
Cumulative Percentage of Subjects Reporting Any Adverse Events of Interest (AEIs) and/or Adverse Events (AEs) Using Adverse Drug Reaction (ADR) Card, Post Dose 1 by Vaccine Group and Overall
Week 40-52
|
42.25 Percentage of subjects
Interval 22.24 to 64.31
|
36.69 Percentage of subjects
Interval 15.84 to 62.0
|
47.46 Percentage of subjects
Interval 23.2 to 72.64
|
43.02 Percentage of subjects
Interval 36.81 to 49.39
|
PRIMARY outcome
Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=139 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Any AEIs and/or AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any, Weeks 40-52
|
23.74 Percentage of subjects
Interval 0.84 to 32.89
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any AEIs and/or AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any, Weeks 40-46
|
33.33 Percentage of subjects
Interval 0.84 to 90.57
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any AEIs and/or AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any, Weeks 40-47
|
45.45 Percentage of subjects
Interval 0.84 to 76.22
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any AEIs and/or AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any, Weeks 40-48
|
44.68 Percentage of subjects
Interval 0.84 to 62.55
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any AEIs and/or AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any, Weeks 40-49
|
30.86 Percentage of subjects
Interval 0.84 to 42.11
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any AEIs and/or AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any, Weeks 40-50
|
23.58 Percentage of subjects
Interval 0.84 to 32.07
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any AEIs and/or AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any, Weeks 40-51
|
23.70 Percentage of subjects
Interval 0.84 to 33.21
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were diarrhoea, nausea, and vomiting.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-51
|
6.69 Percentage of subjects
Interval 0.14 to 33.1
|
5.04 Percentage of subjects
Interval 0.12 to 25.46
|
6.84 Percentage of subjects
Interval 4.06 to 10.69
|
6.32 Percentage of subjects
Interval 4.24 to 9.01
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-52
|
6.69 Percentage of subjects
Interval 0.14 to 33.1
|
5.04 Percentage of subjects
Interval 0.12 to 25.46
|
6.84 Percentage of subjects
Interval 4.06 to 10.69
|
6.32 Percentage of subjects
Interval 4.24 to 9.01
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Diarrhoea,Weeks 40-40
|
—
|
2.86 Percentage of subjects
Interval 0.12 to 13.38
|
—
|
2.86 Percentage of subjects
Interval 0.12 to 13.38
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Diarrhoea,Weeks 40-41
|
—
|
2.48 Percentage of subjects
Interval 0.14 to 10.81
|
—
|
2.48 Percentage of subjects
Interval 0.14 to 10.81
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Diarrhoea,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
3.43 Percentage of subjects
Interval 0.09 to 17.62
|
3.85 Percentage of subjects
Interval 0.11 to 19.24
|
2.27 Percentage of subjects
Interval 0.36 to 7.25
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Diarrhoea,Weeks 40-43
|
1.16 Percentage of subjects
Interval 0.0 to 98.31
|
3.23 Percentage of subjects
Interval 0.16 to 14.35
|
4.62 Percentage of subjects
Interval 0.01 to 34.55
|
2.89 Percentage of subjects
Interval 0.98 to 6.48
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Diarrhoea,Weeks 40-44
|
1.44 Percentage of subjects
Interval 0.0 to 22.84
|
3.45 Percentage of subjects
Interval 0.18 to 15.24
|
4.10 Percentage of subjects
Interval 1.03 to 10.63
|
2.99 Percentage of subjects
Interval 1.4 to 5.56
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-40
|
—
|
2.86 Percentage of subjects
Interval 0.12 to 13.38
|
—
|
2.86 Percentage of subjects
Interval 0.12 to 13.38
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-41
|
—
|
2.48 Percentage of subjects
Interval 0.14 to 10.81
|
—
|
2.48 Percentage of subjects
Interval 0.14 to 10.81
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-42
|
2.13 Percentage of subjects
Interval 0.0 to 57.89
|
4.41 Percentage of subjects
Interval 0.02 to 29.4
|
7.69 Percentage of subjects
Interval 0.19 to 36.17
|
4.03 Percentage of subjects
Interval 1.17 to 9.74
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-43
|
3.49 Percentage of subjects
Interval 0.0 to 98.14
|
4.61 Percentage of subjects
Interval 0.02 to 29.48
|
8.46 Percentage of subjects
Interval 3.32 to 17.07
|
5.20 Percentage of subjects
Interval 2.02 to 10.7
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-44
|
5.29 Percentage of subjects
Interval 0.0 to 42.0
|
4.74 Percentage of subjects
Interval 0.04 to 28.55
|
7.18 Percentage of subjects
Interval 3.98 to 11.75
|
5.67 Percentage of subjects
Interval 2.98 to 9.67
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-45
|
6.38 Percentage of subjects
Interval 0.05 to 37.11
|
5.20 Percentage of subjects
Interval 0.05 to 30.53
|
5.71 Percentage of subjects
Interval 1.68 to 13.59
|
5.78 Percentage of subjects
Interval 3.36 to 9.18
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-46
|
6.49 Percentage of subjects
Interval 0.09 to 34.29
|
5.07 Percentage of subjects
Interval 0.11 to 26.0
|
6.47 Percentage of subjects
Interval 4.01 to 9.81
|
6.09 Percentage of subjects
Interval 3.99 to 8.84
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-47
|
6.69 Percentage of subjects
Interval 0.14 to 33.1
|
5.04 Percentage of subjects
Interval 0.12 to 25.46
|
6.64 Percentage of subjects
Interval 3.91 to 10.42
|
6.23 Percentage of subjects
Interval 4.13 to 8.96
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-48
|
6.69 Percentage of subjects
Interval 0.14 to 33.1
|
5.04 Percentage of subjects
Interval 0.12 to 25.46
|
6.84 Percentage of subjects
Interval 4.06 to 10.69
|
6.32 Percentage of subjects
Interval 4.24 to 9.01
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-49
|
6.69 Percentage of subjects
Interval 0.14 to 33.1
|
5.04 Percentage of subjects
Interval 0.12 to 25.46
|
6.84 Percentage of subjects
Interval 4.06 to 10.69
|
6.32 Percentage of subjects
Interval 4.24 to 9.01
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-50
|
6.69 Percentage of subjects
Interval 0.14 to 33.1
|
5.04 Percentage of subjects
Interval 0.12 to 25.46
|
6.84 Percentage of subjects
Interval 4.06 to 10.69
|
6.32 Percentage of subjects
Interval 4.24 to 9.01
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Diarrhoea,Weeks 40-45
|
1.77 Percentage of subjects
Interval 0.0 to 17.14
|
3.60 Percentage of subjects
Interval 0.21 to 15.27
|
3.71 Percentage of subjects
Interval 0.67 to 11.07
|
3.06 Percentage of subjects
Interval 1.61 to 5.24
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Diarrhoea,Weeks 40-46
|
1.95 Percentage of subjects
Interval 0.0 to 16.3
|
3.26 Percentage of subjects
Interval 0.4 to 11.22
|
4.08 Percentage of subjects
Interval 1.93 to 7.46
|
3.20 Percentage of subjects
Interval 2.02 to 4.79
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Diarrhoea,Weeks 40-47
|
1.82 Percentage of subjects
Interval 0.0 to 14.0
|
3.24 Percentage of subjects
Interval 0.42 to 10.98
|
3.89 Percentage of subjects
Interval 2.28 to 6.16
|
3.07 Percentage of subjects
Interval 1.95 to 4.57
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Diarrhoea,Weeks 40-48
|
1.82 Percentage of subjects
Interval 0.0 to 14.0
|
3.24 Percentage of subjects
Interval 0.42 to 10.98
|
3.97 Percentage of subjects
Interval 2.37 to 6.21
|
3.11 Percentage of subjects
Interval 1.99 to 4.61
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Diarrhoea,Weeks 40-49
|
1.82 Percentage of subjects
Interval 0.0 to 14.0
|
3.24 Percentage of subjects
Interval 0.42 to 10.98
|
3.97 Percentage of subjects
Interval 2.37 to 6.21
|
3.11 Percentage of subjects
Interval 1.99 to 4.61
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Diarrhoea,Weeks 40-50
|
1.82 Percentage of subjects
Interval 0.0 to 14.0
|
3.24 Percentage of subjects
Interval 0.42 to 10.98
|
3.97 Percentage of subjects
Interval 2.37 to 6.21
|
3.11 Percentage of subjects
Interval 1.99 to 4.61
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Diarrhoea,Weeks 40-51
|
1.82 Percentage of subjects
Interval 0.0 to 14.0
|
3.24 Percentage of subjects
Interval 0.42 to 10.98
|
3.97 Percentage of subjects
Interval 2.37 to 6.21
|
3.11 Percentage of subjects
Interval 1.99 to 4.61
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Diarrhoea,Weeks 40-52
|
1.82 Percentage of subjects
Interval 0.0 to 14.0
|
3.24 Percentage of subjects
Interval 0.42 to 10.98
|
3.97 Percentage of subjects
Interval 2.37 to 6.21
|
3.11 Percentage of subjects
Interval 1.99 to 4.61
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Nausea,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Nausea,Weeks 40-41
|
—
|
0.62 Percentage of subjects
Interval 0.0 to 17.42
|
—
|
0.62 Percentage of subjects
Interval 0.0 to 17.42
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Nausea,Weeks 40-42
|
2.13 Percentage of subjects
Interval 0.0 to 57.89
|
1.47 Percentage of subjects
Interval 0.0 to 28.09
|
3.85 Percentage of subjects
Interval 0.11 to 19.24
|
2.02 Percentage of subjects
Interval 0.5 to 5.32
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Nausea,Weeks 40-43
|
2.33 Percentage of subjects
Interval 0.0 to 61.91
|
1.84 Percentage of subjects
Interval 0.0 to 31.06
|
3.08 Percentage of subjects
Interval 0.24 to 12.22
|
2.31 Percentage of subjects
Interval 0.79 to 5.18
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Nausea,Weeks 40-44
|
3.37 Percentage of subjects
Interval 0.04 to 19.87
|
1.72 Percentage of subjects
Interval 0.0 to 26.54
|
3.08 Percentage of subjects
Interval 1.05 to 6.89
|
2.68 Percentage of subjects
Interval 1.31 to 4.83
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Nausea,Weeks 40-45
|
3.90 Percentage of subjects
Interval 0.12 to 19.29
|
1.60 Percentage of subjects
Interval 0.0 to 22.17
|
2.29 Percentage of subjects
Interval 0.99 to 4.45
|
2.61 Percentage of subjects
Interval 1.33 to 4.57
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Nausea,Weeks 40-46
|
3.90 Percentage of subjects
Interval 0.19 to 17.32
|
1.81 Percentage of subjects
Interval 0.0 to 21.35
|
2.88 Percentage of subjects
Interval 0.36 to 9.96
|
2.90 Percentage of subjects
Interval 1.57 to 4.87
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Nausea,Weeks 40-47
|
4.26 Percentage of subjects
Interval 0.19 to 19.12
|
1.80 Percentage of subjects
Interval 0.0 to 20.98
|
2.97 Percentage of subjects
Interval 0.26 to 11.52
|
3.07 Percentage of subjects
Interval 1.57 to 5.34
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Nausea,Weeks 40-48
|
4.26 Percentage of subjects
Interval 0.19 to 19.12
|
1.80 Percentage of subjects
Interval 0.0 to 20.98
|
2.87 Percentage of subjects
Interval 0.34 to 10.12
|
3.02 Percentage of subjects
Interval 1.57 to 5.21
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Nausea,Weeks 40-49
|
4.26 Percentage of subjects
Interval 0.19 to 19.12
|
1.80 Percentage of subjects
Interval 0.0 to 20.98
|
2.87 Percentage of subjects
Interval 0.34 to 10.12
|
3.02 Percentage of subjects
Interval 1.57 to 5.21
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Nausea,Weeks 40-50
|
4.26 Percentage of subjects
Interval 0.19 to 19.12
|
1.80 Percentage of subjects
Interval 0.0 to 20.98
|
2.87 Percentage of subjects
Interval 0.34 to 10.12
|
3.02 Percentage of subjects
Interval 1.57 to 5.21
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Nausea,Weeks 40-51
|
4.26 Percentage of subjects
Interval 0.19 to 19.12
|
1.80 Percentage of subjects
Interval 0.0 to 20.98
|
2.87 Percentage of subjects
Interval 0.34 to 10.12
|
3.02 Percentage of subjects
Interval 1.57 to 5.21
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Nausea,Weeks 40-52
|
4.26 Percentage of subjects
Interval 0.19 to 19.12
|
1.80 Percentage of subjects
Interval 0.0 to 20.98
|
2.87 Percentage of subjects
Interval 0.34 to 10.12
|
3.02 Percentage of subjects
Interval 1.57 to 5.21
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Vomiting,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Vomiting,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Vomiting,Weeks 40-42
|
0.71 Percentage of subjects
Interval 0.01 to 4.4
|
0.00 Percentage of subjects
Interval 0.0 to 1.79
|
5.77 Percentage of subjects
Interval 0.15 to 27.99
|
1.01 Percentage of subjects
Interval 0.03 to 5.13
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Vomiting,Weeks 40-43
|
1.16 Percentage of subjects
Interval 0.0 to 37.75
|
0.00 Percentage of subjects
Interval 0.0 to 1.69
|
4.62 Percentage of subjects
Interval 0.35 to 18.05
|
1.54 Percentage of subjects
Interval 0.12 to 6.23
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Vomiting,Weeks 40-44
|
1.44 Percentage of subjects
Interval 0.04 to 7.62
|
0.00 Percentage of subjects
Interval 0.0 to 1.58
|
4.10 Percentage of subjects
Interval 1.79 to 7.92
|
1.73 Percentage of subjects
Interval 0.39 to 4.82
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Vomiting,Weeks 40-45
|
1.77 Percentage of subjects
Interval 0.09 to 8.03
|
0.00 Percentage of subjects
Interval 0.0 to 1.46
|
3.14 Percentage of subjects
Interval 0.82 to 8.06
|
1.81 Percentage of subjects
Interval 0.68 to 3.87
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Vomiting,Weeks 40-46
|
1.62 Percentage of subjects
Interval 0.18 to 5.94
|
0.00 Percentage of subjects
Interval 0.0 to 1.33
|
2.88 Percentage of subjects
Interval 0.23 to 11.45
|
1.70 Percentage of subjects
Interval 0.61 to 3.71
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Vomiting,Weeks 40-47
|
1.52 Percentage of subjects
Interval 0.25 to 4.8
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
2.97 Percentage of subjects
Interval 0.16 to 13.12
|
1.72 Percentage of subjects
Interval 0.61 to 3.8
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Vomiting,Weeks 40-48
|
1.52 Percentage of subjects
Interval 0.25 to 4.8
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
3.09 Percentage of subjects
Interval 0.36 to 10.85
|
1.79 Percentage of subjects
Interval 0.71 to 3.7
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Vomiting,Weeks 40-49
|
1.52 Percentage of subjects
Interval 0.25 to 4.8
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
3.09 Percentage of subjects
Interval 0.36 to 10.85
|
1.79 Percentage of subjects
Interval 0.71 to 3.7
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Vomiting,Weeks 40-50
|
1.52 Percentage of subjects
Interval 0.25 to 4.8
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
3.09 Percentage of subjects
Interval 0.36 to 10.85
|
1.79 Percentage of subjects
Interval 0.71 to 3.7
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Vomiting,Weeks 40-51
|
1.52 Percentage of subjects
Interval 0.25 to 4.8
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
3.09 Percentage of subjects
Interval 0.36 to 10.85
|
1.79 Percentage of subjects
Interval 0.71 to 3.7
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Vomiting,Weeks 40-52
|
1.52 Percentage of subjects
Interval 0.25 to 4.8
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
3.09 Percentage of subjects
Interval 0.36 to 10.85
|
1.79 Percentage of subjects
Interval 0.71 to 3.7
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Abdominal discomfort,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Abdominal discomfort,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Abdominal discomfort,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Abdominal discomfort,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
0.00 Percentage of subjects
Interval 0.0 to 1.69
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.00 Percentage of subjects
Interval 0.0 to 0.71
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Abdominal discomfort,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 1.76
|
0.00 Percentage of subjects
Interval 0.0 to 1.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.87
|
0.00 Percentage of subjects
Interval 0.0 to 0.58
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Abdominal discomfort,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 1.3
|
0.00 Percentage of subjects
Interval 0.0 to 1.46
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.00 Percentage of subjects
Interval 0.0 to 0.42
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Abdominal discomfort,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 1.19
|
0.00 Percentage of subjects
Interval 0.0 to 1.33
|
0.24 Percentage of subjects
Interval 0.0 to 5.63
|
0.10 Percentage of subjects
Interval 0.0 to 0.7
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Abdominal discomfort,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.23 Percentage of subjects
Interval 0.0 to 5.17
|
0.10 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Abdominal discomfort,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 4.76
|
0.09 Percentage of subjects
Interval 0.0 to 0.64
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Abdominal discomfort,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 4.76
|
0.09 Percentage of subjects
Interval 0.0 to 0.64
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Abdominal discomfort,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 4.76
|
0.09 Percentage of subjects
Interval 0.0 to 0.64
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Abdominal discomfort,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 4.76
|
0.09 Percentage of subjects
Interval 0.0 to 0.64
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Abdominal discomfort,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 4.76
|
0.09 Percentage of subjects
Interval 0.0 to 0.64
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Abdominal pain,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Abdominal pain,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Abdominal pain,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Abdominal pain,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
0.00 Percentage of subjects
Interval 0.0 to 1.69
|
2.31 Percentage of subjects
Interval 0.18 to 9.24
|
0.58 Percentage of subjects
Interval 0.01 to 3.82
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Abdominal pain,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 1.76
|
0.00 Percentage of subjects
Interval 0.0 to 1.58
|
1.54 Percentage of subjects
Interval 0.32 to 4.43
|
0.47 Percentage of subjects
Interval 0.01 to 2.54
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Abdominal pain,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 1.3
|
0.00 Percentage of subjects
Interval 0.0 to 1.46
|
0.86 Percentage of subjects
Interval 0.01 to 5.38
|
0.34 Percentage of subjects
Interval 0.01 to 1.83
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Abdominal pain,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 1.19
|
0.00 Percentage of subjects
Interval 0.0 to 1.33
|
0.72 Percentage of subjects
Interval 0.0 to 6.36
|
0.30 Percentage of subjects
Interval 0.01 to 1.67
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Abdominal pain,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.69 Percentage of subjects
Interval 0.0 to 6.61
|
0.29 Percentage of subjects
Interval 0.01 to 1.63
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Abdominal pain,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.66 Percentage of subjects
Interval 0.0 to 6.86
|
0.28 Percentage of subjects
Interval 0.01 to 1.62
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Abdominal pain,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.66 Percentage of subjects
Interval 0.0 to 6.86
|
0.28 Percentage of subjects
Interval 0.01 to 1.62
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Abdominal pain,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.66 Percentage of subjects
Interval 0.0 to 6.86
|
0.28 Percentage of subjects
Interval 0.01 to 1.62
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Abdominal pain,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.66 Percentage of subjects
Interval 0.0 to 6.86
|
0.28 Percentage of subjects
Interval 0.01 to 1.62
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Abdominal pain,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.66 Percentage of subjects
Interval 0.0 to 6.86
|
0.28 Percentage of subjects
Interval 0.01 to 1.62
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Gingival bleeding,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Gingival bleeding,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Gingival bleeding,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Gingival bleeding,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
0.00 Percentage of subjects
Interval 0.0 to 1.69
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.00 Percentage of subjects
Interval 0.0 to 0.71
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Gingival bleeding,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 1.76
|
0.00 Percentage of subjects
Interval 0.0 to 1.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.87
|
0.00 Percentage of subjects
Interval 0.0 to 0.58
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Gingival bleeding,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 1.3
|
0.40 Percentage of subjects
Interval 0.0 to 5.98
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.11 Percentage of subjects
Interval 0.0 to 0.81
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Gingival bleeding,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 1.19
|
0.36 Percentage of subjects
Interval 0.0 to 4.6
|
0.00 Percentage of subjects
Interval 0.0 to 0.88
|
0.10 Percentage of subjects
Interval 0.0 to 0.7
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Gingival bleeding,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.84
|
0.10 Percentage of subjects
Interval 0.0 to 0.67
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Gingival bleeding,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Gingival bleeding,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Gingival bleeding,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Gingival bleeding,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Gingival bleeding,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Lip swelling,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Lip swelling,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Lip swelling,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.49 Percentage of subjects
Interval 0.0 to 10.27
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.25 Percentage of subjects
Interval 0.0 to 2.0
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Lip swelling,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
0.46 Percentage of subjects
Interval 0.0 to 8.71
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.19 Percentage of subjects
Interval 0.0 to 1.52
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Lip swelling,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 1.76
|
0.43 Percentage of subjects
Interval 0.0 to 7.29
|
0.00 Percentage of subjects
Interval 0.0 to 1.87
|
0.16 Percentage of subjects
Interval 0.0 to 1.11
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Lip swelling,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 1.3
|
0.40 Percentage of subjects
Interval 0.0 to 5.98
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.11 Percentage of subjects
Interval 0.0 to 0.81
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Lip swelling,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 1.19
|
0.36 Percentage of subjects
Interval 0.0 to 4.6
|
0.00 Percentage of subjects
Interval 0.0 to 0.88
|
0.10 Percentage of subjects
Interval 0.0 to 0.7
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Lip swelling,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.84
|
0.10 Percentage of subjects
Interval 0.0 to 0.67
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Lip swelling,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Lip swelling,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Lip swelling,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Lip swelling,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Lip swelling,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Stomatitis,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Stomatitis,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Stomatitis,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.49 Percentage of subjects
Interval 0.0 to 10.27
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.25 Percentage of subjects
Interval 0.0 to 2.0
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Stomatitis,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
0.46 Percentage of subjects
Interval 0.0 to 8.71
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.19 Percentage of subjects
Interval 0.0 to 1.52
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Stomatitis,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 1.76
|
0.43 Percentage of subjects
Interval 0.0 to 7.29
|
0.00 Percentage of subjects
Interval 0.0 to 1.87
|
0.16 Percentage of subjects
Interval 0.0 to 1.11
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Stomatitis,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 1.3
|
0.40 Percentage of subjects
Interval 0.0 to 5.98
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.11 Percentage of subjects
Interval 0.0 to 0.81
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Stomatitis,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 1.19
|
0.36 Percentage of subjects
Interval 0.0 to 4.6
|
0.00 Percentage of subjects
Interval 0.0 to 0.88
|
0.10 Percentage of subjects
Interval 0.0 to 0.7
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Stomatitis,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.84
|
0.10 Percentage of subjects
Interval 0.0 to 0.67
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Stomatitis,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Stomatitis,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Stomatitis,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Stomatitis,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Stomatitis,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tongue discomfort,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tongue discomfort,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tongue discomfort,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.49 Percentage of subjects
Interval 0.0 to 10.27
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.25 Percentage of subjects
Interval 0.0 to 2.0
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tongue discomfort,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
0.46 Percentage of subjects
Interval 0.0 to 8.71
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.19 Percentage of subjects
Interval 0.0 to 1.52
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tongue discomfort,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 1.76
|
0.43 Percentage of subjects
Interval 0.0 to 7.29
|
0.00 Percentage of subjects
Interval 0.0 to 1.87
|
0.16 Percentage of subjects
Interval 0.0 to 1.11
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tongue discomfort,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 1.3
|
0.40 Percentage of subjects
Interval 0.0 to 5.98
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.11 Percentage of subjects
Interval 0.0 to 0.81
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tongue discomfort,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 1.19
|
0.36 Percentage of subjects
Interval 0.0 to 4.6
|
0.00 Percentage of subjects
Interval 0.0 to 0.88
|
0.10 Percentage of subjects
Interval 0.0 to 0.7
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tongue discomfort,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.84
|
0.10 Percentage of subjects
Interval 0.0 to 0.67
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tongue discomfort,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tongue discomfort,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tongue discomfort,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tongue discomfort,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tongue discomfort,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
PRIMARY outcome
Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were diarrhoea, nausea, and vomiting.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=139 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Weeks 40-46
|
33.33 Percentage of subjects
Interval 0.84 to 90.57
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Weeks 40-47
|
13.64 Percentage of subjects
Interval 1.21 to 44.8
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Weeks 40-48
|
6.38 Percentage of subjects
Interval 0.0 to 84.5
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Weeks 40-49
|
3.70 Percentage of subjects
Interval 0.49 to 12.42
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Weeks 40-50
|
3.25 Percentage of subjects
Interval 0.01 to 23.49
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Weeks 40-51
|
2.96 Percentage of subjects
Interval 0.01 to 22.21
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Weeks 40-52
|
2.88 Percentage of subjects
Interval 0.01 to 22.02
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Diarrhoea,Weeks 40-46
|
33.33 Percentage of subjects
Interval 0.84 to 90.57
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Diarrhoea,Weeks 40-47
|
4.55 Percentage of subjects
Interval 0.0 to 86.65
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Diarrhoea,Weeks 40-48
|
2.13 Percentage of subjects
Interval 0.0 to 22.05
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Diarrhoea,Weeks 40-49
|
1.23 Percentage of subjects
Interval 0.03 to 6.69
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Diarrhoea,Weeks 40-50
|
1.63 Percentage of subjects
Interval 0.01 to 12.28
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Diarrhoea,Weeks 40-51
|
1.48 Percentage of subjects
Interval 0.0 to 11.58
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Diarrhoea,Weeks 40-52
|
1.44 Percentage of subjects
Interval 0.0 to 11.48
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Nausea,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Nausea,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 15.44
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Nausea,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Nausea,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 4.45
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Nausea,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 2.95
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Nausea,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 2.7
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Nausea,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 2.62
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Vomiting,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Vomiting,Weeks 40-47
|
4.55 Percentage of subjects
Interval 0.0 to 100.0
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Vomiting,Weeks 40-48
|
2.13 Percentage of subjects
Interval 0.0 to 99.99
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Vomiting,Weeks 40-49
|
1.23 Percentage of subjects
Interval 0.0 to 38.5
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Vomiting,Weeks 40-50
|
0.81 Percentage of subjects
Interval 0.0 to 27.14
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Vomiting,Weeks 40-51
|
0.74 Percentage of subjects
Interval 0.0 to 25.43
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Vomiting,Weeks 40-52
|
0.72 Percentage of subjects
Interval 0.0 to 25.02
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Abdominal pain,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Abdominal pain,Weeks 40-47
|
4.55 Percentage of subjects
Interval 0.0 to 86.65
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Abdominal pain,Weeks 40-48
|
2.13 Percentage of subjects
Interval 0.0 to 22.05
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Abdominal pain,Weeks 40-49
|
1.23 Percentage of subjects
Interval 0.03 to 6.69
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Abdominal pain,Weeks 40-50
|
0.81 Percentage of subjects
Interval 0.02 to 4.45
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Abdominal pain,Weeks 40-51
|
0.74 Percentage of subjects
Interval 0.02 to 4.06
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Abdominal pain,Weeks 40-52
|
0.72 Percentage of subjects
Interval 0.02 to 3.94
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were chills, face oedema, fatigue, injection site erythema, injection site pain, injection site swelling, and pyrexia.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site erythema,Weeks 40-52
|
3.04 Percentage of subjects
Interval 0.03 to 18.73
|
7.55 Percentage of subjects
Interval 1.45 to 21.25
|
5.52 Percentage of subjects
Interval 2.42 to 10.58
|
5.28 Percentage of subjects
Interval 3.52 to 7.57
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site pain,Weeks 40-40
|
—
|
17.14 Percentage of subjects
Interval 9.18 to 28.03
|
—
|
17.14 Percentage of subjects
Interval 9.18 to 28.03
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site pain,Weeks 40-41
|
—
|
18.01 Percentage of subjects
Interval 4.65 to 41.5
|
—
|
18.01 Percentage of subjects
Interval 4.65 to 41.5
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site pain,Weeks 40-42
|
28.37 Percentage of subjects
Interval 7.46 to 59.8
|
16.67 Percentage of subjects
Interval 3.53 to 41.6
|
15.38 Percentage of subjects
Interval 0.28 to 63.3
|
20.65 Percentage of subjects
Interval 12.25 to 31.42
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site pain,Weeks 40-43
|
26.16 Percentage of subjects
Interval 0.02 to 94.78
|
16.13 Percentage of subjects
Interval 2.91 to 42.6
|
10.00 Percentage of subjects
Interval 0.68 to 36.93
|
17.92 Percentage of subjects
Interval 9.29 to 29.82
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site pain,Weeks 40-44
|
25.48 Percentage of subjects
Interval 9.68 to 48.07
|
15.95 Percentage of subjects
Interval 3.05 to 41.46
|
8.72 Percentage of subjects
Interval 4.24 to 15.49
|
16.85 Percentage of subjects
Interval 9.12 to 27.4
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site pain,Weeks 40-45
|
21.63 Percentage of subjects
Interval 2.65 to 59.28
|
17.20 Percentage of subjects
Interval 6.38 to 34.25
|
13.71 Percentage of subjects
Interval 1.03 to 46.65
|
17.23 Percentage of subjects
Interval 10.65 to 25.69
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site pain,Weeks 40-46
|
20.13 Percentage of subjects
Interval 1.26 to 63.88
|
16.67 Percentage of subjects
Interval 5.95 to 33.88
|
14.39 Percentage of subjects
Interval 1.71 to 43.62
|
16.78 Percentage of subjects
Interval 10.78 to 24.38
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site pain,Weeks 40-47
|
19.76 Percentage of subjects
Interval 1.27 to 62.83
|
16.55 Percentage of subjects
Interval 5.74 to 34.13
|
15.10 Percentage of subjects
Interval 1.45 to 47.74
|
16.95 Percentage of subjects
Interval 10.93 to 24.55
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site pain,Weeks 40-48
|
19.76 Percentage of subjects
Interval 1.27 to 62.83
|
16.55 Percentage of subjects
Interval 5.74 to 34.13
|
16.78 Percentage of subjects
Interval 1.01 to 56.72
|
17.64 Percentage of subjects
Interval 11.18 to 25.83
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site pain,Weeks 40-49
|
19.76 Percentage of subjects
Interval 1.27 to 62.83
|
16.55 Percentage of subjects
Interval 5.74 to 34.13
|
16.78 Percentage of subjects
Interval 1.01 to 56.72
|
17.64 Percentage of subjects
Interval 11.18 to 25.83
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site pain,Weeks 40-50
|
19.76 Percentage of subjects
Interval 1.27 to 62.83
|
16.55 Percentage of subjects
Interval 5.74 to 34.13
|
16.78 Percentage of subjects
Interval 1.01 to 56.72
|
17.64 Percentage of subjects
Interval 11.18 to 25.83
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site pain,Weeks 40-51
|
19.76 Percentage of subjects
Interval 1.27 to 62.83
|
16.55 Percentage of subjects
Interval 5.74 to 34.13
|
16.78 Percentage of subjects
Interval 1.01 to 56.72
|
17.64 Percentage of subjects
Interval 11.18 to 25.83
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site pain,Weeks 40-52
|
19.76 Percentage of subjects
Interval 1.27 to 62.83
|
16.55 Percentage of subjects
Interval 5.74 to 34.13
|
16.78 Percentage of subjects
Interval 1.01 to 56.72
|
17.64 Percentage of subjects
Interval 11.18 to 25.83
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site swelling,Weeks 40-40
|
—
|
11.43 Percentage of subjects
Interval 1.34 to 36.13
|
—
|
11.43 Percentage of subjects
Interval 1.34 to 36.13
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site swelling,Weeks 40-41
|
—
|
10.56 Percentage of subjects
Interval 6.27 to 16.37
|
—
|
10.56 Percentage of subjects
Interval 6.27 to 16.37
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site swelling,Weeks 40-42
|
4.96 Percentage of subjects
Interval 0.48 to 18.09
|
10.29 Percentage of subjects
Interval 5.11 to 17.97
|
5.77 Percentage of subjects
Interval 0.15 to 27.99
|
7.81 Percentage of subjects
Interval 4.57 to 12.3
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site swelling,Weeks 40-51
|
5.17 Percentage of subjects
Interval 3.04 to 8.14
|
10.79 Percentage of subjects
Interval 7.31 to 15.19
|
7.28 Percentage of subjects
Interval 1.72 to 18.91
|
7.55 Percentage of subjects
Interval 5.38 to 10.23
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site swelling,Weeks 40-43
|
6.40 Percentage of subjects
Interval 0.0 to 85.72
|
9.68 Percentage of subjects
Interval 3.63 to 19.89
|
6.15 Percentage of subjects
Interval 0.45 to 23.69
|
7.71 Percentage of subjects
Interval 4.99 to 11.28
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site swelling,Weeks 40-44
|
5.29 Percentage of subjects
Interval 0.85 to 16.23
|
9.91 Percentage of subjects
Interval 4.6 to 18.06
|
5.13 Percentage of subjects
Interval 2.49 to 9.23
|
6.93 Percentage of subjects
Interval 4.73 to 9.73
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site swelling,Weeks 40-45
|
4.61 Percentage of subjects
Interval 2.48 to 7.75
|
10.40 Percentage of subjects
Interval 6.19 to 16.11
|
5.71 Percentage of subjects
Interval 3.53 to 8.69
|
6.69 Percentage of subjects
Interval 4.81 to 9.02
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site swelling,Weeks 40-46
|
4.55 Percentage of subjects
Interval 2.51 to 7.51
|
10.87 Percentage of subjects
Interval 7.4 to 15.24
|
6.24 Percentage of subjects
Interval 2.36 to 12.98
|
6.99 Percentage of subjects
Interval 4.86 to 9.69
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site swelling,Weeks 40-47
|
5.17 Percentage of subjects
Interval 3.04 to 8.14
|
10.79 Percentage of subjects
Interval 7.31 to 15.19
|
6.86 Percentage of subjects
Interval 2.09 to 15.94
|
7.38 Percentage of subjects
Interval 5.32 to 9.92
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site swelling,Weeks 40-48
|
5.17 Percentage of subjects
Interval 3.04 to 8.14
|
10.79 Percentage of subjects
Interval 7.31 to 15.19
|
7.28 Percentage of subjects
Interval 1.72 to 18.91
|
7.55 Percentage of subjects
Interval 5.38 to 10.23
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site swelling,Weeks 40-49
|
5.17 Percentage of subjects
Interval 3.04 to 8.14
|
10.79 Percentage of subjects
Interval 7.31 to 15.19
|
7.28 Percentage of subjects
Interval 1.72 to 18.91
|
7.55 Percentage of subjects
Interval 5.38 to 10.23
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site swelling,Weeks 40-52
|
5.17 Percentage of subjects
Interval 3.04 to 8.14
|
10.79 Percentage of subjects
Interval 7.31 to 15.19
|
7.28 Percentage of subjects
Interval 1.72 to 18.91
|
7.55 Percentage of subjects
Interval 5.38 to 10.23
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site swelling,Weeks 40-50
|
5.17 Percentage of subjects
Interval 3.04 to 8.14
|
10.79 Percentage of subjects
Interval 7.31 to 15.19
|
7.28 Percentage of subjects
Interval 1.72 to 18.91
|
7.55 Percentage of subjects
Interval 5.38 to 10.23
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pyrexia,Weeks 40-40
|
—
|
2.86 Percentage of subjects
Interval 0.12 to 13.38
|
—
|
2.86 Percentage of subjects
Interval 0.12 to 13.38
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pyrexia,Weeks 40-41
|
—
|
1.24 Percentage of subjects
Interval 0.0 to 10.8
|
—
|
1.24 Percentage of subjects
Interval 0.0 to 10.8
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pyrexia,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.98 Percentage of subjects
Interval 0.0 to 12.72
|
5.77 Percentage of subjects
Interval 0.15 to 27.99
|
1.26 Percentage of subjects
Interval 0.07 to 5.6
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pyrexia,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
0.92 Percentage of subjects
Interval 0.0 to 13.1
|
10.00 Percentage of subjects
Interval 0.68 to 36.93
|
2.89 Percentage of subjects
Interval 0.09 to 14.4
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pyrexia,Weeks 40-44
|
0.48 Percentage of subjects
Interval 0.0 to 15.39
|
0.86 Percentage of subjects
Interval 0.0 to 13.44
|
7.69 Percentage of subjects
Interval 4.37 to 12.37
|
2.83 Percentage of subjects
Interval 0.32 to 10.09
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pyrexia,Weeks 40-45
|
0.35 Percentage of subjects
Interval 0.0 to 10.83
|
0.80 Percentage of subjects
Interval 0.0 to 13.75
|
6.29 Percentage of subjects
Interval 1.62 to 15.81
|
2.83 Percentage of subjects
Interval 0.51 to 8.52
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pyrexia,Weeks 40-46
|
0.65 Percentage of subjects
Interval 0.0 to 6.66
|
0.72 Percentage of subjects
Interval 0.0 to 14.0
|
6.47 Percentage of subjects
Interval 3.06 to 11.8
|
3.10 Percentage of subjects
Interval 0.87 to 7.65
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pyrexia,Weeks 40-47
|
0.61 Percentage of subjects
Interval 0.0 to 5.98
|
0.72 Percentage of subjects
Interval 0.0 to 14.01
|
6.41 Percentage of subjects
Interval 2.64 to 12.69
|
3.07 Percentage of subjects
Interval 0.86 to 7.56
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pyrexia,Weeks 40-48
|
0.61 Percentage of subjects
Interval 0.0 to 5.98
|
0.72 Percentage of subjects
Interval 0.0 to 14.01
|
6.40 Percentage of subjects
Interval 2.99 to 11.76
|
3.11 Percentage of subjects
Interval 0.92 to 7.51
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pyrexia,Weeks 40-49
|
0.61 Percentage of subjects
Interval 0.0 to 5.98
|
0.72 Percentage of subjects
Interval 0.0 to 14.01
|
6.40 Percentage of subjects
Interval 2.99 to 11.76
|
3.11 Percentage of subjects
Interval 0.92 to 7.51
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pyrexia,Weeks 40-50
|
0.61 Percentage of subjects
Interval 0.0 to 5.98
|
0.72 Percentage of subjects
Interval 0.0 to 14.01
|
6.40 Percentage of subjects
Interval 2.99 to 11.76
|
3.11 Percentage of subjects
Interval 0.92 to 7.51
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pyrexia,Weeks 40-51
|
0.61 Percentage of subjects
Interval 0.0 to 5.98
|
0.72 Percentage of subjects
Interval 0.0 to 14.01
|
6.40 Percentage of subjects
Interval 2.99 to 11.76
|
3.11 Percentage of subjects
Interval 0.92 to 7.51
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pyrexia,Weeks 40-52
|
0.61 Percentage of subjects
Interval 0.0 to 5.98
|
0.72 Percentage of subjects
Interval 0.0 to 14.01
|
6.40 Percentage of subjects
Interval 2.99 to 11.76
|
3.11 Percentage of subjects
Interval 0.92 to 7.51
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Discomfort,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Discomfort,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Discomfort,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Discomfort,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
0.00 Percentage of subjects
Interval 0.0 to 1.69
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.00 Percentage of subjects
Interval 0.0 to 0.71
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Discomfort,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 1.76
|
0.00 Percentage of subjects
Interval 0.0 to 1.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.87
|
0.00 Percentage of subjects
Interval 0.0 to 0.58
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Discomfort,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 1.3
|
0.00 Percentage of subjects
Interval 0.0 to 1.46
|
0.29 Percentage of subjects
Interval 0.0 to 8.11
|
0.11 Percentage of subjects
Interval 0.0 to 0.84
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Discomfort,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 1.19
|
0.00 Percentage of subjects
Interval 0.0 to 1.33
|
0.24 Percentage of subjects
Interval 0.0 to 5.63
|
0.10 Percentage of subjects
Interval 0.0 to 0.7
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Discomfort,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.23 Percentage of subjects
Interval 0.0 to 5.17
|
0.10 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Discomfort,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 4.76
|
0.09 Percentage of subjects
Interval 0.0 to 0.64
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Discomfort,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 4.76
|
0.09 Percentage of subjects
Interval 0.0 to 0.64
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Discomfort,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 4.76
|
0.09 Percentage of subjects
Interval 0.0 to 0.64
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Discomfort,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 4.76
|
0.09 Percentage of subjects
Interval 0.0 to 0.64
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Discomfort,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 4.76
|
0.09 Percentage of subjects
Interval 0.0 to 0.64
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Feeling cold,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Feeling cold,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Feeling cold,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Feeling cold,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
0.00 Percentage of subjects
Interval 0.0 to 1.69
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.00 Percentage of subjects
Interval 0.0 to 0.71
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Feeling cold,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 1.76
|
0.00 Percentage of subjects
Interval 0.0 to 1.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.87
|
0.00 Percentage of subjects
Interval 0.0 to 0.58
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Feeling cold,Weeks 40-45
|
0.35 Percentage of subjects
Interval 0.0 to 5.88
|
0.00 Percentage of subjects
Interval 0.0 to 1.46
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.11 Percentage of subjects
Interval 0.0 to 0.79
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Feeling cold,Weeks 40-46
|
0.32 Percentage of subjects
Interval 0.0 to 4.64
|
0.00 Percentage of subjects
Interval 0.0 to 1.33
|
0.00 Percentage of subjects
Interval 0.0 to 0.88
|
0.10 Percentage of subjects
Interval 0.0 to 0.68
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Feeling cold,Weeks 40-47
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.84
|
0.10 Percentage of subjects
Interval 0.0 to 0.64
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Feeling cold,Weeks 40-48
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.63
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Feeling cold,Weeks 40-49
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.63
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Feeling cold,Weeks 40-50
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.63
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Feeling cold,Weeks 40-51
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.63
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Feeling cold,Weeks 40-52
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.63
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Feeling hot,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Feeling hot,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Feeling hot,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Feeling hot,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
0.00 Percentage of subjects
Interval 0.0 to 1.69
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.00 Percentage of subjects
Interval 0.0 to 0.71
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Feeling hot,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 1.76
|
0.00 Percentage of subjects
Interval 0.0 to 1.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.87
|
0.00 Percentage of subjects
Interval 0.0 to 0.58
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Feeling hot,Weeks 40-45
|
0.35 Percentage of subjects
Interval 0.0 to 5.88
|
0.00 Percentage of subjects
Interval 0.0 to 1.46
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.11 Percentage of subjects
Interval 0.0 to 0.79
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Feeling hot,Weeks 40-46
|
0.32 Percentage of subjects
Interval 0.0 to 4.64
|
0.00 Percentage of subjects
Interval 0.0 to 1.33
|
0.00 Percentage of subjects
Interval 0.0 to 0.88
|
0.10 Percentage of subjects
Interval 0.0 to 0.68
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Feeling hot,Weeks 40-47
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.84
|
0.10 Percentage of subjects
Interval 0.0 to 0.64
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Feeling hot,Weeks 40-48
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.63
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Feeling hot,Weeks 40-49
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.63
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Feeling hot,Weeks 40-50
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.63
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Feeling hot,Weeks 40-51
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.63
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Feeling hot,Weeks 40-52
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.63
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Influenza like illness,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Influenza like illness,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Influenza like illness,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Influenza like illness,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
0.00 Percentage of subjects
Interval 0.0 to 1.69
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.00 Percentage of subjects
Interval 0.0 to 0.71
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Influenza like illness,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 1.76
|
0.00 Percentage of subjects
Interval 0.0 to 1.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.87
|
0.00 Percentage of subjects
Interval 0.0 to 0.58
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Influenza like illness,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 1.3
|
0.00 Percentage of subjects
Interval 0.0 to 1.46
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.00 Percentage of subjects
Interval 0.0 to 0.42
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Influenza like illness,Weeks 40-46
|
0.32 Percentage of subjects
Interval 0.0 to 4.64
|
0.00 Percentage of subjects
Interval 0.0 to 1.33
|
0.24 Percentage of subjects
Interval 0.0 to 5.63
|
0.20 Percentage of subjects
Interval 0.02 to 0.78
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Influenza like illness,Weeks 40-47
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.23 Percentage of subjects
Interval 0.0 to 5.17
|
0.19 Percentage of subjects
Interval 0.02 to 0.73
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Influenza like illness,Weeks 40-48
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 4.76
|
0.19 Percentage of subjects
Interval 0.02 to 0.71
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Influenza like illness,Weeks 40-49
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 4.76
|
0.19 Percentage of subjects
Interval 0.02 to 0.71
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Influenza like illness,Weeks 40-50
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 4.76
|
0.19 Percentage of subjects
Interval 0.02 to 0.71
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Influenza like illness,Weeks 40-51
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 4.76
|
0.19 Percentage of subjects
Interval 0.02 to 0.71
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Influenza like illness,Weeks 40-52
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 4.76
|
0.19 Percentage of subjects
Interval 0.02 to 0.71
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site haematoma,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site haematoma,Weeks 40-41
|
—
|
0.62 Percentage of subjects
Interval 0.0 to 5.51
|
—
|
0.62 Percentage of subjects
Interval 0.0 to 5.51
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site haematoma,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.49 Percentage of subjects
Interval 0.0 to 6.53
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.25 Percentage of subjects
Interval 0.0 to 1.73
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site haematoma,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
0.46 Percentage of subjects
Interval 0.0 to 6.74
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.19 Percentage of subjects
Interval 0.0 to 1.43
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site haematoma,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 1.76
|
0.43 Percentage of subjects
Interval 0.0 to 6.92
|
0.00 Percentage of subjects
Interval 0.0 to 1.87
|
0.16 Percentage of subjects
Interval 0.0 to 1.09
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site haematoma,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 1.3
|
0.40 Percentage of subjects
Interval 0.0 to 7.09
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.11 Percentage of subjects
Interval 0.0 to 0.83
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site haematoma,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 1.19
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
0.00 Percentage of subjects
Interval 0.0 to 0.88
|
0.10 Percentage of subjects
Interval 0.0 to 0.74
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site haematoma,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
0.00 Percentage of subjects
Interval 0.0 to 0.84
|
0.10 Percentage of subjects
Interval 0.0 to 0.71
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site haematoma,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.7
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site haematoma,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.7
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site haematoma,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.7
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site haematoma,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.7
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site haematoma,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.7
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site pruritus,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site pruritus,Weeks 40-41
|
—
|
0.62 Percentage of subjects
Interval 0.0 to 17.42
|
—
|
0.62 Percentage of subjects
Interval 0.0 to 17.42
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site pruritus,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.49 Percentage of subjects
Interval 0.0 to 10.27
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.25 Percentage of subjects
Interval 0.0 to 2.0
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site pruritus,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
0.46 Percentage of subjects
Interval 0.0 to 8.71
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.19 Percentage of subjects
Interval 0.0 to 1.52
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site pruritus,Weeks 40-44
|
0.48 Percentage of subjects
Interval 0.0 to 12.12
|
0.43 Percentage of subjects
Interval 0.0 to 7.29
|
0.00 Percentage of subjects
Interval 0.0 to 1.87
|
0.31 Percentage of subjects
Interval 0.02 to 1.38
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site pruritus,Weeks 40-45
|
0.35 Percentage of subjects
Interval 0.0 to 5.88
|
1.20 Percentage of subjects
Interval 0.0 to 17.05
|
0.29 Percentage of subjects
Interval 0.0 to 8.11
|
0.57 Percentage of subjects
Interval 0.06 to 2.15
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site pruritus,Weeks 40-46
|
0.32 Percentage of subjects
Interval 0.0 to 4.64
|
1.09 Percentage of subjects
Interval 0.0 to 13.3
|
0.24 Percentage of subjects
Interval 0.0 to 5.63
|
0.50 Percentage of subjects
Interval 0.06 to 1.79
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site pruritus,Weeks 40-47
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
1.08 Percentage of subjects
Interval 0.0 to 13.06
|
0.23 Percentage of subjects
Interval 0.0 to 5.17
|
0.48 Percentage of subjects
Interval 0.06 to 1.7
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site pruritus,Weeks 40-48
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
1.08 Percentage of subjects
Interval 0.0 to 13.06
|
0.22 Percentage of subjects
Interval 0.0 to 4.76
|
0.47 Percentage of subjects
Interval 0.06 to 1.67
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site pruritus,Weeks 40-49
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
1.08 Percentage of subjects
Interval 0.0 to 13.06
|
0.22 Percentage of subjects
Interval 0.0 to 4.76
|
0.47 Percentage of subjects
Interval 0.06 to 1.67
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site pruritus,Weeks 40-50
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
1.08 Percentage of subjects
Interval 0.0 to 13.06
|
0.22 Percentage of subjects
Interval 0.0 to 4.76
|
0.47 Percentage of subjects
Interval 0.06 to 1.67
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site pruritus,Weeks 40-51
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
1.08 Percentage of subjects
Interval 0.0 to 13.06
|
0.22 Percentage of subjects
Interval 0.0 to 4.76
|
0.47 Percentage of subjects
Interval 0.06 to 1.67
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site pruritus,Weeks 40-52
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
1.08 Percentage of subjects
Interval 0.0 to 13.06
|
0.22 Percentage of subjects
Interval 0.0 to 4.76
|
0.47 Percentage of subjects
Interval 0.06 to 1.67
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site warmth,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site warmth,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site warmth,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site warmth,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
0.00 Percentage of subjects
Interval 0.0 to 1.69
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.00 Percentage of subjects
Interval 0.0 to 0.71
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site warmth,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 1.76
|
0.00 Percentage of subjects
Interval 0.0 to 1.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.87
|
0.00 Percentage of subjects
Interval 0.0 to 0.58
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site warmth,Weeks 40-45
|
0.35 Percentage of subjects
Interval 0.0 to 10.83
|
0.00 Percentage of subjects
Interval 0.0 to 1.46
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.11 Percentage of subjects
Interval 0.0 to 0.91
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site warmth,Weeks 40-46
|
0.32 Percentage of subjects
Interval 0.0 to 10.19
|
0.00 Percentage of subjects
Interval 0.0 to 1.33
|
0.00 Percentage of subjects
Interval 0.0 to 0.88
|
0.10 Percentage of subjects
Interval 0.0 to 0.81
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site warmth,Weeks 40-47
|
0.30 Percentage of subjects
Interval 0.0 to 9.75
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.84
|
0.10 Percentage of subjects
Interval 0.0 to 0.78
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site warmth,Weeks 40-48
|
0.30 Percentage of subjects
Interval 0.0 to 9.75
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.76
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site warmth,Weeks 40-49
|
0.30 Percentage of subjects
Interval 0.0 to 9.75
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.76
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site warmth,Weeks 40-50
|
0.30 Percentage of subjects
Interval 0.0 to 9.75
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.76
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site warmth,Weeks 40-51
|
0.30 Percentage of subjects
Interval 0.0 to 9.75
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.76
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site warmth,Weeks 40-52
|
0.30 Percentage of subjects
Interval 0.0 to 9.75
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.76
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Malaise,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Malaise,Weeks 40-41
|
—
|
0.62 Percentage of subjects
Interval 0.0 to 5.51
|
—
|
0.62 Percentage of subjects
Interval 0.0 to 5.51
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Malaise,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.49 Percentage of subjects
Interval 0.0 to 6.53
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.25 Percentage of subjects
Interval 0.0 to 1.73
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Malaise,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
0.46 Percentage of subjects
Interval 0.0 to 6.74
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.19 Percentage of subjects
Interval 0.0 to 1.43
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Malaise,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 1.76
|
0.43 Percentage of subjects
Interval 0.0 to 6.92
|
0.00 Percentage of subjects
Interval 0.0 to 1.87
|
0.16 Percentage of subjects
Interval 0.0 to 1.09
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Malaise,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 1.3
|
0.40 Percentage of subjects
Interval 0.0 to 7.09
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.11 Percentage of subjects
Interval 0.0 to 0.83
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Malaise,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 1.19
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
0.00 Percentage of subjects
Interval 0.0 to 0.88
|
0.10 Percentage of subjects
Interval 0.0 to 0.74
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Malaise,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
0.00 Percentage of subjects
Interval 0.0 to 0.84
|
0.10 Percentage of subjects
Interval 0.0 to 0.71
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Malaise,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.7
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Malaise,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.7
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Malaise,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.7
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Malaise,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.7
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Malaise,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.7
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Mucous membrane disorder,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Mucous membrane disorder,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Mucous membrane disorder,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Mucous membrane disorder,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
0.00 Percentage of subjects
Interval 0.0 to 1.69
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.00 Percentage of subjects
Interval 0.0 to 0.71
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Mucous membrane disorder,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 1.76
|
0.00 Percentage of subjects
Interval 0.0 to 1.58
|
0.51 Percentage of subjects
Interval 0.0 to 22.01
|
0.16 Percentage of subjects
Interval 0.0 to 1.34
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Mucous membrane disorder,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 1.3
|
0.00 Percentage of subjects
Interval 0.0 to 1.46
|
0.57 Percentage of subjects
Interval 0.03 to 2.6
|
0.23 Percentage of subjects
Interval 0.03 to 0.82
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Mucous membrane disorder,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 1.19
|
0.00 Percentage of subjects
Interval 0.0 to 1.33
|
0.48 Percentage of subjects
Interval 0.06 to 1.72
|
0.20 Percentage of subjects
Interval 0.02 to 0.72
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Mucous membrane disorder,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.46 Percentage of subjects
Interval 0.06 to 1.64
|
0.19 Percentage of subjects
Interval 0.02 to 0.69
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Mucous membrane disorder,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.44 Percentage of subjects
Interval 0.05 to 1.59
|
0.19 Percentage of subjects
Interval 0.02 to 0.68
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Mucous membrane disorder,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.44 Percentage of subjects
Interval 0.05 to 1.59
|
0.19 Percentage of subjects
Interval 0.02 to 0.68
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Mucous membrane disorder,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.44 Percentage of subjects
Interval 0.05 to 1.59
|
0.19 Percentage of subjects
Interval 0.02 to 0.68
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Mucous membrane disorder,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.44 Percentage of subjects
Interval 0.05 to 1.59
|
0.19 Percentage of subjects
Interval 0.02 to 0.68
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Mucous membrane disorder,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.44 Percentage of subjects
Interval 0.05 to 1.59
|
0.19 Percentage of subjects
Interval 0.02 to 0.68
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Peripheral swelling,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Peripheral swelling,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Peripheral swelling,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Peripheral swelling,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
0.00 Percentage of subjects
Interval 0.0 to 1.69
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.00 Percentage of subjects
Interval 0.0 to 0.71
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Peripheral swelling,Weeks 40-44
|
0.48 Percentage of subjects
Interval 0.0 to 15.39
|
0.00 Percentage of subjects
Interval 0.0 to 1.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.87
|
0.16 Percentage of subjects
Interval 0.0 to 1.29
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Peripheral swelling,Weeks 40-45
|
0.35 Percentage of subjects
Interval 0.0 to 10.83
|
0.00 Percentage of subjects
Interval 0.0 to 1.46
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.11 Percentage of subjects
Interval 0.0 to 0.91
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Peripheral swelling,Weeks 40-46
|
0.32 Percentage of subjects
Interval 0.0 to 10.19
|
0.00 Percentage of subjects
Interval 0.0 to 1.33
|
0.24 Percentage of subjects
Interval 0.0 to 8.39
|
0.20 Percentage of subjects
Interval 0.01 to 1.03
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Peripheral swelling,Weeks 40-47
|
0.30 Percentage of subjects
Interval 0.0 to 9.75
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.23 Percentage of subjects
Interval 0.0 to 7.65
|
0.19 Percentage of subjects
Interval 0.01 to 0.98
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Peripheral swelling,Weeks 40-48
|
0.30 Percentage of subjects
Interval 0.0 to 9.75
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 7.27
|
0.19 Percentage of subjects
Interval 0.01 to 0.96
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Peripheral swelling,Weeks 40-49
|
0.30 Percentage of subjects
Interval 0.0 to 9.75
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 7.27
|
0.19 Percentage of subjects
Interval 0.01 to 0.96
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Peripheral swelling,Weeks 40-50
|
0.30 Percentage of subjects
Interval 0.0 to 9.75
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 7.27
|
0.19 Percentage of subjects
Interval 0.01 to 0.96
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Peripheral swelling,Weeks 40-51
|
0.30 Percentage of subjects
Interval 0.0 to 9.75
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 7.27
|
0.19 Percentage of subjects
Interval 0.01 to 0.96
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Peripheral swelling,Weeks 40-52
|
0.30 Percentage of subjects
Interval 0.0 to 9.75
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 7.27
|
0.19 Percentage of subjects
Interval 0.01 to 0.96
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-40
|
—
|
25.71 Percentage of subjects
Interval 16.01 to 37.56
|
—
|
25.71 Percentage of subjects
Interval 16.01 to 37.56
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-41
|
—
|
27.95 Percentage of subjects
Interval 6.7 to 60.73
|
—
|
27.95 Percentage of subjects
Interval 6.7 to 60.73
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-42
|
31.21 Percentage of subjects
Interval 18.49 to 46.39
|
27.45 Percentage of subjects
Interval 10.68 to 50.73
|
26.92 Percentage of subjects
Interval 0.28 to 88.26
|
28.72 Percentage of subjects
Interval 23.3 to 34.62
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-43
|
29.07 Percentage of subjects
Interval 0.46 to 88.6
|
26.73 Percentage of subjects
Interval 10.78 to 48.84
|
26.92 Percentage of subjects
Interval 8.05 to 55.09
|
27.55 Percentage of subjects
Interval 22.75 to 32.77
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-44
|
31.25 Percentage of subjects
Interval 15.06 to 51.66
|
26.29 Percentage of subjects
Interval 11.02 to 47.35
|
24.10 Percentage of subjects
Interval 18.28 to 30.73
|
27.24 Percentage of subjects
Interval 22.33 to 32.6
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-45
|
27.66 Percentage of subjects
Interval 6.51 to 60.56
|
28.00 Percentage of subjects
Interval 13.58 to 46.73
|
28.00 Percentage of subjects
Interval 7.7 to 58.39
|
27.89 Percentage of subjects
Interval 21.77 to 34.69
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-46
|
26.62 Percentage of subjects
Interval 5.17 to 61.91
|
27.90 Percentage of subjects
Interval 14.72 to 44.61
|
28.06 Percentage of subjects
Interval 8.81 to 56.01
|
27.57 Percentage of subjects
Interval 21.54 to 34.28
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-47
|
26.75 Percentage of subjects
Interval 6.31 to 59.0
|
27.70 Percentage of subjects
Interval 14.69 to 44.2
|
29.06 Percentage of subjects
Interval 8.31 to 59.38
|
27.97 Percentage of subjects
Interval 21.82 to 34.8
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-48
|
26.75 Percentage of subjects
Interval 6.31 to 59.0
|
27.70 Percentage of subjects
Interval 14.69 to 44.2
|
30.24 Percentage of subjects
Interval 7.34 to 64.15
|
28.49 Percentage of subjects
Interval 21.83 to 35.92
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-49
|
26.75 Percentage of subjects
Interval 6.31 to 59.0
|
27.70 Percentage of subjects
Interval 14.69 to 44.2
|
30.24 Percentage of subjects
Interval 7.34 to 64.15
|
28.49 Percentage of subjects
Interval 21.83 to 35.92
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-50
|
26.75 Percentage of subjects
Interval 6.31 to 59.0
|
27.70 Percentage of subjects
Interval 14.69 to 44.2
|
30.24 Percentage of subjects
Interval 7.34 to 64.15
|
28.49 Percentage of subjects
Interval 21.83 to 35.92
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-51
|
26.75 Percentage of subjects
Interval 6.31 to 59.0
|
27.70 Percentage of subjects
Interval 14.69 to 44.2
|
30.24 Percentage of subjects
Interval 7.34 to 64.15
|
28.49 Percentage of subjects
Interval 21.83 to 35.92
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-52
|
26.75 Percentage of subjects
Interval 6.31 to 59.0
|
27.70 Percentage of subjects
Interval 14.69 to 44.2
|
30.24 Percentage of subjects
Interval 7.34 to 64.15
|
28.49 Percentage of subjects
Interval 21.83 to 35.92
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Chills,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Chills,Weeks 40-41
|
—
|
1.86 Percentage of subjects
Interval 0.0 to 44.3
|
—
|
1.86 Percentage of subjects
Interval 0.0 to 44.3
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Chills,Weeks 40-42
|
0.71 Percentage of subjects
Interval 0.01 to 4.4
|
2.45 Percentage of subjects
Interval 0.0 to 42.75
|
1.92 Percentage of subjects
Interval 0.05 to 10.26
|
1.76 Percentage of subjects
Interval 0.09 to 7.99
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Chills,Weeks 40-43
|
0.58 Percentage of subjects
Interval 0.0 to 20.94
|
2.30 Percentage of subjects
Interval 0.0 to 37.38
|
3.08 Percentage of subjects
Interval 0.24 to 12.22
|
1.93 Percentage of subjects
Interval 0.31 to 6.16
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Chills,Weeks 40-44
|
1.44 Percentage of subjects
Interval 0.0 to 18.59
|
2.16 Percentage of subjects
Interval 0.0 to 32.16
|
2.56 Percentage of subjects
Interval 0.72 to 6.37
|
2.05 Percentage of subjects
Interval 0.66 to 4.75
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Chills,Weeks 40-45
|
1.42 Percentage of subjects
Interval 0.01 to 10.19
|
2.40 Percentage of subjects
Interval 0.0 to 31.64
|
2.29 Percentage of subjects
Interval 0.99 to 4.45
|
2.04 Percentage of subjects
Interval 0.88 to 3.99
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Chills,Weeks 40-46
|
1.30 Percentage of subjects
Interval 0.0 to 9.76
|
2.54 Percentage of subjects
Interval 0.0 to 28.8
|
2.88 Percentage of subjects
Interval 0.36 to 9.96
|
2.30 Percentage of subjects
Interval 1.0 to 4.47
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Chills,Weeks 40-47
|
1.52 Percentage of subjects
Interval 0.04 to 7.92
|
2.52 Percentage of subjects
Interval 0.0 to 28.33
|
2.97 Percentage of subjects
Interval 0.26 to 11.52
|
2.39 Percentage of subjects
Interval 1.1 to 4.51
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Chills,Weeks 40-48
|
1.52 Percentage of subjects
Interval 0.04 to 7.92
|
2.52 Percentage of subjects
Interval 0.0 to 28.33
|
2.87 Percentage of subjects
Interval 0.34 to 10.12
|
2.36 Percentage of subjects
Interval 1.1 to 4.38
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Chills,Weeks 40-49
|
1.52 Percentage of subjects
Interval 0.04 to 7.92
|
2.52 Percentage of subjects
Interval 0.0 to 28.33
|
2.87 Percentage of subjects
Interval 0.34 to 10.12
|
2.36 Percentage of subjects
Interval 1.1 to 4.38
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Chills,Weeks 40-50
|
1.52 Percentage of subjects
Interval 0.04 to 7.92
|
2.52 Percentage of subjects
Interval 0.0 to 28.33
|
2.87 Percentage of subjects
Interval 0.34 to 10.12
|
2.36 Percentage of subjects
Interval 1.1 to 4.38
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Chills,Weeks 40-51
|
1.52 Percentage of subjects
Interval 0.04 to 7.92
|
2.52 Percentage of subjects
Interval 0.0 to 28.33
|
2.87 Percentage of subjects
Interval 0.34 to 10.12
|
2.36 Percentage of subjects
Interval 1.1 to 4.38
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Chills,Weeks 40-52
|
1.52 Percentage of subjects
Interval 0.04 to 7.92
|
2.52 Percentage of subjects
Interval 0.0 to 28.33
|
2.87 Percentage of subjects
Interval 0.34 to 10.12
|
2.36 Percentage of subjects
Interval 1.1 to 4.38
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Face oedema,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Face oedema,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Face oedema,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Face oedema,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
0.00 Percentage of subjects
Interval 0.0 to 1.69
|
0.77 Percentage of subjects
Interval 0.02 to 4.21
|
0.19 Percentage of subjects
Interval 0.0 to 1.28
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Face oedema,Weeks 40-44
|
0.48 Percentage of subjects
Interval 0.0 to 15.39
|
0.00 Percentage of subjects
Interval 0.0 to 1.58
|
0.51 Percentage of subjects
Interval 0.01 to 2.82
|
0.31 Percentage of subjects
Interval 0.03 to 1.21
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Face oedema,Weeks 40-45
|
0.35 Percentage of subjects
Interval 0.0 to 10.83
|
0.00 Percentage of subjects
Interval 0.0 to 1.46
|
0.29 Percentage of subjects
Interval 0.0 to 1.82
|
0.23 Percentage of subjects
Interval 0.02 to 0.85
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Face oedema,Weeks 40-46
|
0.32 Percentage of subjects
Interval 0.0 to 10.19
|
0.00 Percentage of subjects
Interval 0.0 to 1.33
|
0.24 Percentage of subjects
Interval 0.0 to 2.15
|
0.20 Percentage of subjects
Interval 0.02 to 0.77
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Face oedema,Weeks 40-47
|
0.30 Percentage of subjects
Interval 0.0 to 9.75
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.23 Percentage of subjects
Interval 0.0 to 2.24
|
0.19 Percentage of subjects
Interval 0.02 to 0.75
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Face oedema,Weeks 40-48
|
0.30 Percentage of subjects
Interval 0.0 to 9.75
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 2.33
|
0.19 Percentage of subjects
Interval 0.02 to 0.74
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Face oedema,Weeks 40-49
|
0.30 Percentage of subjects
Interval 0.0 to 9.75
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 2.33
|
0.19 Percentage of subjects
Interval 0.02 to 0.74
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Face oedema,Weeks 40-50
|
0.30 Percentage of subjects
Interval 0.0 to 9.75
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 2.33
|
0.19 Percentage of subjects
Interval 0.02 to 0.74
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Face oedema,Weeks 40-51
|
0.30 Percentage of subjects
Interval 0.0 to 9.75
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 2.33
|
0.19 Percentage of subjects
Interval 0.02 to 0.74
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Face oedema,Weeks 40-52
|
0.30 Percentage of subjects
Interval 0.0 to 9.75
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 2.33
|
0.19 Percentage of subjects
Interval 0.02 to 0.74
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Fatigue,Weeks 40-40
|
—
|
5.71 Percentage of subjects
Interval 0.22 to 25.74
|
—
|
5.71 Percentage of subjects
Interval 0.22 to 25.74
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Fatigue,Weeks 40-41
|
—
|
6.21 Percentage of subjects
Interval 0.58 to 22.47
|
—
|
6.21 Percentage of subjects
Interval 0.58 to 22.47
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Fatigue,Weeks 40-42
|
2.84 Percentage of subjects
Interval 0.04 to 16.88
|
6.86 Percentage of subjects
Interval 1.33 to 19.37
|
3.85 Percentage of subjects
Interval 0.11 to 19.24
|
5.04 Percentage of subjects
Interval 2.31 to 9.4
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Fatigue,Weeks 40-43
|
2.91 Percentage of subjects
Interval 0.45 to 9.29
|
7.37 Percentage of subjects
Interval 1.58 to 19.91
|
6.92 Percentage of subjects
Interval 1.05 to 21.3
|
5.78 Percentage of subjects
Interval 3.21 to 9.49
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Fatigue,Weeks 40-44
|
4.33 Percentage of subjects
Interval 0.06 to 24.57
|
7.76 Percentage of subjects
Interval 1.72 to 20.58
|
7.18 Percentage of subjects
Interval 2.35 to 16.05
|
6.46 Percentage of subjects
Interval 3.93 to 9.9
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Fatigue,Weeks 40-45
|
4.26 Percentage of subjects
Interval 0.55 to 14.24
|
8.40 Percentage of subjects
Interval 1.72 to 22.87
|
6.86 Percentage of subjects
Interval 0.6 to 25.02
|
6.46 Percentage of subjects
Interval 3.85 to 10.07
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Fatigue,Weeks 40-46
|
3.90 Percentage of subjects
Interval 0.43 to 13.8
|
7.97 Percentage of subjects
Interval 2.29 to 18.89
|
7.43 Percentage of subjects
Interval 0.75 to 25.84
|
6.49 Percentage of subjects
Interval 3.88 to 10.1
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Fatigue,Weeks 40-47
|
3.95 Percentage of subjects
Interval 0.58 to 12.73
|
7.91 Percentage of subjects
Interval 2.33 to 18.52
|
7.78 Percentage of subjects
Interval 0.88 to 26.02
|
6.61 Percentage of subjects
Interval 3.99 to 10.19
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Fatigue,Weeks 40-48
|
3.95 Percentage of subjects
Interval 0.58 to 12.73
|
7.91 Percentage of subjects
Interval 2.33 to 18.52
|
7.51 Percentage of subjects
Interval 1.16 to 22.81
|
6.51 Percentage of subjects
Interval 4.03 to 9.85
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Fatigue,Weeks 40-49
|
3.95 Percentage of subjects
Interval 0.58 to 12.73
|
7.91 Percentage of subjects
Interval 2.33 to 18.52
|
7.51 Percentage of subjects
Interval 1.16 to 22.81
|
6.51 Percentage of subjects
Interval 4.03 to 9.85
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Fatigue,Weeks 40-50
|
3.95 Percentage of subjects
Interval 0.58 to 12.73
|
7.91 Percentage of subjects
Interval 2.33 to 18.52
|
7.51 Percentage of subjects
Interval 1.16 to 22.81
|
6.51 Percentage of subjects
Interval 4.03 to 9.85
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Fatigue,Weeks 40-51
|
3.95 Percentage of subjects
Interval 0.58 to 12.73
|
7.91 Percentage of subjects
Interval 2.33 to 18.52
|
7.51 Percentage of subjects
Interval 1.16 to 22.81
|
6.51 Percentage of subjects
Interval 4.03 to 9.85
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Fatigue,Weeks 40-52
|
3.95 Percentage of subjects
Interval 0.58 to 12.73
|
7.91 Percentage of subjects
Interval 2.33 to 18.52
|
7.51 Percentage of subjects
Interval 1.16 to 22.81
|
6.51 Percentage of subjects
Interval 4.03 to 9.85
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site erythema,Weeks 40-40
|
—
|
8.57 Percentage of subjects
Interval 0.03 to 50.4
|
—
|
8.57 Percentage of subjects
Interval 0.03 to 50.4
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site erythema,Weeks 40-41
|
—
|
8.07 Percentage of subjects
Interval 4.37 to 13.41
|
—
|
8.07 Percentage of subjects
Interval 4.37 to 13.41
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site erythema,Weeks 40-42
|
0.71 Percentage of subjects
Interval 0.01 to 4.4
|
8.82 Percentage of subjects
Interval 2.52 to 20.82
|
5.77 Percentage of subjects
Interval 0.15 to 27.99
|
5.54 Percentage of subjects
Interval 1.6 to 13.3
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site erythema,Weeks 40-43
|
1.16 Percentage of subjects
Interval 0.0 to 37.75
|
8.29 Percentage of subjects
Interval 1.84 to 21.89
|
6.15 Percentage of subjects
Interval 0.45 to 23.69
|
5.39 Percentage of subjects
Interval 2.13 to 10.99
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site erythema,Weeks 40-44
|
1.44 Percentage of subjects
Interval 0.0 to 12.02
|
8.19 Percentage of subjects
Interval 1.91 to 21.22
|
6.15 Percentage of subjects
Interval 3.22 to 10.5
|
5.35 Percentage of subjects
Interval 2.72 to 9.34
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site erythema,Weeks 40-45
|
1.77 Percentage of subjects
Interval 0.09 to 8.03
|
7.60 Percentage of subjects
Interval 1.17 to 23.1
|
5.71 Percentage of subjects
Interval 2.36 to 11.32
|
4.99 Percentage of subjects
Interval 2.9 to 7.92
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site erythema,Weeks 40-46
|
2.27 Percentage of subjects
Interval 0.05 to 12.17
|
7.61 Percentage of subjects
Interval 1.51 to 21.09
|
5.76 Percentage of subjects
Interval 2.62 to 10.76
|
5.19 Percentage of subjects
Interval 3.3 to 7.73
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site erythema,Weeks 40-47
|
3.04 Percentage of subjects
Interval 0.03 to 18.73
|
7.55 Percentage of subjects
Interval 1.45 to 21.25
|
5.49 Percentage of subjects
Interval 2.61 to 10.0
|
5.27 Percentage of subjects
Interval 3.52 to 7.54
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site erythema,Weeks 40-48
|
3.04 Percentage of subjects
Interval 0.03 to 18.73
|
7.55 Percentage of subjects
Interval 1.45 to 21.25
|
5.52 Percentage of subjects
Interval 2.42 to 10.58
|
5.28 Percentage of subjects
Interval 3.52 to 7.57
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site erythema,Weeks 40-49
|
3.04 Percentage of subjects
Interval 0.03 to 18.73
|
7.55 Percentage of subjects
Interval 1.45 to 21.25
|
5.52 Percentage of subjects
Interval 2.42 to 10.58
|
5.28 Percentage of subjects
Interval 3.52 to 7.57
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site erythema,Weeks 40-50
|
3.04 Percentage of subjects
Interval 0.03 to 18.73
|
7.55 Percentage of subjects
Interval 1.45 to 21.25
|
5.52 Percentage of subjects
Interval 2.42 to 10.58
|
5.28 Percentage of subjects
Interval 3.52 to 7.57
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site erythema,Weeks 40-51
|
3.04 Percentage of subjects
Interval 0.03 to 18.73
|
7.55 Percentage of subjects
Interval 1.45 to 21.25
|
5.52 Percentage of subjects
Interval 2.42 to 10.58
|
5.28 Percentage of subjects
Interval 3.52 to 7.57
|
PRIMARY outcome
Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were chills, face oedema, fatigue, injection site erythema, injection site pain, injection site swelling, and pyrexia.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=139 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Weeks 40-47
|
31.82 Percentage of subjects
Interval 0.0 to 99.83
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Weeks 40-48
|
17.02 Percentage of subjects
Interval 7.65 to 30.81
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Weeks 40-49
|
11.11 Percentage of subjects
Interval 5.21 to 20.05
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Weeks 40-50
|
8.94 Percentage of subjects
Interval 4.54 to 15.47
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Weeks 40-51
|
8.89 Percentage of subjects
Interval 4.52 to 15.35
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Weeks 40-52
|
9.35 Percentage of subjects
Interval 4.67 to 16.31
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Chills,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Chills,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 15.44
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Chills,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Chills,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 4.45
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Chills,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 2.95
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Chills,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 2.7
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Chills,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 2.62
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Face oedema,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Face oedema,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 15.44
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Face oedema,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Face oedema,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 4.45
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Face oedema,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 2.95
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Face oedema,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 2.7
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Face oedema,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 2.62
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Fatigue,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Fatigue,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 15.44
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Fatigue,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Fatigue,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 4.45
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Fatigue,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 2.95
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Fatigue,Weeks 40-51
|
0.74 Percentage of subjects
Interval 0.02 to 4.06
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Fatigue,Weeks 40-52
|
0.72 Percentage of subjects
Interval 0.02 to 3.94
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Injection site erythema,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Injection site erythema,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 15.44
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Injection site erythema,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Injection site erythema,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 4.45
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Injection site erythema,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 2.95
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Injection site erythema,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 2.7
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Injection site erythema,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 2.62
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Injection site pain,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Injection site pain,Weeks 40-47
|
27.27 Percentage of subjects
Interval 0.01 to 96.64
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Injection site pain,Weeks 40-48
|
14.89 Percentage of subjects
Interval 6.2 to 28.31
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Injection site pain,Weeks 40-49
|
8.64 Percentage of subjects
Interval 3.55 to 17.0
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Injection site pain,Weeks 40-50
|
5.69 Percentage of subjects
Interval 2.32 to 11.37
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Injection site pain,Weeks 40-51
|
5.19 Percentage of subjects
Interval 2.11 to 10.39
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Injection site pain,Weeks 40-52
|
5.04 Percentage of subjects
Interval 2.05 to 10.1
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Injection site swelling,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Injection site swelling,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 15.44
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Injection site swelling,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Injection site swelling,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 4.45
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Injection site swelling,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 2.95
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Injection site swelling,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 2.7
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Injection site swelling,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 2.62
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Pyrexia,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Pyrexia,Weeks 40-47
|
9.09 Percentage of subjects
Interval 0.0 to 98.76
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Pyrexia,Weeks 40-48
|
6.38 Percentage of subjects
Interval 0.0 to 54.84
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Pyrexia,Weeks 40-49
|
4.94 Percentage of subjects
Interval 0.94 to 14.29
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Pyrexia,Weeks 40-50
|
4.88 Percentage of subjects
Interval 0.81 to 14.85
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Pyrexia,Weeks 40-51
|
4.44 Percentage of subjects
Interval 0.83 to 13.0
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Pyrexia,Weeks 40-52
|
5.04 Percentage of subjects
Interval 1.0 to 14.3
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were anaphylactic reaction and hypersensitivity.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Anaphylactic reaction,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.00 Percentage of subjects
Interval 0.0 to 0.0
|
|
Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Anaphylactic reaction,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.00 Percentage of subjects
Interval 0.0 to 0.0
|
|
Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Any,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 0.0
|
|
Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Any,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 0.0
|
|
Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Any,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.0
|
|
Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Any,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
0.00 Percentage of subjects
Interval 0.0 to 1.69
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.00 Percentage of subjects
Interval 0.0 to 0.0
|
|
Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Any,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 1.76
|
0.00 Percentage of subjects
Interval 0.0 to 1.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.87
|
0.00 Percentage of subjects
Interval 0.0 to 0.0
|
|
Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Any,Weeks 40-45
|
0.35 Percentage of subjects
Interval 0.0 to 5.88
|
0.00 Percentage of subjects
Interval 0.0 to 1.46
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.11 Percentage of subjects
Interval 0.11 to 0.0
|
|
Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Any,Weeks 40-46
|
0.32 Percentage of subjects
Interval 0.0 to 4.64
|
0.00 Percentage of subjects
Interval 0.0 to 1.33
|
0.00 Percentage of subjects
Interval 0.0 to 0.88
|
0.10 Percentage of subjects
Interval 0.1 to 0.0
|
|
Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Any,Weeks 40-47
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.84
|
0.10 Percentage of subjects
Interval 0.1 to 0.0
|
|
Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Any,Weeks 40-48
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.09 to 0.0
|
|
Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Any,Weeks 40-49
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.09 to 0.0
|
|
Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Any,Weeks 40-50
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.09 to 0.0
|
|
Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Any,Weeks 40-51
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.09 to 0.0
|
|
Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Any,Weeks 40-52
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.09 to 0.0
|
|
Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Anaphylactic reaction,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 0.0
|
|
Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Anaphylactic reaction,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 0.0
|
|
Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Anaphylactic reaction,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.0
|
|
Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Anaphylactic reaction,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
0.00 Percentage of subjects
Interval 0.0 to 1.69
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.00 Percentage of subjects
Interval 0.0 to 0.0
|
|
Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Anaphylactic reaction,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 1.76
|
0.00 Percentage of subjects
Interval 0.0 to 1.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.87
|
0.00 Percentage of subjects
Interval 0.0 to 0.0
|
|
Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Anaphylactic reaction,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 1.3
|
0.00 Percentage of subjects
Interval 0.0 to 1.46
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.00 Percentage of subjects
Interval 0.0 to 0.0
|
|
Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Anaphylactic reaction,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 1.19
|
0.00 Percentage of subjects
Interval 0.0 to 1.33
|
0.00 Percentage of subjects
Interval 0.0 to 0.88
|
0.00 Percentage of subjects
Interval 0.0 to 0.0
|
|
Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Anaphylactic reaction,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.84
|
0.00 Percentage of subjects
Interval 0.0 to 0.0
|
|
Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Anaphylactic reaction,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.00 Percentage of subjects
Interval 0.0 to 0.0
|
|
Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Anaphylactic reaction,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.00 Percentage of subjects
Interval 0.0 to 0.0
|
|
Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Anaphylactic reaction,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.00 Percentage of subjects
Interval 0.0 to 0.0
|
|
Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Hypersensitivity,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 0.0
|
|
Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Hypersensitivity,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 0.0
|
|
Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Hypersensitivity,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.0
|
|
Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Hypersensitivity,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
0.00 Percentage of subjects
Interval 0.0 to 1.69
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.00 Percentage of subjects
Interval 0.0 to 0.0
|
|
Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Hypersensitivity,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 1.76
|
0.00 Percentage of subjects
Interval 0.0 to 1.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.87
|
0.00 Percentage of subjects
Interval 0.0 to 0.0
|
|
Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Hypersensitivity,Weeks 40-45
|
0.35 Percentage of subjects
Interval 0.0 to 5.88
|
0.00 Percentage of subjects
Interval 0.0 to 1.46
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.11 Percentage of subjects
Interval 0.11 to 0.0
|
|
Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Hypersensitivity,Weeks 40-46
|
0.32 Percentage of subjects
Interval 0.0 to 4.64
|
0.00 Percentage of subjects
Interval 0.0 to 1.33
|
0.00 Percentage of subjects
Interval 0.0 to 0.88
|
0.10 Percentage of subjects
Interval 0.1 to 0.0
|
|
Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Hypersensitivity,Weeks 40-47
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.84
|
0.10 Percentage of subjects
Interval 0.1 to 0.0
|
|
Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Hypersensitivity,Weeks 40-48
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.09 to 0.0
|
|
Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Hypersensitivity,Weeks 40-49
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.09 to 0.0
|
|
Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Hypersensitivity,Weeks 40-50
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.09 to 0.0
|
|
Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Hypersensitivity,Weeks 40-51
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.09 to 0.0
|
|
Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Hypersensitivity,Weeks 40-52
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.09 to 0.0
|
PRIMARY outcome
Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were anaphylactic reaction and hypersensitivity.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=139 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
|
0 Percentage of subjects
Interval 0.0 to 2.62
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were conjunctivitis and rhinitis.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Any,Weeks 40-40
|
—
|
8.57 Percentage of subjects
Interval 0.31 to 37.07
|
—
|
8.57 Percentage of subjects
Interval 0.31 to 37.07
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Any,Weeks 40-41
|
—
|
8.70 Percentage of subjects
Interval 1.37 to 25.91
|
—
|
8.70 Percentage of subjects
Interval 1.37 to 25.91
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Any,Weeks 40-42
|
0.71 Percentage of subjects
Interval 0.01 to 4.4
|
7.84 Percentage of subjects
Interval 1.03 to 25.06
|
1.92 Percentage of subjects
Interval 0.05 to 10.26
|
4.53 Percentage of subjects
Interval 0.81 to 13.48
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Any,Weeks 40-43
|
1.74 Percentage of subjects
Interval 0.0 to 85.49
|
7.83 Percentage of subjects
Interval 1.22 to 23.66
|
3.85 Percentage of subjects
Interval 0.3 to 15.16
|
4.82 Percentage of subjects
Interval 1.57 to 10.92
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Any,Weeks 40-44
|
2.88 Percentage of subjects
Interval 0.0 to 26.08
|
7.76 Percentage of subjects
Interval 1.39 to 22.35
|
4.62 Percentage of subjects
Interval 1.57 to 10.25
|
5.20 Percentage of subjects
Interval 2.41 to 9.61
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Any,Weeks 40-45
|
4.61 Percentage of subjects
Interval 0.02 to 31.32
|
8.00 Percentage of subjects
Interval 1.85 to 20.84
|
5.14 Percentage of subjects
Interval 0.31 to 21.15
|
5.78 Percentage of subjects
Interval 3.11 to 9.69
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Any,Weeks 40-46
|
4.55 Percentage of subjects
Interval 0.04 to 27.57
|
7.97 Percentage of subjects
Interval 2.19 to 19.25
|
5.76 Percentage of subjects
Interval 0.18 to 27.12
|
5.99 Percentage of subjects
Interval 3.31 to 9.87
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Any,Weeks 40-47
|
4.56 Percentage of subjects
Interval 0.06 to 25.49
|
7.91 Percentage of subjects
Interval 2.17 to 19.14
|
6.18 Percentage of subjects
Interval 0.2 to 28.6
|
6.13 Percentage of subjects
Interval 3.45 to 9.95
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Any,Weeks 40-48
|
4.56 Percentage of subjects
Interval 0.06 to 25.49
|
7.91 Percentage of subjects
Interval 2.17 to 19.14
|
6.40 Percentage of subjects
Interval 0.22 to 29.12
|
6.23 Percentage of subjects
Interval 3.52 to 10.08
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Any,Weeks 40-49
|
4.56 Percentage of subjects
Interval 0.06 to 25.49
|
7.91 Percentage of subjects
Interval 2.17 to 19.14
|
6.40 Percentage of subjects
Interval 0.22 to 29.12
|
6.23 Percentage of subjects
Interval 3.52 to 10.08
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Any,Weeks 40-50
|
4.56 Percentage of subjects
Interval 0.06 to 25.49
|
7.91 Percentage of subjects
Interval 2.17 to 19.14
|
6.40 Percentage of subjects
Interval 0.22 to 29.12
|
6.23 Percentage of subjects
Interval 3.52 to 10.08
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Any,Weeks 40-51
|
4.56 Percentage of subjects
Interval 0.06 to 25.49
|
7.91 Percentage of subjects
Interval 2.17 to 19.14
|
6.40 Percentage of subjects
Interval 0.22 to 29.12
|
6.23 Percentage of subjects
Interval 3.52 to 10.08
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Any,Weeks 40-52
|
4.56 Percentage of subjects
Interval 0.06 to 25.49
|
7.91 Percentage of subjects
Interval 2.17 to 19.14
|
6.40 Percentage of subjects
Interval 0.22 to 29.12
|
6.23 Percentage of subjects
Interval 3.52 to 10.08
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Conjunctivitis,Weeks 40-40
|
—
|
4.29 Percentage of subjects
Interval 0.17 to 19.69
|
—
|
4.29 Percentage of subjects
Interval 0.17 to 19.69
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Conjunctivitis,Weeks 40-41
|
—
|
3.73 Percentage of subjects
Interval 0.22 to 15.88
|
—
|
3.73 Percentage of subjects
Interval 0.22 to 15.88
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Conjunctivitis,Weeks 40-42
|
0.71 Percentage of subjects
Interval 0.01 to 4.4
|
3.92 Percentage of subjects
Interval 0.21 to 16.93
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
2.27 Percentage of subjects
Interval 0.4 to 6.9
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Conjunctivitis,Weeks 40-43
|
1.16 Percentage of subjects
Interval 0.0 to 37.75
|
4.15 Percentage of subjects
Interval 0.24 to 17.56
|
0.77 Percentage of subjects
Interval 0.02 to 4.21
|
2.31 Percentage of subjects
Interval 0.55 to 6.23
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Conjunctivitis,Weeks 40-44
|
1.92 Percentage of subjects
Interval 0.01 to 13.68
|
3.88 Percentage of subjects
Interval 0.37 to 14.38
|
1.03 Percentage of subjects
Interval 0.0 to 11.31
|
2.36 Percentage of subjects
Interval 0.77 to 5.44
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Conjunctivitis,Weeks 40-45
|
3.55 Percentage of subjects
Interval 0.02 to 22.81
|
3.60 Percentage of subjects
Interval 0.51 to 11.82
|
2.00 Percentage of subjects
Interval 0.0 to 16.82
|
2.95 Percentage of subjects
Interval 1.29 to 5.71
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Conjunctivitis,Weeks 40-46
|
3.57 Percentage of subjects
Interval 0.05 to 20.55
|
3.99 Percentage of subjects
Interval 0.61 to 12.61
|
2.64 Percentage of subjects
Interval 0.0 to 22.96
|
3.30 Percentage of subjects
Interval 1.51 to 6.19
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Conjunctivitis,Weeks 40-47
|
3.65 Percentage of subjects
Interval 0.08 to 19.45
|
3.96 Percentage of subjects
Interval 0.63 to 12.36
|
2.75 Percentage of subjects
Interval 0.0 to 21.86
|
3.35 Percentage of subjects
Interval 1.6 to 6.12
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Conjunctivitis,Weeks 40-48
|
3.65 Percentage of subjects
Interval 0.08 to 19.45
|
3.96 Percentage of subjects
Interval 0.63 to 12.36
|
2.87 Percentage of subjects
Interval 0.0 to 22.55
|
3.40 Percentage of subjects
Interval 1.63 to 6.18
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Conjunctivitis,Weeks 40-49
|
3.65 Percentage of subjects
Interval 0.08 to 19.45
|
3.96 Percentage of subjects
Interval 0.63 to 12.36
|
2.87 Percentage of subjects
Interval 0.0 to 22.55
|
3.40 Percentage of subjects
Interval 1.63 to 6.18
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Conjunctivitis,Weeks 40-50
|
3.65 Percentage of subjects
Interval 0.08 to 19.45
|
3.96 Percentage of subjects
Interval 0.63 to 12.36
|
2.87 Percentage of subjects
Interval 0.0 to 22.55
|
3.40 Percentage of subjects
Interval 1.63 to 6.18
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Conjunctivitis,Weeks 40-51
|
3.65 Percentage of subjects
Interval 0.08 to 19.45
|
3.96 Percentage of subjects
Interval 0.63 to 12.36
|
2.87 Percentage of subjects
Interval 0.0 to 22.55
|
3.40 Percentage of subjects
Interval 1.63 to 6.18
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Conjunctivitis,Weeks 40-52
|
3.65 Percentage of subjects
Interval 0.08 to 19.45
|
3.96 Percentage of subjects
Interval 0.63 to 12.36
|
2.87 Percentage of subjects
Interval 0.0 to 22.55
|
3.40 Percentage of subjects
Interval 1.63 to 6.18
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Rhinitis,Weeks 40-40
|
—
|
4.29 Percentage of subjects
Interval 0.17 to 19.69
|
—
|
4.29 Percentage of subjects
Interval 0.17 to 19.69
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Rhinitis,Weeks 40-41
|
—
|
5.59 Percentage of subjects
Interval 0.73 to 18.36
|
—
|
5.59 Percentage of subjects
Interval 0.73 to 18.36
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Rhinitis,Weeks 40-42
|
0.71 Percentage of subjects
Interval 0.01 to 4.4
|
4.90 Percentage of subjects
Interval 0.34 to 19.5
|
1.92 Percentage of subjects
Interval 0.05 to 10.26
|
3.02 Percentage of subjects
Interval 0.61 to 8.7
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Rhinitis,Weeks 40-43
|
1.16 Percentage of subjects
Interval 0.0 to 37.75
|
4.61 Percentage of subjects
Interval 0.2 to 20.63
|
2.31 Percentage of subjects
Interval 0.18 to 9.24
|
2.89 Percentage of subjects
Interval 0.88 to 6.87
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Rhinitis,Weeks 40-44
|
1.92 Percentage of subjects
Interval 0.0 to 17.01
|
4.74 Percentage of subjects
Interval 0.39 to 18.08
|
2.56 Percentage of subjects
Interval 0.59 to 7.01
|
3.15 Percentage of subjects
Interval 1.36 to 6.13
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Rhinitis,Weeks 40-45
|
2.13 Percentage of subjects
Interval 0.06 to 11.14
|
5.20 Percentage of subjects
Interval 1.07 to 14.51
|
2.57 Percentage of subjects
Interval 0.04 to 14.91
|
3.17 Percentage of subjects
Interval 1.54 to 5.75
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Rhinitis,Weeks 40-46
|
1.95 Percentage of subjects
Interval 0.09 to 9.11
|
4.71 Percentage of subjects
Interval 0.66 to 15.28
|
2.88 Percentage of subjects
Interval 0.06 to 15.48
|
3.10 Percentage of subjects
Interval 1.58 to 5.41
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Rhinitis,Weeks 40-47
|
1.82 Percentage of subjects
Interval 0.11 to 8.03
|
4.68 Percentage of subjects
Interval 0.63 to 15.35
|
2.97 Percentage of subjects
Interval 0.05 to 17.0
|
3.07 Percentage of subjects
Interval 1.53 to 5.44
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Rhinitis,Weeks 40-48
|
1.82 Percentage of subjects
Interval 0.11 to 8.03
|
4.68 Percentage of subjects
Interval 0.63 to 15.35
|
2.87 Percentage of subjects
Interval 0.07 to 15.15
|
3.02 Percentage of subjects
Interval 1.54 to 5.28
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Rhinitis,Weeks 40-49
|
1.82 Percentage of subjects
Interval 0.11 to 8.03
|
4.68 Percentage of subjects
Interval 0.63 to 15.35
|
2.87 Percentage of subjects
Interval 0.07 to 15.15
|
3.02 Percentage of subjects
Interval 1.54 to 5.28
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Rhinitis,Weeks 40-50
|
1.82 Percentage of subjects
Interval 0.11 to 8.03
|
4.68 Percentage of subjects
Interval 0.63 to 15.35
|
2.87 Percentage of subjects
Interval 0.07 to 15.15
|
3.02 Percentage of subjects
Interval 1.54 to 5.28
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Rhinitis,Weeks 40-51
|
1.82 Percentage of subjects
Interval 0.11 to 8.03
|
4.68 Percentage of subjects
Interval 0.63 to 15.35
|
2.87 Percentage of subjects
Interval 0.07 to 15.15
|
3.02 Percentage of subjects
Interval 1.54 to 5.28
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Rhinitis,Weeks 40-52
|
1.82 Percentage of subjects
Interval 0.11 to 8.03
|
4.68 Percentage of subjects
Interval 0.63 to 15.35
|
2.87 Percentage of subjects
Interval 0.07 to 15.15
|
3.02 Percentage of subjects
Interval 1.54 to 5.28
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Bronchitis,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Bronchitis,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Bronchitis,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Bronchitis,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
0.00 Percentage of subjects
Interval 0.0 to 1.69
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.00 Percentage of subjects
Interval 0.0 to 0.71
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Bronchitis,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 1.76
|
0.00 Percentage of subjects
Interval 0.0 to 1.58
|
0.51 Percentage of subjects
Interval 0.01 to 2.82
|
0.16 Percentage of subjects
Interval 0.0 to 0.87
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Bronchitis,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 1.3
|
0.00 Percentage of subjects
Interval 0.0 to 1.46
|
0.29 Percentage of subjects
Interval 0.0 to 1.82
|
0.11 Percentage of subjects
Interval 0.0 to 0.63
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Bronchitis,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 1.19
|
0.00 Percentage of subjects
Interval 0.0 to 1.33
|
0.24 Percentage of subjects
Interval 0.0 to 2.15
|
0.10 Percentage of subjects
Interval 0.0 to 0.56
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Bronchitis,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.23 Percentage of subjects
Interval 0.0 to 2.24
|
0.10 Percentage of subjects
Interval 0.0 to 0.55
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Bronchitis,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 2.33
|
0.09 Percentage of subjects
Interval 0.0 to 0.54
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Bronchitis,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 2.33
|
0.09 Percentage of subjects
Interval 0.0 to 0.54
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Bronchitis,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 2.33
|
0.09 Percentage of subjects
Interval 0.0 to 0.54
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Bronchitis,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 2.33
|
0.09 Percentage of subjects
Interval 0.0 to 0.54
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Bronchitis,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 2.33
|
0.09 Percentage of subjects
Interval 0.0 to 0.54
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Ear infection,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Ear infection,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Ear infection,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Ear infection,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
0.00 Percentage of subjects
Interval 0.0 to 1.69
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.00 Percentage of subjects
Interval 0.0 to 0.71
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Ear infection,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 1.76
|
0.00 Percentage of subjects
Interval 0.0 to 1.58
|
0.51 Percentage of subjects
Interval 0.01 to 2.82
|
0.16 Percentage of subjects
Interval 0.0 to 0.87
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Ear infection,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 1.3
|
0.00 Percentage of subjects
Interval 0.0 to 1.46
|
0.29 Percentage of subjects
Interval 0.0 to 1.82
|
0.11 Percentage of subjects
Interval 0.0 to 0.63
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Ear infection,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 1.19
|
0.00 Percentage of subjects
Interval 0.0 to 1.33
|
0.24 Percentage of subjects
Interval 0.0 to 2.15
|
0.10 Percentage of subjects
Interval 0.0 to 0.56
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Ear infection,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.23 Percentage of subjects
Interval 0.0 to 2.24
|
0.10 Percentage of subjects
Interval 0.0 to 0.55
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Ear infection,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 2.33
|
0.09 Percentage of subjects
Interval 0.0 to 0.54
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Ear infection,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 2.33
|
0.09 Percentage of subjects
Interval 0.0 to 0.54
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Ear infection,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 2.33
|
0.09 Percentage of subjects
Interval 0.0 to 0.54
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Ear infection,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 2.33
|
0.09 Percentage of subjects
Interval 0.0 to 0.54
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Ear infection,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 2.33
|
0.09 Percentage of subjects
Interval 0.0 to 0.54
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Herpes simplex,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Herpes simplex,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Herpes simplex,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.49 Percentage of subjects
Interval 0.0 to 10.27
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.25 Percentage of subjects
Interval 0.0 to 2.0
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Herpes simplex,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
0.46 Percentage of subjects
Interval 0.0 to 8.71
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.19 Percentage of subjects
Interval 0.0 to 1.52
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Herpes simplex,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 1.76
|
0.43 Percentage of subjects
Interval 0.0 to 7.29
|
0.00 Percentage of subjects
Interval 0.0 to 1.87
|
0.16 Percentage of subjects
Interval 0.0 to 1.11
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Herpes simplex,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 1.3
|
0.40 Percentage of subjects
Interval 0.0 to 5.98
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.11 Percentage of subjects
Interval 0.0 to 0.81
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Herpes simplex,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 1.19
|
0.36 Percentage of subjects
Interval 0.0 to 4.6
|
0.00 Percentage of subjects
Interval 0.0 to 0.88
|
0.10 Percentage of subjects
Interval 0.0 to 0.7
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Herpes simplex,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.84
|
0.10 Percentage of subjects
Interval 0.0 to 0.67
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Herpes simplex,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Herpes simplex,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Herpes simplex,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Herpes simplex,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Herpes simplex,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Hordeolum,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Hordeolum,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Hordeolum,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Hordeolum,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
0.00 Percentage of subjects
Interval 0.0 to 1.69
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.00 Percentage of subjects
Interval 0.0 to 0.71
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Hordeolum,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 1.76
|
0.00 Percentage of subjects
Interval 0.0 to 1.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.87
|
0.00 Percentage of subjects
Interval 0.0 to 0.58
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Hordeolum,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 1.3
|
0.00 Percentage of subjects
Interval 0.0 to 1.46
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.00 Percentage of subjects
Interval 0.0 to 0.42
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Hordeolum,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 1.19
|
0.00 Percentage of subjects
Interval 0.0 to 1.33
|
0.00 Percentage of subjects
Interval 0.0 to 0.88
|
0.00 Percentage of subjects
Interval 0.0 to 0.37
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Hordeolum,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.23 Percentage of subjects
Interval 0.0 to 7.65
|
0.10 Percentage of subjects
Interval 0.0 to 0.76
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Hordeolum,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 7.27
|
0.09 Percentage of subjects
Interval 0.0 to 0.75
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Hordeolum,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 7.27
|
0.09 Percentage of subjects
Interval 0.0 to 0.75
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Hordeolum,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 7.27
|
0.09 Percentage of subjects
Interval 0.0 to 0.75
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Hordeolum,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 7.27
|
0.09 Percentage of subjects
Interval 0.0 to 0.75
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Hordeolum,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 7.27
|
0.09 Percentage of subjects
Interval 0.0 to 0.75
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Laryngitis,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Laryngitis,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Laryngitis,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Laryngitis,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
0.00 Percentage of subjects
Interval 0.0 to 1.69
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.00 Percentage of subjects
Interval 0.0 to 0.71
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Laryngitis,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 1.76
|
0.00 Percentage of subjects
Interval 0.0 to 1.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.87
|
0.00 Percentage of subjects
Interval 0.0 to 0.58
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Laryngitis,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 1.3
|
0.00 Percentage of subjects
Interval 0.0 to 1.46
|
0.29 Percentage of subjects
Interval 0.0 to 10.35
|
0.11 Percentage of subjects
Interval 0.0 to 0.92
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Laryngitis,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 1.19
|
0.00 Percentage of subjects
Interval 0.0 to 1.33
|
0.24 Percentage of subjects
Interval 0.0 to 8.39
|
0.10 Percentage of subjects
Interval 0.0 to 0.81
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Laryngitis,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.23 Percentage of subjects
Interval 0.0 to 7.65
|
0.10 Percentage of subjects
Interval 0.0 to 0.76
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Laryngitis,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 7.27
|
0.09 Percentage of subjects
Interval 0.0 to 0.75
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Laryngitis,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 7.27
|
0.09 Percentage of subjects
Interval 0.0 to 0.75
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Laryngitis,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 7.27
|
0.09 Percentage of subjects
Interval 0.0 to 0.75
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Laryngitis,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 7.27
|
0.09 Percentage of subjects
Interval 0.0 to 0.75
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Laryngitis,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 7.27
|
0.09 Percentage of subjects
Interval 0.0 to 0.75
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Nasopharyngitis,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Nasopharyngitis,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Nasopharyngitis,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Nasopharyngitis,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
0.00 Percentage of subjects
Interval 0.0 to 1.69
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.00 Percentage of subjects
Interval 0.0 to 0.71
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Nasopharyngitis,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 1.76
|
0.00 Percentage of subjects
Interval 0.0 to 1.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.87
|
0.00 Percentage of subjects
Interval 0.0 to 0.58
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Nasopharyngitis,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 1.3
|
0.00 Percentage of subjects
Interval 0.0 to 1.46
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.00 Percentage of subjects
Interval 0.0 to 0.42
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Nasopharyngitis,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 1.19
|
0.00 Percentage of subjects
Interval 0.0 to 1.33
|
0.00 Percentage of subjects
Interval 0.0 to 0.88
|
0.00 Percentage of subjects
Interval 0.0 to 0.37
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Nasopharyngitis,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.84
|
0.00 Percentage of subjects
Interval 0.0 to 0.35
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Nasopharyngitis,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 7.27
|
0.09 Percentage of subjects
Interval 0.0 to 0.75
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Nasopharyngitis,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 7.27
|
0.09 Percentage of subjects
Interval 0.0 to 0.75
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Nasopharyngitis,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 7.27
|
0.09 Percentage of subjects
Interval 0.0 to 0.75
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Nasopharyngitis,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 7.27
|
0.09 Percentage of subjects
Interval 0.0 to 0.75
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Nasopharyngitis,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 7.27
|
0.09 Percentage of subjects
Interval 0.0 to 0.75
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Oral herpes,Weeks 40-40
|
—
|
1.43 Percentage of subjects
Interval 0.04 to 7.7
|
—
|
1.43 Percentage of subjects
Interval 0.04 to 7.7
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Oral herpes,Weeks 40-41
|
—
|
0.62 Percentage of subjects
Interval 0.0 to 5.51
|
—
|
0.62 Percentage of subjects
Interval 0.0 to 5.51
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Oral herpes,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.49 Percentage of subjects
Interval 0.0 to 6.53
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.25 Percentage of subjects
Interval 0.0 to 1.73
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Oral herpes,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
0.46 Percentage of subjects
Interval 0.0 to 6.74
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.19 Percentage of subjects
Interval 0.0 to 1.43
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Oral herpes,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 1.76
|
0.43 Percentage of subjects
Interval 0.0 to 6.92
|
0.00 Percentage of subjects
Interval 0.0 to 1.87
|
0.16 Percentage of subjects
Interval 0.0 to 1.09
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Oral herpes,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 1.3
|
0.40 Percentage of subjects
Interval 0.0 to 7.09
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.11 Percentage of subjects
Interval 0.0 to 0.83
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Oral herpes,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 1.19
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
0.00 Percentage of subjects
Interval 0.0 to 0.88
|
0.10 Percentage of subjects
Interval 0.0 to 0.74
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Oral herpes,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
0.00 Percentage of subjects
Interval 0.0 to 0.84
|
0.10 Percentage of subjects
Interval 0.0 to 0.71
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Oral herpes,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.7
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Oral herpes,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.7
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Oral herpes,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.7
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Oral herpes,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.7
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Oral herpes,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.7
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Upper respiratory tract infection,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Upper respiratory tract infection,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Upper respiratory tract infection,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Upper respiratory tract infection,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
0.00 Percentage of subjects
Interval 0.0 to 1.69
|
0.77 Percentage of subjects
Interval 0.02 to 4.21
|
0.19 Percentage of subjects
Interval 0.0 to 1.28
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Upper respiratory tract infection,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 1.76
|
0.00 Percentage of subjects
Interval 0.0 to 1.58
|
0.51 Percentage of subjects
Interval 0.01 to 2.82
|
0.16 Percentage of subjects
Interval 0.0 to 0.87
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Upper respiratory tract infection,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 1.3
|
0.00 Percentage of subjects
Interval 0.0 to 1.46
|
0.29 Percentage of subjects
Interval 0.0 to 1.82
|
0.11 Percentage of subjects
Interval 0.0 to 0.63
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Upper respiratory tract infection,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 1.19
|
0.00 Percentage of subjects
Interval 0.0 to 1.33
|
0.24 Percentage of subjects
Interval 0.0 to 2.15
|
0.10 Percentage of subjects
Interval 0.0 to 0.56
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Upper respiratory tract infection,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.23 Percentage of subjects
Interval 0.0 to 2.24
|
0.10 Percentage of subjects
Interval 0.0 to 0.55
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Upper respiratory tract infection,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 2.33
|
0.09 Percentage of subjects
Interval 0.0 to 0.54
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Upper respiratory tract infection,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 2.33
|
0.09 Percentage of subjects
Interval 0.0 to 0.54
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Upper respiratory tract infection,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 2.33
|
0.09 Percentage of subjects
Interval 0.0 to 0.54
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Upper respiratory tract infection,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 2.33
|
0.09 Percentage of subjects
Interval 0.0 to 0.54
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Upper respiratory tract infection,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 2.33
|
0.09 Percentage of subjects
Interval 0.0 to 0.54
|
PRIMARY outcome
Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were conjunctivitis and rhinitis.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=139 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 15.44
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Weeks 40-48
|
6.38 Percentage of subjects
Interval 0.0 to 54.84
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Weeks 40-49
|
3.70 Percentage of subjects
Interval 0.71 to 10.79
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Weeks 40-50
|
3.25 Percentage of subjects
Interval 0.55 to 9.99
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Weeks 40-51
|
2.96 Percentage of subjects
Interval 0.56 to 8.74
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Weeks 40-52
|
2.88 Percentage of subjects
Interval 0.58 to 8.26
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Conjunctivitis,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Conjunctivitis,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 15.44
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Conjunctivitis,Weeks 40-48
|
4.26 Percentage of subjects
Interval 0.0 to 40.16
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Conjunctivitis,Weeks 40-49
|
2.47 Percentage of subjects
Interval 0.3 to 8.64
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Conjunctivitis,Weeks 40-50
|
2.44 Percentage of subjects
Interval 0.42 to 7.53
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Conjunctivitis,Weeks 40-51
|
2.22 Percentage of subjects
Interval 0.42 to 6.58
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Conjunctivitis,Weeks 40-52
|
2.16 Percentage of subjects
Interval 0.44 to 6.22
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Rhinitis,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Rhinitis,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 15.44
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Rhinitis,Weeks 40-48
|
2.13 Percentage of subjects
Interval 0.0 to 22.05
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Rhinitis,Weeks 40-49
|
1.23 Percentage of subjects
Interval 0.03 to 6.69
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Rhinitis,Weeks 40-50
|
0.81 Percentage of subjects
Interval 0.02 to 4.45
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Rhinitis,Weeks 40-51
|
0.74 Percentage of subjects
Interval 0.02 to 4.06
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Rhinitis,Weeks 40-52
|
0.72 Percentage of subjects
Interval 0.02 to 3.94
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEI listed on the ADR card was decreased appetite.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Any,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Any,Weeks 40-41
|
—
|
0.62 Percentage of subjects
Interval 0.0 to 5.51
|
—
|
0.62 Percentage of subjects
Interval 0.0 to 5.51
|
|
Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Any,Weeks 40-42
|
0.71 Percentage of subjects
Interval 0.01 to 4.4
|
0.49 Percentage of subjects
Interval 0.0 to 6.53
|
3.85 Percentage of subjects
Interval 0.11 to 19.24
|
1.01 Percentage of subjects
Interval 0.2 to 2.97
|
|
Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Any,Weeks 40-43
|
0.58 Percentage of subjects
Interval 0.0 to 20.94
|
0.46 Percentage of subjects
Interval 0.0 to 6.74
|
8.46 Percentage of subjects
Interval 0.6 to 31.78
|
2.50 Percentage of subjects
Interval 0.11 to 11.76
|
|
Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Any,Weeks 40-44
|
0.96 Percentage of subjects
Interval 0.0 to 7.53
|
0.43 Percentage of subjects
Interval 0.0 to 6.92
|
8.21 Percentage of subjects
Interval 4.76 to 12.98
|
2.99 Percentage of subjects
Interval 0.34 to 10.65
|
|
Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Any,Weeks 40-45
|
1.77 Percentage of subjects
Interval 0.09 to 8.03
|
0.40 Percentage of subjects
Interval 0.0 to 7.09
|
6.29 Percentage of subjects
Interval 0.63 to 22.23
|
3.17 Percentage of subjects
Interval 0.66 to 9.02
|
|
Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Any,Weeks 40-46
|
1.95 Percentage of subjects
Interval 0.1 to 8.87
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
5.28 Percentage of subjects
Interval 0.1 to 27.37
|
2.90 Percentage of subjects
Interval 0.6 to 8.21
|
|
Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Any,Weeks 40-47
|
2.13 Percentage of subjects
Interval 0.1 to 9.83
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
5.03 Percentage of subjects
Interval 0.06 to 28.27
|
2.87 Percentage of subjects
Interval 0.64 to 7.94
|
|
Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Any,Weeks 40-48
|
2.13 Percentage of subjects
Interval 0.1 to 9.83
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
5.30 Percentage of subjects
Interval 0.27 to 22.74
|
3.02 Percentage of subjects
Interval 0.81 to 7.64
|
|
Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Any,Weeks 40-49
|
2.13 Percentage of subjects
Interval 0.1 to 9.83
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
5.30 Percentage of subjects
Interval 0.27 to 22.74
|
3.02 Percentage of subjects
Interval 0.81 to 7.64
|
|
Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Any,Weeks 40-50
|
2.13 Percentage of subjects
Interval 0.1 to 9.83
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
5.30 Percentage of subjects
Interval 0.27 to 22.74
|
3.02 Percentage of subjects
Interval 0.81 to 7.64
|
|
Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Any,Weeks 40-51
|
2.13 Percentage of subjects
Interval 0.1 to 9.83
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
5.30 Percentage of subjects
Interval 0.27 to 22.74
|
3.02 Percentage of subjects
Interval 0.81 to 7.64
|
|
Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Any,Weeks 40-52
|
2.13 Percentage of subjects
Interval 0.1 to 9.83
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
5.30 Percentage of subjects
Interval 0.27 to 22.74
|
3.02 Percentage of subjects
Interval 0.81 to 7.64
|
|
Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Decreased appetite,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Decreased appetite,Weeks 40-41
|
—
|
0.62 Percentage of subjects
Interval 0.0 to 5.51
|
—
|
0.62 Percentage of subjects
Interval 0.0 to 5.51
|
|
Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Decreased appetite,Weeks 40-42
|
0.71 Percentage of subjects
Interval 0.01 to 4.4
|
0.49 Percentage of subjects
Interval 0.0 to 6.53
|
3.85 Percentage of subjects
Interval 0.11 to 19.24
|
1.01 Percentage of subjects
Interval 0.2 to 2.97
|
|
Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Decreased appetite,Weeks 40-43
|
0.58 Percentage of subjects
Interval 0.0 to 20.94
|
0.46 Percentage of subjects
Interval 0.0 to 6.74
|
8.46 Percentage of subjects
Interval 0.6 to 31.78
|
2.50 Percentage of subjects
Interval 0.11 to 11.76
|
|
Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Decreased appetite,Weeks 40-44
|
0.96 Percentage of subjects
Interval 0.0 to 7.53
|
0.43 Percentage of subjects
Interval 0.0 to 6.92
|
8.21 Percentage of subjects
Interval 4.76 to 12.98
|
2.99 Percentage of subjects
Interval 0.34 to 10.65
|
|
Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Decreased appetite,Weeks 40-45
|
1.77 Percentage of subjects
Interval 0.09 to 8.03
|
0.40 Percentage of subjects
Interval 0.0 to 7.09
|
6.29 Percentage of subjects
Interval 0.63 to 22.23
|
3.17 Percentage of subjects
Interval 0.66 to 9.02
|
|
Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Decreased appetite,Weeks 40-46
|
1.95 Percentage of subjects
Interval 0.1 to 8.87
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
5.28 Percentage of subjects
Interval 0.1 to 27.37
|
2.90 Percentage of subjects
Interval 0.6 to 8.21
|
|
Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Decreased appetite,Weeks 40-47
|
2.13 Percentage of subjects
Interval 0.1 to 9.83
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
5.03 Percentage of subjects
Interval 0.06 to 28.27
|
2.87 Percentage of subjects
Interval 0.64 to 7.94
|
|
Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Decreased appetite,Weeks 40-48
|
2.13 Percentage of subjects
Interval 0.1 to 9.83
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
5.30 Percentage of subjects
Interval 0.27 to 22.74
|
3.02 Percentage of subjects
Interval 0.81 to 7.64
|
|
Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Decreased appetite,Weeks 40-49
|
2.13 Percentage of subjects
Interval 0.1 to 9.83
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
5.30 Percentage of subjects
Interval 0.27 to 22.74
|
3.02 Percentage of subjects
Interval 0.81 to 7.64
|
|
Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Decreased appetite,Weeks 40-50
|
2.13 Percentage of subjects
Interval 0.1 to 9.83
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
5.30 Percentage of subjects
Interval 0.27 to 22.74
|
3.02 Percentage of subjects
Interval 0.81 to 7.64
|
|
Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Decreased appetite,Weeks 40-51
|
2.13 Percentage of subjects
Interval 0.1 to 9.83
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
5.30 Percentage of subjects
Interval 0.27 to 22.74
|
3.02 Percentage of subjects
Interval 0.81 to 7.64
|
|
Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall
Decreased appetite,Weeks 40-52
|
2.13 Percentage of subjects
Interval 0.1 to 9.83
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
5.30 Percentage of subjects
Interval 0.27 to 22.74
|
3.02 Percentage of subjects
Interval 0.81 to 7.64
|
PRIMARY outcome
Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEI listed on the ADR card was decreased appetite.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=139 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Weeks 40-47
|
4.55 Percentage of subjects
Interval 0.0 to 86.65
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Weeks 40-48
|
4.26 Percentage of subjects
Interval 0.0 to 40.16
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Weeks 40-49
|
2.47 Percentage of subjects
Interval 0.3 to 8.64
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Weeks 40-50
|
2.44 Percentage of subjects
Interval 0.42 to 7.53
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Weeks 40-51
|
2.22 Percentage of subjects
Interval 0.42 to 6.58
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Weeks 40-52
|
2.16 Percentage of subjects
Interval 0.44 to 6.22
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Decreased appetite,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Decreased appetite,Weeks 40-47
|
4.55 Percentage of subjects
Interval 0.0 to 86.65
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Decreased appetite,Weeks 40-48
|
4.26 Percentage of subjects
Interval 0.0 to 40.16
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Decreased appetite,Weeks 40-49
|
2.47 Percentage of subjects
Interval 0.3 to 8.64
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Decreased appetite,Weeks 40-50
|
2.44 Percentage of subjects
Interval 0.42 to 7.53
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Decreased appetite,Weeks 40-51
|
2.22 Percentage of subjects
Interval 0.42 to 6.58
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Decreased appetite,Weeks 40-52
|
2.16 Percentage of subjects
Interval 0.44 to 6.22
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were arthropathy and myalgia.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Limb discomfort,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Musculoskeletal pain,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Musculoskeletal pain,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Musculoskeletal pain,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.49 Percentage of subjects
Interval 0.0 to 10.27
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.25 Percentage of subjects
Interval 0.0 to 2.0
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Musculoskeletal pain,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.84
|
0.10 Percentage of subjects
Interval 0.0 to 0.67
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Musculoskeletal pain,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
0.46 Percentage of subjects
Interval 0.0 to 8.71
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.19 Percentage of subjects
Interval 0.0 to 1.52
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Musculoskeletal pain,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 1.76
|
0.43 Percentage of subjects
Interval 0.0 to 7.29
|
0.00 Percentage of subjects
Interval 0.0 to 1.87
|
0.16 Percentage of subjects
Interval 0.0 to 1.11
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Musculoskeletal pain,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 1.3
|
0.40 Percentage of subjects
Interval 0.0 to 5.98
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.11 Percentage of subjects
Interval 0.0 to 0.81
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Musculoskeletal pain,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Musculoskeletal pain,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Musculoskeletal pain,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Musculoskeletal pain,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Musculoskeletal pain,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pain in extremity,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pain in extremity,Weeks 40-41
|
—
|
0.62 Percentage of subjects
Interval 0.0 to 5.51
|
—
|
0.62 Percentage of subjects
Interval 0.0 to 5.51
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pain in extremity,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.49 Percentage of subjects
Interval 0.0 to 6.53
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.25 Percentage of subjects
Interval 0.0 to 1.73
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pain in extremity,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
0.46 Percentage of subjects
Interval 0.0 to 6.74
|
0.77 Percentage of subjects
Interval 0.02 to 4.21
|
0.39 Percentage of subjects
Interval 0.05 to 1.39
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pain in extremity,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 1.76
|
0.43 Percentage of subjects
Interval 0.0 to 6.92
|
0.51 Percentage of subjects
Interval 0.01 to 2.82
|
0.31 Percentage of subjects
Interval 0.04 to 1.13
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pain in extremity,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 1.3
|
0.80 Percentage of subjects
Interval 0.1 to 2.86
|
0.29 Percentage of subjects
Interval 0.0 to 1.82
|
0.34 Percentage of subjects
Interval 0.07 to 0.99
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pain in extremity,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 1.19
|
0.72 Percentage of subjects
Interval 0.09 to 2.59
|
0.24 Percentage of subjects
Interval 0.0 to 2.15
|
0.30 Percentage of subjects
Interval 0.06 to 0.87
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pain in extremity,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.72 Percentage of subjects
Interval 0.09 to 2.57
|
0.23 Percentage of subjects
Interval 0.0 to 2.24
|
0.29 Percentage of subjects
Interval 0.06 to 0.84
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pain in extremity,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.72 Percentage of subjects
Interval 0.09 to 2.57
|
0.22 Percentage of subjects
Interval 0.0 to 2.33
|
0.28 Percentage of subjects
Interval 0.06 to 0.82
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pain in extremity,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.72 Percentage of subjects
Interval 0.09 to 2.57
|
0.22 Percentage of subjects
Interval 0.0 to 2.33
|
0.28 Percentage of subjects
Interval 0.06 to 0.82
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pain in extremity,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.72 Percentage of subjects
Interval 0.09 to 2.57
|
0.22 Percentage of subjects
Interval 0.0 to 2.33
|
0.28 Percentage of subjects
Interval 0.06 to 0.82
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pain in extremity,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.72 Percentage of subjects
Interval 0.09 to 2.57
|
0.22 Percentage of subjects
Interval 0.0 to 2.33
|
0.28 Percentage of subjects
Interval 0.06 to 0.82
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pain in extremity,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.72 Percentage of subjects
Interval 0.09 to 2.57
|
0.22 Percentage of subjects
Interval 0.0 to 2.33
|
0.28 Percentage of subjects
Interval 0.06 to 0.82
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rheumatic disorder,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rheumatic disorder,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rheumatic disorder,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.49 Percentage of subjects
Interval 0.0 to 10.27
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.25 Percentage of subjects
Interval 0.0 to 2.0
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rheumatic disorder,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
0.46 Percentage of subjects
Interval 0.0 to 8.71
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.19 Percentage of subjects
Interval 0.0 to 1.52
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rheumatic disorder,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 1.76
|
0.43 Percentage of subjects
Interval 0.0 to 7.29
|
0.00 Percentage of subjects
Interval 0.0 to 1.87
|
0.16 Percentage of subjects
Interval 0.0 to 1.11
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rheumatic disorder,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 1.3
|
0.40 Percentage of subjects
Interval 0.0 to 5.98
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.11 Percentage of subjects
Interval 0.0 to 0.81
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rheumatic disorder,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 1.19
|
0.72 Percentage of subjects
Interval 0.0 to 9.03
|
0.00 Percentage of subjects
Interval 0.0 to 0.88
|
0.20 Percentage of subjects
Interval 0.0 to 1.39
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rheumatic disorder,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.72 Percentage of subjects
Interval 0.0 to 8.86
|
0.00 Percentage of subjects
Interval 0.0 to 0.84
|
0.19 Percentage of subjects
Interval 0.0 to 1.34
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rheumatic disorder,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.72 Percentage of subjects
Interval 0.0 to 8.86
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.19 Percentage of subjects
Interval 0.0 to 1.32
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rheumatic disorder,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.72 Percentage of subjects
Interval 0.0 to 8.86
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.19 Percentage of subjects
Interval 0.0 to 1.32
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rheumatic disorder,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.72 Percentage of subjects
Interval 0.0 to 8.86
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.19 Percentage of subjects
Interval 0.0 to 1.32
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rheumatic disorder,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.72 Percentage of subjects
Interval 0.0 to 8.86
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.19 Percentage of subjects
Interval 0.0 to 1.32
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rheumatic disorder,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.72 Percentage of subjects
Interval 0.0 to 8.86
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.19 Percentage of subjects
Interval 0.0 to 1.32
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Synovial cyst,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Synovial cyst,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Synovial cyst,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Synovial cyst,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
0.00 Percentage of subjects
Interval 0.0 to 1.69
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.00 Percentage of subjects
Interval 0.0 to 0.71
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Synovial cyst,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 1.76
|
0.00 Percentage of subjects
Interval 0.0 to 1.58
|
0.51 Percentage of subjects
Interval 0.0 to 22.01
|
0.16 Percentage of subjects
Interval 0.0 to 1.34
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Synovial cyst,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 1.3
|
0.00 Percentage of subjects
Interval 0.0 to 1.46
|
0.29 Percentage of subjects
Interval 0.0 to 8.11
|
0.11 Percentage of subjects
Interval 0.0 to 0.84
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Synovial cyst,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 1.19
|
0.00 Percentage of subjects
Interval 0.0 to 1.33
|
0.24 Percentage of subjects
Interval 0.0 to 5.63
|
0.10 Percentage of subjects
Interval 0.0 to 0.7
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Synovial cyst,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.23 Percentage of subjects
Interval 0.0 to 5.17
|
0.10 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Synovial cyst,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 4.76
|
0.09 Percentage of subjects
Interval 0.0 to 0.64
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Synovial cyst,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 4.76
|
0.09 Percentage of subjects
Interval 0.0 to 0.64
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Synovial cyst,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 4.76
|
0.09 Percentage of subjects
Interval 0.0 to 0.64
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Synovial cyst,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 4.76
|
0.09 Percentage of subjects
Interval 0.0 to 0.64
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Synovial cyst,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 4.76
|
0.09 Percentage of subjects
Interval 0.0 to 0.64
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-40
|
—
|
5.71 Percentage of subjects
Interval 0.22 to 25.74
|
—
|
5.71 Percentage of subjects
Interval 0.22 to 25.74
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-41
|
—
|
6.83 Percentage of subjects
Interval 0.05 to 39.06
|
—
|
6.83 Percentage of subjects
Interval 0.05 to 39.06
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-42
|
11.35 Percentage of subjects
Interval 0.1 to 56.46
|
5.88 Percentage of subjects
Interval 0.02 to 38.78
|
7.69 Percentage of subjects
Interval 0.19 to 36.17
|
8.06 Percentage of subjects
Interval 3.59 to 15.14
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-43
|
9.30 Percentage of subjects
Interval 0.0 to 98.75
|
6.91 Percentage of subjects
Interval 0.29 to 29.9
|
7.69 Percentage of subjects
Interval 0.55 to 29.13
|
7.90 Percentage of subjects
Interval 4.2 to 13.29
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-44
|
11.06 Percentage of subjects
Interval 3.48 to 24.62
|
6.90 Percentage of subjects
Interval 0.4 to 27.87
|
6.15 Percentage of subjects
Interval 2.06 to 13.66
|
8.03 Percentage of subjects
Interval 4.88 to 12.3
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-45
|
10.99 Percentage of subjects
Interval 3.84 to 23.27
|
7.60 Percentage of subjects
Interval 0.91 to 25.06
|
7.14 Percentage of subjects
Interval 0.51 to 27.33
|
8.50 Percentage of subjects
Interval 5.54 to 12.37
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-46
|
11.04 Percentage of subjects
Interval 4.44 to 21.74
|
8.33 Percentage of subjects
Interval 1.48 to 23.91
|
7.43 Percentage of subjects
Interval 0.5 to 28.64
|
8.79 Percentage of subjects
Interval 5.87 to 12.53
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-47
|
10.64 Percentage of subjects
Interval 3.62 to 22.86
|
8.27 Percentage of subjects
Interval 1.5 to 23.61
|
7.32 Percentage of subjects
Interval 0.74 to 25.51
|
8.62 Percentage of subjects
Interval 5.9 to 12.07
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-48
|
10.64 Percentage of subjects
Interval 3.62 to 22.86
|
8.27 Percentage of subjects
Interval 1.5 to 23.61
|
8.39 Percentage of subjects
Interval 0.26 to 37.24
|
9.06 Percentage of subjects
Interval 5.82 to 13.29
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-49
|
10.64 Percentage of subjects
Interval 3.62 to 22.86
|
8.27 Percentage of subjects
Interval 1.5 to 23.61
|
8.39 Percentage of subjects
Interval 0.26 to 37.24
|
9.06 Percentage of subjects
Interval 5.82 to 13.29
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-50
|
10.64 Percentage of subjects
Interval 3.62 to 22.86
|
8.27 Percentage of subjects
Interval 1.5 to 23.61
|
8.39 Percentage of subjects
Interval 0.26 to 37.24
|
9.06 Percentage of subjects
Interval 5.82 to 13.29
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-51
|
10.64 Percentage of subjects
Interval 3.62 to 22.86
|
8.27 Percentage of subjects
Interval 1.5 to 23.61
|
8.39 Percentage of subjects
Interval 0.26 to 37.24
|
9.06 Percentage of subjects
Interval 5.82 to 13.29
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-52
|
10.64 Percentage of subjects
Interval 3.62 to 22.86
|
8.27 Percentage of subjects
Interval 1.5 to 23.61
|
8.39 Percentage of subjects
Interval 0.26 to 37.24
|
9.06 Percentage of subjects
Interval 5.82 to 13.29
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Arthropathy,Weeks 40-40
|
—
|
1.43 Percentage of subjects
Interval 0.04 to 7.7
|
—
|
1.43 Percentage of subjects
Interval 0.04 to 7.7
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Arthropathy,Weeks 40-41
|
—
|
1.86 Percentage of subjects
Interval 0.0 to 15.87
|
—
|
1.86 Percentage of subjects
Interval 0.0 to 15.87
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Arthropathy,Weeks 40-42
|
1.42 Percentage of subjects
Interval 0.02 to 8.68
|
1.96 Percentage of subjects
Interval 0.04 to 10.99
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
1.51 Percentage of subjects
Interval 0.52 to 3.4
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Arthropathy,Weeks 40-43
|
1.16 Percentage of subjects
Interval 0.0 to 37.75
|
2.76 Percentage of subjects
Interval 0.24 to 10.75
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
1.54 Percentage of subjects
Interval 0.36 to 4.23
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Arthropathy,Weeks 40-44
|
3.37 Percentage of subjects
Interval 0.01 to 23.06
|
2.59 Percentage of subjects
Interval 0.3 to 9.13
|
0.51 Percentage of subjects
Interval 0.0 to 22.01
|
2.20 Percentage of subjects
Interval 0.68 to 5.22
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Arthropathy,Weeks 40-45
|
3.19 Percentage of subjects
Interval 0.04 to 18.56
|
3.20 Percentage of subjects
Interval 0.3 to 12.02
|
1.71 Percentage of subjects
Interval 0.0 to 27.48
|
2.61 Percentage of subjects
Interval 0.99 to 5.51
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Arthropathy,Weeks 40-46
|
3.25 Percentage of subjects
Interval 0.09 to 16.56
|
3.62 Percentage of subjects
Interval 0.32 to 13.84
|
1.68 Percentage of subjects
Interval 0.0 to 23.32
|
2.70 Percentage of subjects
Interval 1.09 to 5.47
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Arthropathy,Weeks 40-47
|
3.34 Percentage of subjects
Interval 0.15 to 15.29
|
3.60 Percentage of subjects
Interval 0.33 to 13.54
|
1.83 Percentage of subjects
Interval 0.0 to 20.37
|
2.78 Percentage of subjects
Interval 1.22 to 5.36
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Arthropathy,Weeks 40-48
|
3.34 Percentage of subjects
Interval 0.15 to 15.29
|
3.60 Percentage of subjects
Interval 0.33 to 13.54
|
2.43 Percentage of subjects
Interval 0.0 to 29.22
|
3.02 Percentage of subjects
Interval 1.27 to 5.98
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Arthropathy,Weeks 40-49
|
3.34 Percentage of subjects
Interval 0.15 to 15.29
|
3.60 Percentage of subjects
Interval 0.33 to 13.54
|
2.43 Percentage of subjects
Interval 0.0 to 29.22
|
3.02 Percentage of subjects
Interval 1.27 to 5.98
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Arthropathy,Weeks 40-50
|
3.34 Percentage of subjects
Interval 0.15 to 15.29
|
3.60 Percentage of subjects
Interval 0.33 to 13.54
|
2.43 Percentage of subjects
Interval 0.0 to 29.22
|
3.02 Percentage of subjects
Interval 1.27 to 5.98
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Arthropathy,Weeks 40-51
|
3.34 Percentage of subjects
Interval 0.15 to 15.29
|
3.60 Percentage of subjects
Interval 0.33 to 13.54
|
2.43 Percentage of subjects
Interval 0.0 to 29.22
|
3.02 Percentage of subjects
Interval 1.27 to 5.98
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Arthropathy,Weeks 40-52
|
3.34 Percentage of subjects
Interval 0.15 to 15.29
|
3.60 Percentage of subjects
Interval 0.33 to 13.54
|
2.43 Percentage of subjects
Interval 0.0 to 29.22
|
3.02 Percentage of subjects
Interval 1.27 to 5.98
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Myalgia,Weeks 40-40
|
—
|
5.71 Percentage of subjects
Interval 0.22 to 25.74
|
—
|
5.71 Percentage of subjects
Interval 0.22 to 25.74
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Myalgia,Weeks 40-41
|
—
|
5.59 Percentage of subjects
Interval 0.07 to 31.12
|
—
|
5.59 Percentage of subjects
Interval 0.07 to 31.12
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Myalgia,Weeks 40-42
|
9.93 Percentage of subjects
Interval 0.09 to 50.96
|
4.41 Percentage of subjects
Interval 0.0 to 35.58
|
7.69 Percentage of subjects
Interval 0.19 to 36.17
|
6.80 Percentage of subjects
Interval 2.81 to 13.43
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Myalgia,Weeks 40-43
|
8.14 Percentage of subjects
Interval 0.0 to 97.65
|
4.61 Percentage of subjects
Interval 0.02 to 30.64
|
6.92 Percentage of subjects
Interval 0.5 to 26.44
|
6.36 Percentage of subjects
Interval 2.91 to 11.83
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Myalgia,Weeks 40-44
|
8.17 Percentage of subjects
Interval 0.63 to 30.15
|
4.74 Percentage of subjects
Interval 0.06 to 26.99
|
5.13 Percentage of subjects
Interval 2.49 to 9.23
|
5.98 Percentage of subjects
Interval 3.2 to 10.06
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Myalgia,Weeks 40-45
|
8.51 Percentage of subjects
Interval 1.71 to 23.33
|
5.20 Percentage of subjects
Interval 0.28 to 21.98
|
5.71 Percentage of subjects
Interval 0.71 to 19.1
|
6.46 Percentage of subjects
Interval 4.09 to 9.63
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Myalgia,Weeks 40-46
|
8.77 Percentage of subjects
Interval 2.71 to 19.96
|
5.43 Percentage of subjects
Interval 0.59 to 19.03
|
6.00 Percentage of subjects
Interval 0.68 to 20.51
|
6.69 Percentage of subjects
Interval 4.44 to 9.62
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Myalgia,Weeks 40-47
|
8.21 Percentage of subjects
Interval 1.64 to 22.59
|
5.40 Percentage of subjects
Interval 0.57 to 18.99
|
5.95 Percentage of subjects
Interval 0.95 to 18.16
|
6.51 Percentage of subjects
Interval 4.39 to 9.25
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Myalgia,Weeks 40-48
|
8.21 Percentage of subjects
Interval 1.64 to 22.59
|
5.40 Percentage of subjects
Interval 0.57 to 18.99
|
6.84 Percentage of subjects
Interval 0.36 to 28.26
|
6.89 Percentage of subjects
Interval 4.33 to 10.3
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Myalgia,Weeks 40-49
|
8.21 Percentage of subjects
Interval 1.64 to 22.59
|
5.40 Percentage of subjects
Interval 0.57 to 18.99
|
6.84 Percentage of subjects
Interval 0.36 to 28.26
|
6.89 Percentage of subjects
Interval 4.33 to 10.3
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Myalgia,Weeks 40-50
|
8.21 Percentage of subjects
Interval 1.64 to 22.59
|
5.40 Percentage of subjects
Interval 0.57 to 18.99
|
6.84 Percentage of subjects
Interval 0.36 to 28.26
|
6.89 Percentage of subjects
Interval 4.33 to 10.3
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Myalgia,Weeks 40-51
|
8.21 Percentage of subjects
Interval 1.64 to 22.59
|
5.40 Percentage of subjects
Interval 0.57 to 18.99
|
6.84 Percentage of subjects
Interval 0.36 to 28.26
|
6.89 Percentage of subjects
Interval 4.33 to 10.3
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Myalgia,Weeks 40-52
|
8.21 Percentage of subjects
Interval 1.64 to 22.59
|
5.40 Percentage of subjects
Interval 0.57 to 18.99
|
6.84 Percentage of subjects
Interval 0.36 to 28.26
|
6.89 Percentage of subjects
Interval 4.33 to 10.3
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Limb discomfort,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Limb discomfort,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Limb discomfort,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Limb discomfort,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
0.00 Percentage of subjects
Interval 0.0 to 1.69
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.00 Percentage of subjects
Interval 0.0 to 0.71
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Limb discomfort,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 1.76
|
0.00 Percentage of subjects
Interval 0.0 to 1.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.87
|
0.00 Percentage of subjects
Interval 0.0 to 0.58
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Limb discomfort,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 1.3
|
0.40 Percentage of subjects
Interval 0.0 to 5.98
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.11 Percentage of subjects
Interval 0.0 to 0.81
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Limb discomfort,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 1.19
|
0.36 Percentage of subjects
Interval 0.0 to 4.6
|
0.00 Percentage of subjects
Interval 0.0 to 0.88
|
0.10 Percentage of subjects
Interval 0.0 to 0.7
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Limb discomfort,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.84
|
0.10 Percentage of subjects
Interval 0.0 to 0.67
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Limb discomfort,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Limb discomfort,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Limb discomfort,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Limb discomfort,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Musculoskeletal pain,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 1.19
|
0.36 Percentage of subjects
Interval 0.0 to 4.6
|
0.00 Percentage of subjects
Interval 0.0 to 0.88
|
0.10 Percentage of subjects
Interval 0.0 to 0.7
|
PRIMARY outcome
Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were arthropathy and myalgia.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=139 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Weeks 40-47
|
4.55 Percentage of subjects
Interval 0.0 to 86.65
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Weeks 40-48
|
2.13 Percentage of subjects
Interval 0.0 to 22.05
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Weeks 40-49
|
1.23 Percentage of subjects
Interval 0.03 to 6.69
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Weeks 40-50
|
0.81 Percentage of subjects
Interval 0.02 to 4.45
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Weeks 40-51
|
0.74 Percentage of subjects
Interval 0.02 to 4.06
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Weeks 40-52
|
0.72 Percentage of subjects
Interval 0.02 to 3.94
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Arthropathy,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Arthropathy,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 15.44
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Arthropathy,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Arthropathy,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 4.45
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Arthropathy,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 2.95
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Arthropathy,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 2.7
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Arthropathy,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 2.62
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Myalgia,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Myalgia,Weeks 40-47
|
4.55 Percentage of subjects
Interval 0.0 to 86.65
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Myalgia,Weeks 40-48
|
2.13 Percentage of subjects
Interval 0.0 to 22.05
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Myalgia,Weeks 40-49
|
1.23 Percentage of subjects
Interval 0.03 to 6.69
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Myalgia,Weeks 40-50
|
0.81 Percentage of subjects
Interval 0.02 to 4.45
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Myalgia,Weeks 40-51
|
0.74 Percentage of subjects
Interval 0.02 to 4.06
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Myalgia,Weeks 40-52
|
0.72 Percentage of subjects
Interval 0.02 to 3.94
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were febrile convulsion and headache.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Somnolence,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 1.3
|
0.00 Percentage of subjects
Interval 0.0 to 1.46
|
0.29 Percentage of subjects
Interval 0.0 to 8.11
|
0.11 Percentage of subjects
Interval 0.0 to 0.84
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Somnolence,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 1.19
|
0.00 Percentage of subjects
Interval 0.0 to 1.33
|
0.24 Percentage of subjects
Interval 0.0 to 5.63
|
0.10 Percentage of subjects
Interval 0.0 to 0.7
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Somnolence,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.23 Percentage of subjects
Interval 0.0 to 5.17
|
0.10 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Somnolence,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 4.76
|
0.09 Percentage of subjects
Interval 0.0 to 0.64
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Somnolence,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 4.76
|
0.09 Percentage of subjects
Interval 0.0 to 0.64
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Somnolence,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 4.76
|
0.09 Percentage of subjects
Interval 0.0 to 0.64
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-40
|
—
|
5.71 Percentage of subjects
Interval 0.22 to 25.74
|
—
|
5.71 Percentage of subjects
Interval 0.22 to 25.74
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-41
|
—
|
6.83 Percentage of subjects
Interval 1.53 to 18.2
|
—
|
6.83 Percentage of subjects
Interval 1.53 to 18.2
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-42
|
5.67 Percentage of subjects
Interval 0.0 to 68.1
|
6.37 Percentage of subjects
Interval 1.38 to 17.25
|
1.92 Percentage of subjects
Interval 0.05 to 10.26
|
5.54 Percentage of subjects
Interval 3.25 to 8.74
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-43
|
6.40 Percentage of subjects
Interval 0.0 to 85.72
|
6.45 Percentage of subjects
Interval 1.56 to 16.67
|
5.38 Percentage of subjects
Interval 0.4 to 20.9
|
6.17 Percentage of subjects
Interval 4.19 to 8.7
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-44
|
8.17 Percentage of subjects
Interval 0.32 to 34.96
|
6.47 Percentage of subjects
Interval 1.76 to 15.84
|
4.10 Percentage of subjects
Interval 1.79 to 7.92
|
6.30 Percentage of subjects
Interval 4.05 to 9.28
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-45
|
9.57 Percentage of subjects
Interval 0.7 to 34.96
|
6.80 Percentage of subjects
Interval 1.93 to 16.33
|
6.57 Percentage of subjects
Interval 1.02 to 20.19
|
7.60 Percentage of subjects
Interval 4.91 to 11.12
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-46
|
8.77 Percentage of subjects
Interval 1.25 to 27.02
|
7.61 Percentage of subjects
Interval 1.89 to 19.29
|
6.95 Percentage of subjects
Interval 0.84 to 23.06
|
7.69 Percentage of subjects
Interval 5.2 to 10.88
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-47
|
8.21 Percentage of subjects
Interval 1.64 to 22.61
|
7.91 Percentage of subjects
Interval 1.75 to 21.01
|
6.86 Percentage of subjects
Interval 1.15 to 20.43
|
7.57 Percentage of subjects
Interval 5.29 to 10.42
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-48
|
8.21 Percentage of subjects
Interval 1.64 to 22.61
|
7.91 Percentage of subjects
Interval 1.75 to 21.01
|
7.95 Percentage of subjects
Interval 0.59 to 29.68
|
8.02 Percentage of subjects
Interval 5.33 to 11.49
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-49
|
8.21 Percentage of subjects
Interval 1.64 to 22.61
|
7.91 Percentage of subjects
Interval 1.75 to 21.01
|
7.95 Percentage of subjects
Interval 0.59 to 29.68
|
8.02 Percentage of subjects
Interval 5.33 to 11.49
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-50
|
8.21 Percentage of subjects
Interval 1.64 to 22.61
|
7.91 Percentage of subjects
Interval 1.75 to 21.01
|
7.95 Percentage of subjects
Interval 0.59 to 29.68
|
8.02 Percentage of subjects
Interval 5.33 to 11.49
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-51
|
8.21 Percentage of subjects
Interval 1.64 to 22.61
|
7.91 Percentage of subjects
Interval 1.75 to 21.01
|
7.95 Percentage of subjects
Interval 0.59 to 29.68
|
8.02 Percentage of subjects
Interval 5.33 to 11.49
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-52
|
8.21 Percentage of subjects
Interval 1.64 to 22.61
|
7.91 Percentage of subjects
Interval 1.75 to 21.01
|
7.95 Percentage of subjects
Interval 0.59 to 29.68
|
8.02 Percentage of subjects
Interval 5.33 to 11.49
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Febrile convulsion,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Febrile convulsion,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Febrile convulsion,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Febrile convulsion,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
0.00 Percentage of subjects
Interval 0.0 to 1.69
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.00 Percentage of subjects
Interval 0.0 to 0.71
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Febrile convulsion,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 1.76
|
0.00 Percentage of subjects
Interval 0.0 to 1.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.87
|
0.00 Percentage of subjects
Interval 0.0 to 0.58
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Febrile convulsion,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 1.3
|
0.00 Percentage of subjects
Interval 0.0 to 1.46
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.00 Percentage of subjects
Interval 0.0 to 0.42
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Febrile convulsion,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 1.19
|
0.00 Percentage of subjects
Interval 0.0 to 1.33
|
0.00 Percentage of subjects
Interval 0.0 to 0.88
|
0.00 Percentage of subjects
Interval 0.0 to 0.37
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Febrile convulsion,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.84
|
0.00 Percentage of subjects
Interval 0.0 to 0.35
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Febrile convulsion,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.00 Percentage of subjects
Interval 0.0 to 0.35
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Febrile convulsion,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.00 Percentage of subjects
Interval 0.0 to 0.35
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Febrile convulsion,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.00 Percentage of subjects
Interval 0.0 to 0.35
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Febrile convulsion,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.00 Percentage of subjects
Interval 0.0 to 0.35
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Febrile convulsion,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.00 Percentage of subjects
Interval 0.0 to 0.35
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Headache,Weeks 40-40
|
—
|
4.29 Percentage of subjects
Interval 0.17 to 19.69
|
—
|
4.29 Percentage of subjects
Interval 0.17 to 19.69
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Headache,Weeks 40-41
|
—
|
6.21 Percentage of subjects
Interval 1.37 to 16.71
|
—
|
6.21 Percentage of subjects
Interval 1.37 to 16.71
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Headache,Weeks 40-42
|
4.96 Percentage of subjects
Interval 0.48 to 18.09
|
5.88 Percentage of subjects
Interval 1.3 to 15.88
|
1.92 Percentage of subjects
Interval 0.05 to 10.26
|
5.04 Percentage of subjects
Interval 3.1 to 7.67
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Headache,Weeks 40-43
|
5.81 Percentage of subjects
Interval 0.0 to 63.02
|
5.99 Percentage of subjects
Interval 1.42 to 15.7
|
5.38 Percentage of subjects
Interval 0.4 to 20.9
|
5.78 Percentage of subjects
Interval 3.93 to 8.15
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Headache,Weeks 40-44
|
7.69 Percentage of subjects
Interval 0.39 to 31.51
|
6.03 Percentage of subjects
Interval 1.58 to 15.11
|
4.10 Percentage of subjects
Interval 1.79 to 7.92
|
5.98 Percentage of subjects
Interval 3.97 to 8.61
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Headache,Weeks 40-45
|
8.51 Percentage of subjects
Interval 1.02 to 27.75
|
6.40 Percentage of subjects
Interval 1.59 to 16.37
|
5.71 Percentage of subjects
Interval 2.34 to 11.38
|
6.80 Percentage of subjects
Interval 4.81 to 9.3
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Headache,Weeks 40-46
|
7.79 Percentage of subjects
Interval 1.46 to 22.06
|
7.25 Percentage of subjects
Interval 1.39 to 20.44
|
6.24 Percentage of subjects
Interval 1.71 to 15.26
|
6.99 Percentage of subjects
Interval 5.02 to 9.44
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Headache,Weeks 40-47
|
7.29 Percentage of subjects
Interval 1.66 to 19.22
|
7.55 Percentage of subjects
Interval 1.25 to 22.42
|
6.18 Percentage of subjects
Interval 2.16 to 13.41
|
6.90 Percentage of subjects
Interval 5.02 to 9.21
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Headache,Weeks 40-48
|
7.29 Percentage of subjects
Interval 1.66 to 19.22
|
7.55 Percentage of subjects
Interval 1.25 to 22.42
|
7.28 Percentage of subjects
Interval 1.08 to 22.49
|
7.36 Percentage of subjects
Interval 5.12 to 10.18
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Headache,Weeks 40-49
|
7.29 Percentage of subjects
Interval 1.66 to 19.22
|
7.55 Percentage of subjects
Interval 1.25 to 22.42
|
7.28 Percentage of subjects
Interval 1.08 to 22.49
|
7.36 Percentage of subjects
Interval 5.12 to 10.18
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Headache,Weeks 40-50
|
7.29 Percentage of subjects
Interval 1.66 to 19.22
|
7.55 Percentage of subjects
Interval 1.25 to 22.42
|
7.28 Percentage of subjects
Interval 1.08 to 22.49
|
7.36 Percentage of subjects
Interval 5.12 to 10.18
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Headache,Weeks 40-51
|
7.29 Percentage of subjects
Interval 1.66 to 19.22
|
7.55 Percentage of subjects
Interval 1.25 to 22.42
|
7.28 Percentage of subjects
Interval 1.08 to 22.49
|
7.36 Percentage of subjects
Interval 5.12 to 10.18
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Headache,Weeks 40-52
|
7.29 Percentage of subjects
Interval 1.66 to 19.22
|
7.55 Percentage of subjects
Interval 1.25 to 22.42
|
7.28 Percentage of subjects
Interval 1.08 to 22.49
|
7.36 Percentage of subjects
Interval 5.12 to 10.18
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Aphonia,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Aphonia,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Aphonia,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Aphonia,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
0.00 Percentage of subjects
Interval 0.0 to 1.69
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.00 Percentage of subjects
Interval 0.0 to 0.71
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Aphonia,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 1.76
|
0.00 Percentage of subjects
Interval 0.0 to 1.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.87
|
0.00 Percentage of subjects
Interval 0.0 to 0.58
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Aphonia,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 1.3
|
0.00 Percentage of subjects
Interval 0.0 to 1.46
|
0.29 Percentage of subjects
Interval 0.0 to 8.11
|
0.11 Percentage of subjects
Interval 0.0 to 0.84
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Aphonia,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 1.19
|
0.00 Percentage of subjects
Interval 0.0 to 1.33
|
0.24 Percentage of subjects
Interval 0.0 to 5.63
|
0.10 Percentage of subjects
Interval 0.0 to 0.7
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Aphonia,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.23 Percentage of subjects
Interval 0.0 to 5.17
|
0.10 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Aphonia,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 4.76
|
0.09 Percentage of subjects
Interval 0.0 to 0.64
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Aphonia,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 4.76
|
0.09 Percentage of subjects
Interval 0.0 to 0.64
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Aphonia,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 4.76
|
0.09 Percentage of subjects
Interval 0.0 to 0.64
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Aphonia,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 4.76
|
0.09 Percentage of subjects
Interval 0.0 to 0.64
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Aphonia,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 4.76
|
0.09 Percentage of subjects
Interval 0.0 to 0.64
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dizziness,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dizziness,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dizziness,Weeks 40-42
|
0.71 Percentage of subjects
Interval 0.0 to 97.4
|
0.00 Percentage of subjects
Interval 0.0 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.25 Percentage of subjects
Interval 0.0 to 2.41
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dizziness,Weeks 40-43
|
0.58 Percentage of subjects
Interval 0.0 to 86.72
|
0.00 Percentage of subjects
Interval 0.0 to 1.69
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.19 Percentage of subjects
Interval 0.0 to 1.68
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dizziness,Weeks 40-44
|
0.48 Percentage of subjects
Interval 0.0 to 12.12
|
0.00 Percentage of subjects
Interval 0.0 to 1.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.87
|
0.16 Percentage of subjects
Interval 0.0 to 1.2
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dizziness,Weeks 40-45
|
1.06 Percentage of subjects
Interval 0.0 to 16.76
|
0.00 Percentage of subjects
Interval 0.0 to 1.46
|
0.29 Percentage of subjects
Interval 0.0 to 8.11
|
0.45 Percentage of subjects
Interval 0.02 to 2.2
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dizziness,Weeks 40-46
|
0.97 Percentage of subjects
Interval 0.0 to 13.4
|
0.00 Percentage of subjects
Interval 0.0 to 1.33
|
0.24 Percentage of subjects
Interval 0.0 to 5.63
|
0.40 Percentage of subjects
Interval 0.02 to 1.85
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dizziness,Weeks 40-47
|
0.91 Percentage of subjects
Interval 0.0 to 11.33
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.23 Percentage of subjects
Interval 0.0 to 5.17
|
0.38 Percentage of subjects
Interval 0.02 to 1.72
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dizziness,Weeks 40-48
|
0.91 Percentage of subjects
Interval 0.0 to 11.33
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 4.76
|
0.38 Percentage of subjects
Interval 0.02 to 1.69
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dizziness,Weeks 40-49
|
0.91 Percentage of subjects
Interval 0.0 to 11.33
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 4.76
|
0.38 Percentage of subjects
Interval 0.02 to 1.69
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dizziness,Weeks 40-50
|
0.91 Percentage of subjects
Interval 0.0 to 11.33
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 4.76
|
0.38 Percentage of subjects
Interval 0.02 to 1.69
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dizziness,Weeks 40-51
|
0.91 Percentage of subjects
Interval 0.0 to 11.33
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 4.76
|
0.38 Percentage of subjects
Interval 0.02 to 1.69
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dizziness,Weeks 40-52
|
0.91 Percentage of subjects
Interval 0.0 to 11.33
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 4.76
|
0.38 Percentage of subjects
Interval 0.02 to 1.69
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Poor quality sleep,Weeks 40-40
|
—
|
1.43 Percentage of subjects
Interval 0.04 to 7.7
|
—
|
1.43 Percentage of subjects
Interval 0.04 to 7.7
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Poor quality sleep,Weeks 40-41
|
—
|
0.62 Percentage of subjects
Interval 0.0 to 5.51
|
—
|
0.62 Percentage of subjects
Interval 0.0 to 5.51
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Poor quality sleep,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.49 Percentage of subjects
Interval 0.0 to 6.53
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.25 Percentage of subjects
Interval 0.0 to 1.73
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Poor quality sleep,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
0.46 Percentage of subjects
Interval 0.0 to 6.74
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.19 Percentage of subjects
Interval 0.0 to 1.43
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Poor quality sleep,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 1.76
|
0.43 Percentage of subjects
Interval 0.0 to 6.92
|
0.00 Percentage of subjects
Interval 0.0 to 1.87
|
0.16 Percentage of subjects
Interval 0.0 to 1.09
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Poor quality sleep,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 1.3
|
0.40 Percentage of subjects
Interval 0.0 to 7.09
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.11 Percentage of subjects
Interval 0.0 to 0.83
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Poor quality sleep,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 1.19
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
0.00 Percentage of subjects
Interval 0.0 to 0.88
|
0.10 Percentage of subjects
Interval 0.0 to 0.74
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Poor quality sleep,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
0.00 Percentage of subjects
Interval 0.0 to 0.84
|
0.10 Percentage of subjects
Interval 0.0 to 0.71
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Poor quality sleep,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.7
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Poor quality sleep,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.7
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Poor quality sleep,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.7
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Poor quality sleep,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.7
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Poor quality sleep,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.7
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Somnolence,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Somnolence,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Somnolence,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Somnolence,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
0.00 Percentage of subjects
Interval 0.0 to 1.69
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.00 Percentage of subjects
Interval 0.0 to 0.71
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Somnolence,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 1.76
|
0.00 Percentage of subjects
Interval 0.0 to 1.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.87
|
0.00 Percentage of subjects
Interval 0.0 to 0.58
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Somnolence,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 4.76
|
0.09 Percentage of subjects
Interval 0.0 to 0.64
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Somnolence,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 4.76
|
0.09 Percentage of subjects
Interval 0.0 to 0.64
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tremor,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tremor,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tremor,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tremor,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
0.00 Percentage of subjects
Interval 0.0 to 1.69
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.00 Percentage of subjects
Interval 0.0 to 0.71
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tremor,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 1.76
|
0.00 Percentage of subjects
Interval 0.0 to 1.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.87
|
0.00 Percentage of subjects
Interval 0.0 to 0.58
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tremor,Weeks 40-45
|
0.35 Percentage of subjects
Interval 0.0 to 5.88
|
0.00 Percentage of subjects
Interval 0.0 to 1.46
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.11 Percentage of subjects
Interval 0.0 to 0.79
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tremor,Weeks 40-46
|
0.32 Percentage of subjects
Interval 0.0 to 4.64
|
0.00 Percentage of subjects
Interval 0.0 to 1.33
|
0.00 Percentage of subjects
Interval 0.0 to 0.88
|
0.10 Percentage of subjects
Interval 0.0 to 0.68
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tremor,Weeks 40-47
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.84
|
0.10 Percentage of subjects
Interval 0.0 to 0.64
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tremor,Weeks 40-48
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.63
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tremor,Weeks 40-49
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.63
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tremor,Weeks 40-50
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.63
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tremor,Weeks 40-51
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.63
|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tremor,Weeks 40-52
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.63
|
PRIMARY outcome
Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were febrile convulsion and headache.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=139 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
|
0 Percentage of subjects
Interval 0.0 to 2.62
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEI listed on the ADR card was irritability.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Insomnia,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
1.96 Percentage of subjects
Interval 0.0 to 35.78
|
1.92 Percentage of subjects
Interval 0.05 to 10.26
|
1.26 Percentage of subjects
Interval 0.02 to 7.26
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
2.30 Percentage of subjects
Interval 0.0 to 37.38
|
3.85 Percentage of subjects
Interval 0.3 to 15.16
|
1.93 Percentage of subjects
Interval 0.19 to 7.28
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-44
|
0.48 Percentage of subjects
Interval 0.0 to 15.39
|
2.16 Percentage of subjects
Interval 0.0 to 32.16
|
3.59 Percentage of subjects
Interval 1.46 to 7.26
|
2.05 Percentage of subjects
Interval 0.51 to 5.4
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-45
|
0.71 Percentage of subjects
Interval 0.0 to 7.8
|
2.00 Percentage of subjects
Interval 0.0 to 27.03
|
2.29 Percentage of subjects
Interval 0.34 to 7.45
|
1.70 Percentage of subjects
Interval 0.55 to 3.92
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-46
|
0.97 Percentage of subjects
Interval 0.0 to 8.41
|
1.81 Percentage of subjects
Interval 0.0 to 21.35
|
2.40 Percentage of subjects
Interval 0.19 to 9.65
|
1.80 Percentage of subjects
Interval 0.71 to 3.72
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-47
|
0.91 Percentage of subjects
Interval 0.0 to 7.18
|
1.80 Percentage of subjects
Interval 0.0 to 20.98
|
2.52 Percentage of subjects
Interval 0.54 to 7.09
|
1.82 Percentage of subjects
Interval 0.78 to 3.57
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-48
|
0.91 Percentage of subjects
Interval 0.0 to 7.18
|
1.80 Percentage of subjects
Interval 0.0 to 20.98
|
2.43 Percentage of subjects
Interval 0.4 to 7.64
|
1.79 Percentage of subjects
Interval 0.76 to 3.54
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-49
|
0.91 Percentage of subjects
Interval 0.0 to 7.18
|
1.80 Percentage of subjects
Interval 0.0 to 20.98
|
2.43 Percentage of subjects
Interval 0.4 to 7.64
|
1.79 Percentage of subjects
Interval 0.76 to 3.54
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-50
|
0.91 Percentage of subjects
Interval 0.0 to 7.18
|
1.80 Percentage of subjects
Interval 0.0 to 20.98
|
2.43 Percentage of subjects
Interval 0.4 to 7.64
|
1.79 Percentage of subjects
Interval 0.76 to 3.54
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-51
|
0.91 Percentage of subjects
Interval 0.0 to 7.18
|
1.80 Percentage of subjects
Interval 0.0 to 20.98
|
2.43 Percentage of subjects
Interval 0.4 to 7.64
|
1.79 Percentage of subjects
Interval 0.76 to 3.54
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-52
|
0.91 Percentage of subjects
Interval 0.0 to 7.18
|
1.80 Percentage of subjects
Interval 0.0 to 20.98
|
2.43 Percentage of subjects
Interval 0.4 to 7.64
|
1.79 Percentage of subjects
Interval 0.76 to 3.54
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Irritability,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Irritability,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Irritability,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
1.47 Percentage of subjects
Interval 0.0 to 28.09
|
1.92 Percentage of subjects
Interval 0.05 to 10.26
|
1.01 Percentage of subjects
Interval 0.03 to 5.49
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Irritability,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
1.84 Percentage of subjects
Interval 0.0 to 31.06
|
3.85 Percentage of subjects
Interval 0.3 to 15.16
|
1.73 Percentage of subjects
Interval 0.18 to 6.51
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Irritability,Weeks 40-44
|
0.48 Percentage of subjects
Interval 0.0 to 15.39
|
1.72 Percentage of subjects
Interval 0.0 to 26.54
|
3.59 Percentage of subjects
Interval 1.46 to 7.26
|
1.89 Percentage of subjects
Interval 0.49 to 4.92
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Irritability,Weeks 40-45
|
0.71 Percentage of subjects
Interval 0.0 to 7.8
|
1.60 Percentage of subjects
Interval 0.0 to 22.17
|
2.29 Percentage of subjects
Interval 0.34 to 7.45
|
1.59 Percentage of subjects
Interval 0.53 to 3.62
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Irritability,Weeks 40-46
|
0.97 Percentage of subjects
Interval 0.0 to 8.41
|
1.45 Percentage of subjects
Interval 0.0 to 17.4
|
2.40 Percentage of subjects
Interval 0.19 to 9.65
|
1.70 Percentage of subjects
Interval 0.67 to 3.51
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Irritability,Weeks 40-47
|
0.91 Percentage of subjects
Interval 0.0 to 7.18
|
1.44 Percentage of subjects
Interval 0.0 to 17.09
|
2.52 Percentage of subjects
Interval 0.54 to 7.09
|
1.72 Percentage of subjects
Interval 0.75 to 3.37
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Irritability,Weeks 40-48
|
0.91 Percentage of subjects
Interval 0.0 to 7.18
|
1.44 Percentage of subjects
Interval 0.0 to 17.09
|
2.43 Percentage of subjects
Interval 0.4 to 7.64
|
1.70 Percentage of subjects
Interval 0.73 to 3.34
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Irritability,Weeks 40-49
|
0.91 Percentage of subjects
Interval 0.0 to 7.18
|
1.44 Percentage of subjects
Interval 0.0 to 17.09
|
2.43 Percentage of subjects
Interval 0.4 to 7.64
|
1.70 Percentage of subjects
Interval 0.73 to 3.34
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Mood swings,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Mood swings,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Mood swings,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Mood swings,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
0.00 Percentage of subjects
Interval 0.0 to 1.69
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.00 Percentage of subjects
Interval 0.0 to 0.71
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Mood swings,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 1.76
|
0.00 Percentage of subjects
Interval 0.0 to 1.58
|
0.51 Percentage of subjects
Interval 0.0 to 22.01
|
0.16 Percentage of subjects
Interval 0.0 to 1.34
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Mood swings,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 1.3
|
0.00 Percentage of subjects
Interval 0.0 to 1.46
|
0.29 Percentage of subjects
Interval 0.0 to 8.11
|
0.11 Percentage of subjects
Interval 0.0 to 0.84
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Mood swings,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 1.19
|
0.00 Percentage of subjects
Interval 0.0 to 1.33
|
0.24 Percentage of subjects
Interval 0.0 to 5.63
|
0.10 Percentage of subjects
Interval 0.0 to 0.7
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Mood swings,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.23 Percentage of subjects
Interval 0.0 to 5.17
|
0.10 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Mood swings,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 4.76
|
0.09 Percentage of subjects
Interval 0.0 to 0.64
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Mood swings,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 4.76
|
0.09 Percentage of subjects
Interval 0.0 to 0.64
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Mood swings,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 4.76
|
0.09 Percentage of subjects
Interval 0.0 to 0.64
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Mood swings,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 4.76
|
0.09 Percentage of subjects
Interval 0.0 to 0.64
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Mood swings,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 4.76
|
0.09 Percentage of subjects
Interval 0.0 to 0.64
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Sleep disorder,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Sleep disorder,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Sleep disorder,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.49 Percentage of subjects
Interval 0.0 to 10.27
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.25 Percentage of subjects
Interval 0.0 to 2.0
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Sleep disorder,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
0.46 Percentage of subjects
Interval 0.0 to 8.71
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.19 Percentage of subjects
Interval 0.0 to 1.52
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Sleep disorder,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 1.76
|
0.43 Percentage of subjects
Interval 0.0 to 7.29
|
0.00 Percentage of subjects
Interval 0.0 to 1.87
|
0.16 Percentage of subjects
Interval 0.0 to 1.11
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Sleep disorder,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 1.3
|
0.40 Percentage of subjects
Interval 0.0 to 5.98
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.11 Percentage of subjects
Interval 0.0 to 0.81
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Sleep disorder,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 1.19
|
0.36 Percentage of subjects
Interval 0.0 to 4.6
|
0.00 Percentage of subjects
Interval 0.0 to 0.88
|
0.10 Percentage of subjects
Interval 0.0 to 0.7
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Sleep disorder,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.84
|
0.10 Percentage of subjects
Interval 0.0 to 0.67
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Sleep disorder,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Sleep disorder,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Sleep disorder,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Sleep disorder,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Sleep disorder,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Irritability,Weeks 40-50
|
0.91 Percentage of subjects
Interval 0.0 to 7.18
|
1.44 Percentage of subjects
Interval 0.0 to 17.09
|
2.43 Percentage of subjects
Interval 0.4 to 7.64
|
1.70 Percentage of subjects
Interval 0.73 to 3.34
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Irritability,Weeks 40-51
|
0.91 Percentage of subjects
Interval 0.0 to 7.18
|
1.44 Percentage of subjects
Interval 0.0 to 17.09
|
2.43 Percentage of subjects
Interval 0.4 to 7.64
|
1.70 Percentage of subjects
Interval 0.73 to 3.34
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Irritability,Weeks 40-52
|
0.91 Percentage of subjects
Interval 0.0 to 7.18
|
1.44 Percentage of subjects
Interval 0.0 to 17.09
|
2.43 Percentage of subjects
Interval 0.4 to 7.64
|
1.70 Percentage of subjects
Interval 0.73 to 3.34
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Insomnia,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Insomnia,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Insomnia,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.49 Percentage of subjects
Interval 0.0 to 10.27
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.25 Percentage of subjects
Interval 0.0 to 2.0
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Insomnia,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
0.46 Percentage of subjects
Interval 0.0 to 8.71
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.19 Percentage of subjects
Interval 0.0 to 1.52
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Insomnia,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 1.76
|
0.43 Percentage of subjects
Interval 0.0 to 7.29
|
0.00 Percentage of subjects
Interval 0.0 to 1.87
|
0.16 Percentage of subjects
Interval 0.0 to 1.11
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Insomnia,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 1.3
|
0.40 Percentage of subjects
Interval 0.0 to 5.98
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.11 Percentage of subjects
Interval 0.0 to 0.81
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Insomnia,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 1.19
|
0.36 Percentage of subjects
Interval 0.0 to 4.6
|
0.00 Percentage of subjects
Interval 0.0 to 0.88
|
0.10 Percentage of subjects
Interval 0.0 to 0.7
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Insomnia,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.84
|
0.10 Percentage of subjects
Interval 0.0 to 0.67
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Insomnia,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Insomnia,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Insomnia,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Insomnia,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
PRIMARY outcome
Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEI listed on the ADR card was irritability.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=139 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 15.44
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Weeks 40-48
|
4.26 Percentage of subjects
Interval 0.0 to 40.16
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Weeks 40-49
|
4.94 Percentage of subjects
Interval 0.59 to 16.86
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Weeks 40-50
|
3.25 Percentage of subjects
Interval 0.35 to 11.68
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Weeks 40-51
|
2.96 Percentage of subjects
Interval 0.32 to 10.76
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Weeks 40-52
|
2.88 Percentage of subjects
Interval 0.31 to 10.46
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Irritability,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Irritability,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 15.44
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Irritability,Weeks 40-48
|
4.26 Percentage of subjects
Interval 0.0 to 40.16
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Irritability,Weeks 40-49
|
4.94 Percentage of subjects
Interval 0.59 to 16.86
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Irritability,Weeks 40-50
|
3.25 Percentage of subjects
Interval 0.35 to 11.68
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Irritability,Weeks 40-51
|
2.96 Percentage of subjects
Interval 0.32 to 10.76
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Irritability,Weeks 40-52
|
2.88 Percentage of subjects
Interval 0.31 to 10.46
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were cough, dysphonia, epistaxis, nasal congestion, oropharyngeal pain, rhinorrhoea, and wheezing.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Wheezing,Weeks 40-45
|
0.35 Percentage of subjects
Interval 0.0 to 5.12
|
1.20 Percentage of subjects
Interval 0.0 to 17.05
|
0.57 Percentage of subjects
Interval 0.03 to 2.6
|
0.68 Percentage of subjects
Interval 0.16 to 1.89
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Wheezing,Weeks 40-46
|
0.32 Percentage of subjects
Interval 0.0 to 5.39
|
1.09 Percentage of subjects
Interval 0.0 to 13.3
|
0.48 Percentage of subjects
Interval 0.06 to 1.72
|
0.60 Percentage of subjects
Interval 0.15 to 1.6
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Wheezing,Weeks 40-44
|
0.48 Percentage of subjects
Interval 0.0 to 3.76
|
1.29 Percentage of subjects
Interval 0.0 to 20.54
|
1.03 Percentage of subjects
Interval 0.0 to 11.81
|
0.94 Percentage of subjects
Interval 0.2 to 2.68
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-40
|
—
|
8.57 Percentage of subjects
Interval 0.31 to 37.07
|
—
|
8.57 Percentage of subjects
Interval 0.31 to 37.07
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-41
|
—
|
11.18 Percentage of subjects
Interval 1.36 to 35.08
|
—
|
11.18 Percentage of subjects
Interval 1.36 to 35.08
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-42
|
9.93 Percentage of subjects
Interval 0.87 to 34.53
|
10.78 Percentage of subjects
Interval 1.35 to 33.71
|
26.92 Percentage of subjects
Interval 0.28 to 88.26
|
12.59 Percentage of subjects
Interval 6.42 to 21.49
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-43
|
11.63 Percentage of subjects
Interval 0.0 to 88.89
|
11.52 Percentage of subjects
Interval 1.74 to 33.76
|
26.15 Percentage of subjects
Interval 8.21 to 52.91
|
15.22 Percentage of subjects
Interval 7.32 to 26.68
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-44
|
13.94 Percentage of subjects
Interval 1.58 to 43.03
|
11.21 Percentage of subjects
Interval 2.04 to 30.99
|
23.59 Percentage of subjects
Interval 17.82 to 30.18
|
15.91 Percentage of subjects
Interval 9.5 to 24.32
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-45
|
15.60 Percentage of subjects
Interval 2.23 to 44.35
|
12.00 Percentage of subjects
Interval 2.45 to 31.67
|
22.57 Percentage of subjects
Interval 15.58 to 30.91
|
17.35 Percentage of subjects
Interval 12.31 to 23.41
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-46
|
14.94 Percentage of subjects
Interval 3.31 to 37.29
|
11.59 Percentage of subjects
Interval 3.01 to 27.99
|
22.30 Percentage of subjects
Interval 15.71 to 30.1
|
17.08 Percentage of subjects
Interval 12.48 to 22.55
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-47
|
14.59 Percentage of subjects
Interval 4.03 to 33.6
|
11.51 Percentage of subjects
Interval 3.04 to 27.6
|
22.65 Percentage of subjects
Interval 13.27 to 34.59
|
17.15 Percentage of subjects
Interval 12.5 to 22.67
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-48
|
14.59 Percentage of subjects
Interval 4.03 to 33.6
|
11.51 Percentage of subjects
Interval 3.04 to 27.6
|
22.96 Percentage of subjects
Interval 12.87 to 35.99
|
17.36 Percentage of subjects
Interval 12.64 to 22.96
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-49
|
14.59 Percentage of subjects
Interval 4.03 to 33.6
|
11.51 Percentage of subjects
Interval 3.04 to 27.6
|
22.96 Percentage of subjects
Interval 12.87 to 35.99
|
17.36 Percentage of subjects
Interval 12.64 to 22.96
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-50
|
14.59 Percentage of subjects
Interval 4.03 to 33.6
|
11.51 Percentage of subjects
Interval 3.04 to 27.6
|
22.96 Percentage of subjects
Interval 12.87 to 35.99
|
17.36 Percentage of subjects
Interval 12.64 to 22.96
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-51
|
14.59 Percentage of subjects
Interval 4.03 to 33.6
|
11.51 Percentage of subjects
Interval 3.04 to 27.6
|
22.96 Percentage of subjects
Interval 12.87 to 35.99
|
17.36 Percentage of subjects
Interval 12.64 to 22.96
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-52
|
14.59 Percentage of subjects
Interval 4.03 to 33.6
|
11.51 Percentage of subjects
Interval 3.04 to 27.6
|
22.96 Percentage of subjects
Interval 12.87 to 35.99
|
17.36 Percentage of subjects
Interval 12.64 to 22.96
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Cough,Weeks 40-40
|
—
|
7.14 Percentage of subjects
Interval 0.27 to 31.53
|
—
|
7.14 Percentage of subjects
Interval 0.27 to 31.53
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Cough,Weeks 40-41
|
—
|
4.35 Percentage of subjects
Interval 0.09 to 22.77
|
—
|
4.35 Percentage of subjects
Interval 0.09 to 22.77
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Cough,Weeks 40-42
|
2.84 Percentage of subjects
Interval 0.04 to 16.88
|
4.41 Percentage of subjects
Interval 0.22 to 19.28
|
15.38 Percentage of subjects
Interval 0.28 to 63.3
|
5.29 Percentage of subjects
Interval 1.74 to 11.93
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Cough,Weeks 40-43
|
3.49 Percentage of subjects
Interval 0.05 to 20.0
|
4.15 Percentage of subjects
Interval 0.19 to 18.61
|
15.38 Percentage of subjects
Interval 9.66 to 22.76
|
6.74 Percentage of subjects
Interval 1.9 to 16.23
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Cough,Weeks 40-44
|
3.37 Percentage of subjects
Interval 1.36 to 6.81
|
3.88 Percentage of subjects
Interval 0.14 to 18.39
|
14.36 Percentage of subjects
Interval 9.76 to 20.08
|
6.93 Percentage of subjects
Interval 2.42 to 14.99
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Cough,Weeks 40-45
|
3.90 Percentage of subjects
Interval 1.27 to 8.9
|
4.40 Percentage of subjects
Interval 0.49 to 15.44
|
10.86 Percentage of subjects
Interval 4.37 to 21.39
|
6.80 Percentage of subjects
Interval 3.44 to 11.85
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Cough,Weeks 40-46
|
3.57 Percentage of subjects
Interval 1.8 to 6.3
|
3.99 Percentage of subjects
Interval 0.39 to 14.69
|
10.55 Percentage of subjects
Interval 4.21 to 20.9
|
6.59 Percentage of subjects
Interval 3.39 to 11.38
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Cough,Weeks 40-47
|
3.65 Percentage of subjects
Interval 1.89 to 6.3
|
3.96 Percentage of subjects
Interval 0.38 to 14.67
|
10.53 Percentage of subjects
Interval 3.58 to 22.65
|
6.61 Percentage of subjects
Interval 3.43 to 11.32
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Cough,Weeks 40-48
|
3.65 Percentage of subjects
Interval 1.89 to 6.3
|
3.96 Percentage of subjects
Interval 0.38 to 14.67
|
10.60 Percentage of subjects
Interval 3.48 to 23.18
|
6.70 Percentage of subjects
Interval 3.53 to 11.37
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Cough,Weeks 40-49
|
3.65 Percentage of subjects
Interval 1.89 to 6.3
|
3.96 Percentage of subjects
Interval 0.38 to 14.67
|
10.60 Percentage of subjects
Interval 3.48 to 23.18
|
6.70 Percentage of subjects
Interval 3.53 to 11.37
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Cough,Weeks 40-50
|
3.65 Percentage of subjects
Interval 1.89 to 6.3
|
3.96 Percentage of subjects
Interval 0.38 to 14.67
|
10.60 Percentage of subjects
Interval 3.48 to 23.18
|
6.70 Percentage of subjects
Interval 3.53 to 11.37
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Cough,Weeks 40-51
|
3.65 Percentage of subjects
Interval 1.89 to 6.3
|
3.96 Percentage of subjects
Interval 0.38 to 14.67
|
10.60 Percentage of subjects
Interval 3.48 to 23.18
|
6.70 Percentage of subjects
Interval 3.53 to 11.37
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Cough,Weeks 40-52
|
3.65 Percentage of subjects
Interval 1.89 to 6.3
|
3.96 Percentage of subjects
Interval 0.38 to 14.67
|
10.60 Percentage of subjects
Interval 3.48 to 23.18
|
6.70 Percentage of subjects
Interval 3.53 to 11.37
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dysphonia,Weeks 40-40
|
—
|
4.29 Percentage of subjects
Interval 0.17 to 19.69
|
—
|
4.29 Percentage of subjects
Interval 0.17 to 19.69
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dysphonia,Weeks 40-41
|
—
|
2.48 Percentage of subjects
Interval 0.14 to 10.81
|
—
|
2.48 Percentage of subjects
Interval 0.14 to 10.81
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dysphonia,Weeks 40-42
|
1.42 Percentage of subjects
Interval 0.02 to 8.68
|
3.43 Percentage of subjects
Interval 0.09 to 17.62
|
3.85 Percentage of subjects
Interval 0.11 to 19.24
|
2.77 Percentage of subjects
Interval 1.05 to 5.86
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dysphonia,Weeks 40-43
|
1.74 Percentage of subjects
Interval 0.03 to 10.34
|
3.23 Percentage of subjects
Interval 0.16 to 14.35
|
3.08 Percentage of subjects
Interval 0.24 to 12.22
|
2.70 Percentage of subjects
Interval 1.4 to 4.67
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dysphonia,Weeks 40-44
|
1.44 Percentage of subjects
Interval 0.3 to 4.16
|
3.02 Percentage of subjects
Interval 0.26 to 11.63
|
2.56 Percentage of subjects
Interval 0.59 to 7.01
|
2.36 Percentage of subjects
Interval 1.33 to 3.87
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dysphonia,Weeks 40-45
|
1.06 Percentage of subjects
Interval 0.14 to 3.71
|
3.60 Percentage of subjects
Interval 0.21 to 15.27
|
2.57 Percentage of subjects
Interval 1.18 to 4.83
|
2.38 Percentage of subjects
Interval 1.29 to 4.0
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dysphonia,Weeks 40-46
|
0.97 Percentage of subjects
Interval 0.07 to 4.1
|
3.26 Percentage of subjects
Interval 0.4 to 11.22
|
2.40 Percentage of subjects
Interval 1.16 to 4.37
|
2.20 Percentage of subjects
Interval 1.29 to 3.49
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dysphonia,Weeks 40-47
|
1.22 Percentage of subjects
Interval 0.33 to 3.08
|
3.24 Percentage of subjects
Interval 0.42 to 10.98
|
2.29 Percentage of subjects
Interval 1.1 to 4.17
|
2.20 Percentage of subjects
Interval 1.38 to 3.33
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dysphonia,Weeks 40-48
|
1.22 Percentage of subjects
Interval 0.33 to 3.08
|
3.24 Percentage of subjects
Interval 0.42 to 10.98
|
2.21 Percentage of subjects
Interval 1.06 to 4.02
|
2.17 Percentage of subjects
Interval 1.35 to 3.29
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dysphonia,Weeks 40-49
|
1.22 Percentage of subjects
Interval 0.33 to 3.08
|
3.24 Percentage of subjects
Interval 0.42 to 10.98
|
2.21 Percentage of subjects
Interval 1.06 to 4.02
|
2.17 Percentage of subjects
Interval 1.35 to 3.29
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dysphonia,Weeks 40-50
|
1.22 Percentage of subjects
Interval 0.33 to 3.08
|
3.24 Percentage of subjects
Interval 0.42 to 10.98
|
2.21 Percentage of subjects
Interval 1.06 to 4.02
|
2.17 Percentage of subjects
Interval 1.35 to 3.29
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dysphonia,Weeks 40-51
|
1.22 Percentage of subjects
Interval 0.33 to 3.08
|
3.24 Percentage of subjects
Interval 0.42 to 10.98
|
2.21 Percentage of subjects
Interval 1.06 to 4.02
|
2.17 Percentage of subjects
Interval 1.35 to 3.29
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dysphonia,Weeks 40-52
|
1.22 Percentage of subjects
Interval 0.33 to 3.08
|
3.24 Percentage of subjects
Interval 0.42 to 10.98
|
2.21 Percentage of subjects
Interval 1.06 to 4.02
|
2.17 Percentage of subjects
Interval 1.35 to 3.29
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Epistaxis,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Epistaxis,Weeks 40-41
|
—
|
1.24 Percentage of subjects
Interval 0.01 to 8.05
|
—
|
1.24 Percentage of subjects
Interval 0.01 to 8.05
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Epistaxis,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
1.47 Percentage of subjects
Interval 0.01 to 10.56
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.76 Percentage of subjects
Interval 0.04 to 3.42
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Epistaxis,Weeks 40-43
|
0.58 Percentage of subjects
Interval 0.0 to 86.72
|
1.84 Percentage of subjects
Interval 0.0 to 14.96
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.96 Percentage of subjects
Interval 0.08 to 3.95
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Epistaxis,Weeks 40-44
|
0.48 Percentage of subjects
Interval 0.0 to 12.12
|
1.72 Percentage of subjects
Interval 0.01 to 12.04
|
0.00 Percentage of subjects
Interval 0.0 to 1.87
|
0.79 Percentage of subjects
Interval 0.08 to 2.98
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Epistaxis,Weeks 40-45
|
0.35 Percentage of subjects
Interval 0.0 to 5.88
|
1.60 Percentage of subjects
Interval 0.03 to 9.43
|
1.14 Percentage of subjects
Interval 0.0 to 12.47
|
1.02 Percentage of subjects
Interval 0.32 to 2.4
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Epistaxis,Weeks 40-46
|
0.32 Percentage of subjects
Interval 0.0 to 4.64
|
1.45 Percentage of subjects
Interval 0.07 to 6.84
|
0.96 Percentage of subjects
Interval 0.0 to 9.17
|
0.90 Percentage of subjects
Interval 0.31 to 2.01
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Epistaxis,Weeks 40-47
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
1.44 Percentage of subjects
Interval 0.07 to 6.68
|
0.92 Percentage of subjects
Interval 0.0 to 7.97
|
0.86 Percentage of subjects
Interval 0.31 to 1.9
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Epistaxis,Weeks 40-48
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
1.44 Percentage of subjects
Interval 0.07 to 6.68
|
0.88 Percentage of subjects
Interval 0.0 to 7.39
|
0.85 Percentage of subjects
Interval 0.31 to 1.86
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Epistaxis,Weeks 40-49
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
1.44 Percentage of subjects
Interval 0.07 to 6.68
|
0.88 Percentage of subjects
Interval 0.0 to 7.39
|
0.85 Percentage of subjects
Interval 0.31 to 1.86
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Epistaxis,Weeks 40-50
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
1.44 Percentage of subjects
Interval 0.07 to 6.68
|
0.88 Percentage of subjects
Interval 0.0 to 7.39
|
0.85 Percentage of subjects
Interval 0.31 to 1.86
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Epistaxis,Weeks 40-51
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
1.44 Percentage of subjects
Interval 0.07 to 6.68
|
0.88 Percentage of subjects
Interval 0.0 to 7.39
|
0.85 Percentage of subjects
Interval 0.31 to 1.86
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Epistaxis,Weeks 40-52
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
1.44 Percentage of subjects
Interval 0.07 to 6.68
|
0.88 Percentage of subjects
Interval 0.0 to 7.39
|
0.85 Percentage of subjects
Interval 0.31 to 1.86
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Nasal congestion,Weeks 40-40
|
—
|
5.71 Percentage of subjects
Interval 0.22 to 25.74
|
—
|
5.71 Percentage of subjects
Interval 0.22 to 25.74
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Nasal congestion,Weeks 40-41
|
—
|
3.73 Percentage of subjects
Interval 0.0 to 29.85
|
—
|
3.73 Percentage of subjects
Interval 0.0 to 29.85
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Nasal congestion,Weeks 40-42
|
2.84 Percentage of subjects
Interval 0.04 to 16.88
|
3.92 Percentage of subjects
Interval 0.07 to 21.23
|
15.38 Percentage of subjects
Interval 0.28 to 63.3
|
5.04 Percentage of subjects
Interval 1.52 to 11.85
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Nasal congestion,Weeks 40-43
|
2.91 Percentage of subjects
Interval 0.45 to 9.29
|
4.15 Percentage of subjects
Interval 0.19 to 18.61
|
10.77 Percentage of subjects
Interval 0.72 to 39.43
|
5.39 Percentage of subjects
Interval 1.89 to 11.74
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Nasal congestion,Weeks 40-44
|
3.85 Percentage of subjects
Interval 0.21 to 16.51
|
4.31 Percentage of subjects
Interval 0.34 to 16.84
|
10.26 Percentage of subjects
Interval 6.38 to 15.4
|
5.98 Percentage of subjects
Interval 2.91 to 10.73
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Nasal congestion,Weeks 40-45
|
3.55 Percentage of subjects
Interval 0.72 to 10.14
|
4.00 Percentage of subjects
Interval 0.27 to 16.33
|
8.00 Percentage of subjects
Interval 5.38 to 11.35
|
5.44 Percentage of subjects
Interval 3.17 to 8.64
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Nasal congestion,Weeks 40-46
|
3.25 Percentage of subjects
Interval 0.46 to 10.64
|
3.62 Percentage of subjects
Interval 0.17 to 16.3
|
8.15 Percentage of subjects
Interval 5.71 to 11.21
|
5.39 Percentage of subjects
Interval 3.02 to 8.8
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Nasal congestion,Weeks 40-47
|
3.04 Percentage of subjects
Interval 0.31 to 11.21
|
3.60 Percentage of subjects
Interval 0.16 to 16.32
|
8.01 Percentage of subjects
Interval 5.64 to 10.96
|
5.27 Percentage of subjects
Interval 2.9 to 8.7
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Nasal congestion,Weeks 40-48
|
3.04 Percentage of subjects
Interval 0.31 to 11.21
|
3.60 Percentage of subjects
Interval 0.16 to 16.32
|
8.17 Percentage of subjects
Interval 5.82 to 11.08
|
5.38 Percentage of subjects
Interval 3.01 to 8.77
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Nasal congestion,Weeks 40-49
|
3.04 Percentage of subjects
Interval 0.31 to 11.21
|
3.60 Percentage of subjects
Interval 0.16 to 16.32
|
8.17 Percentage of subjects
Interval 5.82 to 11.08
|
5.38 Percentage of subjects
Interval 3.01 to 8.77
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Nasal congestion,Weeks 40-50
|
3.04 Percentage of subjects
Interval 0.31 to 11.21
|
3.60 Percentage of subjects
Interval 0.16 to 16.32
|
8.17 Percentage of subjects
Interval 5.82 to 11.08
|
5.38 Percentage of subjects
Interval 3.01 to 8.77
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Nasal congestion,Weeks 40-51
|
3.04 Percentage of subjects
Interval 0.31 to 11.21
|
3.60 Percentage of subjects
Interval 0.16 to 16.32
|
8.17 Percentage of subjects
Interval 5.82 to 11.08
|
5.38 Percentage of subjects
Interval 3.01 to 8.77
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Nasal congestion,Weeks 40-52
|
3.04 Percentage of subjects
Interval 0.31 to 11.21
|
3.60 Percentage of subjects
Interval 0.16 to 16.32
|
8.17 Percentage of subjects
Interval 5.82 to 11.08
|
5.38 Percentage of subjects
Interval 3.01 to 8.77
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Oropharyngeal pain,Weeks 40-40
|
—
|
5.71 Percentage of subjects
Interval 0.22 to 25.74
|
—
|
5.71 Percentage of subjects
Interval 0.22 to 25.74
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Oropharyngeal pain,Weeks 40-41
|
—
|
5.59 Percentage of subjects
Interval 0.11 to 28.89
|
—
|
5.59 Percentage of subjects
Interval 0.11 to 28.89
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Oropharyngeal pain,Weeks 40-42
|
3.55 Percentage of subjects
Interval 0.04 to 20.8
|
5.88 Percentage of subjects
Interval 0.61 to 20.68
|
1.92 Percentage of subjects
Interval 0.05 to 10.26
|
4.53 Percentage of subjects
Interval 2.13 to 8.35
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Oropharyngeal pain,Weeks 40-43
|
3.49 Percentage of subjects
Interval 0.05 to 20.0
|
5.53 Percentage of subjects
Interval 0.42 to 21.36
|
5.38 Percentage of subjects
Interval 0.4 to 20.9
|
4.82 Percentage of subjects
Interval 2.86 to 7.54
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Oropharyngeal pain,Weeks 40-44
|
3.37 Percentage of subjects
Interval 1.25 to 7.18
|
5.17 Percentage of subjects
Interval 0.25 to 22.45
|
4.62 Percentage of subjects
Interval 2.13 to 8.58
|
4.41 Percentage of subjects
Interval 2.85 to 6.48
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Oropharyngeal pain,Weeks 40-45
|
3.19 Percentage of subjects
Interval 1.05 to 7.26
|
5.60 Percentage of subjects
Interval 0.77 to 18.1
|
4.86 Percentage of subjects
Interval 2.65 to 8.09
|
4.54 Percentage of subjects
Interval 3.24 to 6.16
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Oropharyngeal pain,Weeks 40-46
|
3.25 Percentage of subjects
Interval 1.24 to 6.82
|
5.43 Percentage of subjects
Interval 0.8 to 17.17
|
5.28 Percentage of subjects
Interval 1.62 to 12.31
|
4.70 Percentage of subjects
Interval 3.28 to 6.48
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Oropharyngeal pain,Weeks 40-47
|
3.04 Percentage of subjects
Interval 1.09 to 6.6
|
5.40 Percentage of subjects
Interval 0.77 to 17.24
|
5.26 Percentage of subjects
Interval 2.14 to 10.55
|
4.60 Percentage of subjects
Interval 3.24 to 6.31
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Oropharyngeal pain,Weeks 40-48
|
3.04 Percentage of subjects
Interval 1.09 to 6.6
|
5.40 Percentage of subjects
Interval 0.77 to 17.24
|
5.74 Percentage of subjects
Interval 1.33 to 15.2
|
4.81 Percentage of subjects
Interval 3.17 to 6.97
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Oropharyngeal pain,Weeks 40-49
|
3.04 Percentage of subjects
Interval 1.09 to 6.6
|
5.40 Percentage of subjects
Interval 0.77 to 17.24
|
5.74 Percentage of subjects
Interval 1.33 to 15.2
|
4.81 Percentage of subjects
Interval 3.17 to 6.97
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Oropharyngeal pain,Weeks 40-50
|
3.04 Percentage of subjects
Interval 1.09 to 6.6
|
5.40 Percentage of subjects
Interval 0.77 to 17.24
|
5.74 Percentage of subjects
Interval 1.33 to 15.2
|
4.81 Percentage of subjects
Interval 3.17 to 6.97
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Oropharyngeal pain,Weeks 40-51
|
3.04 Percentage of subjects
Interval 1.09 to 6.6
|
5.40 Percentage of subjects
Interval 0.77 to 17.24
|
5.74 Percentage of subjects
Interval 1.33 to 15.2
|
4.81 Percentage of subjects
Interval 3.17 to 6.97
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Oropharyngeal pain,Weeks 40-52
|
3.04 Percentage of subjects
Interval 1.09 to 6.6
|
5.40 Percentage of subjects
Interval 0.77 to 17.24
|
5.74 Percentage of subjects
Interval 1.33 to 15.2
|
4.81 Percentage of subjects
Interval 3.17 to 6.97
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rhinorrhoea,Weeks 40-40
|
—
|
4.29 Percentage of subjects
Interval 0.17 to 19.69
|
—
|
4.29 Percentage of subjects
Interval 0.17 to 19.69
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rhinorrhoea,Weeks 40-41
|
—
|
5.59 Percentage of subjects
Interval 1.62 to 13.39
|
—
|
5.59 Percentage of subjects
Interval 1.62 to 13.39
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rhinorrhoea,Weeks 40-42
|
3.55 Percentage of subjects
Interval 0.0 to 90.3
|
5.88 Percentage of subjects
Interval 1.3 to 15.88
|
7.69 Percentage of subjects
Interval 0.19 to 36.17
|
5.29 Percentage of subjects
Interval 2.45 to 9.8
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rhinorrhoea,Weeks 40-43
|
5.81 Percentage of subjects
Interval 0.0 to 99.97
|
5.53 Percentage of subjects
Interval 1.56 to 13.44
|
9.23 Percentage of subjects
Interval 0.64 to 34.38
|
6.55 Percentage of subjects
Interval 2.99 to 12.19
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rhinorrhoea,Weeks 40-44
|
7.69 Percentage of subjects
Interval 0.0 to 56.43
|
5.17 Percentage of subjects
Interval 1.62 to 11.95
|
9.74 Percentage of subjects
Interval 5.97 to 14.8
|
7.40 Percentage of subjects
Interval 3.92 to 12.5
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rhinorrhoea,Weeks 40-45
|
9.93 Percentage of subjects
Interval 0.04 to 55.87
|
5.60 Percentage of subjects
Interval 1.92 to 12.31
|
10.00 Percentage of subjects
Interval 7.01 to 13.72
|
8.73 Percentage of subjects
Interval 5.35 to 13.27
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rhinorrhoea,Weeks 40-46
|
9.74 Percentage of subjects
Interval 0.09 to 49.87
|
5.43 Percentage of subjects
Interval 2.16 to 11.03
|
9.83 Percentage of subjects
Interval 6.2 to 14.62
|
8.59 Percentage of subjects
Interval 5.53 to 12.59
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rhinorrhoea,Weeks 40-47
|
9.12 Percentage of subjects
Interval 0.19 to 42.57
|
5.40 Percentage of subjects
Interval 2.17 to 10.88
|
10.07 Percentage of subjects
Interval 4.58 to 18.56
|
8.52 Percentage of subjects
Interval 5.66 to 12.21
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rhinorrhoea,Weeks 40-48
|
9.12 Percentage of subjects
Interval 0.19 to 42.57
|
5.40 Percentage of subjects
Interval 2.17 to 10.88
|
10.38 Percentage of subjects
Interval 4.53 to 19.56
|
8.68 Percentage of subjects
Interval 5.8 to 12.38
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rhinorrhoea,Weeks 40-49
|
9.12 Percentage of subjects
Interval 0.19 to 42.57
|
5.40 Percentage of subjects
Interval 2.17 to 10.88
|
10.38 Percentage of subjects
Interval 4.53 to 19.56
|
8.68 Percentage of subjects
Interval 5.8 to 12.38
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rhinorrhoea,Weeks 40-50
|
9.12 Percentage of subjects
Interval 0.19 to 42.57
|
5.40 Percentage of subjects
Interval 2.17 to 10.88
|
10.38 Percentage of subjects
Interval 4.53 to 19.56
|
8.68 Percentage of subjects
Interval 5.8 to 12.38
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rhinorrhoea,Weeks 40-51
|
9.12 Percentage of subjects
Interval 0.19 to 42.57
|
5.40 Percentage of subjects
Interval 2.17 to 10.88
|
10.38 Percentage of subjects
Interval 4.53 to 19.56
|
8.68 Percentage of subjects
Interval 5.8 to 12.38
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rhinorrhoea,Weeks 40-52
|
9.12 Percentage of subjects
Interval 0.19 to 42.57
|
5.40 Percentage of subjects
Interval 2.17 to 10.88
|
10.38 Percentage of subjects
Interval 4.53 to 19.56
|
8.68 Percentage of subjects
Interval 5.8 to 12.38
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Wheezing,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Wheezing,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Wheezing,Weeks 40-42
|
0.71 Percentage of subjects
Interval 0.01 to 4.4
|
0.49 Percentage of subjects
Interval 0.0 to 10.27
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.50 Percentage of subjects
Interval 0.06 to 1.81
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Wheezing,Weeks 40-43
|
0.58 Percentage of subjects
Interval 0.0 to 20.94
|
1.38 Percentage of subjects
Interval 0.0 to 24.2
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.77 Percentage of subjects
Interval 0.03 to 3.82
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dyspnoea,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
1.08 Percentage of subjects
Interval 0.0 to 13.06
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.28 Percentage of subjects
Interval 0.0 to 1.98
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Increased upper airway secretion,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Increased upper airway secretion,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Increased upper airway secretion,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Increased upper airway secretion,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
0.00 Percentage of subjects
Interval 0.0 to 1.69
|
0.77 Percentage of subjects
Interval 0.02 to 4.21
|
0.19 Percentage of subjects
Interval 0.0 to 1.28
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Increased upper airway secretion,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 1.76
|
0.00 Percentage of subjects
Interval 0.0 to 1.58
|
0.51 Percentage of subjects
Interval 0.01 to 2.82
|
0.16 Percentage of subjects
Interval 0.0 to 0.87
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Increased upper airway secretion,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 1.3
|
0.00 Percentage of subjects
Interval 0.0 to 1.46
|
0.29 Percentage of subjects
Interval 0.0 to 1.82
|
0.11 Percentage of subjects
Interval 0.0 to 0.63
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Increased upper airway secretion,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 1.19
|
0.00 Percentage of subjects
Interval 0.0 to 1.33
|
0.24 Percentage of subjects
Interval 0.0 to 2.15
|
0.10 Percentage of subjects
Interval 0.0 to 0.56
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Increased upper airway secretion,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.23 Percentage of subjects
Interval 0.0 to 2.24
|
0.10 Percentage of subjects
Interval 0.0 to 0.55
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Increased upper airway secretion,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 2.33
|
0.09 Percentage of subjects
Interval 0.0 to 0.54
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Increased upper airway secretion,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 2.33
|
0.09 Percentage of subjects
Interval 0.0 to 0.54
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Increased upper airway secretion,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 2.33
|
0.09 Percentage of subjects
Interval 0.0 to 0.54
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Increased upper airway secretion,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 2.33
|
0.09 Percentage of subjects
Interval 0.0 to 0.54
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Increased upper airway secretion,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 2.33
|
0.09 Percentage of subjects
Interval 0.0 to 0.54
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Sneezing,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Sneezing,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Sneezing,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Sneezing,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
0.00 Percentage of subjects
Interval 0.0 to 1.69
|
0.77 Percentage of subjects
Interval 0.02 to 4.21
|
0.19 Percentage of subjects
Interval 0.0 to 1.28
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Sneezing,Weeks 40-44
|
0.48 Percentage of subjects
Interval 0.0 to 15.39
|
0.00 Percentage of subjects
Interval 0.0 to 1.58
|
1.03 Percentage of subjects
Interval 0.12 to 3.66
|
0.47 Percentage of subjects
Interval 0.05 to 1.73
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Sneezing,Weeks 40-45
|
0.35 Percentage of subjects
Interval 0.0 to 10.83
|
0.00 Percentage of subjects
Interval 0.0 to 1.46
|
0.57 Percentage of subjects
Interval 0.01 to 3.61
|
0.34 Percentage of subjects
Interval 0.04 to 1.23
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Sneezing,Weeks 40-46
|
0.32 Percentage of subjects
Interval 0.0 to 10.19
|
0.00 Percentage of subjects
Interval 0.0 to 1.33
|
0.48 Percentage of subjects
Interval 0.0 to 4.27
|
0.30 Percentage of subjects
Interval 0.03 to 1.13
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Sneezing,Weeks 40-47
|
0.30 Percentage of subjects
Interval 0.0 to 9.75
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.46 Percentage of subjects
Interval 0.0 to 4.44
|
0.29 Percentage of subjects
Interval 0.03 to 1.1
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Sneezing,Weeks 40-48
|
0.30 Percentage of subjects
Interval 0.0 to 9.75
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.44 Percentage of subjects
Interval 0.0 to 4.62
|
0.28 Percentage of subjects
Interval 0.03 to 1.09
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Sneezing,Weeks 40-49
|
0.30 Percentage of subjects
Interval 0.0 to 9.75
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.44 Percentage of subjects
Interval 0.0 to 4.62
|
0.28 Percentage of subjects
Interval 0.03 to 1.09
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Wheezing,Weeks 40-47
|
0.30 Percentage of subjects
Interval 0.0 to 5.54
|
1.08 Percentage of subjects
Interval 0.0 to 13.06
|
0.46 Percentage of subjects
Interval 0.06 to 1.64
|
0.57 Percentage of subjects
Interval 0.14 to 1.56
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Wheezing,Weeks 40-48
|
0.30 Percentage of subjects
Interval 0.0 to 5.54
|
1.08 Percentage of subjects
Interval 0.0 to 13.06
|
0.44 Percentage of subjects
Interval 0.05 to 1.59
|
0.57 Percentage of subjects
Interval 0.14 to 1.53
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Wheezing,Weeks 40-49
|
0.30 Percentage of subjects
Interval 0.0 to 5.54
|
1.08 Percentage of subjects
Interval 0.0 to 13.06
|
0.44 Percentage of subjects
Interval 0.05 to 1.59
|
0.57 Percentage of subjects
Interval 0.14 to 1.53
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Wheezing,Weeks 40-50
|
0.30 Percentage of subjects
Interval 0.0 to 5.54
|
1.08 Percentage of subjects
Interval 0.0 to 13.06
|
0.44 Percentage of subjects
Interval 0.05 to 1.59
|
0.57 Percentage of subjects
Interval 0.14 to 1.53
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Wheezing,Weeks 40-51
|
0.30 Percentage of subjects
Interval 0.0 to 5.54
|
1.08 Percentage of subjects
Interval 0.0 to 13.06
|
0.44 Percentage of subjects
Interval 0.05 to 1.59
|
0.57 Percentage of subjects
Interval 0.14 to 1.53
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Wheezing,Weeks 40-52
|
0.30 Percentage of subjects
Interval 0.0 to 5.54
|
1.08 Percentage of subjects
Interval 0.0 to 13.06
|
0.44 Percentage of subjects
Interval 0.05 to 1.59
|
0.57 Percentage of subjects
Interval 0.14 to 1.53
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dry throat,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dry throat,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dry throat,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dry throat,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
0.00 Percentage of subjects
Interval 0.0 to 1.69
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.00 Percentage of subjects
Interval 0.0 to 0.71
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dry throat,Weeks 40-44
|
0.48 Percentage of subjects
Interval 0.0 to 15.39
|
0.00 Percentage of subjects
Interval 0.0 to 1.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.87
|
0.16 Percentage of subjects
Interval 0.0 to 1.29
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dry throat,Weeks 40-45
|
0.35 Percentage of subjects
Interval 0.0 to 10.83
|
0.00 Percentage of subjects
Interval 0.0 to 1.46
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.11 Percentage of subjects
Interval 0.0 to 0.91
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dry throat,Weeks 40-46
|
0.32 Percentage of subjects
Interval 0.0 to 10.19
|
0.00 Percentage of subjects
Interval 0.0 to 1.33
|
0.00 Percentage of subjects
Interval 0.0 to 0.88
|
0.10 Percentage of subjects
Interval 0.0 to 0.81
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dry throat,Weeks 40-47
|
0.30 Percentage of subjects
Interval 0.0 to 9.75
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.84
|
0.10 Percentage of subjects
Interval 0.0 to 0.78
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dry throat,Weeks 40-48
|
0.30 Percentage of subjects
Interval 0.0 to 9.75
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.76
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dry throat,Weeks 40-49
|
0.30 Percentage of subjects
Interval 0.0 to 9.75
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.76
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dry throat,Weeks 40-50
|
0.30 Percentage of subjects
Interval 0.0 to 9.75
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.76
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dry throat,Weeks 40-51
|
0.30 Percentage of subjects
Interval 0.0 to 9.75
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.76
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dry throat,Weeks 40-52
|
0.30 Percentage of subjects
Interval 0.0 to 9.75
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.76
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dyspnoea,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dyspnoea,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dyspnoea,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.98 Percentage of subjects
Interval 0.0 to 19.61
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.50 Percentage of subjects
Interval 0.0 to 3.97
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dyspnoea,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
1.38 Percentage of subjects
Interval 0.0 to 24.2
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.58 Percentage of subjects
Interval 0.0 to 4.52
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dyspnoea,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 1.76
|
1.29 Percentage of subjects
Interval 0.0 to 20.54
|
0.00 Percentage of subjects
Interval 0.0 to 1.87
|
0.47 Percentage of subjects
Interval 0.0 to 3.29
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dyspnoea,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 1.3
|
1.20 Percentage of subjects
Interval 0.0 to 17.05
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.34 Percentage of subjects
Interval 0.0 to 2.41
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dyspnoea,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 1.19
|
1.09 Percentage of subjects
Interval 0.0 to 13.3
|
0.00 Percentage of subjects
Interval 0.0 to 0.88
|
0.30 Percentage of subjects
Interval 0.0 to 2.08
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dyspnoea,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
1.08 Percentage of subjects
Interval 0.0 to 13.06
|
0.00 Percentage of subjects
Interval 0.0 to 0.84
|
0.29 Percentage of subjects
Interval 0.0 to 2.0
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dyspnoea,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
1.08 Percentage of subjects
Interval 0.0 to 13.06
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.28 Percentage of subjects
Interval 0.0 to 1.98
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dyspnoea,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
1.08 Percentage of subjects
Interval 0.0 to 13.06
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.28 Percentage of subjects
Interval 0.0 to 1.98
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dyspnoea,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
1.08 Percentage of subjects
Interval 0.0 to 13.06
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.28 Percentage of subjects
Interval 0.0 to 1.98
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dyspnoea,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
1.08 Percentage of subjects
Interval 0.0 to 13.06
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.28 Percentage of subjects
Interval 0.0 to 1.98
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Sneezing,Weeks 40-50
|
0.30 Percentage of subjects
Interval 0.0 to 9.75
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.44 Percentage of subjects
Interval 0.0 to 4.62
|
0.28 Percentage of subjects
Interval 0.03 to 1.09
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Sneezing,Weeks 40-51
|
0.30 Percentage of subjects
Interval 0.0 to 9.75
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.44 Percentage of subjects
Interval 0.0 to 4.62
|
0.28 Percentage of subjects
Interval 0.03 to 1.09
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Sneezing,Weeks 40-52
|
0.30 Percentage of subjects
Interval 0.0 to 9.75
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.44 Percentage of subjects
Interval 0.0 to 4.62
|
0.28 Percentage of subjects
Interval 0.03 to 1.09
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Throat clearing,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Throat clearing,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Throat clearing,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Throat clearing,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
0.00 Percentage of subjects
Interval 0.0 to 1.69
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.00 Percentage of subjects
Interval 0.0 to 0.71
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Throat clearing,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 1.76
|
0.00 Percentage of subjects
Interval 0.0 to 1.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.87
|
0.00 Percentage of subjects
Interval 0.0 to 0.58
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Throat clearing,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 1.3
|
0.00 Percentage of subjects
Interval 0.0 to 1.46
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.00 Percentage of subjects
Interval 0.0 to 0.42
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Throat clearing,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 1.19
|
0.00 Percentage of subjects
Interval 0.0 to 1.33
|
0.00 Percentage of subjects
Interval 0.0 to 0.88
|
0.00 Percentage of subjects
Interval 0.0 to 0.37
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Throat clearing,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.23 Percentage of subjects
Interval 0.0 to 5.17
|
0.10 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Throat clearing,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 4.76
|
0.09 Percentage of subjects
Interval 0.0 to 0.64
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Throat clearing,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 4.76
|
0.09 Percentage of subjects
Interval 0.0 to 0.64
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Throat clearing,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 4.76
|
0.09 Percentage of subjects
Interval 0.0 to 0.64
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Throat clearing,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 4.76
|
0.09 Percentage of subjects
Interval 0.0 to 0.64
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Throat clearing,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.22 Percentage of subjects
Interval 0.0 to 4.76
|
0.09 Percentage of subjects
Interval 0.0 to 0.64
|
PRIMARY outcome
Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were cough, dysphonia, epistaxis, nasal congestion, oropharyngeal pain, rhinorrhoea, and wheezing.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=139 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Weeks 40-47
|
13.64 Percentage of subjects
Interval 0.0 to 100.0
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Weeks 40-48
|
25.53 Percentage of subjects
Interval 5.89 to 57.29
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Weeks 40-49
|
18.52 Percentage of subjects
Interval 8.61 to 32.71
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Weeks 40-50
|
13.82 Percentage of subjects
Interval 8.26 to 21.2
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Weeks 40-51
|
14.07 Percentage of subjects
Interval 6.54 to 25.27
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Weeks 40-52
|
13.67 Percentage of subjects
Interval 6.04 to 25.29
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Cough,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Cough,Weeks 40-47
|
13.64 Percentage of subjects
Interval 0.0 to 100.0
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Cough,Weeks 40-48
|
17.02 Percentage of subjects
Interval 0.0 to 90.61
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Cough,Weeks 40-49
|
13.58 Percentage of subjects
Interval 1.89 to 39.84
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Cough,Weeks 40-50
|
10.57 Percentage of subjects
Interval 3.5 to 23.04
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Cough,Weeks 40-51
|
9.63 Percentage of subjects
Interval 2.9 to 22.07
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Cough,Weeks 40-52
|
9.35 Percentage of subjects
Interval 2.66 to 22.05
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Dysphonia,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Dysphonia,Weeks 40-47
|
4.55 Percentage of subjects
Interval 0.0 to 100.0
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Dysphonia,Weeks 40-48
|
6.38 Percentage of subjects
Interval 0.0 to 84.5
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Dysphonia,Weeks 40-49
|
3.70 Percentage of subjects
Interval 0.49 to 12.42
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Dysphonia,Weeks 40-50
|
2.44 Percentage of subjects
Interval 0.37 to 7.9
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Dysphonia,Weeks 40-51
|
2.22 Percentage of subjects
Interval 0.3 to 7.5
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Dysphonia,Weeks 40-52
|
2.16 Percentage of subjects
Interval 0.27 to 7.48
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Epistaxis,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Epistaxis,Weeks 40-47
|
4.55 Percentage of subjects
Interval 0.0 to 86.65
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Epistaxis,Weeks 40-48
|
2.13 Percentage of subjects
Interval 0.0 to 22.05
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Epistaxis,Weeks 40-49
|
1.23 Percentage of subjects
Interval 0.03 to 6.69
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Epistaxis,Weeks 40-50
|
0.81 Percentage of subjects
Interval 0.02 to 4.45
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Epistaxis,Weeks 40-51
|
0.74 Percentage of subjects
Interval 0.02 to 4.06
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Epistaxis,Weeks 40-52
|
0.72 Percentage of subjects
Interval 0.02 to 3.94
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Nasal congestion,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Nasal congestion,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 15.44
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Nasal congestion,Weeks 40-48
|
6.38 Percentage of subjects
Interval 0.0 to 54.84
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Nasal congestion,Weeks 40-49
|
4.94 Percentage of subjects
Interval 0.59 to 16.86
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Nasal congestion,Weeks 40-50
|
3.25 Percentage of subjects
Interval 0.35 to 11.68
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Nasal congestion,Weeks 40-51
|
2.96 Percentage of subjects
Interval 0.32 to 10.76
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Nasal congestion,Weeks 40-52
|
2.88 Percentage of subjects
Interval 0.31 to 10.46
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Oropharyngeal pain,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Oropharyngeal pain,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 15.44
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Oropharyngeal pain,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Oropharyngeal pain,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 4.45
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Oropharyngeal pain,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 2.95
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Oropharyngeal pain,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 2.7
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Oropharyngeal pain,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 2.62
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Rhinorrhoea,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Rhinorrhoea,Weeks 40-47
|
4.55 Percentage of subjects
Interval 0.0 to 100.0
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Rhinorrhoea,Weeks 40-48
|
12.77 Percentage of subjects
Interval 3.33 to 30.49
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Rhinorrhoea,Weeks 40-49
|
9.88 Percentage of subjects
Interval 1.33 to 30.59
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Rhinorrhoea,Weeks 40-50
|
7.32 Percentage of subjects
Interval 1.89 to 18.28
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Rhinorrhoea,Weeks 40-51
|
7.41 Percentage of subjects
Interval 0.6 to 27.31
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Rhinorrhoea,Weeks 40-52
|
7.19 Percentage of subjects
Interval 0.54 to 27.2
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Wheezing,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Wheezing,Weeks 40-47
|
4.55 Percentage of subjects
Interval 0.0 to 100.0
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Wheezing,Weeks 40-48
|
4.26 Percentage of subjects
Interval 0.0 to 97.64
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Wheezing,Weeks 40-49
|
2.47 Percentage of subjects
Interval 0.01 to 18.68
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Wheezing,Weeks 40-50
|
1.63 Percentage of subjects
Interval 0.01 to 12.28
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Wheezing,Weeks 40-51
|
1.48 Percentage of subjects
Interval 0.0 to 11.58
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Wheezing,Weeks 40-52
|
1.44 Percentage of subjects
Interval 0.0 to 11.48
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Sneezing,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Sneezing,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 15.44
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Sneezing,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Sneezing,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 4.45
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Sneezing,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 2.95
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Sneezing,Weeks 40-51
|
0.74 Percentage of subjects
Interval 0.02 to 4.06
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Sneezing,Weeks 40-52
|
0.72 Percentage of subjects
Interval 0.02 to 3.94
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were rash and rash generalised.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Hyperhidrosis,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-40
|
—
|
2.86 Percentage of subjects
Interval 0.12 to 13.38
|
—
|
2.86 Percentage of subjects
Interval 0.12 to 13.38
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-41
|
—
|
1.86 Percentage of subjects
Interval 0.11 to 8.11
|
—
|
1.86 Percentage of subjects
Interval 0.11 to 8.11
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
1.96 Percentage of subjects
Interval 0.11 to 8.66
|
3.85 Percentage of subjects
Interval 0.11 to 19.24
|
1.51 Percentage of subjects
Interval 0.27 to 4.66
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-43
|
0.58 Percentage of subjects
Interval 0.0 to 86.72
|
2.30 Percentage of subjects
Interval 0.08 to 11.24
|
1.54 Percentage of subjects
Interval 0.12 to 6.2
|
1.54 Percentage of subjects
Interval 0.43 to 3.85
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-44
|
0.48 Percentage of subjects
Interval 0.0 to 12.12
|
2.16 Percentage of subjects
Interval 0.15 to 9.0
|
2.05 Percentage of subjects
Interval 0.28 to 6.91
|
1.57 Percentage of subjects
Interval 0.66 to 3.15
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-45
|
2.13 Percentage of subjects
Interval 0.0 to 23.4
|
2.00 Percentage of subjects
Interval 0.23 to 7.13
|
1.71 Percentage of subjects
Interval 0.0 to 14.61
|
1.93 Percentage of subjects
Interval 0.77 to 3.97
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-46
|
1.95 Percentage of subjects
Interval 0.0 to 18.56
|
2.17 Percentage of subjects
Interval 0.27 to 7.54
|
1.44 Percentage of subjects
Interval 0.0 to 12.96
|
1.80 Percentage of subjects
Interval 0.74 to 3.63
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-47
|
1.82 Percentage of subjects
Interval 0.0 to 15.58
|
2.16 Percentage of subjects
Interval 0.28 to 7.38
|
1.37 Percentage of subjects
Interval 0.0 to 11.8
|
1.72 Percentage of subjects
Interval 0.74 to 3.38
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-48
|
1.82 Percentage of subjects
Interval 0.0 to 15.58
|
2.16 Percentage of subjects
Interval 0.28 to 7.38
|
1.32 Percentage of subjects
Interval 0.0 to 11.51
|
1.70 Percentage of subjects
Interval 0.72 to 3.36
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-49
|
1.82 Percentage of subjects
Interval 0.0 to 15.58
|
2.16 Percentage of subjects
Interval 0.28 to 7.38
|
1.32 Percentage of subjects
Interval 0.0 to 11.51
|
1.70 Percentage of subjects
Interval 0.72 to 3.36
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-50
|
1.82 Percentage of subjects
Interval 0.0 to 15.58
|
2.16 Percentage of subjects
Interval 0.28 to 7.38
|
1.32 Percentage of subjects
Interval 0.0 to 11.51
|
1.70 Percentage of subjects
Interval 0.72 to 3.36
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-51
|
1.82 Percentage of subjects
Interval 0.0 to 15.58
|
2.16 Percentage of subjects
Interval 0.28 to 7.38
|
1.32 Percentage of subjects
Interval 0.0 to 11.51
|
1.70 Percentage of subjects
Interval 0.72 to 3.36
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-52
|
1.82 Percentage of subjects
Interval 0.0 to 15.58
|
2.16 Percentage of subjects
Interval 0.28 to 7.38
|
1.32 Percentage of subjects
Interval 0.0 to 11.51
|
1.70 Percentage of subjects
Interval 0.72 to 3.36
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rash,Weeks 40-40
|
—
|
1.43 Percentage of subjects
Interval 0.04 to 7.7
|
—
|
1.43 Percentage of subjects
Interval 0.04 to 7.7
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rash,Weeks 40-41
|
—
|
0.62 Percentage of subjects
Interval 0.0 to 5.51
|
—
|
0.62 Percentage of subjects
Interval 0.0 to 5.51
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rash,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.49 Percentage of subjects
Interval 0.0 to 6.53
|
1.92 Percentage of subjects
Interval 0.05 to 10.26
|
0.50 Percentage of subjects
Interval 0.04 to 2.11
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rash,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
0.46 Percentage of subjects
Interval 0.0 to 6.74
|
0.77 Percentage of subjects
Interval 0.02 to 4.21
|
0.39 Percentage of subjects
Interval 0.05 to 1.39
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rash,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 1.76
|
0.43 Percentage of subjects
Interval 0.0 to 6.92
|
1.54 Percentage of subjects
Interval 0.04 to 8.18
|
0.63 Percentage of subjects
Interval 0.15 to 1.73
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rash,Weeks 40-45
|
0.35 Percentage of subjects
Interval 0.0 to 5.88
|
0.40 Percentage of subjects
Interval 0.0 to 7.09
|
1.14 Percentage of subjects
Interval 0.0 to 9.92
|
0.68 Percentage of subjects
Interval 0.2 to 1.69
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rash,Weeks 40-46
|
0.32 Percentage of subjects
Interval 0.0 to 4.64
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
0.96 Percentage of subjects
Interval 0.0 to 8.78
|
0.60 Percentage of subjects
Interval 0.17 to 1.52
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rash,Weeks 40-47
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
0.92 Percentage of subjects
Interval 0.0 to 7.98
|
0.57 Percentage of subjects
Interval 0.16 to 1.43
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rash,Weeks 40-48
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
0.88 Percentage of subjects
Interval 0.0 to 7.79
|
0.57 Percentage of subjects
Interval 0.16 to 1.42
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rash,Weeks 40-49
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
0.88 Percentage of subjects
Interval 0.0 to 7.79
|
0.57 Percentage of subjects
Interval 0.16 to 1.42
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rash,Weeks 40-50
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
0.88 Percentage of subjects
Interval 0.0 to 7.79
|
0.57 Percentage of subjects
Interval 0.16 to 1.42
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rash,Weeks 40-51
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
0.88 Percentage of subjects
Interval 0.0 to 7.79
|
0.57 Percentage of subjects
Interval 0.16 to 1.42
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rash,Weeks 40-52
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
0.88 Percentage of subjects
Interval 0.0 to 7.79
|
0.57 Percentage of subjects
Interval 0.16 to 1.42
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rash generalised,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rash generalised,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rash generalised,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rash generalised,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
0.00 Percentage of subjects
Interval 0.0 to 1.69
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.00 Percentage of subjects
Interval 0.0 to 0.71
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rash generalised,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 1.76
|
0.00 Percentage of subjects
Interval 0.0 to 1.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.87
|
0.00 Percentage of subjects
Interval 0.0 to 0.58
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rash generalised,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 1.3
|
0.00 Percentage of subjects
Interval 0.0 to 1.46
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.00 Percentage of subjects
Interval 0.0 to 0.42
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rash generalised,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 1.19
|
0.36 Percentage of subjects
Interval 0.0 to 4.6
|
0.00 Percentage of subjects
Interval 0.0 to 0.88
|
0.10 Percentage of subjects
Interval 0.0 to 0.7
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rash generalised,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.84
|
0.10 Percentage of subjects
Interval 0.0 to 0.67
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rash generalised,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rash generalised,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rash generalised,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rash generalised,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rash generalised,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Erythema,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Erythema,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Erythema,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.79
|
1.92 Percentage of subjects
Interval 0.05 to 10.26
|
0.25 Percentage of subjects
Interval 0.0 to 2.11
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Erythema,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
0.00 Percentage of subjects
Interval 0.0 to 1.69
|
0.77 Percentage of subjects
Interval 0.02 to 4.21
|
0.19 Percentage of subjects
Interval 0.0 to 1.28
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Erythema,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 1.76
|
0.00 Percentage of subjects
Interval 0.0 to 1.58
|
0.51 Percentage of subjects
Interval 0.01 to 2.82
|
0.16 Percentage of subjects
Interval 0.0 to 0.87
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Erythema,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 1.3
|
0.00 Percentage of subjects
Interval 0.0 to 1.46
|
0.57 Percentage of subjects
Interval 0.0 to 5.05
|
0.23 Percentage of subjects
Interval 0.02 to 0.86
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Erythema,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 1.19
|
0.00 Percentage of subjects
Interval 0.0 to 1.33
|
0.48 Percentage of subjects
Interval 0.0 to 4.46
|
0.20 Percentage of subjects
Interval 0.02 to 0.77
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Erythema,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.46 Percentage of subjects
Interval 0.0 to 4.05
|
0.19 Percentage of subjects
Interval 0.02 to 0.74
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Erythema,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.44 Percentage of subjects
Interval 0.0 to 3.95
|
0.19 Percentage of subjects
Interval 0.02 to 0.73
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Hyperhidrosis,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Erythema,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.44 Percentage of subjects
Interval 0.0 to 3.95
|
0.19 Percentage of subjects
Interval 0.02 to 0.73
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Erythema,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.44 Percentage of subjects
Interval 0.0 to 3.95
|
0.19 Percentage of subjects
Interval 0.02 to 0.73
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Erythema,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.44 Percentage of subjects
Interval 0.0 to 3.95
|
0.19 Percentage of subjects
Interval 0.02 to 0.73
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Erythema,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.44 Percentage of subjects
Interval 0.0 to 3.95
|
0.19 Percentage of subjects
Interval 0.02 to 0.73
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pruritus generalised,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Hyperhidrosis,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
0.00 Percentage of subjects
Interval 0.0 to 1.69
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.00 Percentage of subjects
Interval 0.0 to 0.71
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Hyperhidrosis,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 1.76
|
0.00 Percentage of subjects
Interval 0.0 to 1.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.87
|
0.00 Percentage of subjects
Interval 0.0 to 0.58
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Hyperhidrosis,Weeks 40-45
|
0.35 Percentage of subjects
Interval 0.0 to 5.88
|
0.00 Percentage of subjects
Interval 0.0 to 1.46
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.11 Percentage of subjects
Interval 0.0 to 0.79
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Hyperhidrosis,Weeks 40-46
|
0.32 Percentage of subjects
Interval 0.0 to 4.64
|
0.00 Percentage of subjects
Interval 0.0 to 1.33
|
0.00 Percentage of subjects
Interval 0.0 to 0.88
|
0.10 Percentage of subjects
Interval 0.0 to 0.68
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Hyperhidrosis,Weeks 40-47
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.84
|
0.10 Percentage of subjects
Interval 0.0 to 0.64
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Hyperhidrosis,Weeks 40-48
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.63
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Hyperhidrosis,Weeks 40-49
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.63
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Hyperhidrosis,Weeks 40-50
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.63
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Hyperhidrosis,Weeks 40-51
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.63
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Hyperhidrosis,Weeks 40-52
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.63
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pruritus,Weeks 40-40
|
—
|
1.43 Percentage of subjects
Interval 0.04 to 7.7
|
—
|
1.43 Percentage of subjects
Interval 0.04 to 7.7
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pruritus,Weeks 40-41
|
—
|
1.24 Percentage of subjects
Interval 0.01 to 8.05
|
—
|
1.24 Percentage of subjects
Interval 0.01 to 8.05
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pruritus,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
1.47 Percentage of subjects
Interval 0.01 to 10.56
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.76 Percentage of subjects
Interval 0.04 to 3.42
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pruritus,Weeks 40-43
|
0.58 Percentage of subjects
Interval 0.0 to 86.72
|
1.84 Percentage of subjects
Interval 0.0 to 14.96
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.96 Percentage of subjects
Interval 0.08 to 3.95
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pruritus,Weeks 40-44
|
0.48 Percentage of subjects
Interval 0.0 to 12.12
|
1.72 Percentage of subjects
Interval 0.01 to 12.04
|
0.00 Percentage of subjects
Interval 0.0 to 1.87
|
0.79 Percentage of subjects
Interval 0.08 to 2.98
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pruritus,Weeks 40-45
|
1.06 Percentage of subjects
Interval 0.0 to 10.5
|
1.60 Percentage of subjects
Interval 0.03 to 9.43
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.79 Percentage of subjects
Interval 0.15 to 2.42
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pruritus,Weeks 40-46
|
0.97 Percentage of subjects
Interval 0.0 to 8.41
|
1.81 Percentage of subjects
Interval 0.03 to 10.38
|
0.00 Percentage of subjects
Interval 0.0 to 0.88
|
0.80 Percentage of subjects
Interval 0.13 to 2.54
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pruritus,Weeks 40-47
|
0.91 Percentage of subjects
Interval 0.0 to 7.18
|
1.80 Percentage of subjects
Interval 0.03 to 10.15
|
0.00 Percentage of subjects
Interval 0.0 to 0.84
|
0.77 Percentage of subjects
Interval 0.13 to 2.41
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pruritus,Weeks 40-48
|
0.91 Percentage of subjects
Interval 0.0 to 7.18
|
1.80 Percentage of subjects
Interval 0.03 to 10.15
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.75 Percentage of subjects
Interval 0.13 to 2.39
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pruritus,Weeks 40-49
|
0.91 Percentage of subjects
Interval 0.0 to 7.18
|
1.80 Percentage of subjects
Interval 0.03 to 10.15
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.75 Percentage of subjects
Interval 0.13 to 2.39
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pruritus,Weeks 40-50
|
0.91 Percentage of subjects
Interval 0.0 to 7.18
|
1.80 Percentage of subjects
Interval 0.03 to 10.15
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.75 Percentage of subjects
Interval 0.13 to 2.39
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pruritus,Weeks 40-51
|
0.91 Percentage of subjects
Interval 0.0 to 7.18
|
1.80 Percentage of subjects
Interval 0.03 to 10.15
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.75 Percentage of subjects
Interval 0.13 to 2.39
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pruritus,Weeks 40-52
|
0.91 Percentage of subjects
Interval 0.0 to 7.18
|
1.80 Percentage of subjects
Interval 0.03 to 10.15
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.75 Percentage of subjects
Interval 0.13 to 2.39
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pruritus generalised,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pruritus generalised,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pruritus generalised,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
0.00 Percentage of subjects
Interval 0.0 to 1.69
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.00 Percentage of subjects
Interval 0.0 to 0.71
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pruritus generalised,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 1.76
|
0.00 Percentage of subjects
Interval 0.0 to 1.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.87
|
0.00 Percentage of subjects
Interval 0.0 to 0.58
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pruritus generalised,Weeks 40-45
|
0.71 Percentage of subjects
Interval 0.0 to 11.46
|
0.00 Percentage of subjects
Interval 0.0 to 1.46
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.23 Percentage of subjects
Interval 0.0 to 1.58
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pruritus generalised,Weeks 40-46
|
0.65 Percentage of subjects
Interval 0.0 to 9.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.33
|
0.00 Percentage of subjects
Interval 0.0 to 0.88
|
0.20 Percentage of subjects
Interval 0.0 to 1.36
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pruritus generalised,Weeks 40-47
|
0.61 Percentage of subjects
Interval 0.0 to 7.67
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.84
|
0.19 Percentage of subjects
Interval 0.0 to 1.27
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pruritus generalised,Weeks 40-48
|
0.61 Percentage of subjects
Interval 0.0 to 7.67
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.19 Percentage of subjects
Interval 0.0 to 1.26
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pruritus generalised,Weeks 40-49
|
0.61 Percentage of subjects
Interval 0.0 to 7.67
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.19 Percentage of subjects
Interval 0.0 to 1.26
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pruritus generalised,Weeks 40-50
|
0.61 Percentage of subjects
Interval 0.0 to 7.67
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.19 Percentage of subjects
Interval 0.0 to 1.26
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pruritus generalised,Weeks 40-51
|
0.61 Percentage of subjects
Interval 0.0 to 7.67
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.19 Percentage of subjects
Interval 0.0 to 1.26
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pruritus generalised,Weeks 40-52
|
0.61 Percentage of subjects
Interval 0.0 to 7.67
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.19 Percentage of subjects
Interval 0.0 to 1.26
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Hyperhidrosis,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
PRIMARY outcome
Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were rash and rash generalised.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=139 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 15.44
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Weeks 40-48
|
2.13 Percentage of subjects
Interval 0.0 to 22.05
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Weeks 40-49
|
1.23 Percentage of subjects
Interval 0.03 to 6.69
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Weeks 40-50
|
0.81 Percentage of subjects
Interval 0.02 to 4.45
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Weeks 40-51
|
0.74 Percentage of subjects
Interval 0.02 to 4.06
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Weeks 40-52
|
0.72 Percentage of subjects
Interval 0.02 to 3.94
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Rash,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Rash,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 15.44
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Rash,Weeks 40-48
|
2.13 Percentage of subjects
Interval 0.0 to 22.05
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Rash,Weeks 40-49
|
1.23 Percentage of subjects
Interval 0.03 to 6.69
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Rash,Weeks 40-50
|
0.81 Percentage of subjects
Interval 0.02 to 4.45
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Rash,Weeks 40-51
|
0.74 Percentage of subjects
Interval 0.02 to 4.06
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Rash,Weeks 40-52
|
0.72 Percentage of subjects
Interval 0.02 to 3.94
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Rash generalised,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Rash generalised,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 15.44
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Rash generalised,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Rash generalised,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 4.45
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Rash generalised,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 2.95
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Rash generalised,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 2.7
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Rash generalised,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 2.62
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. There were no predefined AEIs listed on the ADR card for cardiac disorders.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-40
|
—
|
1.43 Percentage of subjects
Interval 0.04 to 7.7
|
—
|
1.43 Percentage of subjects
Interval 0.04 to 7.7
|
|
Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-41
|
—
|
0.62 Percentage of subjects
Interval 0.0 to 5.51
|
—
|
0.62 Percentage of subjects
Interval 0.0 to 5.51
|
|
Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.49 Percentage of subjects
Interval 0.0 to 6.53
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.25 Percentage of subjects
Interval 0.0 to 1.73
|
|
Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
0.46 Percentage of subjects
Interval 0.0 to 6.74
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.19 Percentage of subjects
Interval 0.0 to 1.43
|
|
Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 1.76
|
0.43 Percentage of subjects
Interval 0.0 to 6.92
|
0.00 Percentage of subjects
Interval 0.0 to 1.87
|
0.16 Percentage of subjects
Interval 0.0 to 1.09
|
|
Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 1.3
|
0.40 Percentage of subjects
Interval 0.0 to 7.09
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.11 Percentage of subjects
Interval 0.0 to 0.83
|
|
Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 1.19
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
0.00 Percentage of subjects
Interval 0.0 to 0.88
|
0.10 Percentage of subjects
Interval 0.0 to 0.74
|
|
Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
0.00 Percentage of subjects
Interval 0.0 to 0.84
|
0.10 Percentage of subjects
Interval 0.0 to 0.71
|
|
Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.7
|
|
Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.7
|
|
Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.7
|
|
Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.7
|
|
Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.7
|
|
Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tachycardia,Weeks 40-40
|
—
|
1.43 Percentage of subjects
Interval 0.04 to 7.7
|
—
|
1.43 Percentage of subjects
Interval 0.04 to 7.7
|
|
Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tachycardia,Weeks 40-41
|
—
|
0.62 Percentage of subjects
Interval 0.0 to 5.51
|
—
|
0.62 Percentage of subjects
Interval 0.0 to 5.51
|
|
Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tachycardia,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.49 Percentage of subjects
Interval 0.0 to 6.53
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.25 Percentage of subjects
Interval 0.0 to 1.73
|
|
Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tachycardia,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
0.46 Percentage of subjects
Interval 0.0 to 6.74
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.19 Percentage of subjects
Interval 0.0 to 1.43
|
|
Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tachycardia,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 1.76
|
0.43 Percentage of subjects
Interval 0.0 to 6.92
|
0.00 Percentage of subjects
Interval 0.0 to 1.87
|
0.16 Percentage of subjects
Interval 0.0 to 1.09
|
|
Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tachycardia,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 1.3
|
0.40 Percentage of subjects
Interval 0.0 to 7.09
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.11 Percentage of subjects
Interval 0.0 to 0.83
|
|
Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tachycardia,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 1.19
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
0.00 Percentage of subjects
Interval 0.0 to 0.88
|
0.10 Percentage of subjects
Interval 0.0 to 0.74
|
|
Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tachycardia,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
0.00 Percentage of subjects
Interval 0.0 to 0.84
|
0.10 Percentage of subjects
Interval 0.0 to 0.71
|
|
Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tachycardia,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.7
|
|
Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tachycardia,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.7
|
|
Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tachycardia,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.7
|
|
Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tachycardia,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.7
|
|
Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tachycardia,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.7
|
PRIMARY outcome
Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. There were no predefined AEIs listed on the ADR card for cardiac disorders.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=139 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
|
0 Percentage of subjects
Interval 0.0 to 2.62
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. There were no predefined AEIs listed on the ADR card for ear and labyrinth disorders.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-41
|
—
|
1.24 Percentage of subjects
Interval 0.01 to 8.05
|
—
|
1.24 Percentage of subjects
Interval 0.01 to 8.05
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.98 Percentage of subjects
Interval 0.06 to 4.38
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.50 Percentage of subjects
Interval 0.05 to 1.99
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
0.92 Percentage of subjects
Interval 0.08 to 3.65
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.39 Percentage of subjects
Interval 0.03 to 1.63
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-44
|
0.48 Percentage of subjects
Interval 0.0 to 15.39
|
0.86 Percentage of subjects
Interval 0.1 to 3.08
|
0.51 Percentage of subjects
Interval 0.01 to 2.82
|
0.63 Percentage of subjects
Interval 0.17 to 1.6
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-45
|
0.35 Percentage of subjects
Interval 0.0 to 10.83
|
1.60 Percentage of subjects
Interval 0.03 to 9.43
|
0.29 Percentage of subjects
Interval 0.0 to 1.82
|
0.68 Percentage of subjects
Interval 0.13 to 2.03
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-46
|
0.32 Percentage of subjects
Interval 0.0 to 10.19
|
1.81 Percentage of subjects
Interval 0.03 to 10.38
|
0.24 Percentage of subjects
Interval 0.0 to 2.15
|
0.70 Percentage of subjects
Interval 0.11 to 2.31
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-47
|
0.30 Percentage of subjects
Interval 0.0 to 9.75
|
1.80 Percentage of subjects
Interval 0.03 to 10.15
|
0.23 Percentage of subjects
Interval 0.0 to 2.24
|
0.67 Percentage of subjects
Interval 0.1 to 2.24
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-48
|
0.30 Percentage of subjects
Interval 0.0 to 9.75
|
1.80 Percentage of subjects
Interval 0.03 to 10.15
|
0.22 Percentage of subjects
Interval 0.0 to 2.33
|
0.66 Percentage of subjects
Interval 0.1 to 2.22
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-49
|
0.30 Percentage of subjects
Interval 0.0 to 9.75
|
1.80 Percentage of subjects
Interval 0.03 to 10.15
|
0.22 Percentage of subjects
Interval 0.0 to 2.33
|
0.66 Percentage of subjects
Interval 0.1 to 2.22
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-50
|
0.30 Percentage of subjects
Interval 0.0 to 9.75
|
1.80 Percentage of subjects
Interval 0.03 to 10.15
|
0.22 Percentage of subjects
Interval 0.0 to 2.33
|
0.66 Percentage of subjects
Interval 0.1 to 2.22
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-51
|
0.30 Percentage of subjects
Interval 0.0 to 9.75
|
1.80 Percentage of subjects
Interval 0.03 to 10.15
|
0.22 Percentage of subjects
Interval 0.0 to 2.33
|
0.66 Percentage of subjects
Interval 0.1 to 2.22
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-52
|
0.30 Percentage of subjects
Interval 0.0 to 9.75
|
1.80 Percentage of subjects
Interval 0.03 to 10.15
|
0.22 Percentage of subjects
Interval 0.0 to 2.33
|
0.66 Percentage of subjects
Interval 0.1 to 2.22
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear haemorrhage,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear haemorrhage,Weeks 40-41
|
—
|
0.62 Percentage of subjects
Interval 0.0 to 5.51
|
—
|
0.62 Percentage of subjects
Interval 0.0 to 5.51
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear haemorrhage,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.49 Percentage of subjects
Interval 0.0 to 6.53
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.25 Percentage of subjects
Interval 0.0 to 1.73
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear haemorrhage,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
0.46 Percentage of subjects
Interval 0.0 to 6.74
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.19 Percentage of subjects
Interval 0.0 to 1.43
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear haemorrhage,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 1.76
|
0.43 Percentage of subjects
Interval 0.0 to 6.92
|
0.00 Percentage of subjects
Interval 0.0 to 1.87
|
0.16 Percentage of subjects
Interval 0.0 to 1.09
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear haemorrhage,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 1.3
|
0.40 Percentage of subjects
Interval 0.0 to 7.09
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.11 Percentage of subjects
Interval 0.0 to 0.83
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear haemorrhage,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 1.19
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
0.00 Percentage of subjects
Interval 0.0 to 0.88
|
0.10 Percentage of subjects
Interval 0.0 to 0.74
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear haemorrhage,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
0.00 Percentage of subjects
Interval 0.0 to 0.84
|
0.10 Percentage of subjects
Interval 0.0 to 0.71
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear haemorrhage,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.7
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear haemorrhage,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.7
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear haemorrhage,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.7
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear haemorrhage,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.7
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear haemorrhage,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.7
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear pain,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear pain,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear pain,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear pain,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
0.00 Percentage of subjects
Interval 0.0 to 1.69
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.00 Percentage of subjects
Interval 0.0 to 0.71
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear pain,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 1.76
|
0.00 Percentage of subjects
Interval 0.0 to 1.58
|
0.51 Percentage of subjects
Interval 0.01 to 2.82
|
0.16 Percentage of subjects
Interval 0.0 to 0.87
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear pain,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 1.3
|
0.00 Percentage of subjects
Interval 0.0 to 1.46
|
0.29 Percentage of subjects
Interval 0.0 to 1.82
|
0.11 Percentage of subjects
Interval 0.0 to 0.63
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear pain,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 1.19
|
0.36 Percentage of subjects
Interval 0.0 to 4.6
|
0.24 Percentage of subjects
Interval 0.0 to 2.15
|
0.20 Percentage of subjects
Interval 0.02 to 0.72
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear pain,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.23 Percentage of subjects
Interval 0.0 to 2.24
|
0.19 Percentage of subjects
Interval 0.02 to 0.69
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear pain,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.22 Percentage of subjects
Interval 0.0 to 2.33
|
0.19 Percentage of subjects
Interval 0.02 to 0.68
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear pain,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.22 Percentage of subjects
Interval 0.0 to 2.33
|
0.19 Percentage of subjects
Interval 0.02 to 0.68
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear pain,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.22 Percentage of subjects
Interval 0.0 to 2.33
|
0.19 Percentage of subjects
Interval 0.02 to 0.68
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear pain,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.22 Percentage of subjects
Interval 0.0 to 2.33
|
0.19 Percentage of subjects
Interval 0.02 to 0.68
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear pain,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.22 Percentage of subjects
Interval 0.0 to 2.33
|
0.19 Percentage of subjects
Interval 0.02 to 0.68
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear pruritus,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear pruritus,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear pruritus,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear pruritus,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
0.00 Percentage of subjects
Interval 0.0 to 1.69
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.00 Percentage of subjects
Interval 0.0 to 0.71
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear pruritus,Weeks 40-44
|
0.48 Percentage of subjects
Interval 0.0 to 15.39
|
0.00 Percentage of subjects
Interval 0.0 to 1.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.87
|
0.16 Percentage of subjects
Interval 0.0 to 1.29
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear pruritus,Weeks 40-45
|
0.35 Percentage of subjects
Interval 0.0 to 10.83
|
0.00 Percentage of subjects
Interval 0.0 to 1.46
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.11 Percentage of subjects
Interval 0.0 to 0.91
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear pruritus,Weeks 40-46
|
0.32 Percentage of subjects
Interval 0.0 to 10.19
|
0.00 Percentage of subjects
Interval 0.0 to 1.33
|
0.00 Percentage of subjects
Interval 0.0 to 0.88
|
0.10 Percentage of subjects
Interval 0.0 to 0.81
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear pruritus,Weeks 40-47
|
0.30 Percentage of subjects
Interval 0.0 to 9.75
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.84
|
0.10 Percentage of subjects
Interval 0.0 to 0.78
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear pruritus,Weeks 40-48
|
0.30 Percentage of subjects
Interval 0.0 to 9.75
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.76
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear pruritus,Weeks 40-49
|
0.30 Percentage of subjects
Interval 0.0 to 9.75
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.76
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear pruritus,Weeks 40-50
|
0.30 Percentage of subjects
Interval 0.0 to 9.75
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.76
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear pruritus,Weeks 40-51
|
0.30 Percentage of subjects
Interval 0.0 to 9.75
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.76
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear pruritus,Weeks 40-52
|
0.30 Percentage of subjects
Interval 0.0 to 9.75
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.76
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tinnitus,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tinnitus,Weeks 40-41
|
—
|
0.62 Percentage of subjects
Interval 0.0 to 17.42
|
—
|
0.62 Percentage of subjects
Interval 0.0 to 17.42
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tinnitus,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.49 Percentage of subjects
Interval 0.0 to 10.27
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.25 Percentage of subjects
Interval 0.0 to 2.0
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tinnitus,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
0.46 Percentage of subjects
Interval 0.0 to 8.71
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.19 Percentage of subjects
Interval 0.0 to 1.52
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tinnitus,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 1.76
|
0.43 Percentage of subjects
Interval 0.0 to 7.29
|
0.00 Percentage of subjects
Interval 0.0 to 1.87
|
0.16 Percentage of subjects
Interval 0.0 to 1.11
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tinnitus,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 1.3
|
0.40 Percentage of subjects
Interval 0.0 to 5.98
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.11 Percentage of subjects
Interval 0.0 to 0.81
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tinnitus,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 1.19
|
0.36 Percentage of subjects
Interval 0.0 to 4.6
|
0.00 Percentage of subjects
Interval 0.0 to 0.88
|
0.10 Percentage of subjects
Interval 0.0 to 0.7
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tinnitus,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.84
|
0.10 Percentage of subjects
Interval 0.0 to 0.67
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tinnitus,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tinnitus,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tinnitus,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tinnitus,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tinnitus,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Vertigo,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Vertigo,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Vertigo,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Vertigo,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
0.00 Percentage of subjects
Interval 0.0 to 1.69
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.00 Percentage of subjects
Interval 0.0 to 0.71
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Vertigo,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 1.76
|
0.00 Percentage of subjects
Interval 0.0 to 1.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.87
|
0.00 Percentage of subjects
Interval 0.0 to 0.58
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Vertigo,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 1.3
|
0.80 Percentage of subjects
Interval 0.0 to 11.66
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.23 Percentage of subjects
Interval 0.0 to 1.61
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Vertigo,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 1.19
|
0.72 Percentage of subjects
Interval 0.0 to 9.03
|
0.00 Percentage of subjects
Interval 0.0 to 0.88
|
0.20 Percentage of subjects
Interval 0.0 to 1.39
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Vertigo,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.72 Percentage of subjects
Interval 0.0 to 8.86
|
0.00 Percentage of subjects
Interval 0.0 to 0.84
|
0.19 Percentage of subjects
Interval 0.0 to 1.34
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Vertigo,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.72 Percentage of subjects
Interval 0.0 to 8.86
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.19 Percentage of subjects
Interval 0.0 to 1.32
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Vertigo,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.72 Percentage of subjects
Interval 0.0 to 8.86
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.19 Percentage of subjects
Interval 0.0 to 1.32
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Vertigo,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.72 Percentage of subjects
Interval 0.0 to 8.86
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.19 Percentage of subjects
Interval 0.0 to 1.32
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Vertigo,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.72 Percentage of subjects
Interval 0.0 to 8.86
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.19 Percentage of subjects
Interval 0.0 to 1.32
|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Vertigo,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.72 Percentage of subjects
Interval 0.0 to 8.86
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.19 Percentage of subjects
Interval 0.0 to 1.32
|
PRIMARY outcome
Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. There were no predefined AEIs listed on the ADR card for ear and labyrinth disorders.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=139 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
|
0 Percentage of subjects
Interval 0.0 to 2.62
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. There were no predefined AEIs listed on the ADR card for eye disorders.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Eye discharge,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.49 Percentage of subjects
Interval 0.0 to 10.27
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.25 Percentage of subjects
Interval 0.0 to 2.0
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Eye discharge,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
0.46 Percentage of subjects
Interval 0.0 to 8.71
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.19 Percentage of subjects
Interval 0.0 to 1.52
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Eye discharge,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 1.76
|
0.43 Percentage of subjects
Interval 0.0 to 7.29
|
0.00 Percentage of subjects
Interval 0.0 to 1.87
|
0.16 Percentage of subjects
Interval 0.0 to 1.11
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Eye discharge,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 1.3
|
0.40 Percentage of subjects
Interval 0.0 to 5.98
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.11 Percentage of subjects
Interval 0.0 to 0.81
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Eye discharge,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 1.19
|
0.36 Percentage of subjects
Interval 0.0 to 4.6
|
0.00 Percentage of subjects
Interval 0.0 to 0.88
|
0.10 Percentage of subjects
Interval 0.0 to 0.7
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Eye discharge,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.84
|
0.10 Percentage of subjects
Interval 0.0 to 0.67
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Eye discharge,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Eye discharge,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Eye discharge,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Eye discharge,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Eye discharge,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Eye pruritus,Weeks 40-40
|
—
|
1.43 Percentage of subjects
Interval 0.04 to 7.7
|
—
|
1.43 Percentage of subjects
Interval 0.04 to 7.7
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Eye pruritus,Weeks 40-41
|
—
|
0.62 Percentage of subjects
Interval 0.0 to 5.51
|
—
|
0.62 Percentage of subjects
Interval 0.0 to 5.51
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Eye pruritus,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.49 Percentage of subjects
Interval 0.0 to 6.53
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.25 Percentage of subjects
Interval 0.0 to 1.73
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Eye pruritus,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
0.46 Percentage of subjects
Interval 0.0 to 6.74
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.19 Percentage of subjects
Interval 0.0 to 1.43
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Eye pruritus,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 1.76
|
0.43 Percentage of subjects
Interval 0.0 to 6.92
|
0.00 Percentage of subjects
Interval 0.0 to 1.87
|
0.16 Percentage of subjects
Interval 0.0 to 1.09
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Eye pruritus,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 1.3
|
0.40 Percentage of subjects
Interval 0.0 to 7.09
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.11 Percentage of subjects
Interval 0.0 to 0.83
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Eye pruritus,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 1.19
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
0.00 Percentage of subjects
Interval 0.0 to 0.88
|
0.10 Percentage of subjects
Interval 0.0 to 0.74
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Eye pruritus,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
0.00 Percentage of subjects
Interval 0.0 to 0.84
|
0.10 Percentage of subjects
Interval 0.0 to 0.71
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Eye pruritus,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.7
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Eye pruritus,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.7
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Eye pruritus,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.7
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Eye pruritus,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.7
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Eye pruritus,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 7.23
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.7
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Lacrimation increased,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Lacrimation increased,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Lacrimation increased,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.49 Percentage of subjects
Interval 0.0 to 10.27
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.25 Percentage of subjects
Interval 0.0 to 2.0
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Lacrimation increased,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
0.46 Percentage of subjects
Interval 0.0 to 8.71
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.19 Percentage of subjects
Interval 0.0 to 1.52
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Lacrimation increased,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 1.76
|
0.43 Percentage of subjects
Interval 0.0 to 7.29
|
0.00 Percentage of subjects
Interval 0.0 to 1.87
|
0.16 Percentage of subjects
Interval 0.0 to 1.11
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Lacrimation increased,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 1.3
|
0.40 Percentage of subjects
Interval 0.0 to 5.98
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.11 Percentage of subjects
Interval 0.0 to 0.81
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Lacrimation increased,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 1.19
|
0.36 Percentage of subjects
Interval 0.0 to 4.6
|
0.00 Percentage of subjects
Interval 0.0 to 0.88
|
0.10 Percentage of subjects
Interval 0.0 to 0.7
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Lacrimation increased,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.84
|
0.10 Percentage of subjects
Interval 0.0 to 0.67
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Lacrimation increased,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Lacrimation increased,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Lacrimation increased,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Lacrimation increased,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Lacrimation increased,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Swelling of eyelid,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Swelling of eyelid,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Swelling of eyelid,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Swelling of eyelid,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
0.00 Percentage of subjects
Interval 0.0 to 1.69
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.00 Percentage of subjects
Interval 0.0 to 0.71
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Swelling of eyelid,Weeks 40-44
|
0.48 Percentage of subjects
Interval 0.0 to 15.39
|
0.00 Percentage of subjects
Interval 0.0 to 1.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.87
|
0.16 Percentage of subjects
Interval 0.0 to 1.29
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Swelling of eyelid,Weeks 40-45
|
0.35 Percentage of subjects
Interval 0.0 to 10.83
|
0.00 Percentage of subjects
Interval 0.0 to 1.46
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.11 Percentage of subjects
Interval 0.0 to 0.91
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Swelling of eyelid,Weeks 40-46
|
0.32 Percentage of subjects
Interval 0.0 to 10.19
|
0.00 Percentage of subjects
Interval 0.0 to 1.33
|
0.00 Percentage of subjects
Interval 0.0 to 0.88
|
0.10 Percentage of subjects
Interval 0.0 to 0.81
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Swelling of eyelid,Weeks 40-47
|
0.30 Percentage of subjects
Interval 0.0 to 9.75
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.84
|
0.10 Percentage of subjects
Interval 0.0 to 0.78
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Swelling of eyelid,Weeks 40-48
|
0.30 Percentage of subjects
Interval 0.0 to 9.75
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.76
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Swelling of eyelid,Weeks 40-49
|
0.30 Percentage of subjects
Interval 0.0 to 9.75
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.76
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Swelling of eyelid,Weeks 40-50
|
0.30 Percentage of subjects
Interval 0.0 to 9.75
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.76
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Swelling of eyelid,Weeks 40-51
|
0.30 Percentage of subjects
Interval 0.0 to 9.75
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.76
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Swelling of eyelid,Weeks 40-52
|
0.30 Percentage of subjects
Interval 0.0 to 9.75
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.76
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-40
|
—
|
1.43 Percentage of subjects
Interval 0.04 to 7.7
|
—
|
1.43 Percentage of subjects
Interval 0.04 to 7.7
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-41
|
—
|
0.62 Percentage of subjects
Interval 0.0 to 5.51
|
—
|
0.62 Percentage of subjects
Interval 0.0 to 5.51
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
1.47 Percentage of subjects
Interval 0.01 to 10.56
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.76 Percentage of subjects
Interval 0.04 to 3.42
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
1.38 Percentage of subjects
Interval 0.02 to 8.51
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.58 Percentage of subjects
Interval 0.03 to 2.71
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-44
|
0.48 Percentage of subjects
Interval 0.0 to 15.39
|
1.29 Percentage of subjects
Interval 0.04 to 6.74
|
0.00 Percentage of subjects
Interval 0.0 to 1.87
|
0.63 Percentage of subjects
Interval 0.08 to 2.25
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-45
|
0.35 Percentage of subjects
Interval 0.0 to 10.83
|
1.20 Percentage of subjects
Interval 0.08 to 5.23
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.45 Percentage of subjects
Interval 0.05 to 1.66
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-46
|
0.32 Percentage of subjects
Interval 0.0 to 10.19
|
1.09 Percentage of subjects
Interval 0.14 to 3.8
|
0.00 Percentage of subjects
Interval 0.0 to 0.88
|
0.40 Percentage of subjects
Interval 0.05 to 1.45
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-47
|
0.30 Percentage of subjects
Interval 0.0 to 9.75
|
1.08 Percentage of subjects
Interval 0.14 to 3.72
|
0.00 Percentage of subjects
Interval 0.0 to 0.84
|
0.38 Percentage of subjects
Interval 0.04 to 1.4
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-48
|
0.30 Percentage of subjects
Interval 0.0 to 9.75
|
1.08 Percentage of subjects
Interval 0.14 to 3.72
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.38 Percentage of subjects
Interval 0.04 to 1.38
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-49
|
0.30 Percentage of subjects
Interval 0.0 to 9.75
|
1.08 Percentage of subjects
Interval 0.14 to 3.72
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.38 Percentage of subjects
Interval 0.04 to 1.38
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-50
|
0.30 Percentage of subjects
Interval 0.0 to 9.75
|
1.08 Percentage of subjects
Interval 0.14 to 3.72
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.38 Percentage of subjects
Interval 0.04 to 1.38
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-51
|
0.30 Percentage of subjects
Interval 0.0 to 9.75
|
1.08 Percentage of subjects
Interval 0.14 to 3.72
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.38 Percentage of subjects
Interval 0.04 to 1.38
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-52
|
0.30 Percentage of subjects
Interval 0.0 to 9.75
|
1.08 Percentage of subjects
Interval 0.14 to 3.72
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.38 Percentage of subjects
Interval 0.04 to 1.38
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Eye discharge,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Eye discharge,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
PRIMARY outcome
Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. There were no predefined AEIs listed on the ADR card for eye disorders.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=139 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Weeks 40-47
|
9.09 Percentage of subjects
Interval 0.0 to 98.76
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Weeks 40-48
|
4.26 Percentage of subjects
Interval 0.0 to 40.16
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Weeks 40-49
|
2.47 Percentage of subjects
Interval 0.3 to 8.64
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Weeks 40-50
|
1.63 Percentage of subjects
Interval 0.2 to 5.75
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Weeks 40-51
|
1.48 Percentage of subjects
Interval 0.18 to 5.25
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Weeks 40-52
|
1.44 Percentage of subjects
Interval 0.17 to 5.1
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Eye pruritus,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Eye pruritus,Weeks 40-47
|
9.09 Percentage of subjects
Interval 0.0 to 98.76
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Eye pruritus,Weeks 40-50
|
1.63 Percentage of subjects
Interval 0.2 to 5.75
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Eye pruritus,Weeks 40-51
|
1.48 Percentage of subjects
Interval 0.18 to 5.25
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Eye pruritus,Weeks 40-52
|
1.44 Percentage of subjects
Interval 0.17 to 5.1
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. There were no predefined AEIs listed on the ADR card for injury, poisoning and procedural complications.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
|
Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
|
Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
0.00 Percentage of subjects
Interval 0.0 to 1.69
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.00 Percentage of subjects
Interval 0.0 to 0.71
|
|
Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 1.76
|
0.00 Percentage of subjects
Interval 0.0 to 1.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.87
|
0.00 Percentage of subjects
Interval 0.0 to 0.58
|
|
Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 1.3
|
0.40 Percentage of subjects
Interval 0.0 to 5.98
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.11 Percentage of subjects
Interval 0.0 to 0.81
|
|
Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 1.19
|
0.36 Percentage of subjects
Interval 0.0 to 4.6
|
0.00 Percentage of subjects
Interval 0.0 to 0.88
|
0.10 Percentage of subjects
Interval 0.0 to 0.7
|
|
Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.84
|
0.10 Percentage of subjects
Interval 0.0 to 0.67
|
|
Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Muscle strain,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Muscle strain,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
|
Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Muscle strain,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
|
Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Muscle strain,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
0.00 Percentage of subjects
Interval 0.0 to 1.69
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.00 Percentage of subjects
Interval 0.0 to 0.71
|
|
Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Muscle strain,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 1.76
|
0.00 Percentage of subjects
Interval 0.0 to 1.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.87
|
0.00 Percentage of subjects
Interval 0.0 to 0.58
|
|
Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Muscle strain,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 1.3
|
0.40 Percentage of subjects
Interval 0.0 to 5.98
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.11 Percentage of subjects
Interval 0.0 to 0.81
|
|
Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Muscle strain,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 1.19
|
0.36 Percentage of subjects
Interval 0.0 to 4.6
|
0.00 Percentage of subjects
Interval 0.0 to 0.88
|
0.10 Percentage of subjects
Interval 0.0 to 0.7
|
|
Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Muscle strain,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.84
|
0.10 Percentage of subjects
Interval 0.0 to 0.67
|
|
Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Muscle strain,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Muscle strain,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Muscle strain,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Muscle strain,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Muscle strain,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 1.11
|
0.36 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.66
|
PRIMARY outcome
Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. There were no predefined AEIs listed on the ADR card for injury, poisoning and procedural complications.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=139 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
|
0 Percentage of subjects
Interval 0.0 to 2.62
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. There were no predefined AEIs listed on the ADR card for investigations.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
|
Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.98 Percentage of subjects
Interval 0.0 to 19.61
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.50 Percentage of subjects
Interval 0.0 to 3.97
|
|
Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
1.38 Percentage of subjects
Interval 0.0 to 24.2
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.58 Percentage of subjects
Interval 0.0 to 4.52
|
|
Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 1.76
|
1.29 Percentage of subjects
Interval 0.0 to 20.54
|
0.00 Percentage of subjects
Interval 0.0 to 1.87
|
0.47 Percentage of subjects
Interval 0.0 to 3.29
|
|
Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-45
|
0.35 Percentage of subjects
Interval 0.0 to 5.88
|
1.20 Percentage of subjects
Interval 0.0 to 17.05
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.45 Percentage of subjects
Interval 0.02 to 2.2
|
|
Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-46
|
0.32 Percentage of subjects
Interval 0.0 to 4.64
|
1.09 Percentage of subjects
Interval 0.0 to 13.3
|
0.00 Percentage of subjects
Interval 0.0 to 0.88
|
0.40 Percentage of subjects
Interval 0.02 to 1.88
|
|
Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-47
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
1.08 Percentage of subjects
Interval 0.0 to 13.06
|
0.00 Percentage of subjects
Interval 0.0 to 0.84
|
0.38 Percentage of subjects
Interval 0.02 to 1.79
|
|
Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-48
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
1.08 Percentage of subjects
Interval 0.0 to 13.06
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.38 Percentage of subjects
Interval 0.02 to 1.77
|
|
Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Heart rate increased,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.98 Percentage of subjects
Interval 0.0 to 19.61
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.50 Percentage of subjects
Interval 0.0 to 3.97
|
|
Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-49
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
1.08 Percentage of subjects
Interval 0.0 to 13.06
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.38 Percentage of subjects
Interval 0.02 to 1.77
|
|
Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-50
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
1.08 Percentage of subjects
Interval 0.0 to 13.06
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.38 Percentage of subjects
Interval 0.02 to 1.77
|
|
Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-51
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
1.08 Percentage of subjects
Interval 0.0 to 13.06
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.38 Percentage of subjects
Interval 0.02 to 1.77
|
|
Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-52
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
1.08 Percentage of subjects
Interval 0.0 to 13.06
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.38 Percentage of subjects
Interval 0.02 to 1.77
|
|
Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Heart rate increased,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Heart rate increased,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
|
Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Heart rate increased,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.12
|
1.38 Percentage of subjects
Interval 0.0 to 24.2
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.58 Percentage of subjects
Interval 0.0 to 4.52
|
|
Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Heart rate increased,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 1.76
|
1.29 Percentage of subjects
Interval 0.0 to 20.54
|
0.00 Percentage of subjects
Interval 0.0 to 1.87
|
0.47 Percentage of subjects
Interval 0.0 to 3.29
|
|
Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Heart rate increased,Weeks 40-45
|
0.35 Percentage of subjects
Interval 0.0 to 5.88
|
1.20 Percentage of subjects
Interval 0.0 to 17.05
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.45 Percentage of subjects
Interval 0.02 to 2.2
|
|
Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Heart rate increased,Weeks 40-46
|
0.32 Percentage of subjects
Interval 0.0 to 4.64
|
1.09 Percentage of subjects
Interval 0.0 to 13.3
|
0.00 Percentage of subjects
Interval 0.0 to 0.88
|
0.40 Percentage of subjects
Interval 0.02 to 1.88
|
|
Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Heart rate increased,Weeks 40-47
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
1.08 Percentage of subjects
Interval 0.0 to 13.06
|
0.00 Percentage of subjects
Interval 0.0 to 0.84
|
0.38 Percentage of subjects
Interval 0.02 to 1.79
|
|
Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Heart rate increased,Weeks 40-48
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
1.08 Percentage of subjects
Interval 0.0 to 13.06
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.38 Percentage of subjects
Interval 0.02 to 1.77
|
|
Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Heart rate increased,Weeks 40-49
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
1.08 Percentage of subjects
Interval 0.0 to 13.06
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.38 Percentage of subjects
Interval 0.02 to 1.77
|
|
Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Heart rate increased,Weeks 40-50
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
1.08 Percentage of subjects
Interval 0.0 to 13.06
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.38 Percentage of subjects
Interval 0.02 to 1.77
|
|
Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Heart rate increased,Weeks 40-51
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
1.08 Percentage of subjects
Interval 0.0 to 13.06
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.38 Percentage of subjects
Interval 0.02 to 1.77
|
|
Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Heart rate increased,Weeks 40-52
|
0.30 Percentage of subjects
Interval 0.0 to 3.9
|
1.08 Percentage of subjects
Interval 0.0 to 13.06
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.38 Percentage of subjects
Interval 0.02 to 1.77
|
PRIMARY outcome
Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52.There were no predefined AEIs listed on the ADR card for investigations.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=139 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
|
0 Percentage of subjects
Interval 0.0 to 2.62
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. There were no predefined AEIs listed on the ADR card for vascular disorders.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
|
Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-42
|
0.71 Percentage of subjects
Interval 0.01 to 4.4
|
0.00 Percentage of subjects
Interval 0.0 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.25 Percentage of subjects
Interval 0.01 to 1.42
|
|
Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-43
|
0.58 Percentage of subjects
Interval 0.0 to 20.94
|
0.00 Percentage of subjects
Interval 0.0 to 1.69
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.19 Percentage of subjects
Interval 0.0 to 1.25
|
|
Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-44
|
0.48 Percentage of subjects
Interval 0.0 to 3.76
|
0.00 Percentage of subjects
Interval 0.0 to 1.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.87
|
0.16 Percentage of subjects
Interval 0.0 to 0.99
|
|
Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-45
|
0.35 Percentage of subjects
Interval 0.0 to 5.12
|
0.00 Percentage of subjects
Interval 0.0 to 1.46
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.11 Percentage of subjects
Interval 0.0 to 0.77
|
|
Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-46
|
0.32 Percentage of subjects
Interval 0.0 to 5.39
|
0.00 Percentage of subjects
Interval 0.0 to 1.33
|
0.00 Percentage of subjects
Interval 0.0 to 0.88
|
0.10 Percentage of subjects
Interval 0.0 to 0.7
|
|
Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-47
|
0.30 Percentage of subjects
Interval 0.0 to 5.54
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.84
|
0.10 Percentage of subjects
Interval 0.0 to 0.68
|
|
Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-48
|
0.30 Percentage of subjects
Interval 0.0 to 5.54
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.67
|
|
Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-49
|
0.30 Percentage of subjects
Interval 0.0 to 5.54
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.67
|
|
Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-50
|
0.30 Percentage of subjects
Interval 0.0 to 5.54
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.67
|
|
Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-51
|
0.30 Percentage of subjects
Interval 0.0 to 5.54
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.67
|
|
Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Weeks 40-52
|
0.30 Percentage of subjects
Interval 0.0 to 5.54
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.67
|
|
Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Hot flush,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Hot flush,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.27
|
|
Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Hot flush,Weeks 40-42
|
0.71 Percentage of subjects
Interval 0.01 to 4.4
|
0.00 Percentage of subjects
Interval 0.0 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.25 Percentage of subjects
Interval 0.01 to 1.42
|
|
Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Hot flush,Weeks 40-43
|
0.58 Percentage of subjects
Interval 0.0 to 20.94
|
0.00 Percentage of subjects
Interval 0.0 to 1.69
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.19 Percentage of subjects
Interval 0.0 to 1.25
|
|
Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Hot flush,Weeks 40-44
|
0.48 Percentage of subjects
Interval 0.0 to 3.76
|
0.00 Percentage of subjects
Interval 0.0 to 1.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.87
|
0.16 Percentage of subjects
Interval 0.0 to 0.99
|
|
Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Hot flush,Weeks 40-45
|
0.35 Percentage of subjects
Interval 0.0 to 5.12
|
0.00 Percentage of subjects
Interval 0.0 to 1.46
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.11 Percentage of subjects
Interval 0.0 to 0.77
|
|
Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Hot flush,Weeks 40-46
|
0.32 Percentage of subjects
Interval 0.0 to 5.39
|
0.00 Percentage of subjects
Interval 0.0 to 1.33
|
0.00 Percentage of subjects
Interval 0.0 to 0.88
|
0.10 Percentage of subjects
Interval 0.0 to 0.7
|
|
Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Hot flush,Weeks 40-47
|
0.30 Percentage of subjects
Interval 0.0 to 5.54
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.84
|
0.10 Percentage of subjects
Interval 0.0 to 0.68
|
|
Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Hot flush,Weeks 40-48
|
0.30 Percentage of subjects
Interval 0.0 to 5.54
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.67
|
|
Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Hot flush,Weeks 40-49
|
0.30 Percentage of subjects
Interval 0.0 to 5.54
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.67
|
|
Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Hot flush,Weeks 40-50
|
0.30 Percentage of subjects
Interval 0.0 to 5.54
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.67
|
|
Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Hot flush,Weeks 40-51
|
0.30 Percentage of subjects
Interval 0.0 to 5.54
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.67
|
|
Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Hot flush,Weeks 40-52
|
0.30 Percentage of subjects
Interval 0.0 to 5.54
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.09 Percentage of subjects
Interval 0.0 to 0.67
|
PRIMARY outcome
Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. There were no predefined AEIs listed on the ADR card for vascular disorders.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=139 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
|
0 Percentage of subjects
Interval 0.0 to 2.62
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Any AEIs and/or Other Aes, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Week 40
|
—
|
32.86 Percentage of subjects
Interval 12.23 to 59.9
|
—
|
32.86 Percentage of subjects
Interval 12.23 to 59.9
|
|
Weekly Percentage of Subjects Reporting Any AEIs and/or Other Aes, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Week 41
|
—
|
36.26 Percentage of subjects
Interval 0.95 to 92.78
|
—
|
36.26 Percentage of subjects
Interval 0.95 to 92.78
|
|
Weekly Percentage of Subjects Reporting Any AEIs and/or Other Aes, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Week 42
|
45.39 Percentage of subjects
Interval 36.99 to 53.98
|
32.56 Percentage of subjects
Interval 19.08 to 48.54
|
44.23 Percentage of subjects
Interval 0.11 to 99.54
|
42.80 Percentage of subjects
Interval 35.52 to 50.31
|
|
Weekly Percentage of Subjects Reporting Any AEIs and/or Other Aes, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Week 43
|
45.16 Percentage of subjects
Interval 27.32 to 63.97
|
38.46 Percentage of subjects
Interval 13.86 to 68.42
|
47.44 Percentage of subjects
Interval 36.01 to 59.07
|
45.90 Percentage of subjects
Interval 36.85 to 55.16
|
|
Weekly Percentage of Subjects Reporting Any AEIs and/or Other Aes, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Week 44
|
55.56 Percentage of subjects
Interval 0.01 to 100.0
|
20.00 Percentage of subjects
Interval 4.33 to 48.09
|
35.38 Percentage of subjects
Interval 7.27 to 74.31
|
39.66 Percentage of subjects
Interval 19.21 to 63.16
|
|
Weekly Percentage of Subjects Reporting Any AEIs and/or Other Aes, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Week 45
|
35.14 Percentage of subjects
Interval 0.51 to 94.16
|
66.67 Percentage of subjects
Interval 40.99 to 86.66
|
50.97 Percentage of subjects
Interval 22.51 to 78.97
|
47.37 Percentage of subjects
Interval 32.15 to 62.96
|
|
Weekly Percentage of Subjects Reporting Any AEIs and/or Other Aes, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Week 46
|
26.92 Percentage of subjects
Interval 11.57 to 47.79
|
42.31 Percentage of subjects
Interval 23.35 to 63.08
|
38.81 Percentage of subjects
Interval 27.14 to 51.5
|
36.97 Percentage of subjects
Interval 28.01 to 46.66
|
|
Weekly Percentage of Subjects Reporting Any AEIs and/or Other Aes, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Week 47
|
38.10 Percentage of subjects
Interval 18.11 to 61.56
|
50.00 Percentage of subjects
Interval 1.26 to 98.74
|
70.00 Percentage of subjects
Interval 0.0 to 100.0
|
53.49 Percentage of subjects
Interval 16.09 to 88.07
|
|
Weekly Percentage of Subjects Reporting Any AEIs and/or Other Aes, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Week 48
|
—
|
—
|
81.25 Percentage of subjects
Interval 0.01 to 100.0
|
81.25 Percentage of subjects
Interval 0.01 to 100.0
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=139 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Any AEIs and/or AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Week 52
|
25.00 Percentage of subjects
Interval 0.63 to 80.59
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any AEIs and/or AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Week 46
|
33.33 Percentage of subjects
Interval 0.84 to 90.57
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any AEIs and/or AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Week 47
|
47.37 Percentage of subjects
Interval 24.45 to 71.14
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any AEIs and/or AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Week 48
|
44.00 Percentage of subjects
Interval 24.4 to 65.07
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any AEIs and/or AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Week 49
|
11.76 Percentage of subjects
Interval 0.58 to 44.96
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any AEIs and/or AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Week 50
|
9.52 Percentage of subjects
Interval 2.66 to 22.62
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any AEIs and/or AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Week 51
|
25.00 Percentage of subjects
Interval 0.0 to 100.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were diarrhoea, nausea, and vomiting.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 40
|
—
|
2.86 Percentage of subjects
Interval 0.12 to 13.38
|
—
|
2.86 Percentage of subjects
Interval 0.12 to 13.38
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 41
|
—
|
2.20 Percentage of subjects
Interval 0.01 to 16.5
|
—
|
2.20 Percentage of subjects
Interval 0.01 to 16.5
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 42
|
2.13 Percentage of subjects
Interval 0.0 to 57.89
|
11.63 Percentage of subjects
Interval 0.0 to 97.87
|
7.69 Percentage of subjects
Interval 0.19 to 36.17
|
5.08 Percentage of subjects
Interval 0.6 to 17.38
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 43
|
9.68 Percentage of subjects
Interval 2.04 to 25.75
|
7.69 Percentage of subjects
Interval 0.19 to 36.03
|
8.97 Percentage of subjects
Interval 0.05 to 50.25
|
9.02 Percentage of subjects
Interval 4.59 to 15.56
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 44
|
13.89 Percentage of subjects
Interval 0.0 to 87.39
|
6.67 Percentage of subjects
Interval 0.17 to 31.95
|
4.62 Percentage of subjects
Interval 0.4 to 17.47
|
7.76 Percentage of subjects
Interval 2.02 to 19.22
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 45
|
9.46 Percentage of subjects
Interval 3.89 to 18.52
|
11.11 Percentage of subjects
Interval 1.38 to 34.71
|
3.87 Percentage of subjects
Interval 0.04 to 23.24
|
6.07 Percentage of subjects
Interval 1.97 to 13.71
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 46
|
7.69 Percentage of subjects
Interval 0.95 to 25.13
|
3.85 Percentage of subjects
Interval 0.1 to 19.64
|
10.45 Percentage of subjects
Interval 1.35 to 32.48
|
8.40 Percentage of subjects
Interval 2.93 to 18.07
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 47
|
9.52 Percentage of subjects
Interval 1.17 to 30.38
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
10.00 Percentage of subjects
Interval 1.23 to 31.7
|
9.30 Percentage of subjects
Interval 2.59 to 22.14
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 48
|
—
|
—
|
12.50 Percentage of subjects
Interval 0.0 to 99.41
|
12.50 Percentage of subjects
Interval 0.0 to 99.41
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Diarrhoea,Week 40
|
—
|
2.86 Percentage of subjects
Interval 0.12 to 13.38
|
—
|
2.86 Percentage of subjects
Interval 0.12 to 13.38
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Diarrhoea,Week 41
|
—
|
2.20 Percentage of subjects
Interval 0.01 to 16.5
|
—
|
2.20 Percentage of subjects
Interval 0.01 to 16.5
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Diarrhoea,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
6.98 Percentage of subjects
Interval 0.0 to 87.92
|
3.85 Percentage of subjects
Interval 0.11 to 19.24
|
2.12 Percentage of subjects
Interval 0.03 to 12.28
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Diarrhoea,Week 43
|
6.45 Percentage of subjects
Interval 0.79 to 21.42
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
5.13 Percentage of subjects
Interval 0.0 to 75.69
|
4.92 Percentage of subjects
Interval 1.81 to 10.44
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Diarrhoea,Week 44
|
2.78 Percentage of subjects
Interval 0.0 to 84.65
|
6.67 Percentage of subjects
Interval 0.17 to 31.95
|
3.08 Percentage of subjects
Interval 0.0 to 24.91
|
3.45 Percentage of subjects
Interval 0.95 to 8.59
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Diarrhoea,Week 45
|
2.70 Percentage of subjects
Interval 0.0 to 85.98
|
5.56 Percentage of subjects
Interval 0.14 to 27.29
|
3.23 Percentage of subjects
Interval 0.0 to 33.25
|
3.24 Percentage of subjects
Interval 0.6 to 9.6
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Diarrhoea,Week 46
|
3.85 Percentage of subjects
Interval 0.1 to 19.64
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
5.97 Percentage of subjects
Interval 0.15 to 29.14
|
4.20 Percentage of subjects
Interval 0.4 to 15.52
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Diarrhoea,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Diarrhoea,Week 48
|
—
|
—
|
6.25 Percentage of subjects
Interval 0.0 to 89.64
|
6.25 Percentage of subjects
Interval 0.0 to 89.64
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Nausea,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Nausea,Week 41
|
—
|
1.10 Percentage of subjects
Interval 0.0 to 21.06
|
—
|
1.10 Percentage of subjects
Interval 0.0 to 21.06
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Nausea,Week 42
|
2.13 Percentage of subjects
Interval 0.0 to 57.89
|
4.65 Percentage of subjects
Interval 0.0 to 74.17
|
3.85 Percentage of subjects
Interval 0.11 to 19.24
|
2.97 Percentage of subjects
Interval 0.9 to 7.05
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Nausea,Week 43
|
3.23 Percentage of subjects
Interval 0.08 to 16.7
|
7.69 Percentage of subjects
Interval 0.19 to 36.03
|
2.56 Percentage of subjects
Interval 0.31 to 8.96
|
3.28 Percentage of subjects
Interval 0.9 to 8.18
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Nausea,Week 44
|
8.33 Percentage of subjects
Interval 1.75 to 22.47
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
3.08 Percentage of subjects
Interval 0.0 to 24.91
|
4.31 Percentage of subjects
Interval 0.9 to 12.07
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Nausea,Week 45
|
5.41 Percentage of subjects
Interval 0.0 to 64.32
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
1.29 Percentage of subjects
Interval 0.0 to 12.14
|
2.43 Percentage of subjects
Interval 0.24 to 9.1
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Nausea,Week 46
|
3.85 Percentage of subjects
Interval 0.1 to 19.64
|
3.85 Percentage of subjects
Interval 0.1 to 19.64
|
5.97 Percentage of subjects
Interval 0.15 to 29.14
|
5.04 Percentage of subjects
Interval 1.43 to 12.26
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Nausea,Week 47
|
9.52 Percentage of subjects
Interval 1.17 to 30.38
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
5.00 Percentage of subjects
Interval 0.0 to 99.98
|
6.98 Percentage of subjects
Interval 1.18 to 20.68
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Nausea,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Vomiting,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Vomiting,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Vomiting,Week 42
|
0.71 Percentage of subjects
Interval 0.01 to 4.4
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
5.77 Percentage of subjects
Interval 0.15 to 27.99
|
1.69 Percentage of subjects
Interval 0.07 to 8.2
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Vomiting,Week 43
|
3.23 Percentage of subjects
Interval 0.08 to 16.7
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
3.85 Percentage of subjects
Interval 0.57 to 12.37
|
3.28 Percentage of subjects
Interval 0.9 to 8.18
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Vomiting,Week 44
|
2.78 Percentage of subjects
Interval 0.0 to 84.65
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
3.08 Percentage of subjects
Interval 0.0 to 24.91
|
2.59 Percentage of subjects
Interval 0.54 to 7.37
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Vomiting,Week 45
|
2.70 Percentage of subjects
Interval 0.0 to 39.0
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
1.94 Percentage of subjects
Interval 0.0 to 28.41
|
2.02 Percentage of subjects
Interval 0.25 to 7.13
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Vomiting,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
1.49 Percentage of subjects
Interval 0.0 to 42.07
|
0.84 Percentage of subjects
Interval 0.0 to 9.95
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Vomiting,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
5.00 Percentage of subjects
Interval 0.0 to 99.71
|
2.33 Percentage of subjects
Interval 0.0 to 25.06
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Vomiting,Week 48
|
—
|
—
|
6.25 Percentage of subjects
Interval 0.0 to 89.64
|
6.25 Percentage of subjects
Interval 0.0 to 89.64
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Abdominal discomfort,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Abdominal discomfort,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Abdominal discomfort,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 1.55
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Abdominal discomfort,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Abdominal discomfort,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 3.13
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Abdominal discomfort,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
0.00 Percentage of subjects
Interval 0.0 to 1.48
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Abdominal discomfort,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
1.49 Percentage of subjects
Interval 0.04 to 8.04
|
0.84 Percentage of subjects
Interval 0.01 to 5.12
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Abdominal discomfort,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Abdominal discomfort,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Abdominal pain,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Abdominal pain,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Abdominal pain,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 1.55
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Abdominal pain,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
3.85 Percentage of subjects
Interval 0.57 to 12.37
|
2.46 Percentage of subjects
Interval 0.11 to 11.37
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Abdominal pain,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 3.13
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Abdominal pain,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
0.00 Percentage of subjects
Interval 0.0 to 1.48
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Abdominal pain,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Abdominal pain,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Abdominal pain,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Gingival bleeding,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Gingival bleeding,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Gingival bleeding,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 1.55
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Gingival bleeding,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Gingival bleeding,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 3.13
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Gingival bleeding,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
5.56 Percentage of subjects
Interval 0.14 to 27.29
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
0.40 Percentage of subjects
Interval 0.0 to 4.05
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Gingival bleeding,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Gingival bleeding,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Gingival bleeding,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Lip swelling,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Lip swelling,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Lip swelling,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
2.33 Percentage of subjects
Interval 0.0 to 47.9
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.42 Percentage of subjects
Interval 0.0 to 4.2
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Lip swelling,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Lip swelling,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 3.13
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Lip swelling,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
0.00 Percentage of subjects
Interval 0.0 to 1.48
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Lip swelling,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Lip swelling,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Lip swelling,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Stomatitis,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Stomatitis,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Stomatitis,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
2.33 Percentage of subjects
Interval 0.0 to 47.9
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.42 Percentage of subjects
Interval 0.0 to 4.2
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Stomatitis,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Stomatitis,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 3.13
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Stomatitis,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
0.00 Percentage of subjects
Interval 0.0 to 1.48
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Stomatitis,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Stomatitis,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Stomatitis,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tongue discomfort,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tongue discomfort,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tongue discomfort,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
2.33 Percentage of subjects
Interval 0.0 to 47.9
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.42 Percentage of subjects
Interval 0.0 to 4.2
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tongue discomfort,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tongue discomfort,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 3.13
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tongue discomfort,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
0.00 Percentage of subjects
Interval 0.0 to 1.48
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tongue discomfort,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tongue discomfort,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tongue discomfort,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were diarrhoea, nausea, and vomiting.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=139 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Week 46
|
33.33 Percentage of subjects
Interval 0.84 to 90.57
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Week 47
|
10.53 Percentage of subjects
Interval 0.0 to 91.11
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 13.72
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Week 49
|
0.00 Percentage of subjects
Interval 0.0 to 10.28
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Week 50
|
2.38 Percentage of subjects
Interval 0.0 to 58.03
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Week 51
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Week 52
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Diarrhoea,Week 46
|
33.33 Percentage of subjects
Interval 0.84 to 90.57
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Diarrhoea,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Diarrhoea,Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 13.72
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Diarrhoea,Week 49
|
0.00 Percentage of subjects
Interval 0.0 to 10.28
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Diarrhoea,Week 50
|
2.38 Percentage of subjects
Interval 0.0 to 58.03
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Diarrhoea,Week 51
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Diarrhoea,Week 52
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Nausea,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Nausea,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Nausea,Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 13.72
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Nausea,Week 49
|
0.00 Percentage of subjects
Interval 0.0 to 10.28
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Nausea,Week 50
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Nausea,Week 51
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Nausea,Week 52
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Vomiting,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Vomiting,Week 47
|
5.26 Percentage of subjects
Interval 0.0 to 100.0
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Vomiting,Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 13.72
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Vomiting,Week 49
|
0.00 Percentage of subjects
Interval 0.0 to 10.28
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Vomiting,Week 50
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Vomiting,Week 51
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Vomiting,Week 52
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Abdominal pain,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Abdominal pain,Week 47
|
5.26 Percentage of subjects
Interval 0.0 to 95.26
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Abdominal pain,Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 13.72
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Abdominal pain,Week 49
|
0.00 Percentage of subjects
Interval 0.0 to 10.28
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Abdominal pain,Week 50
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Abdominal pain,Week 51
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Abdominal pain,Week 52
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were chills, face oedema, fatigue, injection site erythema, injection site pain, injection site swelling, and pyrexia.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 40
|
—
|
25.71 Percentage of subjects
Interval 16.01 to 37.56
|
—
|
25.71 Percentage of subjects
Interval 16.01 to 37.56
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 41
|
—
|
29.67 Percentage of subjects
Interval 0.86 to 86.02
|
—
|
29.67 Percentage of subjects
Interval 0.86 to 86.02
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 42
|
31.21 Percentage of subjects
Interval 18.49 to 46.39
|
25.58 Percentage of subjects
Interval 1.1 to 77.48
|
26.92 Percentage of subjects
Interval 0.28 to 88.26
|
29.24 Percentage of subjects
Interval 23.52 to 35.49
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 43
|
19.35 Percentage of subjects
Interval 7.45 to 37.47
|
15.38 Percentage of subjects
Interval 1.92 to 45.45
|
26.92 Percentage of subjects
Interval 17.5 to 38.16
|
23.77 Percentage of subjects
Interval 15.38 to 33.97
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 44
|
41.67 Percentage of subjects
Interval 0.0 to 100.0
|
20.00 Percentage of subjects
Interval 4.33 to 48.09
|
18.46 Percentage of subjects
Interval 2.7 to 50.43
|
25.86 Percentage of subjects
Interval 8.25 to 52.11
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 45
|
17.57 Percentage of subjects
Interval 0.0 to 96.81
|
50.00 Percentage of subjects
Interval 26.02 to 73.98
|
32.90 Percentage of subjects
Interval 6.71 to 70.97
|
29.55 Percentage of subjects
Interval 14.19 to 49.27
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 46
|
15.38 Percentage of subjects
Interval 4.36 to 34.87
|
26.92 Percentage of subjects
Interval 11.57 to 47.79
|
28.36 Percentage of subjects
Interval 13.66 to 47.42
|
25.21 Percentage of subjects
Interval 15.92 to 36.52
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 47
|
28.57 Percentage of subjects
Interval 11.28 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
50.00 Percentage of subjects
Interval 3.46 to 96.54
|
37.21 Percentage of subjects
Interval 16.09 to 62.67
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 48
|
—
|
—
|
62.50 Percentage of subjects
Interval 2.31 to 99.81
|
62.50 Percentage of subjects
Interval 2.31 to 99.81
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Chills,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Chills,Week 41
|
—
|
3.30 Percentage of subjects
Interval 0.0 to 51.97
|
—
|
3.30 Percentage of subjects
Interval 0.0 to 51.97
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Chills,Week 42
|
0.71 Percentage of subjects
Interval 0.01 to 4.4
|
4.65 Percentage of subjects
Interval 0.0 to 74.17
|
1.92 Percentage of subjects
Interval 0.05 to 10.26
|
1.69 Percentage of subjects
Interval 0.24 to 5.71
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Chills,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
3.85 Percentage of subjects
Interval 0.57 to 12.37
|
2.46 Percentage of subjects
Interval 0.11 to 11.37
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Chills,Week 44
|
5.56 Percentage of subjects
Interval 0.0 to 98.06
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
1.54 Percentage of subjects
Interval 0.0 to 49.55
|
2.59 Percentage of subjects
Interval 0.04 to 14.92
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Chills,Week 45
|
1.35 Percentage of subjects
Interval 0.0 to 21.52
|
5.56 Percentage of subjects
Interval 0.14 to 27.29
|
1.94 Percentage of subjects
Interval 0.4 to 5.55
|
2.02 Percentage of subjects
Interval 0.66 to 4.66
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Chills,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
3.85 Percentage of subjects
Interval 0.1 to 19.64
|
5.97 Percentage of subjects
Interval 0.15 to 29.14
|
4.20 Percentage of subjects
Interval 0.4 to 15.52
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Chills,Week 47
|
4.76 Percentage of subjects
Interval 0.12 to 23.82
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
5.00 Percentage of subjects
Interval 0.0 to 99.98
|
4.65 Percentage of subjects
Interval 0.54 to 16.09
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Chills,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Face oedema,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Face oedema,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Face oedema,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 1.55
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Face oedema,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
1.28 Percentage of subjects
Interval 0.03 to 6.94
|
0.82 Percentage of subjects
Interval 0.02 to 4.48
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Face oedema,Week 44
|
2.78 Percentage of subjects
Interval 0.0 to 84.65
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.86 Percentage of subjects
Interval 0.0 to 7.14
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Face oedema,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
0.00 Percentage of subjects
Interval 0.0 to 1.48
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Face oedema,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Face oedema,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Face oedema,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Fatigue,Week 40
|
—
|
5.71 Percentage of subjects
Interval 0.22 to 25.74
|
—
|
5.71 Percentage of subjects
Interval 0.22 to 25.74
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Fatigue,Week 41
|
—
|
6.59 Percentage of subjects
Interval 0.04 to 39.62
|
—
|
6.59 Percentage of subjects
Interval 0.04 to 39.62
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Fatigue,Week 42
|
2.84 Percentage of subjects
Interval 0.04 to 16.88
|
9.30 Percentage of subjects
Interval 0.0 to 94.72
|
3.85 Percentage of subjects
Interval 0.11 to 19.24
|
4.24 Percentage of subjects
Interval 1.42 to 9.5
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Fatigue,Week 43
|
3.23 Percentage of subjects
Interval 0.08 to 16.7
|
15.38 Percentage of subjects
Interval 1.92 to 45.45
|
8.97 Percentage of subjects
Interval 0.05 to 50.25
|
8.20 Percentage of subjects
Interval 3.43 to 15.98
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Fatigue,Week 44
|
11.11 Percentage of subjects
Interval 0.0 to 99.99
|
13.33 Percentage of subjects
Interval 1.66 to 40.46
|
7.69 Percentage of subjects
Interval 0.14 to 37.96
|
9.48 Percentage of subjects
Interval 3.06 to 21.05
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Fatigue,Week 45
|
4.05 Percentage of subjects
Interval 0.0 to 53.08
|
16.67 Percentage of subjects
Interval 3.58 to 41.42
|
6.45 Percentage of subjects
Interval 0.01 to 45.16
|
6.48 Percentage of subjects
Interval 1.76 to 15.92
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Fatigue,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
3.85 Percentage of subjects
Interval 0.1 to 19.64
|
10.45 Percentage of subjects
Interval 4.3 to 20.35
|
6.72 Percentage of subjects
Interval 1.58 to 17.54
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Fatigue,Week 47
|
4.76 Percentage of subjects
Interval 0.12 to 23.82
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
15.00 Percentage of subjects
Interval 0.01 to 81.57
|
9.30 Percentage of subjects
Interval 1.44 to 27.75
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Fatigue,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site erythema,Week 40
|
—
|
8.57 Percentage of subjects
Interval 0.03 to 50.4
|
—
|
8.57 Percentage of subjects
Interval 0.03 to 50.4
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site erythema,Week 41
|
—
|
7.69 Percentage of subjects
Interval 3.15 to 15.21
|
—
|
7.69 Percentage of subjects
Interval 3.15 to 15.21
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site erythema,Week 42
|
0.71 Percentage of subjects
Interval 0.01 to 4.4
|
11.63 Percentage of subjects
Interval 0.0 to 100.0
|
5.77 Percentage of subjects
Interval 0.15 to 27.99
|
3.81 Percentage of subjects
Interval 0.3 to 14.98
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site erythema,Week 43
|
3.23 Percentage of subjects
Interval 0.08 to 16.7
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
6.41 Percentage of subjects
Interval 0.92 to 20.26
|
4.92 Percentage of subjects
Interval 1.32 to 12.25
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site erythema,Week 44
|
2.78 Percentage of subjects
Interval 0.0 to 99.94
|
6.67 Percentage of subjects
Interval 0.17 to 31.95
|
6.15 Percentage of subjects
Interval 1.7 to 15.01
|
5.17 Percentage of subjects
Interval 1.92 to 10.92
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site erythema,Week 45
|
2.70 Percentage of subjects
Interval 0.0 to 85.98
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
5.16 Percentage of subjects
Interval 0.14 to 25.09
|
4.05 Percentage of subjects
Interval 1.0 to 10.57
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site erythema,Week 46
|
7.69 Percentage of subjects
Interval 0.95 to 25.13
|
7.69 Percentage of subjects
Interval 0.95 to 25.13
|
5.97 Percentage of subjects
Interval 1.65 to 14.59
|
6.72 Percentage of subjects
Interval 2.95 to 12.82
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site erythema,Week 47
|
14.29 Percentage of subjects
Interval 3.05 to 36.34
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
6.98 Percentage of subjects
Interval 0.07 to 38.51
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site erythema,Week 48
|
—
|
—
|
6.25 Percentage of subjects
Interval 0.0 to 89.64
|
6.25 Percentage of subjects
Interval 0.0 to 89.64
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site pain,Week 40
|
—
|
17.14 Percentage of subjects
Interval 9.18 to 28.03
|
—
|
17.14 Percentage of subjects
Interval 9.18 to 28.03
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site pain,Week 41
|
—
|
18.68 Percentage of subjects
Interval 0.45 to 69.26
|
—
|
18.68 Percentage of subjects
Interval 0.45 to 69.26
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site pain,Week 42
|
28.37 Percentage of subjects
Interval 7.46 to 59.8
|
11.63 Percentage of subjects
Interval 3.89 to 25.08
|
15.38 Percentage of subjects
Interval 0.28 to 63.3
|
22.46 Percentage of subjects
Interval 11.43 to 37.26
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site pain,Week 43
|
16.13 Percentage of subjects
Interval 5.45 to 33.73
|
7.69 Percentage of subjects
Interval 0.19 to 36.03
|
6.41 Percentage of subjects
Interval 0.92 to 20.26
|
9.02 Percentage of subjects
Interval 2.58 to 21.26
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site pain,Week 44
|
22.22 Percentage of subjects
Interval 0.17 to 83.21
|
13.33 Percentage of subjects
Interval 1.66 to 40.46
|
6.15 Percentage of subjects
Interval 1.57 to 15.56
|
12.07 Percentage of subjects
Interval 3.94 to 26.25
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site pain,Week 45
|
10.81 Percentage of subjects
Interval 0.08 to 55.52
|
33.33 Percentage of subjects
Interval 13.34 to 59.01
|
20.00 Percentage of subjects
Interval 1.69 to 60.38
|
18.22 Percentage of subjects
Interval 7.78 to 33.71
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site pain,Week 46
|
3.85 Percentage of subjects
Interval 0.1 to 19.64
|
11.54 Percentage of subjects
Interval 2.45 to 30.15
|
17.91 Percentage of subjects
Interval 9.61 to 29.2
|
13.45 Percentage of subjects
Interval 6.23 to 24.24
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site pain,Week 47
|
14.29 Percentage of subjects
Interval 3.05 to 36.34
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
30.00 Percentage of subjects
Interval 0.0 to 100.0
|
20.93 Percentage of subjects
Interval 4.47 to 50.12
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site pain,Week 48
|
—
|
—
|
62.50 Percentage of subjects
Interval 2.31 to 99.81
|
62.50 Percentage of subjects
Interval 2.31 to 99.81
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site swelling,Week 40
|
—
|
11.43 Percentage of subjects
Interval 1.34 to 36.13
|
—
|
11.43 Percentage of subjects
Interval 1.34 to 36.13
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site swelling,Week 41
|
—
|
9.89 Percentage of subjects
Interval 2.71 to 23.6
|
—
|
9.89 Percentage of subjects
Interval 2.71 to 23.6
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site swelling,Week 42
|
4.96 Percentage of subjects
Interval 0.48 to 18.09
|
9.30 Percentage of subjects
Interval 0.0 to 100.0
|
5.77 Percentage of subjects
Interval 0.15 to 27.99
|
5.93 Percentage of subjects
Interval 2.76 to 10.94
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site swelling,Week 43
|
12.90 Percentage of subjects
Interval 3.63 to 29.83
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
6.41 Percentage of subjects
Interval 0.92 to 20.26
|
7.38 Percentage of subjects
Interval 2.54 to 16.06
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site swelling,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
13.33 Percentage of subjects
Interval 1.66 to 40.46
|
3.08 Percentage of subjects
Interval 0.37 to 10.68
|
3.45 Percentage of subjects
Interval 0.57 to 10.72
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site swelling,Week 45
|
2.70 Percentage of subjects
Interval 0.0 to 100.0
|
16.67 Percentage of subjects
Interval 3.58 to 41.42
|
6.45 Percentage of subjects
Interval 2.78 to 12.43
|
6.07 Percentage of subjects
Interval 1.95 to 13.77
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site swelling,Week 46
|
3.85 Percentage of subjects
Interval 0.1 to 19.64
|
15.38 Percentage of subjects
Interval 4.36 to 34.87
|
8.96 Percentage of subjects
Interval 1.32 to 27.23
|
9.24 Percentage of subjects
Interval 3.77 to 18.19
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site swelling,Week 47
|
14.29 Percentage of subjects
Interval 3.05 to 36.34
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
20.00 Percentage of subjects
Interval 0.0 to 99.87
|
16.28 Percentage of subjects
Interval 6.5 to 31.42
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site swelling,Week 48
|
—
|
—
|
18.75 Percentage of subjects
Interval 0.0 to 100.0
|
18.75 Percentage of subjects
Interval 0.0 to 100.0
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pyrexia,Week 40
|
—
|
2.86 Percentage of subjects
Interval 0.12 to 13.38
|
—
|
2.86 Percentage of subjects
Interval 0.12 to 13.38
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pyrexia,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pyrexia,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
5.77 Percentage of subjects
Interval 0.15 to 27.99
|
1.27 Percentage of subjects
Interval 0.0 to 11.17
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pyrexia,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
12.82 Percentage of subjects
Interval 1.67 to 38.65
|
8.20 Percentage of subjects
Interval 0.32 to 35.08
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pyrexia,Week 44
|
2.78 Percentage of subjects
Interval 0.0 to 84.65
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
3.08 Percentage of subjects
Interval 0.0 to 28.63
|
2.59 Percentage of subjects
Interval 0.54 to 7.37
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pyrexia,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
4.52 Percentage of subjects
Interval 0.41 to 16.82
|
2.83 Percentage of subjects
Interval 0.61 to 7.92
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pyrexia,Week 46
|
3.85 Percentage of subjects
Interval 0.1 to 19.64
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
7.46 Percentage of subjects
Interval 1.19 to 22.48
|
5.04 Percentage of subjects
Interval 0.91 to 14.89
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pyrexia,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
5.00 Percentage of subjects
Interval 0.0 to 99.71
|
2.33 Percentage of subjects
Interval 0.0 to 25.06
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pyrexia,Week 48
|
—
|
—
|
6.25 Percentage of subjects
Interval 0.0 to 89.64
|
6.25 Percentage of subjects
Interval 0.0 to 89.64
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Discomfort,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Discomfort,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Discomfort,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 1.55
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Discomfort,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Discomfort,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 3.13
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Discomfort,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.65 Percentage of subjects
Interval 0.0 to 7.91
|
0.40 Percentage of subjects
Interval 0.0 to 2.58
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Discomfort,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Discomfort,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Discomfort,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Feeling cold,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Feeling cold,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Feeling cold,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 1.55
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Feeling cold,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Feeling cold,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 3.13
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Feeling cold,Week 45
|
1.35 Percentage of subjects
Interval 0.0 to 21.52
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
0.40 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Feeling cold,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Feeling cold,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Feeling cold,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Feeling hot,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Feeling hot,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Feeling hot,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 1.55
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Feeling hot,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Feeling hot,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 3.13
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Feeling hot,Week 45
|
1.35 Percentage of subjects
Interval 0.0 to 21.52
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
0.40 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Feeling hot,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Feeling hot,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Feeling hot,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Influenza like illness,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Influenza like illness,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Influenza like illness,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 1.55
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Influenza like illness,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Influenza like illness,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 3.13
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Influenza like illness,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
0.00 Percentage of subjects
Interval 0.0 to 1.48
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Influenza like illness,Week 46
|
3.85 Percentage of subjects
Interval 0.1 to 19.64
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
1.49 Percentage of subjects
Interval 0.04 to 8.04
|
1.68 Percentage of subjects
Interval 0.2 to 5.94
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Influenza like illness,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Influenza like illness,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site haematoma,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site haematoma,Week 41
|
—
|
1.10 Percentage of subjects
Interval 0.0 to 20.56
|
—
|
1.10 Percentage of subjects
Interval 0.0 to 20.56
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site haematoma,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 1.55
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site haematoma,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site haematoma,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 3.13
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site haematoma,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
0.00 Percentage of subjects
Interval 0.0 to 1.48
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site haematoma,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site haematoma,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site haematoma,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site pruritus,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site pruritus,Week 41
|
—
|
1.10 Percentage of subjects
Interval 0.0 to 21.06
|
—
|
1.10 Percentage of subjects
Interval 0.0 to 21.06
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site pruritus,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 1.55
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site pruritus,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site pruritus,Week 44
|
2.78 Percentage of subjects
Interval 0.0 to 99.94
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.86 Percentage of subjects
Interval 0.0 to 8.39
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site pruritus,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
11.11 Percentage of subjects
Interval 1.38 to 34.71
|
0.65 Percentage of subjects
Interval 0.0 to 7.91
|
1.21 Percentage of subjects
Interval 0.03 to 6.55
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site pruritus,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site pruritus,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site pruritus,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site warmth,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site warmth,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site warmth,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 1.55
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site warmth,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site warmth,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 3.13
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site warmth,Week 45
|
1.35 Percentage of subjects
Interval 0.0 to 99.69
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
0.40 Percentage of subjects
Interval 0.0 to 4.19
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site warmth,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site warmth,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Injection site warmth,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Malaise,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Malaise,Week 41
|
—
|
1.10 Percentage of subjects
Interval 0.0 to 20.56
|
—
|
1.10 Percentage of subjects
Interval 0.0 to 20.56
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Malaise,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 1.55
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Malaise,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Malaise,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 3.13
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Malaise,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
0.00 Percentage of subjects
Interval 0.0 to 1.48
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Malaise,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Malaise,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Malaise,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Mucous membrane disorder,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Mucous membrane disorder,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Mucous membrane disorder,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 1.55
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Mucous membrane disorder,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Mucous membrane disorder,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
1.54 Percentage of subjects
Interval 0.0 to 47.01
|
0.86 Percentage of subjects
Interval 0.0 to 8.91
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Mucous membrane disorder,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.65 Percentage of subjects
Interval 0.0 to 11.49
|
0.40 Percentage of subjects
Interval 0.0 to 3.03
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Mucous membrane disorder,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Mucous membrane disorder,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Mucous membrane disorder,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Peripheral swelling,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Peripheral swelling,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Peripheral swelling,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 1.55
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Peripheral swelling,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Peripheral swelling,Week 44
|
2.78 Percentage of subjects
Interval 0.0 to 84.65
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.86 Percentage of subjects
Interval 0.0 to 7.14
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Peripheral swelling,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
0.00 Percentage of subjects
Interval 0.0 to 1.48
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Peripheral swelling,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
1.49 Percentage of subjects
Interval 0.0 to 42.07
|
0.84 Percentage of subjects
Interval 0.0 to 9.95
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Peripheral swelling,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Peripheral swelling,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were chills, face oedema, fatigue, injection site erythema, injection site pain, injection site swelling, and pyrexia.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=139 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Week 47
|
36.84 Percentage of subjects
Interval 0.0 to 100.0
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Week 48
|
4.00 Percentage of subjects
Interval 0.1 to 20.35
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Week 49
|
2.94 Percentage of subjects
Interval 0.07 to 15.33
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Week 50
|
4.76 Percentage of subjects
Interval 0.58 to 16.16
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Week 51
|
8.33 Percentage of subjects
Interval 0.21 to 38.48
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Week 52
|
25.00 Percentage of subjects
Interval 0.63 to 80.59
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Chills,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Chills,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Chills,Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 13.72
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Chills,Week 49
|
0.00 Percentage of subjects
Interval 0.0 to 10.28
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Chills,Week 50
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Chills,Week 51
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Chills,Week 52
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Face oedema,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Face oedema,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Face oedema,Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 13.72
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Face oedema,Week 49
|
0.00 Percentage of subjects
Interval 0.0 to 10.28
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Face oedema,Week 50
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Face oedema,Week 51
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Face oedema,Week 52
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Fatigue,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Fatigue,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Fatigue,Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 13.72
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Fatigue,Week 49
|
0.00 Percentage of subjects
Interval 0.0 to 10.28
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Fatigue,Week 50
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Fatigue,Week 51
|
8.33 Percentage of subjects
Interval 0.21 to 38.48
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Fatigue,Week 52
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Injection site erythema,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Injection site erythema,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Injection site erythema,Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 13.72
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Injection site erythema,Week 49
|
0.00 Percentage of subjects
Interval 0.0 to 10.28
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Injection site erythema,Week 50
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Injection site erythema,Week 51
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Injection site erythema,Week 52
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Injection site pain,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Injection site pain,Week 47
|
31.58 Percentage of subjects
Interval 0.0 to 99.96
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Injection site pain,Week 48
|
4.00 Percentage of subjects
Interval 0.1 to 20.35
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Injection site pain,Week 49
|
0.00 Percentage of subjects
Interval 0.0 to 10.28
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Injection site pain,Week 50
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Injection site pain,Week 51
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Injection site pain,Week 52
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Injection site swelling,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Injection site swelling,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Injection site swelling,Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 13.72
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Injection site swelling,Week 49
|
0.00 Percentage of subjects
Interval 0.0 to 10.28
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Injection site swelling,Week 50
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Injection site swelling,Week 51
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Injection site swelling,Week 52
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Pyrexia,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Pyrexia,Week 47
|
10.53 Percentage of subjects
Interval 0.0 to 99.89
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Pyrexia,Week 48
|
4.00 Percentage of subjects
Interval 0.1 to 20.35
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Pyrexia,Week 49
|
2.94 Percentage of subjects
Interval 0.07 to 15.33
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Pyrexia,Week 50
|
4.76 Percentage of subjects
Interval 0.58 to 16.16
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Pyrexia,Week 51
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Pyrexia,Week 52
|
25.00 Percentage of subjects
Interval 0.63 to 80.59
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were anaphylactic reaction and hypersensitivity.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
|
Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 1.55
|
|
Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 3.13
|
|
Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 45
|
1.35 Percentage of subjects
Interval 0.0 to 21.52
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
0.40 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
|
Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Anaphylactic reaction,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Anaphylactic reaction,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
|
Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Anaphylactic reaction,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 1.55
|
|
Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Anaphylactic reaction,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Anaphylactic reaction,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 3.13
|
|
Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Anaphylactic reaction,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
0.00 Percentage of subjects
Interval 0.0 to 1.48
|
|
Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Anaphylactic reaction,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
|
Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Anaphylactic reaction,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Anaphylactic reaction,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Hypersensitivity,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Hypersensitivity,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
|
Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Hypersensitivity,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 1.55
|
|
Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Hypersensitivity,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Hypersensitivity,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 3.13
|
|
Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Hypersensitivity,Week 45
|
1.35 Percentage of subjects
Interval 0.0 to 21.52
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
0.40 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Hypersensitivity,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
|
Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Hypersensitivity,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Hypersensitivity,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=139 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
|
0 Percentage of subjects
Interval 0.0 to 2.62
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were conjunctivitis and rhinitis.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Herpes simplex,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 3.13
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Herpes simplex,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Herpes simplex,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
0.00 Percentage of subjects
Interval 0.0 to 1.48
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Herpes simplex,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Herpes simplex,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Herpes simplex,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Hordeolum,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Hordeolum,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Hordeolum,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 1.55
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Hordeolum,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Hordeolum,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 3.13
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Hordeolum,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
0.00 Percentage of subjects
Interval 0.0 to 1.48
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Hordeolum,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Hordeolum,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
5.00 Percentage of subjects
Interval 0.0 to 99.71
|
2.33 Percentage of subjects
Interval 0.0 to 25.06
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Hordeolum,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Laryngitis,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Laryngitis,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Laryngitis,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 1.55
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Laryngitis,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Laryngitis,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 3.13
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Laryngitis,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.65 Percentage of subjects
Interval 0.0 to 19.47
|
0.40 Percentage of subjects
Interval 0.0 to 4.07
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Laryngitis,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Laryngitis,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Laryngitis,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Nasopharyngitis,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Nasopharyngitis,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Nasopharyngitis,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 1.55
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Nasopharyngitis,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Nasopharyngitis,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 3.13
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Nasopharyngitis,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
0.00 Percentage of subjects
Interval 0.0 to 1.48
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Nasopharyngitis,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Nasopharyngitis,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Nasopharyngitis,Week 48
|
—
|
—
|
6.25 Percentage of subjects
Interval 0.0 to 100.0
|
6.25 Percentage of subjects
Interval 0.0 to 100.0
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Oral herpes,Week 40
|
—
|
1.43 Percentage of subjects
Interval 0.04 to 7.7
|
—
|
1.43 Percentage of subjects
Interval 0.04 to 7.7
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Oral herpes,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Oral herpes,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 1.55
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Oral herpes,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Oral herpes,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 3.13
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Oral herpes,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
0.00 Percentage of subjects
Interval 0.0 to 1.48
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Oral herpes,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Oral herpes,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Oral herpes,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Upper respiratory tract infection,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Upper respiratory tract infection,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Upper respiratory tract infection,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 1.55
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Upper respiratory tract infection,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
1.28 Percentage of subjects
Interval 0.03 to 6.94
|
0.82 Percentage of subjects
Interval 0.02 to 4.48
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Upper respiratory tract infection,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 3.13
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Upper respiratory tract infection,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
0.00 Percentage of subjects
Interval 0.0 to 1.48
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Upper respiratory tract infection,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Upper respiratory tract infection,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Upper respiratory tract infection,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Bronchitis,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Bronchitis,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Bronchitis,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 1.55
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Bronchitis,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Bronchitis,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
1.54 Percentage of subjects
Interval 0.04 to 8.28
|
0.86 Percentage of subjects
Interval 0.02 to 4.71
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Bronchitis,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
0.00 Percentage of subjects
Interval 0.0 to 1.48
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Bronchitis,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Bronchitis,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Bronchitis,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear infection,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear infection,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear infection,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 1.55
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear infection,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear infection,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear infection,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
1.54 Percentage of subjects
Interval 0.04 to 8.28
|
0.86 Percentage of subjects
Interval 0.02 to 4.71
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear infection,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
0.00 Percentage of subjects
Interval 0.0 to 1.48
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear infection,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear infection,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Herpes simplex,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Herpes simplex,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Herpes simplex,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
2.33 Percentage of subjects
Interval 0.0 to 47.9
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.42 Percentage of subjects
Interval 0.0 to 4.2
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 40
|
—
|
8.57 Percentage of subjects
Interval 0.31 to 37.07
|
—
|
8.57 Percentage of subjects
Interval 0.31 to 37.07
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 41
|
—
|
8.79 Percentage of subjects
Interval 0.32 to 37.74
|
—
|
8.79 Percentage of subjects
Interval 0.32 to 37.74
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 42
|
0.71 Percentage of subjects
Interval 0.01 to 4.4
|
4.65 Percentage of subjects
Interval 0.0 to 74.17
|
1.92 Percentage of subjects
Interval 0.05 to 10.26
|
1.69 Percentage of subjects
Interval 0.24 to 5.71
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 43
|
6.45 Percentage of subjects
Interval 0.79 to 21.42
|
7.69 Percentage of subjects
Interval 0.19 to 36.03
|
5.13 Percentage of subjects
Interval 0.75 to 16.35
|
5.74 Percentage of subjects
Interval 2.34 to 11.46
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 44
|
8.33 Percentage of subjects
Interval 1.75 to 22.47
|
6.67 Percentage of subjects
Interval 0.17 to 31.95
|
6.15 Percentage of subjects
Interval 0.05 to 35.17
|
6.90 Percentage of subjects
Interval 2.81 to 13.71
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 45
|
9.46 Percentage of subjects
Interval 0.0 to 69.82
|
11.11 Percentage of subjects
Interval 1.38 to 34.71
|
5.81 Percentage of subjects
Interval 0.09 to 30.59
|
7.29 Percentage of subjects
Interval 3.51 to 13.08
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 46
|
3.85 Percentage of subjects
Interval 0.1 to 19.64
|
7.69 Percentage of subjects
Interval 0.95 to 25.13
|
8.96 Percentage of subjects
Interval 1.32 to 27.23
|
7.56 Percentage of subjects
Interval 3.17 to 14.77
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 47
|
4.76 Percentage of subjects
Interval 0.12 to 23.82
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
15.00 Percentage of subjects
Interval 0.01 to 81.57
|
9.30 Percentage of subjects
Interval 1.44 to 27.75
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 48
|
—
|
—
|
12.50 Percentage of subjects
Interval 0.0 to 99.41
|
12.50 Percentage of subjects
Interval 0.0 to 99.41
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Conjunctivitis,Week 40
|
—
|
4.29 Percentage of subjects
Interval 0.17 to 19.69
|
—
|
4.29 Percentage of subjects
Interval 0.17 to 19.69
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Conjunctivitis,Week 41
|
—
|
3.30 Percentage of subjects
Interval 0.0 to 27.97
|
—
|
3.30 Percentage of subjects
Interval 0.0 to 27.97
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Conjunctivitis,Week 42
|
0.71 Percentage of subjects
Interval 0.01 to 4.4
|
4.65 Percentage of subjects
Interval 0.0 to 74.17
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
1.27 Percentage of subjects
Interval 0.07 to 5.72
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Conjunctivitis,Week 43
|
3.23 Percentage of subjects
Interval 0.08 to 16.7
|
7.69 Percentage of subjects
Interval 0.19 to 36.03
|
1.28 Percentage of subjects
Interval 0.03 to 6.94
|
2.46 Percentage of subjects
Interval 0.33 to 8.3
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Conjunctivitis,Week 44
|
5.56 Percentage of subjects
Interval 0.0 to 65.52
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
1.54 Percentage of subjects
Interval 0.0 to 49.55
|
2.59 Percentage of subjects
Interval 0.11 to 12.18
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Conjunctivitis,Week 45
|
8.11 Percentage of subjects
Interval 0.0 to 83.19
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
3.23 Percentage of subjects
Interval 0.09 to 16.57
|
4.45 Percentage of subjects
Interval 1.83 to 8.91
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Conjunctivitis,Week 46
|
3.85 Percentage of subjects
Interval 0.1 to 19.64
|
7.69 Percentage of subjects
Interval 0.95 to 25.13
|
5.97 Percentage of subjects
Interval 0.87 to 18.86
|
5.88 Percentage of subjects
Interval 2.4 to 11.74
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Conjunctivitis,Week 47
|
4.76 Percentage of subjects
Interval 0.12 to 23.82
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
5.00 Percentage of subjects
Interval 0.0 to 99.71
|
4.65 Percentage of subjects
Interval 0.57 to 15.81
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Conjunctivitis,Week 48
|
—
|
—
|
6.25 Percentage of subjects
Interval 0.0 to 89.64
|
6.25 Percentage of subjects
Interval 0.0 to 89.64
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rhinitis,Week 40
|
—
|
4.29 Percentage of subjects
Interval 0.17 to 19.69
|
—
|
4.29 Percentage of subjects
Interval 0.17 to 19.69
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rhinitis,Week 41
|
—
|
6.59 Percentage of subjects
Interval 0.04 to 39.62
|
—
|
6.59 Percentage of subjects
Interval 0.04 to 39.62
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rhinitis,Week 42
|
0.71 Percentage of subjects
Interval 0.01 to 4.4
|
2.33 Percentage of subjects
Interval 0.0 to 47.9
|
1.92 Percentage of subjects
Interval 0.05 to 10.26
|
1.27 Percentage of subjects
Interval 0.26 to 3.67
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rhinitis,Week 43
|
3.23 Percentage of subjects
Interval 0.08 to 16.7
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
2.56 Percentage of subjects
Interval 0.31 to 8.96
|
2.46 Percentage of subjects
Interval 0.51 to 7.02
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rhinitis,Week 44
|
5.56 Percentage of subjects
Interval 0.0 to 98.06
|
6.67 Percentage of subjects
Interval 0.17 to 31.95
|
3.08 Percentage of subjects
Interval 0.0 to 24.91
|
4.31 Percentage of subjects
Interval 0.97 to 11.71
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rhinitis,Week 45
|
2.70 Percentage of subjects
Interval 0.0 to 39.0
|
11.11 Percentage of subjects
Interval 1.38 to 34.71
|
2.58 Percentage of subjects
Interval 0.0 to 28.73
|
3.24 Percentage of subjects
Interval 0.81 to 8.44
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rhinitis,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
4.48 Percentage of subjects
Interval 0.34 to 17.63
|
2.52 Percentage of subjects
Interval 0.2 to 10.12
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rhinitis,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
5.00 Percentage of subjects
Interval 0.0 to 99.98
|
2.33 Percentage of subjects
Interval 0.0 to 27.06
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rhinitis,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were conjunctivitis and rhinitis.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=139 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Week 48
|
12.00 Percentage of subjects
Interval 2.55 to 31.22
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Week 49
|
0.00 Percentage of subjects
Interval 0.0 to 10.28
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Week 50
|
2.38 Percentage of subjects
Interval 0.06 to 12.57
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Week 51
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Week 52
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Conjunctivitis,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Conjunctivitis,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Conjunctivitis,Week 48
|
8.00 Percentage of subjects
Interval 0.98 to 26.03
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Conjunctivitis,Week 49
|
0.00 Percentage of subjects
Interval 0.0 to 10.28
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Conjunctivitis,Week 50
|
2.38 Percentage of subjects
Interval 0.06 to 12.57
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Conjunctivitis,Week 51
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Conjunctivitis,Week 52
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Rhinitis,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Rhinitis,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Rhinitis,Week 48
|
4.00 Percentage of subjects
Interval 0.1 to 20.35
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Rhinitis,Week 49
|
0.00 Percentage of subjects
Interval 0.0 to 10.28
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Rhinitis,Week 50
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Rhinitis,Week 51
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Rhinitis,Week 52
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card was decreased appetite.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Decreased appetite,Week 42
|
0.71 Percentage of subjects
Interval 0.01 to 4.4
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
3.85 Percentage of subjects
Interval 0.11 to 19.24
|
1.27 Percentage of subjects
Interval 0.12 to 4.95
|
|
Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 41
|
—
|
1.10 Percentage of subjects
Interval 0.0 to 20.56
|
—
|
1.10 Percentage of subjects
Interval 0.0 to 20.56
|
|
Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 42
|
0.71 Percentage of subjects
Interval 0.01 to 4.4
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
3.85 Percentage of subjects
Interval 0.11 to 19.24
|
1.27 Percentage of subjects
Interval 0.12 to 4.95
|
|
Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
11.54 Percentage of subjects
Interval 1.53 to 35.14
|
7.38 Percentage of subjects
Interval 0.3 to 31.94
|
|
Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 44
|
2.78 Percentage of subjects
Interval 0.0 to 84.65
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
7.69 Percentage of subjects
Interval 2.54 to 17.05
|
5.17 Percentage of subjects
Interval 1.92 to 10.92
|
|
Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 45
|
4.05 Percentage of subjects
Interval 0.0 to 53.08
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
3.87 Percentage of subjects
Interval 0.0 to 38.62
|
3.64 Percentage of subjects
Interval 0.66 to 10.89
|
|
Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 46
|
3.85 Percentage of subjects
Interval 0.1 to 19.64
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.84 Percentage of subjects
Interval 0.0 to 7.7
|
|
Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 47
|
4.76 Percentage of subjects
Interval 0.12 to 23.82
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
2.33 Percentage of subjects
Interval 0.03 to 14.14
|
|
Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 48
|
—
|
—
|
12.50 Percentage of subjects
Interval 0.0 to 99.41
|
12.50 Percentage of subjects
Interval 0.0 to 99.41
|
|
Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Decreased appetite,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Decreased appetite,Week 41
|
—
|
1.10 Percentage of subjects
Interval 0.0 to 20.56
|
—
|
1.10 Percentage of subjects
Interval 0.0 to 20.56
|
|
Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Decreased appetite,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
11.54 Percentage of subjects
Interval 1.53 to 35.14
|
7.38 Percentage of subjects
Interval 0.3 to 31.94
|
|
Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Decreased appetite,Week 44
|
2.78 Percentage of subjects
Interval 0.0 to 84.65
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
7.69 Percentage of subjects
Interval 2.54 to 17.05
|
5.17 Percentage of subjects
Interval 1.92 to 10.92
|
|
Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Decreased appetite,Week 45
|
4.05 Percentage of subjects
Interval 0.0 to 53.08
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
3.87 Percentage of subjects
Interval 0.0 to 38.62
|
3.64 Percentage of subjects
Interval 0.66 to 10.89
|
|
Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Decreased appetite,Week 46
|
3.85 Percentage of subjects
Interval 0.1 to 19.64
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.84 Percentage of subjects
Interval 0.0 to 7.7
|
|
Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Decreased appetite,Week 47
|
4.76 Percentage of subjects
Interval 0.12 to 23.82
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
2.33 Percentage of subjects
Interval 0.03 to 14.14
|
|
Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Decreased appetite,Week 48
|
—
|
—
|
12.50 Percentage of subjects
Interval 0.0 to 99.41
|
12.50 Percentage of subjects
Interval 0.0 to 99.41
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card was decreased appetite.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=139 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Week 47
|
5.26 Percentage of subjects
Interval 0.0 to 95.26
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Week 48
|
4.00 Percentage of subjects
Interval 0.1 to 20.35
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Week 49
|
0.00 Percentage of subjects
Interval 0.0 to 10.28
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Week 50
|
2.38 Percentage of subjects
Interval 0.06 to 12.57
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Week 51
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Week 52
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Decreased appetite,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Decreased appetite,Week 47
|
5.26 Percentage of subjects
Interval 0.0 to 95.26
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Decreased appetite,Week 48
|
4.00 Percentage of subjects
Interval 0.1 to 20.35
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Decreased appetite,Week 49
|
0.00 Percentage of subjects
Interval 0.0 to 10.28
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Decreased appetite,Week 50
|
2.38 Percentage of subjects
Interval 0.06 to 12.57
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Decreased appetite,Week 51
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Decreased appetite,Week 52
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were arthropathy and myalgia.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 40
|
—
|
5.71 Percentage of subjects
Interval 0.22 to 25.74
|
—
|
5.71 Percentage of subjects
Interval 0.22 to 25.74
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 41
|
—
|
7.69 Percentage of subjects
Interval 0.0 to 71.12
|
—
|
7.69 Percentage of subjects
Interval 0.0 to 71.12
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 42
|
11.35 Percentage of subjects
Interval 0.1 to 56.46
|
2.33 Percentage of subjects
Interval 0.0 to 47.9
|
7.69 Percentage of subjects
Interval 0.19 to 36.17
|
8.90 Percentage of subjects
Interval 3.78 to 17.15
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
23.08 Percentage of subjects
Interval 5.04 to 53.81
|
7.69 Percentage of subjects
Interval 1.08 to 24.1
|
7.38 Percentage of subjects
Interval 1.08 to 22.89
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 44
|
19.44 Percentage of subjects
Interval 0.05 to 83.92
|
6.67 Percentage of subjects
Interval 0.17 to 31.95
|
3.08 Percentage of subjects
Interval 0.0 to 72.8
|
8.62 Percentage of subjects
Interval 0.56 to 32.97
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 45
|
10.81 Percentage of subjects
Interval 0.08 to 55.52
|
16.67 Percentage of subjects
Interval 3.58 to 41.42
|
8.39 Percentage of subjects
Interval 0.37 to 34.98
|
9.72 Percentage of subjects
Interval 5.35 to 15.89
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 46
|
11.54 Percentage of subjects
Interval 2.45 to 30.15
|
15.38 Percentage of subjects
Interval 4.36 to 34.87
|
8.96 Percentage of subjects
Interval 1.32 to 27.23
|
10.92 Percentage of subjects
Interval 5.95 to 17.96
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 47
|
4.76 Percentage of subjects
Interval 0.12 to 23.82
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
5.00 Percentage of subjects
Interval 0.0 to 99.71
|
4.65 Percentage of subjects
Interval 0.57 to 15.81
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 48
|
—
|
—
|
37.50 Percentage of subjects
Interval 0.0 to 100.0
|
37.50 Percentage of subjects
Interval 0.0 to 100.0
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Arthropathy,Week 40
|
—
|
1.43 Percentage of subjects
Interval 0.04 to 7.7
|
—
|
1.43 Percentage of subjects
Interval 0.04 to 7.7
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Arthropathy,Week 41
|
—
|
2.20 Percentage of subjects
Interval 0.0 to 37.37
|
—
|
2.20 Percentage of subjects
Interval 0.0 to 37.37
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Arthropathy,Week 42
|
1.42 Percentage of subjects
Interval 0.02 to 8.68
|
2.33 Percentage of subjects
Interval 0.0 to 47.9
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
1.27 Percentage of subjects
Interval 0.26 to 3.67
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Arthropathy,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
15.38 Percentage of subjects
Interval 1.92 to 45.45
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
1.64 Percentage of subjects
Interval 0.0 to 25.52
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Arthropathy,Week 44
|
13.89 Percentage of subjects
Interval 0.7 to 50.99
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
1.54 Percentage of subjects
Interval 0.0 to 47.01
|
5.17 Percentage of subjects
Interval 0.23 to 22.97
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Arthropathy,Week 45
|
2.70 Percentage of subjects
Interval 0.0 to 85.98
|
11.11 Percentage of subjects
Interval 1.38 to 34.71
|
3.23 Percentage of subjects
Interval 0.09 to 16.57
|
3.64 Percentage of subjects
Interval 1.29 to 7.95
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Arthropathy,Week 46
|
3.85 Percentage of subjects
Interval 0.1 to 19.64
|
7.69 Percentage of subjects
Interval 0.95 to 25.13
|
1.49 Percentage of subjects
Interval 0.04 to 8.04
|
3.36 Percentage of subjects
Interval 0.8 to 8.99
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Arthropathy,Week 47
|
4.76 Percentage of subjects
Interval 0.12 to 23.82
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
5.00 Percentage of subjects
Interval 0.0 to 99.71
|
4.65 Percentage of subjects
Interval 0.57 to 15.81
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Arthropathy,Week 48
|
—
|
—
|
18.75 Percentage of subjects
Interval 0.0 to 99.99
|
18.75 Percentage of subjects
Interval 0.0 to 99.99
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Myalgia,Week 40
|
—
|
5.71 Percentage of subjects
Interval 0.22 to 25.74
|
—
|
5.71 Percentage of subjects
Interval 0.22 to 25.74
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Myalgia,Week 41
|
—
|
5.49 Percentage of subjects
Interval 0.0 to 52.38
|
—
|
5.49 Percentage of subjects
Interval 0.0 to 52.38
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Myalgia,Week 42
|
9.93 Percentage of subjects
Interval 0.09 to 50.96
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
7.69 Percentage of subjects
Interval 0.19 to 36.17
|
7.63 Percentage of subjects
Interval 2.78 to 16.09
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Myalgia,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
7.69 Percentage of subjects
Interval 0.19 to 36.03
|
6.41 Percentage of subjects
Interval 0.92 to 20.26
|
4.92 Percentage of subjects
Interval 0.74 to 15.51
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Myalgia,Week 44
|
8.33 Percentage of subjects
Interval 1.75 to 22.47
|
6.67 Percentage of subjects
Interval 0.17 to 31.95
|
1.54 Percentage of subjects
Interval 0.0 to 47.01
|
4.31 Percentage of subjects
Interval 0.36 to 16.52
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Myalgia,Week 45
|
9.46 Percentage of subjects
Interval 0.0 to 69.82
|
11.11 Percentage of subjects
Interval 1.38 to 34.71
|
6.45 Percentage of subjects
Interval 0.15 to 31.44
|
7.69 Percentage of subjects
Interval 3.98 to 13.17
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Myalgia,Week 46
|
11.54 Percentage of subjects
Interval 2.45 to 30.15
|
7.69 Percentage of subjects
Interval 0.95 to 25.13
|
7.46 Percentage of subjects
Interval 1.19 to 22.48
|
8.40 Percentage of subjects
Interval 4.1 to 14.91
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Myalgia,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
5.00 Percentage of subjects
Interval 0.0 to 99.71
|
2.33 Percentage of subjects
Interval 0.0 to 25.06
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Myalgia,Week 48
|
—
|
—
|
31.25 Percentage of subjects
Interval 0.0 to 100.0
|
31.25 Percentage of subjects
Interval 0.0 to 100.0
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Limb discomfort,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Limb discomfort,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Limb discomfort,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 1.55
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Limb discomfort,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Limb discomfort,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 3.13
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Limb discomfort,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
5.56 Percentage of subjects
Interval 0.14 to 27.29
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
0.40 Percentage of subjects
Interval 0.0 to 4.05
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Limb discomfort,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Limb discomfort,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Limb discomfort,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Musculoskeletal pain,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Musculoskeletal pain,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Musculoskeletal pain,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
2.33 Percentage of subjects
Interval 0.0 to 47.9
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.42 Percentage of subjects
Interval 0.0 to 4.2
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Musculoskeletal pain,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Musculoskeletal pain,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 3.13
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Musculoskeletal pain,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
0.00 Percentage of subjects
Interval 0.0 to 1.48
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Musculoskeletal pain,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Musculoskeletal pain,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Musculoskeletal pain,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pain in extremity,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pain in extremity,Week 41
|
—
|
1.10 Percentage of subjects
Interval 0.0 to 20.56
|
—
|
1.10 Percentage of subjects
Interval 0.0 to 20.56
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pain in extremity,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 1.55
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pain in extremity,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
1.28 Percentage of subjects
Interval 0.03 to 6.94
|
0.82 Percentage of subjects
Interval 0.02 to 4.48
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pain in extremity,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 3.13
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pain in extremity,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
5.56 Percentage of subjects
Interval 0.14 to 27.29
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
0.40 Percentage of subjects
Interval 0.0 to 4.05
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pain in extremity,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pain in extremity,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pain in extremity,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rheumatic disorder,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rheumatic disorder,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rheumatic disorder,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
2.33 Percentage of subjects
Interval 0.0 to 47.9
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.42 Percentage of subjects
Interval 0.0 to 4.2
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rheumatic disorder,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rheumatic disorder,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 3.13
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rheumatic disorder,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
0.00 Percentage of subjects
Interval 0.0 to 1.48
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rheumatic disorder,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
3.85 Percentage of subjects
Interval 0.1 to 19.64
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.84 Percentage of subjects
Interval 0.0 to 7.7
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rheumatic disorder,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rheumatic disorder,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Synovial cyst,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Synovial cyst,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Synovial cyst,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 1.55
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Synovial cyst,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Synovial cyst,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
1.54 Percentage of subjects
Interval 0.0 to 47.01
|
0.86 Percentage of subjects
Interval 0.0 to 8.91
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Synovial cyst,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
0.00 Percentage of subjects
Interval 0.0 to 1.48
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Synovial cyst,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Synovial cyst,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Synovial cyst,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were arthropathy and myalgia.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=139 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Week 47
|
5.26 Percentage of subjects
Interval 0.0 to 95.26
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 13.72
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Week 49
|
0.00 Percentage of subjects
Interval 0.0 to 10.28
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Week 50
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Week 51
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Week 52
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Arthropathy,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Arthropathy,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Arthropathy,Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 13.72
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Arthropathy,Week 49
|
0.00 Percentage of subjects
Interval 0.0 to 10.28
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Arthropathy,Week 50
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Arthropathy,Week 51
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Arthropathy,Week 52
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Myalgia,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Myalgia,Week 47
|
5.26 Percentage of subjects
Interval 0.0 to 95.26
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Myalgia,Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 13.72
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Myalgia,Week 49
|
0.00 Percentage of subjects
Interval 0.0 to 10.28
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Myalgia,Week 50
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Myalgia,Week 51
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Myalgia,Week 52
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were febrile convulsion and headache.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 40
|
—
|
5.71 Percentage of subjects
Interval 0.22 to 25.74
|
—
|
5.71 Percentage of subjects
Interval 0.22 to 25.74
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 41
|
—
|
7.69 Percentage of subjects
Interval 0.47 to 30.27
|
—
|
7.69 Percentage of subjects
Interval 0.47 to 30.27
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 42
|
5.67 Percentage of subjects
Interval 0.0 to 68.1
|
4.65 Percentage of subjects
Interval 0.0 to 74.17
|
1.92 Percentage of subjects
Interval 0.05 to 10.26
|
4.66 Percentage of subjects
Interval 2.35 to 8.19
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 43
|
9.68 Percentage of subjects
Interval 2.04 to 25.75
|
7.69 Percentage of subjects
Interval 0.19 to 36.03
|
7.69 Percentage of subjects
Interval 1.08 to 24.1
|
8.20 Percentage of subjects
Interval 4.0 to 14.56
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 44
|
16.67 Percentage of subjects
Interval 0.0 to 98.03
|
6.67 Percentage of subjects
Interval 0.17 to 31.95
|
1.54 Percentage of subjects
Interval 0.04 to 8.28
|
6.90 Percentage of subjects
Interval 0.53 to 25.99
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 45
|
13.51 Percentage of subjects
Interval 0.84 to 47.92
|
11.11 Percentage of subjects
Interval 1.38 to 34.71
|
9.68 Percentage of subjects
Interval 2.09 to 25.51
|
10.93 Percentage of subjects
Interval 7.16 to 15.78
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
15.38 Percentage of subjects
Interval 4.36 to 34.87
|
8.96 Percentage of subjects
Interval 1.32 to 27.23
|
8.40 Percentage of subjects
Interval 2.11 to 21.07
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
50.00 Percentage of subjects
Interval 1.26 to 98.74
|
5.00 Percentage of subjects
Interval 0.0 to 99.71
|
4.65 Percentage of subjects
Interval 0.01 to 34.34
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 48
|
—
|
—
|
37.50 Percentage of subjects
Interval 0.19 to 97.69
|
37.50 Percentage of subjects
Interval 0.19 to 97.69
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Febrile convulsion,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Febrile convulsion,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Febrile convulsion,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 1.55
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Febrile convulsion,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Febrile convulsion,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 3.13
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Febrile convulsion,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
0.00 Percentage of subjects
Interval 0.0 to 1.48
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Febrile convulsion,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Febrile convulsion,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Febrile convulsion,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Headache,Week 40
|
—
|
4.29 Percentage of subjects
Interval 0.17 to 19.69
|
—
|
4.29 Percentage of subjects
Interval 0.17 to 19.69
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Headache,Week 41
|
—
|
7.69 Percentage of subjects
Interval 0.47 to 30.27
|
—
|
7.69 Percentage of subjects
Interval 0.47 to 30.27
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Headache,Week 42
|
4.96 Percentage of subjects
Interval 0.48 to 18.09
|
4.65 Percentage of subjects
Interval 0.0 to 74.17
|
1.92 Percentage of subjects
Interval 0.05 to 10.26
|
4.24 Percentage of subjects
Interval 2.05 to 7.65
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Headache,Week 43
|
9.68 Percentage of subjects
Interval 2.04 to 25.75
|
7.69 Percentage of subjects
Interval 0.19 to 36.03
|
7.69 Percentage of subjects
Interval 1.08 to 24.1
|
8.20 Percentage of subjects
Interval 4.0 to 14.56
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Headache,Week 44
|
16.67 Percentage of subjects
Interval 0.0 to 98.03
|
6.67 Percentage of subjects
Interval 0.17 to 31.95
|
1.54 Percentage of subjects
Interval 0.04 to 8.28
|
6.90 Percentage of subjects
Interval 0.53 to 25.99
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Headache,Week 45
|
10.81 Percentage of subjects
Interval 3.04 to 25.35
|
11.11 Percentage of subjects
Interval 1.38 to 34.71
|
7.74 Percentage of subjects
Interval 3.11 to 15.48
|
8.91 Percentage of subjects
Interval 5.67 to 13.17
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Headache,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
15.38 Percentage of subjects
Interval 4.36 to 34.87
|
8.96 Percentage of subjects
Interval 1.32 to 27.23
|
8.40 Percentage of subjects
Interval 2.11 to 21.07
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Headache,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
50.00 Percentage of subjects
Interval 1.26 to 98.74
|
5.00 Percentage of subjects
Interval 0.0 to 99.71
|
4.65 Percentage of subjects
Interval 0.01 to 34.34
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Headache,Week 48
|
—
|
—
|
37.50 Percentage of subjects
Interval 0.19 to 97.69
|
37.50 Percentage of subjects
Interval 0.19 to 97.69
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Aphonia,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Aphonia,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Aphonia,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 1.55
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Aphonia,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Aphonia,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 3.13
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Aphonia,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.65 Percentage of subjects
Interval 0.0 to 7.91
|
0.40 Percentage of subjects
Interval 0.0 to 2.58
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Aphonia,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Aphonia,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Aphonia,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dizziness,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dizziness,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dizziness,Week 42
|
0.71 Percentage of subjects
Interval 0.0 to 97.4
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.42 Percentage of subjects
Interval 0.0 to 4.77
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dizziness,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dizziness,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 3.13
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dizziness,Week 45
|
2.70 Percentage of subjects
Interval 0.0 to 39.0
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.65 Percentage of subjects
Interval 0.0 to 7.91
|
1.21 Percentage of subjects
Interval 0.15 to 4.34
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dizziness,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dizziness,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dizziness,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Poor quality sleep,Week 40
|
—
|
1.43 Percentage of subjects
Interval 0.04 to 7.7
|
—
|
1.43 Percentage of subjects
Interval 0.04 to 7.7
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Poor quality sleep,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Poor quality sleep,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 1.55
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Poor quality sleep,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Poor quality sleep,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 3.13
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Poor quality sleep,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
0.00 Percentage of subjects
Interval 0.0 to 1.48
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Poor quality sleep,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Poor quality sleep,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Poor quality sleep,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Somnolence,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Somnolence,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Somnolence,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 1.55
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Somnolence,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Somnolence,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 3.13
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Somnolence,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.65 Percentage of subjects
Interval 0.0 to 7.91
|
0.40 Percentage of subjects
Interval 0.0 to 2.58
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Somnolence,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Somnolence,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Somnolence,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tremor,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tremor,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tremor,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 1.55
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tremor,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tremor,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 3.13
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tremor,Week 45
|
1.35 Percentage of subjects
Interval 0.0 to 21.52
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
0.40 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tremor,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tremor,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tremor,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were febrile convulsion and headache.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=139 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
|
0 Percentage of subjects
Interval 0.0 to 2.62
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEI listed on the ADR card was irritability.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
|
Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
9.30 Percentage of subjects
Interval 0.0 to 94.72
|
1.92 Percentage of subjects
Interval 0.05 to 10.26
|
2.12 Percentage of subjects
Interval 0.01 to 14.95
|
|
Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
7.69 Percentage of subjects
Interval 0.19 to 36.03
|
5.13 Percentage of subjects
Interval 0.75 to 16.35
|
4.10 Percentage of subjects
Interval 0.69 to 12.52
|
|
Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 44
|
2.78 Percentage of subjects
Interval 0.0 to 84.65
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
3.08 Percentage of subjects
Interval 0.0 to 24.91
|
2.59 Percentage of subjects
Interval 0.54 to 7.37
|
|
Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 45
|
1.35 Percentage of subjects
Interval 0.0 to 21.52
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.65 Percentage of subjects
Interval 0.0 to 11.49
|
0.81 Percentage of subjects
Interval 0.1 to 2.89
|
|
Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 46
|
3.85 Percentage of subjects
Interval 0.1 to 19.64
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
2.99 Percentage of subjects
Interval 0.0 to 47.77
|
2.52 Percentage of subjects
Interval 0.1 to 12.03
|
|
Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
5.00 Percentage of subjects
Interval 0.0 to 99.98
|
2.33 Percentage of subjects
Interval 0.0 to 27.06
|
|
Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Irritability,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Irritability,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
|
Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Irritability,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
6.98 Percentage of subjects
Interval 0.0 to 87.92
|
1.92 Percentage of subjects
Interval 0.05 to 10.26
|
1.69 Percentage of subjects
Interval 0.01 to 11.37
|
|
Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Irritability,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
7.69 Percentage of subjects
Interval 0.19 to 36.03
|
5.13 Percentage of subjects
Interval 0.75 to 16.35
|
4.10 Percentage of subjects
Interval 0.69 to 12.52
|
|
Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Irritability,Week 44
|
2.78 Percentage of subjects
Interval 0.0 to 84.65
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
3.08 Percentage of subjects
Interval 0.0 to 24.91
|
2.59 Percentage of subjects
Interval 0.54 to 7.37
|
|
Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Irritability,Week 45
|
1.35 Percentage of subjects
Interval 0.0 to 21.52
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.65 Percentage of subjects
Interval 0.0 to 11.49
|
0.81 Percentage of subjects
Interval 0.1 to 2.89
|
|
Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Irritability,Week 46
|
3.85 Percentage of subjects
Interval 0.1 to 19.64
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
2.99 Percentage of subjects
Interval 0.0 to 47.77
|
2.52 Percentage of subjects
Interval 0.1 to 12.03
|
|
Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Irritability,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
5.00 Percentage of subjects
Interval 0.0 to 99.98
|
2.33 Percentage of subjects
Interval 0.0 to 27.06
|
|
Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Irritability,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Insomnia,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Insomnia,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
|
Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Insomnia,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
2.33 Percentage of subjects
Interval 0.0 to 47.9
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.42 Percentage of subjects
Interval 0.0 to 4.2
|
|
Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Insomnia,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Insomnia,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 3.13
|
|
Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Insomnia,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
0.00 Percentage of subjects
Interval 0.0 to 1.48
|
|
Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Insomnia,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
|
Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Insomnia,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Insomnia,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Mood swings,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Mood swings,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
|
Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Mood swings,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 1.55
|
|
Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Mood swings,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Mood swings,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
1.54 Percentage of subjects
Interval 0.0 to 47.01
|
0.86 Percentage of subjects
Interval 0.0 to 8.91
|
|
Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Mood swings,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
0.00 Percentage of subjects
Interval 0.0 to 1.48
|
|
Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Mood swings,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
|
Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Mood swings,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Mood swings,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Sleep disorder,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Sleep disorder,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
|
Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Sleep disorder,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
2.33 Percentage of subjects
Interval 0.0 to 47.9
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.42 Percentage of subjects
Interval 0.0 to 4.2
|
|
Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Sleep disorder,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Sleep disorder,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 3.13
|
|
Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Sleep disorder,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
0.00 Percentage of subjects
Interval 0.0 to 1.48
|
|
Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Sleep disorder,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
|
Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Sleep disorder,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Sleep disorder,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEI listed on the ADR card was irritability.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=139 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Week 48
|
8.00 Percentage of subjects
Interval 0.98 to 26.03
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Week 49
|
5.88 Percentage of subjects
Interval 0.01 to 40.78
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Week 50
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Week 51
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Week 52
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Irritability,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Irritability,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Irritability,Week 48
|
8.00 Percentage of subjects
Interval 0.98 to 26.03
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Irritability,Week 49
|
5.88 Percentage of subjects
Interval 0.01 to 40.78
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Irritability,Week 50
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Irritability,Week 51
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Irritability,Week 52
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were cough, dysphonia, epistaxis, nasal congestion, oropharyngeal pain, rhinorrhoea, and wheezing.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Epistaxis,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 3.13
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Epistaxis,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
2.58 Percentage of subjects
Interval 0.01 to 19.41
|
1.62 Percentage of subjects
Interval 0.17 to 5.98
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 40
|
—
|
8.57 Percentage of subjects
Interval 0.31 to 37.07
|
—
|
8.57 Percentage of subjects
Interval 0.31 to 37.07
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 41
|
—
|
13.19 Percentage of subjects
Interval 0.09 to 63.62
|
—
|
13.19 Percentage of subjects
Interval 0.09 to 63.62
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 42
|
9.93 Percentage of subjects
Interval 0.87 to 34.53
|
9.30 Percentage of subjects
Interval 0.0 to 94.72
|
26.92 Percentage of subjects
Interval 0.28 to 88.26
|
13.56 Percentage of subjects
Interval 4.5 to 29.03
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 43
|
19.35 Percentage of subjects
Interval 7.45 to 37.47
|
23.08 Percentage of subjects
Interval 5.04 to 53.81
|
25.64 Percentage of subjects
Interval 16.42 to 36.79
|
23.77 Percentage of subjects
Interval 16.53 to 32.32
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 44
|
25.00 Percentage of subjects
Interval 12.12 to 42.2
|
6.67 Percentage of subjects
Interval 0.17 to 31.95
|
18.46 Percentage of subjects
Interval 8.54 to 32.71
|
18.97 Percentage of subjects
Interval 12.28 to 27.29
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 45
|
20.27 Percentage of subjects
Interval 7.81 to 39.06
|
22.22 Percentage of subjects
Interval 6.41 to 47.64
|
21.29 Percentage of subjects
Interval 6.33 to 45.42
|
21.05 Percentage of subjects
Interval 15.27 to 27.84
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 46
|
7.69 Percentage of subjects
Interval 0.95 to 25.13
|
7.69 Percentage of subjects
Interval 0.95 to 25.13
|
20.90 Percentage of subjects
Interval 11.92 to 32.57
|
15.13 Percentage of subjects
Interval 6.18 to 29.01
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 47
|
9.52 Percentage of subjects
Interval 1.17 to 30.38
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
30.00 Percentage of subjects
Interval 0.0 to 100.0
|
18.60 Percentage of subjects
Interval 0.88 to 63.28
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 48
|
—
|
—
|
31.25 Percentage of subjects
Interval 0.0 to 99.95
|
31.25 Percentage of subjects
Interval 0.0 to 99.95
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Cough,Week 40
|
—
|
7.14 Percentage of subjects
Interval 0.27 to 31.53
|
—
|
7.14 Percentage of subjects
Interval 0.27 to 31.53
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Cough,Week 41
|
—
|
2.20 Percentage of subjects
Interval 0.01 to 16.5
|
—
|
2.20 Percentage of subjects
Interval 0.01 to 16.5
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Cough,Week 42
|
2.84 Percentage of subjects
Interval 0.04 to 16.88
|
4.65 Percentage of subjects
Interval 0.0 to 74.17
|
15.38 Percentage of subjects
Interval 0.28 to 63.3
|
5.93 Percentage of subjects
Interval 0.85 to 18.82
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Cough,Week 43
|
6.45 Percentage of subjects
Interval 0.79 to 21.42
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
15.38 Percentage of subjects
Interval 5.28 to 32.08
|
11.48 Percentage of subjects
Interval 3.55 to 25.67
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Cough,Week 44
|
2.78 Percentage of subjects
Interval 0.0 to 84.65
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
12.31 Percentage of subjects
Interval 5.47 to 22.82
|
7.76 Percentage of subjects
Interval 2.75 to 16.6
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Cough,Week 45
|
5.41 Percentage of subjects
Interval 0.0 to 64.32
|
11.11 Percentage of subjects
Interval 1.38 to 34.71
|
6.45 Percentage of subjects
Interval 1.05 to 19.5
|
6.48 Percentage of subjects
Interval 3.75 to 10.31
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Cough,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
8.96 Percentage of subjects
Interval 3.36 to 18.48
|
5.04 Percentage of subjects
Interval 0.67 to 16.58
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Cough,Week 47
|
4.76 Percentage of subjects
Interval 0.12 to 23.82
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
10.00 Percentage of subjects
Interval 0.0 to 100.0
|
6.98 Percentage of subjects
Interval 0.3 to 29.98
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Cough,Week 48
|
—
|
—
|
12.50 Percentage of subjects
Interval 0.0 to 99.41
|
12.50 Percentage of subjects
Interval 0.0 to 99.41
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dysphonia,Week 40
|
—
|
4.29 Percentage of subjects
Interval 0.17 to 19.69
|
—
|
4.29 Percentage of subjects
Interval 0.17 to 19.69
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dysphonia,Week 41
|
—
|
1.10 Percentage of subjects
Interval 0.0 to 21.06
|
—
|
1.10 Percentage of subjects
Interval 0.0 to 21.06
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dysphonia,Week 42
|
1.42 Percentage of subjects
Interval 0.02 to 8.68
|
6.98 Percentage of subjects
Interval 0.0 to 87.92
|
3.85 Percentage of subjects
Interval 0.11 to 19.24
|
2.97 Percentage of subjects
Interval 0.61 to 8.45
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dysphonia,Week 43
|
3.23 Percentage of subjects
Interval 0.08 to 16.7
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
2.56 Percentage of subjects
Interval 0.31 to 8.96
|
2.46 Percentage of subjects
Interval 0.51 to 7.02
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dysphonia,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
1.54 Percentage of subjects
Interval 0.0 to 47.01
|
0.86 Percentage of subjects
Interval 0.0 to 8.91
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dysphonia,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
11.11 Percentage of subjects
Interval 1.38 to 34.71
|
2.58 Percentage of subjects
Interval 0.71 to 6.48
|
2.43 Percentage of subjects
Interval 0.55 to 6.66
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dysphonia,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
1.49 Percentage of subjects
Interval 0.0 to 42.07
|
0.84 Percentage of subjects
Interval 0.0 to 9.95
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dysphonia,Week 47
|
4.76 Percentage of subjects
Interval 0.12 to 23.82
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
2.33 Percentage of subjects
Interval 0.03 to 14.14
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dysphonia,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Epistaxis,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Epistaxis,Week 41
|
—
|
2.20 Percentage of subjects
Interval 0.01 to 16.5
|
—
|
2.20 Percentage of subjects
Interval 0.01 to 16.5
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Epistaxis,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
2.33 Percentage of subjects
Interval 0.0 to 47.9
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.42 Percentage of subjects
Interval 0.0 to 4.2
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Epistaxis,Week 43
|
3.23 Percentage of subjects
Interval 0.08 to 16.7
|
7.69 Percentage of subjects
Interval 0.19 to 36.03
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
1.64 Percentage of subjects
Interval 0.0 to 14.48
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Sneezing,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
0.00 Percentage of subjects
Interval 0.0 to 1.48
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Sneezing,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Sneezing,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Sneezing,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Throat clearing,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Throat clearing,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Throat clearing,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 1.55
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Throat clearing,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Throat clearing,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 3.13
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Throat clearing,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
0.00 Percentage of subjects
Interval 0.0 to 1.48
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Throat clearing,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Throat clearing,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
5.00 Percentage of subjects
Interval 0.0 to 99.98
|
2.33 Percentage of subjects
Interval 0.0 to 27.06
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Throat clearing,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Epistaxis,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Epistaxis,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Epistaxis,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Nasal congestion,Week 40
|
—
|
5.71 Percentage of subjects
Interval 0.22 to 25.74
|
—
|
5.71 Percentage of subjects
Interval 0.22 to 25.74
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Nasal congestion,Week 41
|
—
|
2.20 Percentage of subjects
Interval 0.0 to 37.37
|
—
|
2.20 Percentage of subjects
Interval 0.0 to 37.37
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Nasal congestion,Week 42
|
2.84 Percentage of subjects
Interval 0.04 to 16.88
|
4.65 Percentage of subjects
Interval 0.0 to 74.17
|
15.38 Percentage of subjects
Interval 0.28 to 63.3
|
5.93 Percentage of subjects
Interval 0.85 to 18.82
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Nasal congestion,Week 43
|
3.23 Percentage of subjects
Interval 0.08 to 16.7
|
7.69 Percentage of subjects
Interval 0.19 to 36.03
|
7.69 Percentage of subjects
Interval 1.08 to 24.1
|
6.56 Percentage of subjects
Interval 2.69 to 13.0
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Nasal congestion,Week 44
|
8.33 Percentage of subjects
Interval 0.0 to 99.81
|
6.67 Percentage of subjects
Interval 0.17 to 31.95
|
9.23 Percentage of subjects
Interval 1.68 to 26.07
|
8.62 Percentage of subjects
Interval 4.21 to 15.28
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Nasal congestion,Week 45
|
2.70 Percentage of subjects
Interval 0.0 to 39.0
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
5.16 Percentage of subjects
Interval 1.41 to 12.74
|
4.05 Percentage of subjects
Interval 1.96 to 7.32
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Nasal congestion,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
8.96 Percentage of subjects
Interval 2.78 to 20.33
|
5.04 Percentage of subjects
Interval 0.28 to 21.29
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Nasal congestion,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
5.00 Percentage of subjects
Interval 0.0 to 99.71
|
2.33 Percentage of subjects
Interval 0.0 to 25.06
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Nasal congestion,Week 48
|
—
|
—
|
12.50 Percentage of subjects
Interval 0.0 to 99.41
|
12.50 Percentage of subjects
Interval 0.0 to 99.41
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Oropharyngeal pain,Week 40
|
—
|
5.71 Percentage of subjects
Interval 0.22 to 25.74
|
—
|
5.71 Percentage of subjects
Interval 0.22 to 25.74
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Oropharyngeal pain,Week 41
|
—
|
5.49 Percentage of subjects
Interval 0.0 to 49.36
|
—
|
5.49 Percentage of subjects
Interval 0.0 to 49.36
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Oropharyngeal pain,Week 42
|
3.55 Percentage of subjects
Interval 0.04 to 20.8
|
6.98 Percentage of subjects
Interval 0.0 to 87.92
|
1.92 Percentage of subjects
Interval 0.05 to 10.26
|
3.81 Percentage of subjects
Interval 1.76 to 7.12
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Oropharyngeal pain,Week 43
|
3.23 Percentage of subjects
Interval 0.08 to 16.7
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
7.69 Percentage of subjects
Interval 1.08 to 24.1
|
5.74 Percentage of subjects
Interval 1.26 to 15.53
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Oropharyngeal pain,Week 44
|
2.78 Percentage of subjects
Interval 0.0 to 99.94
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
3.08 Percentage of subjects
Interval 0.0 to 24.91
|
2.59 Percentage of subjects
Interval 0.4 to 8.31
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Oropharyngeal pain,Week 45
|
2.70 Percentage of subjects
Interval 0.0 to 39.0
|
11.11 Percentage of subjects
Interval 1.38 to 34.71
|
5.16 Percentage of subjects
Interval 1.79 to 11.3
|
4.86 Percentage of subjects
Interval 2.54 to 8.33
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Oropharyngeal pain,Week 46
|
3.85 Percentage of subjects
Interval 0.1 to 19.64
|
3.85 Percentage of subjects
Interval 0.1 to 19.64
|
7.46 Percentage of subjects
Interval 0.18 to 35.54
|
5.88 Percentage of subjects
Interval 1.23 to 16.24
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Oropharyngeal pain,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
5.00 Percentage of subjects
Interval 0.0 to 99.71
|
2.33 Percentage of subjects
Interval 0.0 to 25.06
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Oropharyngeal pain,Week 48
|
—
|
—
|
18.75 Percentage of subjects
Interval 0.0 to 99.99
|
18.75 Percentage of subjects
Interval 0.0 to 99.99
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rhinorrhoea,Week 40
|
—
|
4.29 Percentage of subjects
Interval 0.17 to 19.69
|
—
|
4.29 Percentage of subjects
Interval 0.17 to 19.69
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rhinorrhoea,Week 41
|
—
|
6.59 Percentage of subjects
Interval 0.46 to 25.51
|
—
|
6.59 Percentage of subjects
Interval 0.46 to 25.51
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rhinorrhoea,Week 42
|
3.55 Percentage of subjects
Interval 0.0 to 90.3
|
6.98 Percentage of subjects
Interval 0.0 to 87.92
|
7.69 Percentage of subjects
Interval 0.19 to 36.17
|
5.08 Percentage of subjects
Interval 1.26 to 13.14
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rhinorrhoea,Week 43
|
16.13 Percentage of subjects
Interval 5.45 to 33.73
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
10.26 Percentage of subjects
Interval 1.39 to 31.54
|
10.66 Percentage of subjects
Interval 4.95 to 19.36
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rhinorrhoea,Week 44
|
16.67 Percentage of subjects
Interval 6.37 to 32.81
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
10.77 Percentage of subjects
Interval 4.44 to 20.94
|
11.21 Percentage of subjects
Interval 6.1 to 18.4
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rhinorrhoea,Week 45
|
16.22 Percentage of subjects
Interval 8.67 to 26.61
|
11.11 Percentage of subjects
Interval 1.38 to 34.71
|
10.32 Percentage of subjects
Interval 2.41 to 26.28
|
12.15 Percentage of subjects
Interval 7.21 to 18.78
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rhinorrhoea,Week 46
|
7.69 Percentage of subjects
Interval 0.95 to 25.13
|
3.85 Percentage of subjects
Interval 0.1 to 19.64
|
8.96 Percentage of subjects
Interval 0.58 to 34.08
|
7.56 Percentage of subjects
Interval 3.52 to 13.87
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rhinorrhoea,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
15.00 Percentage of subjects
Interval 0.0 to 100.0
|
6.98 Percentage of subjects
Interval 0.0 to 60.43
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rhinorrhoea,Week 48
|
—
|
—
|
18.75 Percentage of subjects
Interval 0.3 to 72.31
|
18.75 Percentage of subjects
Interval 0.3 to 72.31
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Wheezing,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Wheezing,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Wheezing,Week 42
|
0.71 Percentage of subjects
Interval 0.01 to 4.4
|
2.33 Percentage of subjects
Interval 0.0 to 47.9
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.85 Percentage of subjects
Interval 0.1 to 3.03
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Wheezing,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
15.38 Percentage of subjects
Interval 1.92 to 45.45
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
1.64 Percentage of subjects
Interval 0.0 to 25.52
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Wheezing,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
3.08 Percentage of subjects
Interval 0.0 to 24.91
|
1.72 Percentage of subjects
Interval 0.18 to 6.35
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Wheezing,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
0.00 Percentage of subjects
Interval 0.0 to 1.48
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Wheezing,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Wheezing,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Wheezing,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dry throat,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dry throat,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dry throat,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 1.55
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dry throat,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dry throat,Week 44
|
2.78 Percentage of subjects
Interval 0.0 to 84.65
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.86 Percentage of subjects
Interval 0.0 to 7.14
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dry throat,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
0.00 Percentage of subjects
Interval 0.0 to 1.48
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dry throat,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dry throat,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dry throat,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dyspnoea,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dyspnoea,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dyspnoea,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
4.65 Percentage of subjects
Interval 0.0 to 74.17
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.85 Percentage of subjects
Interval 0.0 to 8.26
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dyspnoea,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
7.69 Percentage of subjects
Interval 0.19 to 36.03
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.82 Percentage of subjects
Interval 0.0 to 13.55
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dyspnoea,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 3.13
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dyspnoea,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
0.00 Percentage of subjects
Interval 0.0 to 1.48
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dyspnoea,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dyspnoea,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Dyspnoea,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Increased upper airway secretion,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Increased upper airway secretion,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Increased upper airway secretion,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 1.55
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Increased upper airway secretion,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
1.28 Percentage of subjects
Interval 0.03 to 6.94
|
0.82 Percentage of subjects
Interval 0.02 to 4.48
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Increased upper airway secretion,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 3.13
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Increased upper airway secretion,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
0.00 Percentage of subjects
Interval 0.0 to 1.48
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Increased upper airway secretion,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Increased upper airway secretion,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Increased upper airway secretion,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Sneezing,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Sneezing,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Sneezing,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 1.55
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Sneezing,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
1.28 Percentage of subjects
Interval 0.03 to 6.94
|
0.82 Percentage of subjects
Interval 0.02 to 4.48
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Sneezing,Week 44
|
2.78 Percentage of subjects
Interval 0.0 to 84.65
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
1.54 Percentage of subjects
Interval 0.04 to 8.28
|
1.72 Percentage of subjects
Interval 0.21 to 6.09
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were cough, dysphonia, epistaxis, nasal congestion, oropharyngeal pain, rhinorrhoea, and wheezing.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=139 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Wheezing,Week 49
|
0.00 Percentage of subjects
Interval 0.0 to 10.28
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Week 47
|
15.79 Percentage of subjects
Interval 0.0 to 100.0
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Week 48
|
36.00 Percentage of subjects
Interval 17.97 to 57.48
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Week 49
|
8.82 Percentage of subjects
Interval 0.01 to 58.08
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Week 50
|
4.76 Percentage of subjects
Interval 0.58 to 16.16
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Week 51
|
16.67 Percentage of subjects
Interval 0.0 to 100.0
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Week 52
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Cough,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Cough,Week 47
|
15.79 Percentage of subjects
Interval 0.0 to 100.0
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Cough,Week 48
|
20.00 Percentage of subjects
Interval 6.83 to 40.7
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Cough,Week 49
|
8.82 Percentage of subjects
Interval 0.01 to 58.08
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Cough,Week 50
|
4.76 Percentage of subjects
Interval 0.58 to 16.16
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Cough,Week 51
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Cough,Week 52
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Dysphonia,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Dysphonia,Week 47
|
5.26 Percentage of subjects
Interval 0.0 to 100.0
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Dysphonia,Week 48
|
8.00 Percentage of subjects
Interval 0.98 to 26.03
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Dysphonia,Week 49
|
0.00 Percentage of subjects
Interval 0.0 to 10.28
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Dysphonia,Week 50
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Dysphonia,Week 51
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Dysphonia,Week 52
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Epistaxis,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Epistaxis,Week 47
|
5.26 Percentage of subjects
Interval 0.0 to 95.26
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Epistaxis,Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 13.72
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Epistaxis,Week 49
|
0.00 Percentage of subjects
Interval 0.0 to 10.28
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Epistaxis,Week 50
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Epistaxis,Week 51
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Epistaxis,Week 52
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Nasal congestion,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Nasal congestion,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Nasal congestion,Week 48
|
12.00 Percentage of subjects
Interval 2.55 to 31.22
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Nasal congestion,Week 49
|
2.94 Percentage of subjects
Interval 0.0 to 67.58
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Nasal congestion,Week 50
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Nasal congestion,Week 51
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Nasal congestion,Week 52
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Oropharyngeal pain,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Oropharyngeal pain,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Oropharyngeal pain,Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 13.72
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Oropharyngeal pain,Week 49
|
0.00 Percentage of subjects
Interval 0.0 to 10.28
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Oropharyngeal pain,Week 50
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Oropharyngeal pain,Week 51
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Oropharyngeal pain,Week 52
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Rhinorrhoea,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Rhinorrhoea,Week 47
|
5.26 Percentage of subjects
Interval 0.0 to 100.0
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Rhinorrhoea,Week 48
|
20.00 Percentage of subjects
Interval 6.83 to 40.7
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Rhinorrhoea,Week 49
|
5.88 Percentage of subjects
Interval 0.0 to 77.51
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Rhinorrhoea,Week 50
|
2.38 Percentage of subjects
Interval 0.06 to 12.57
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Rhinorrhoea,Week 51
|
8.33 Percentage of subjects
Interval 0.0 to 100.0
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Rhinorrhoea,Week 52
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Wheezing,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Wheezing,Week 47
|
5.26 Percentage of subjects
Interval 0.0 to 100.0
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Wheezing,Week 48
|
4.00 Percentage of subjects
Interval 0.1 to 20.35
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Wheezing,Week 50
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Wheezing,Week 51
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Wheezing,Week 52
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Sneezing,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Sneezing,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Sneezing,Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 13.72
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Sneezing,Week 49
|
0.00 Percentage of subjects
Interval 0.0 to 10.28
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Sneezing,Week 50
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Sneezing,Week 51
|
8.33 Percentage of subjects
Interval 0.21 to 38.48
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Sneezing,Week 52
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were rash and rash generalised.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rash,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
1.92 Percentage of subjects
Interval 0.05 to 10.26
|
0.42 Percentage of subjects
Interval 0.0 to 3.83
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rash,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 40
|
—
|
2.86 Percentage of subjects
Interval 0.12 to 13.38
|
—
|
2.86 Percentage of subjects
Interval 0.12 to 13.38
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 41
|
—
|
1.10 Percentage of subjects
Interval 0.0 to 21.06
|
—
|
1.10 Percentage of subjects
Interval 0.0 to 21.06
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
2.33 Percentage of subjects
Interval 0.0 to 47.9
|
3.85 Percentage of subjects
Interval 0.11 to 19.24
|
1.27 Percentage of subjects
Interval 0.02 to 7.52
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 43
|
3.23 Percentage of subjects
Interval 0.08 to 16.7
|
7.69 Percentage of subjects
Interval 0.19 to 36.03
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
1.64 Percentage of subjects
Interval 0.0 to 14.48
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
3.08 Percentage of subjects
Interval 0.0 to 28.63
|
1.72 Percentage of subjects
Interval 0.15 to 6.81
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 45
|
6.76 Percentage of subjects
Interval 1.9 to 16.31
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
1.29 Percentage of subjects
Interval 0.0 to 35.42
|
2.83 Percentage of subjects
Interval 0.2 to 11.67
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
3.85 Percentage of subjects
Interval 0.1 to 19.64
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.84 Percentage of subjects
Interval 0.0 to 7.7
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rash,Week 40
|
—
|
1.43 Percentage of subjects
Interval 0.04 to 7.7
|
—
|
1.43 Percentage of subjects
Interval 0.04 to 7.7
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rash,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rash,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
3.08 Percentage of subjects
Interval 0.0 to 28.63
|
1.72 Percentage of subjects
Interval 0.15 to 6.81
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rash,Week 45
|
1.35 Percentage of subjects
Interval 0.0 to 21.52
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.65 Percentage of subjects
Interval 0.0 to 19.47
|
0.81 Percentage of subjects
Interval 0.03 to 3.98
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rash,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rash,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rash,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rash generalised,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rash generalised,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rash generalised,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 1.55
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rash generalised,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rash generalised,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 3.13
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rash generalised,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
0.00 Percentage of subjects
Interval 0.0 to 1.48
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rash generalised,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
3.85 Percentage of subjects
Interval 0.1 to 19.64
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.84 Percentage of subjects
Interval 0.0 to 7.7
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rash generalised,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Rash generalised,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Erythema,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Erythema,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Erythema,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
1.92 Percentage of subjects
Interval 0.05 to 10.26
|
0.42 Percentage of subjects
Interval 0.0 to 3.83
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Erythema,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Erythema,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 3.13
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Erythema,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.65 Percentage of subjects
Interval 0.0 to 19.47
|
0.40 Percentage of subjects
Interval 0.0 to 4.07
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Erythema,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Erythema,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Erythema,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Hyperhidrosis,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Hyperhidrosis,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Hyperhidrosis,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 1.55
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Hyperhidrosis,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Hyperhidrosis,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 3.13
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Hyperhidrosis,Week 45
|
1.35 Percentage of subjects
Interval 0.0 to 21.52
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
0.40 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Hyperhidrosis,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Hyperhidrosis,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Hyperhidrosis,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pruritus,Week 40
|
—
|
1.43 Percentage of subjects
Interval 0.04 to 7.7
|
—
|
1.43 Percentage of subjects
Interval 0.04 to 7.7
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pruritus,Week 41
|
—
|
1.10 Percentage of subjects
Interval 0.0 to 21.06
|
—
|
1.10 Percentage of subjects
Interval 0.0 to 21.06
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pruritus,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
2.33 Percentage of subjects
Interval 0.0 to 47.9
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.42 Percentage of subjects
Interval 0.0 to 4.2
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pruritus,Week 43
|
3.23 Percentage of subjects
Interval 0.08 to 16.7
|
7.69 Percentage of subjects
Interval 0.19 to 36.03
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
1.64 Percentage of subjects
Interval 0.0 to 14.48
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pruritus,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 3.13
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pruritus,Week 45
|
2.70 Percentage of subjects
Interval 0.0 to 85.98
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
0.81 Percentage of subjects
Interval 0.03 to 4.1
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pruritus,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
3.85 Percentage of subjects
Interval 0.1 to 19.64
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.84 Percentage of subjects
Interval 0.0 to 7.7
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pruritus,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pruritus,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pruritus generalised,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pruritus generalised,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pruritus generalised,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 1.55
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pruritus generalised,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pruritus generalised,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 3.13
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pruritus generalised,Week 45
|
2.70 Percentage of subjects
Interval 0.0 to 39.0
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
0.81 Percentage of subjects
Interval 0.0 to 5.9
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pruritus generalised,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pruritus generalised,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Pruritus generalised,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were rash and rash generalised.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=139 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Week 48
|
4.00 Percentage of subjects
Interval 0.1 to 20.35
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Week 49
|
0.00 Percentage of subjects
Interval 0.0 to 10.28
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Week 50
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Week 51
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Week 52
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Rash,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Rash,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Rash,Week 48
|
4.00 Percentage of subjects
Interval 0.1 to 20.35
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Rash,Week 49
|
0.00 Percentage of subjects
Interval 0.0 to 10.28
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Rash,Week 50
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Rash,Week 51
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Rash,Week 52
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Rash generalised,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Rash generalised,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Rash generalised,Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 13.72
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Rash generalised,Week 49
|
0.00 Percentage of subjects
Interval 0.0 to 10.28
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Rash generalised,Week 50
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Rash generalised,Week 51
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Rash generalised,Week 52
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. There were no predefined AEIs listed on the ADR card for cardiac disorders.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 40
|
—
|
1.43 Percentage of subjects
Interval 0.04 to 7.7
|
—
|
1.43 Percentage of subjects
Interval 0.04 to 7.7
|
|
Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
|
Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 1.55
|
|
Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 3.13
|
|
Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
0.00 Percentage of subjects
Interval 0.0 to 1.48
|
|
Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
|
Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tachycardia,Week 40
|
—
|
1.43 Percentage of subjects
Interval 0.04 to 7.7
|
—
|
1.43 Percentage of subjects
Interval 0.04 to 7.7
|
|
Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tachycardia,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
|
Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tachycardia,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 1.55
|
|
Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tachycardia,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tachycardia,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 3.13
|
|
Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tachycardia,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
0.00 Percentage of subjects
Interval 0.0 to 1.48
|
|
Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tachycardia,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
|
Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tachycardia,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tachycardia,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. There were no predefined AEIs listed on the ADR card for cardiac disorders.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=139 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
|
0 Percentage of subjects
Interval 0.0 to 2.62
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. There were no predefined AEIs listed on the ADR card for ear and labyrinth disorders.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear pain,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 1.55
|
|
Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear pain,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear pain,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
1.54 Percentage of subjects
Interval 0.04 to 8.28
|
0.86 Percentage of subjects
Interval 0.02 to 4.71
|
|
Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear pain,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
0.00 Percentage of subjects
Interval 0.0 to 1.48
|
|
Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear pain,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
3.85 Percentage of subjects
Interval 0.1 to 19.64
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.84 Percentage of subjects
Interval 0.0 to 7.7
|
|
Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear pain,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear pain,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear pruritus,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear pruritus,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
|
Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear pruritus,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 1.55
|
|
Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear pruritus,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear pruritus,Week 44
|
2.78 Percentage of subjects
Interval 0.0 to 84.65
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.86 Percentage of subjects
Interval 0.0 to 7.14
|
|
Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear pruritus,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
0.00 Percentage of subjects
Interval 0.0 to 1.48
|
|
Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear pruritus,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
|
Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear pruritus,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear pruritus,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tinnitus,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tinnitus,Week 41
|
—
|
1.10 Percentage of subjects
Interval 0.0 to 21.06
|
—
|
1.10 Percentage of subjects
Interval 0.0 to 21.06
|
|
Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tinnitus,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 1.55
|
|
Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tinnitus,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tinnitus,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 3.13
|
|
Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tinnitus,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
0.00 Percentage of subjects
Interval 0.0 to 1.48
|
|
Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tinnitus,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
|
Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tinnitus,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Tinnitus,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Vertigo,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Vertigo,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
|
Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Vertigo,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 1.55
|
|
Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Vertigo,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Vertigo,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 3.13
|
|
Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Vertigo,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
11.11 Percentage of subjects
Interval 1.38 to 34.71
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
0.81 Percentage of subjects
Interval 0.0 to 7.97
|
|
Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Vertigo,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
|
Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Vertigo,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Vertigo,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 41
|
—
|
2.20 Percentage of subjects
Interval 0.01 to 16.5
|
—
|
2.20 Percentage of subjects
Interval 0.01 to 16.5
|
|
Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 1.55
|
|
Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 44
|
2.78 Percentage of subjects
Interval 0.0 to 84.65
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
1.54 Percentage of subjects
Interval 0.04 to 8.28
|
1.72 Percentage of subjects
Interval 0.21 to 6.09
|
|
Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
11.11 Percentage of subjects
Interval 1.38 to 34.71
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
0.81 Percentage of subjects
Interval 0.0 to 7.97
|
|
Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
3.85 Percentage of subjects
Interval 0.1 to 19.64
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.84 Percentage of subjects
Interval 0.0 to 7.7
|
|
Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear haemorrhage,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear haemorrhage,Week 41
|
—
|
1.10 Percentage of subjects
Interval 0.0 to 20.56
|
—
|
1.10 Percentage of subjects
Interval 0.0 to 20.56
|
|
Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear haemorrhage,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 1.55
|
|
Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear haemorrhage,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear haemorrhage,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 3.13
|
|
Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear haemorrhage,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
0.00 Percentage of subjects
Interval 0.0 to 1.48
|
|
Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear haemorrhage,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
|
Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear haemorrhage,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear haemorrhage,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear pain,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Ear pain,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. There were no predefined AEIs listed on the ADR card for ear and labyrinth disorders.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=139 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
|
0 Percentage of subjects
Interval 0.0 to 2.62
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. There were no predefined AEIs listed on the ADR card for eye disorders.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 40
|
—
|
1.43 Percentage of subjects
Interval 0.04 to 7.7
|
—
|
1.43 Percentage of subjects
Interval 0.04 to 7.7
|
|
Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
|
Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
4.65 Percentage of subjects
Interval 0.0 to 74.17
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.85 Percentage of subjects
Interval 0.0 to 8.26
|
|
Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 44
|
2.78 Percentage of subjects
Interval 0.0 to 84.65
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.86 Percentage of subjects
Interval 0.0 to 7.14
|
|
Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
0.00 Percentage of subjects
Interval 0.0 to 1.48
|
|
Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
|
Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Eye discharge,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Eye discharge,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
|
Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Eye discharge,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
2.33 Percentage of subjects
Interval 0.0 to 47.9
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.42 Percentage of subjects
Interval 0.0 to 4.2
|
|
Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Eye discharge,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Eye discharge,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 3.13
|
|
Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Eye discharge,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
0.00 Percentage of subjects
Interval 0.0 to 1.48
|
|
Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Eye discharge,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
|
Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Eye discharge,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Eye discharge,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Eye pruritus,Week 40
|
—
|
1.43 Percentage of subjects
Interval 0.04 to 7.7
|
—
|
1.43 Percentage of subjects
Interval 0.04 to 7.7
|
|
Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Eye pruritus,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
|
Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Eye pruritus,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 1.55
|
|
Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Eye pruritus,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Eye pruritus,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 3.13
|
|
Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Eye pruritus,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
0.00 Percentage of subjects
Interval 0.0 to 1.48
|
|
Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Eye pruritus,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
|
Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Eye pruritus,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Eye pruritus,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Lacrimation increased,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Lacrimation increased,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
|
Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Lacrimation increased,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
2.33 Percentage of subjects
Interval 0.0 to 47.9
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.42 Percentage of subjects
Interval 0.0 to 4.2
|
|
Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Lacrimation increased,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Lacrimation increased,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 3.13
|
|
Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Lacrimation increased,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
0.00 Percentage of subjects
Interval 0.0 to 1.48
|
|
Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Lacrimation increased,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
|
Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Lacrimation increased,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Lacrimation increased,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Swelling of eyelid,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Swelling of eyelid,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
|
Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Swelling of eyelid,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 1.55
|
|
Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Swelling of eyelid,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Swelling of eyelid,Week 44
|
2.78 Percentage of subjects
Interval 0.0 to 84.65
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.86 Percentage of subjects
Interval 0.0 to 7.14
|
|
Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Swelling of eyelid,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
0.00 Percentage of subjects
Interval 0.0 to 1.48
|
|
Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Swelling of eyelid,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
|
Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Swelling of eyelid,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Swelling of eyelid,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. There were no predefined AEIs listed on the ADR card for eye disorders.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=139 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Eye pruritus,Week 51
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Week 47
|
10.53 Percentage of subjects
Interval 0.0 to 99.89
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 13.72
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Week 49
|
0.00 Percentage of subjects
Interval 0.0 to 10.28
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Week 50
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Week 51
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Any,Week 52
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Eye pruritus,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Eye pruritus,Week 47
|
10.53 Percentage of subjects
Interval 0.0 to 99.89
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Eye pruritus,Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 13.72
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Eye pruritus,Week 49
|
0.00 Percentage of subjects
Interval 0.0 to 10.28
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Eye pruritus,Week 50
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
Eye pruritus,Week 52
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. There were no predefined AEIs listed on the ADR card for injury, poisoning and procedural complications.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
|
Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 1.55
|
|
Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 3.13
|
|
Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
5.56 Percentage of subjects
Interval 0.14 to 27.29
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
0.40 Percentage of subjects
Interval 0.0 to 4.05
|
|
Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
|
Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Muscle strain,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Muscle strain,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
|
Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Muscle strain,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 1.55
|
|
Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Muscle strain,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Muscle strain,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 3.13
|
|
Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Muscle strain,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
5.56 Percentage of subjects
Interval 0.14 to 27.29
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
0.40 Percentage of subjects
Interval 0.0 to 4.05
|
|
Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Muscle strain,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
|
Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Muscle strain,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Muscle strain,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. There were no predefined AEIs listed on the ADR card for injury, poisoning and procedural complications.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=139 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
|
0 Percentage of subjects
Interval 0.0 to 2.62
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. There were no predefined AEIs listed on the ADR card for investigations.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
|
Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
4.65 Percentage of subjects
Interval 0.0 to 74.17
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.85 Percentage of subjects
Interval 0.0 to 8.26
|
|
Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
7.69 Percentage of subjects
Interval 0.19 to 36.03
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.82 Percentage of subjects
Interval 0.0 to 13.55
|
|
Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 3.13
|
|
Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 45
|
1.35 Percentage of subjects
Interval 0.0 to 21.52
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
0.40 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
|
Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Heart rate increased,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Heart rate increased,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
|
Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Heart rate increased,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.58
|
4.65 Percentage of subjects
Interval 0.0 to 74.17
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.85 Percentage of subjects
Interval 0.0 to 8.26
|
|
Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Heart rate increased,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
7.69 Percentage of subjects
Interval 0.19 to 36.03
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.82 Percentage of subjects
Interval 0.0 to 13.55
|
|
Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Heart rate increased,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 3.13
|
|
Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Heart rate increased,Week 45
|
1.35 Percentage of subjects
Interval 0.0 to 21.52
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
0.40 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Heart rate increased,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
|
Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Heart rate increased,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Heart rate increased,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. There were no predefined AEIs listed on the ADR card for investigations.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=139 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
|
0 Percentage of subjects
Interval 0.0 to 2.62
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. There were no predefined AEIs listed on the ADR card for vascular disorders.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
|
Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 42
|
0.71 Percentage of subjects
Interval 0.01 to 4.4
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.42 Percentage of subjects
Interval 0.01 to 2.34
|
|
Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 3.13
|
|
Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
0.00 Percentage of subjects
Interval 0.0 to 1.48
|
|
Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
|
Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Any,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Hot flush,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
|
Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Hot flush,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.97
|
|
Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Hot flush,Week 42
|
0.71 Percentage of subjects
Interval 0.01 to 4.4
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.42 Percentage of subjects
Interval 0.01 to 2.34
|
|
Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Hot flush,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
|
Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Hot flush,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 3.13
|
|
Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Hot flush,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
0.00 Percentage of subjects
Interval 0.0 to 1.48
|
|
Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Hot flush,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
|
Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Hot flush,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall
Hot flush,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. There were no predefined AEIs listed on the ADR card for vascular disorders.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=139 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group
|
0 Percentage of subjects
Interval 0.0 to 2.62
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as "6 months to 17 years", "18 to 65 years" and "\>65 years". All subjects who received the second dose of vaccine, were in the first age stratum: "6 months to 17 years". Please, refer to outcome n°36 for the overall (across age strata) post-dose 2 results.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 41
|
—
|
32.00 Percentage of subjects
Interval 0.06 to 96.94
|
—
|
32.00 Percentage of subjects
Interval 0.06 to 96.94
|
|
Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 42
|
29.41 Percentage of subjects
Interval 0.0 to 100.0
|
24.14 Percentage of subjects
Interval 0.76 to 77.59
|
—
|
26.09 Percentage of subjects
Interval 10.2 to 48.46
|
|
Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 43
|
46.43 Percentage of subjects
Interval 27.51 to 66.13
|
40.00 Percentage of subjects
Interval 12.16 to 73.76
|
—
|
44.74 Percentage of subjects
Interval 15.59 to 76.89
|
|
Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 44
|
57.14 Percentage of subjects
Interval 0.28 to 99.96
|
9.09 Percentage of subjects
Interval 0.23 to 41.28
|
—
|
45.65 Percentage of subjects
Interval 1.56 to 96.94
|
|
Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 45
|
36.62 Percentage of subjects
Interval 1.04 to 92.67
|
50.00 Percentage of subjects
Interval 18.71 to 81.29
|
—
|
38.27 Percentage of subjects
Interval 18.79 to 60.98
|
|
Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 46
|
26.92 Percentage of subjects
Interval 11.57 to 47.79
|
33.33 Percentage of subjects
Interval 9.92 to 65.11
|
—
|
28.95 Percentage of subjects
Interval 3.8 to 71.27
|
|
Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 47
|
31.58 Percentage of subjects
Interval 12.58 to 56.55
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
—
|
30.00 Percentage of subjects
Interval 3.86 to 73.12
|
|
Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 42
|
—
|
—
|
44.23 Percentage of subjects
Interval 0.11 to 99.54
|
44.23 Percentage of subjects
Interval 0.11 to 99.54
|
|
Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 43
|
—
|
—
|
47.44 Percentage of subjects
Interval 36.01 to 59.07
|
47.44 Percentage of subjects
Interval 36.01 to 59.07
|
|
Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 44
|
—
|
—
|
33.33 Percentage of subjects
Interval 10.12 to 64.74
|
33.33 Percentage of subjects
Interval 10.12 to 64.74
|
|
Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 45
|
—
|
—
|
47.13 Percentage of subjects
Interval 10.74 to 86.08
|
47.13 Percentage of subjects
Interval 10.74 to 86.08
|
|
Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 46
|
—
|
—
|
31.03 Percentage of subjects
Interval 13.11 to 54.42
|
31.03 Percentage of subjects
Interval 13.11 to 54.42
|
|
Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 47
|
—
|
—
|
70.59 Percentage of subjects
Interval 0.0 to 100.0
|
70.59 Percentage of subjects
Interval 0.0 to 100.0
|
|
Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 48
|
—
|
—
|
81.25 Percentage of subjects
Interval 0.01 to 100.0
|
81.25 Percentage of subjects
Interval 0.01 to 100.0
|
|
Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 40
|
—
|
46.15 Percentage of subjects
Interval 0.35 to 99.22
|
—
|
46.15 Percentage of subjects
Interval 0.35 to 99.22
|
|
Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 41
|
—
|
41.46 Percentage of subjects
Interval 0.08 to 99.36
|
—
|
41.46 Percentage of subjects
Interval 0.08 to 99.36
|
|
Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 42
|
47.58 Percentage of subjects
Interval 38.54 to 56.74
|
50.00 Percentage of subjects
Interval 0.43 to 99.57
|
—
|
47.83 Percentage of subjects
Interval 39.26 to 56.49
|
|
Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 43
|
33.33 Percentage of subjects
Interval 0.84 to 90.57
|
33.33 Percentage of subjects
Interval 0.84 to 90.57
|
—
|
33.33 Percentage of subjects
Interval 4.33 to 77.72
|
|
Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
50.00 Percentage of subjects
Interval 6.76 to 93.24
|
60.00 Percentage of subjects
Interval 14.66 to 94.73
|
50.00 Percentage of subjects
Interval 18.71 to 81.29
|
|
Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
87.50 Percentage of subjects
Interval 47.35 to 99.68
|
55.88 Percentage of subjects
Interval 43.32 to 67.92
|
56.96 Percentage of subjects
Interval 35.12 to 76.98
|
|
Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 46
|
—
|
50.00 Percentage of subjects
Interval 23.04 to 76.96
|
44.74 Percentage of subjects
Interval 28.62 to 61.7
|
46.15 Percentage of subjects
Interval 20.68 to 73.21
|
|
Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 47
|
100 Percentage of subjects
Interval 15.81 to 100.0
|
100 Percentage of subjects
Interval 2.5 to 100.0
|
66.67 Percentage of subjects
Interval 9.43 to 99.16
|
83.33 Percentage of subjects
Interval 22.88 to 99.95
|
|
Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 40
|
—
|
25.00 Percentage of subjects
Interval 12.33 to 41.82
|
—
|
25.00 Percentage of subjects
Interval 12.33 to 41.82
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as "6 months to 17 years", "18 to 65 years" and "\>65 years". All subjects who received the second dose of vaccine, were in the first age stratum: "6 months to 17 years". Please, refer to outcome n°38 for the overall (across age strata) post-dose 2 results.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 42
|
—
|
—
|
7.69 Percentage of subjects
Interval 0.19 to 36.17
|
7.69 Percentage of subjects
Interval 0.19 to 36.17
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 43
|
—
|
—
|
8.97 Percentage of subjects
Interval 0.05 to 50.25
|
8.97 Percentage of subjects
Interval 0.05 to 50.25
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 44
|
—
|
—
|
3.33 Percentage of subjects
Interval 0.41 to 11.53
|
3.33 Percentage of subjects
Interval 0.41 to 11.53
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 45
|
—
|
—
|
5.75 Percentage of subjects
Interval 0.79 to 18.58
|
5.75 Percentage of subjects
Interval 0.79 to 18.58
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 46
|
—
|
—
|
6.90 Percentage of subjects
Interval 0.0 to 49.97
|
6.90 Percentage of subjects
Interval 0.0 to 49.97
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 47
|
—
|
—
|
11.76 Percentage of subjects
Interval 0.0 to 83.56
|
11.76 Percentage of subjects
Interval 0.0 to 83.56
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 48
|
—
|
—
|
12.50 Percentage of subjects
Interval 0.0 to 99.41
|
12.50 Percentage of subjects
Interval 0.0 to 99.41
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 40
|
—
|
3.85 Percentage of subjects
Interval 0.0 to 45.2
|
—
|
3.85 Percentage of subjects
Interval 0.0 to 45.2
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 42
|
1.61 Percentage of subjects
Interval 0.2 to 5.7
|
14.29 Percentage of subjects
Interval 0.0 to 100.0
|
—
|
2.90 Percentage of subjects
Interval 0.0 to 29.19
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
33.33 Percentage of subjects
Interval 0.84 to 90.57
|
—
|
16.67 Percentage of subjects
Interval 0.0 to 100.0
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
25.00 Percentage of subjects
Interval 0.63 to 80.59
|
20.00 Percentage of subjects
Interval 0.51 to 71.64
|
20.00 Percentage of subjects
Interval 2.52 to 55.61
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
25.00 Percentage of subjects
Interval 3.19 to 65.09
|
1.47 Percentage of subjects
Interval 0.04 to 7.92
|
3.80 Percentage of subjects
Interval 0.0 to 50.11
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 46
|
—
|
7.14 Percentage of subjects
Interval 0.18 to 33.87
|
13.16 Percentage of subjects
Interval 4.41 to 28.09
|
11.54 Percentage of subjects
Interval 0.02 to 66.5
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 40
|
—
|
2.27 Percentage of subjects
Interval 0.06 to 12.02
|
—
|
2.27 Percentage of subjects
Interval 0.06 to 12.02
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 41
|
—
|
4.00 Percentage of subjects
Interval 0.0 to 34.94
|
—
|
4.00 Percentage of subjects
Interval 0.0 to 34.94
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 42
|
5.88 Percentage of subjects
Interval 0.0 to 94.68
|
10.34 Percentage of subjects
Interval 0.51 to 40.58
|
—
|
8.70 Percentage of subjects
Interval 2.42 to 20.79
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 43
|
10.71 Percentage of subjects
Interval 2.27 to 28.23
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
—
|
7.89 Percentage of subjects
Interval 0.0 to 97.58
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 44
|
14.29 Percentage of subjects
Interval 0.0 to 80.69
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
—
|
10.87 Percentage of subjects
Interval 0.26 to 47.98
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 45
|
9.86 Percentage of subjects
Interval 4.06 to 19.26
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
—
|
8.64 Percentage of subjects
Interval 2.48 to 20.4
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 46
|
7.69 Percentage of subjects
Interval 0.95 to 25.13
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
—
|
5.26 Percentage of subjects
Interval 0.0 to 96.53
|
|
Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 47
|
10.53 Percentage of subjects
Interval 1.3 to 33.14
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
—
|
10.00 Percentage of subjects
Interval 1.23 to 31.7
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as "6 months to 17 years", "18 to 65 years" and "\>65 years". All subjects who received the second dose of vaccine, were in the first age stratum: "6 months to 17 years". Please, refer to outcome n°40 for the overall (across age strata) post-dose 2 results.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 42
|
—
|
—
|
26.92 percentage of subjects
Interval 0.28 to 88.26
|
26.92 percentage of subjects
Interval 0.28 to 88.26
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 43
|
—
|
—
|
26.92 percentage of subjects
Interval 17.5 to 38.16
|
26.92 percentage of subjects
Interval 17.5 to 38.16
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 44
|
—
|
—
|
16.67 percentage of subjects
Interval 6.34 to 32.9
|
16.67 percentage of subjects
Interval 6.34 to 32.9
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 45
|
—
|
—
|
24.14 percentage of subjects
Interval 15.6 to 34.5
|
24.14 percentage of subjects
Interval 15.6 to 34.5
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 46
|
—
|
—
|
24.14 percentage of subjects
Interval 2.85 to 64.5
|
24.14 percentage of subjects
Interval 2.85 to 64.5
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 47
|
—
|
—
|
47.06 percentage of subjects
Interval 22.98 to 72.19
|
47.06 percentage of subjects
Interval 22.98 to 72.19
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 48
|
—
|
—
|
62.50 percentage of subjects
Interval 2.31 to 99.81
|
62.50 percentage of subjects
Interval 2.31 to 99.81
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 40
|
—
|
42.31 percentage of subjects
Interval 1.05 to 96.43
|
—
|
42.31 percentage of subjects
Interval 1.05 to 96.43
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 41
|
—
|
36.59 percentage of subjects
Interval 0.25 to 96.81
|
—
|
36.59 percentage of subjects
Interval 0.25 to 96.81
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 42
|
33.06 percentage of subjects
Interval 24.88 to 42.08
|
42.86 percentage of subjects
Interval 17.66 to 71.14
|
—
|
34.06 percentage of subjects
Interval 26.21 to 42.61
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 43
|
0.00 percentage of subjects
Interval 0.0 to 70.76
|
33.33 percentage of subjects
Interval 0.84 to 90.57
|
—
|
16.67 percentage of subjects
Interval 0.0 to 100.0
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 44
|
0.00 percentage of subjects
Interval 0.0 to 97.5
|
50.00 percentage of subjects
Interval 6.76 to 93.24
|
40.00 percentage of subjects
Interval 5.27 to 85.34
|
40.00 percentage of subjects
Interval 12.16 to 73.76
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 45
|
0.00 percentage of subjects
Interval 0.0 to 70.76
|
62.50 percentage of subjects
Interval 24.49 to 91.48
|
44.12 percentage of subjects
Interval 32.08 to 56.68
|
44.30 percentage of subjects
Interval 31.16 to 58.06
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 46
|
—
|
35.71 percentage of subjects
Interval 12.76 to 64.86
|
31.58 percentage of subjects
Interval 17.5 to 48.65
|
32.69 percentage of subjects
Interval 14.19 to 56.24
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 47
|
100 percentage of subjects
Interval 15.81 to 100.0
|
0.00 percentage of subjects
Interval 0.0 to 97.5
|
66.67 percentage of subjects
Interval 9.43 to 99.16
|
66.67 percentage of subjects
Interval 7.08 to 99.52
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 40
|
—
|
15.91 percentage of subjects
Interval 6.64 to 30.07
|
—
|
15.91 percentage of subjects
Interval 6.64 to 30.07
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 41
|
—
|
24.00 percentage of subjects
Interval 0.07 to 89.8
|
—
|
24.00 percentage of subjects
Interval 0.07 to 89.8
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 42
|
17.65 percentage of subjects
Interval 0.0 to 100.0
|
17.24 percentage of subjects
Interval 0.7 to 61.56
|
—
|
17.39 percentage of subjects
Interval 7.82 to 31.42
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 43
|
21.43 percentage of subjects
Interval 8.3 to 40.95
|
10.00 percentage of subjects
Interval 0.25 to 44.5
|
—
|
18.42 percentage of subjects
Interval 0.0 to 91.91
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 44
|
42.86 percentage of subjects
Interval 0.0 to 100.0
|
9.09 percentage of subjects
Interval 0.23 to 41.28
|
—
|
34.78 percentage of subjects
Interval 1.29 to 89.85
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 45
|
18.31 percentage of subjects
Interval 0.0 to 96.43
|
40.00 percentage of subjects
Interval 12.16 to 73.76
|
—
|
20.99 percentage of subjects
Interval 2.46 to 58.55
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 46
|
15.38 percentage of subjects
Interval 4.36 to 34.87
|
16.67 percentage of subjects
Interval 2.09 to 48.41
|
—
|
15.79 percentage of subjects
Interval 6.02 to 31.25
|
|
Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 47
|
21.05 percentage of subjects
Interval 6.05 to 45.57
|
0.00 percentage of subjects
Interval 0.0 to 97.5
|
—
|
20.00 percentage of subjects
Interval 3.08 to 52.97
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as "6 months to 17 years", "18 to 65 years" and "\>65 years". All subjects who received the second dose of vaccine, were in the first age stratum: "6 months to 17 years". Please, refer to outcome n°42 for the overall (across age strata) post-dose 2 results.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 42
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
|
Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 43
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
|
Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 44
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.96
|
0.00 Percentage of subjects
Interval 0.0 to 5.96
|
|
Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 45
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 4.15
|
0.00 Percentage of subjects
Interval 0.0 to 4.15
|
|
Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 46
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
|
Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 47
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
|
Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
|
Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
|
Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.93
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.64
|
|
Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
|
Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 5.28
|
0.00 Percentage of subjects
Interval 0.0 to 4.56
|
|
Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 46
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
|
Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
|
Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 8.04
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 8.04
|
|
Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 7.11
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 7.11
|
|
Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 7.71
|
|
Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 12.34
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
|
Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 10.0
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 7.71
|
|
Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 45
|
1.41 Percentage of subjects
Interval 0.0 to 23.79
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
—
|
1.23 Percentage of subjects
Interval 0.03 to 6.69
|
|
Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
|
Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as "6 months to 17 years", "18 to 65 years" and "\>65 years". All subjects who received the second dose of vaccine, were in the first age stratum: "6 months to 17 years". Please, refer to outcome n°44 for the overall (across age strata) post-dose 2 results.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 42
|
—
|
—
|
1.92 Percentage of subjects
Interval 0.05 to 10.26
|
1.92 Percentage of subjects
Interval 0.05 to 10.26
|
|
Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 43
|
—
|
—
|
5.13 Percentage of subjects
Interval 0.75 to 16.35
|
5.13 Percentage of subjects
Interval 0.75 to 16.35
|
|
Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 44
|
—
|
—
|
6.67 Percentage of subjects
Interval 0.01 to 46.29
|
6.67 Percentage of subjects
Interval 0.01 to 46.29
|
|
Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 45
|
—
|
—
|
3.45 Percentage of subjects
Interval 0.02 to 21.98
|
3.45 Percentage of subjects
Interval 0.02 to 21.98
|
|
Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 46
|
—
|
—
|
6.90 Percentage of subjects
Interval 0.0 to 49.97
|
6.90 Percentage of subjects
Interval 0.0 to 49.97
|
|
Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 47
|
—
|
—
|
17.65 Percentage of subjects
Interval 3.8 to 43.43
|
17.65 Percentage of subjects
Interval 3.8 to 43.43
|
|
Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 48
|
—
|
—
|
12.50 Percentage of subjects
Interval 0.0 to 99.41
|
12.50 Percentage of subjects
Interval 0.0 to 99.41
|
|
Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 40
|
—
|
11.54 Percentage of subjects
Interval 0.0 to 87.11
|
—
|
11.54 Percentage of subjects
Interval 0.0 to 87.11
|
|
Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 41
|
—
|
12.20 Percentage of subjects
Interval 0.05 to 62.92
|
—
|
12.20 Percentage of subjects
Interval 0.05 to 62.92
|
|
Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 42
|
0.81 Percentage of subjects
Interval 0.02 to 4.41
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
—
|
0.72 Percentage of subjects
Interval 0.02 to 3.97
|
|
Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
33.33 Percentage of subjects
Interval 0.84 to 90.57
|
—
|
16.67 Percentage of subjects
Interval 0.0 to 100.0
|
|
Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
25.00 Percentage of subjects
Interval 0.63 to 80.59
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
10.00 Percentage of subjects
Interval 0.0 to 78.43
|
|
Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
12.50 Percentage of subjects
Interval 0.32 to 52.65
|
8.82 Percentage of subjects
Interval 3.31 to 18.22
|
8.86 Percentage of subjects
Interval 3.64 to 17.41
|
|
Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 46
|
—
|
7.14 Percentage of subjects
Interval 0.18 to 33.87
|
10.53 Percentage of subjects
Interval 2.94 to 24.8
|
9.62 Percentage of subjects
Interval 0.41 to 39.32
|
|
Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
|
Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 40
|
—
|
6.82 Percentage of subjects
Interval 1.43 to 18.66
|
—
|
6.82 Percentage of subjects
Interval 1.43 to 18.66
|
|
Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 41
|
—
|
6.00 Percentage of subjects
Interval 0.45 to 23.11
|
—
|
6.00 Percentage of subjects
Interval 0.45 to 23.11
|
|
Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
6.90 Percentage of subjects
Interval 0.37 to 28.25
|
—
|
4.35 Percentage of subjects
Interval 0.17 to 20.04
|
|
Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 43
|
7.14 Percentage of subjects
Interval 0.88 to 23.5
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
—
|
5.26 Percentage of subjects
Interval 0.0 to 90.58
|
|
Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 44
|
8.57 Percentage of subjects
Interval 1.8 to 23.06
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
—
|
6.52 Percentage of subjects
Interval 0.54 to 24.21
|
|
Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 45
|
9.86 Percentage of subjects
Interval 0.0 to 68.01
|
10.00 Percentage of subjects
Interval 0.25 to 44.5
|
—
|
9.88 Percentage of subjects
Interval 3.78 to 20.08
|
|
Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 46
|
3.85 Percentage of subjects
Interval 0.1 to 19.64
|
8.33 Percentage of subjects
Interval 0.21 to 38.48
|
—
|
5.26 Percentage of subjects
Interval 0.0 to 70.17
|
|
Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 47
|
5.26 Percentage of subjects
Interval 0.13 to 26.03
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
—
|
5.00 Percentage of subjects
Interval 0.13 to 24.87
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as "6 months to 17 years", "18 to 65 years" and "\>65 years". All subjects who received the second dose of vaccine, were in the first age stratum: "6 months to 17 years". Please, refer to outcome n°46 for the overall (across age strata) post-dose 2 results.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 42
|
—
|
—
|
3.85 Percentage of subjects
Interval 0.11 to 19.24
|
3.85 Percentage of subjects
Interval 0.11 to 19.24
|
|
Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 43
|
—
|
—
|
11.54 Percentage of subjects
Interval 1.53 to 35.14
|
11.54 Percentage of subjects
Interval 1.53 to 35.14
|
|
Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 44
|
—
|
—
|
6.67 Percentage of subjects
Interval 1.85 to 16.2
|
6.67 Percentage of subjects
Interval 1.85 to 16.2
|
|
Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 45
|
—
|
—
|
6.90 Percentage of subjects
Interval 1.95 to 16.58
|
6.90 Percentage of subjects
Interval 1.95 to 16.58
|
|
Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 46
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
|
Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 47
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
|
Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 48
|
—
|
—
|
12.50 Percentage of subjects
Interval 0.0 to 99.41
|
12.50 Percentage of subjects
Interval 0.0 to 99.41
|
|
Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
20.00 Percentage of subjects
Interval 0.51 to 71.64
|
10.00 Percentage of subjects
Interval 0.0 to 66.77
|
|
Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 5.28
|
0.00 Percentage of subjects
Interval 0.0 to 4.56
|
|
Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 46
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
|
Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
|
Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 8.04
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 8.04
|
|
Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 7.11
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 7.11
|
|
Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 7.71
|
|
Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 12.34
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
|
Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 44
|
2.86 Percentage of subjects
Interval 0.0 to 82.04
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
—
|
2.17 Percentage of subjects
Interval 0.0 to 20.88
|
|
Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 45
|
4.23 Percentage of subjects
Interval 0.0 to 57.27
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
—
|
3.70 Percentage of subjects
Interval 0.18 to 16.55
|
|
Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 46
|
3.85 Percentage of subjects
Interval 0.1 to 19.64
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
—
|
2.63 Percentage of subjects
Interval 0.0 to 79.87
|
|
Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 47
|
5.26 Percentage of subjects
Interval 0.13 to 26.03
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
—
|
5.00 Percentage of subjects
Interval 0.13 to 24.87
|
|
Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
|
Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 41
|
—
|
2.44 Percentage of subjects
Interval 0.0 to 24.59
|
—
|
2.44 Percentage of subjects
Interval 0.0 to 24.59
|
|
Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 42
|
0.81 Percentage of subjects
Interval 0.02 to 4.41
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
—
|
0.72 Percentage of subjects
Interval 0.02 to 3.97
|
|
Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as "6 months to 17 years", "18 to 65 years" and "\>65 years". All subjects who received the second dose of vaccine, were in the first age stratum: "6 months to 17 years". Please, refer to outcome n°48 for the overall (across age strata) post-dose 2 results.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
|
Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
25.00 Percentage of subjects
Interval 0.63 to 80.59
|
20.00 Percentage of subjects
Interval 0.51 to 71.64
|
20.00 Percentage of subjects
Interval 2.52 to 55.61
|
|
Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
12.50 Percentage of subjects
Interval 0.32 to 52.65
|
14.71 Percentage of subjects
Interval 7.28 to 25.39
|
13.92 Percentage of subjects
Interval 7.16 to 23.55
|
|
Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 46
|
—
|
21.43 Percentage of subjects
Interval 4.66 to 50.8
|
13.16 Percentage of subjects
Interval 4.41 to 28.09
|
15.38 Percentage of subjects
Interval 0.01 to 80.48
|
|
Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
|
Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 40
|
—
|
6.82 Percentage of subjects
Interval 1.43 to 18.66
|
—
|
6.82 Percentage of subjects
Interval 1.43 to 18.66
|
|
Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 41
|
—
|
4.00 Percentage of subjects
Interval 0.0 to 34.94
|
—
|
4.00 Percentage of subjects
Interval 0.0 to 34.94
|
|
Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
3.45 Percentage of subjects
Interval 0.09 to 17.76
|
—
|
2.17 Percentage of subjects
Interval 0.06 to 11.53
|
|
Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 12.34
|
30.00 Percentage of subjects
Interval 6.67 to 65.25
|
—
|
7.89 Percentage of subjects
Interval 0.0 to 100.0
|
|
Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 44
|
20.00 Percentage of subjects
Interval 0.0 to 92.27
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
—
|
15.22 Percentage of subjects
Interval 0.84 to 53.59
|
|
Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 45
|
11.27 Percentage of subjects
Interval 0.16 to 52.91
|
20.00 Percentage of subjects
Interval 2.52 to 55.61
|
—
|
12.35 Percentage of subjects
Interval 4.17 to 26.4
|
|
Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 46
|
11.54 Percentage of subjects
Interval 2.45 to 30.15
|
8.33 Percentage of subjects
Interval 0.21 to 38.48
|
—
|
10.53 Percentage of subjects
Interval 0.61 to 39.92
|
|
Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 47
|
5.26 Percentage of subjects
Interval 0.13 to 26.03
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
—
|
5.00 Percentage of subjects
Interval 0.13 to 24.87
|
|
Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 42
|
—
|
—
|
7.69 Percentage of subjects
Interval 0.19 to 36.17
|
7.69 Percentage of subjects
Interval 0.19 to 36.17
|
|
Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 43
|
—
|
—
|
7.69 Percentage of subjects
Interval 1.08 to 24.1
|
7.69 Percentage of subjects
Interval 1.08 to 24.1
|
|
Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 44
|
—
|
—
|
1.67 Percentage of subjects
Interval 0.0 to 55.06
|
1.67 Percentage of subjects
Interval 0.0 to 55.06
|
|
Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 45
|
—
|
—
|
3.45 Percentage of subjects
Interval 0.07 to 18.45
|
3.45 Percentage of subjects
Interval 0.07 to 18.45
|
|
Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 46
|
—
|
—
|
3.45 Percentage of subjects
Interval 0.0 to 56.0
|
3.45 Percentage of subjects
Interval 0.0 to 56.0
|
|
Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 47
|
—
|
—
|
5.88 Percentage of subjects
Interval 0.0 to 98.47
|
5.88 Percentage of subjects
Interval 0.0 to 98.47
|
|
Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 48
|
—
|
—
|
37.50 Percentage of subjects
Interval 0.0 to 100.0
|
37.50 Percentage of subjects
Interval 0.0 to 100.0
|
|
Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 40
|
—
|
3.85 Percentage of subjects
Interval 0.0 to 45.2
|
—
|
3.85 Percentage of subjects
Interval 0.0 to 45.2
|
|
Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 41
|
—
|
12.20 Percentage of subjects
Interval 0.0 to 80.65
|
—
|
12.20 Percentage of subjects
Interval 0.0 to 80.65
|
|
Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 42
|
12.90 Percentage of subjects
Interval 7.56 to 20.11
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
—
|
11.59 Percentage of subjects
Interval 5.18 to 21.48
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as "6 months to 17 years", "18 to 65 years" and "\>65 years". All subjects who received the second dose of vaccine, were in the first age stratum: "6 months to 17 years". Please, refer to outcome n°50 for the overall (across age strata) post-dose 2 results.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 42
|
—
|
—
|
1.92 Percentage of subjects
Interval 0.05 to 10.26
|
1.92 Percentage of subjects
Interval 0.05 to 10.26
|
|
Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 43
|
—
|
—
|
7.69 Percentage of subjects
Interval 1.08 to 24.1
|
7.69 Percentage of subjects
Interval 1.08 to 24.1
|
|
Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 44
|
—
|
—
|
1.67 Percentage of subjects
Interval 0.04 to 8.94
|
1.67 Percentage of subjects
Interval 0.04 to 8.94
|
|
Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 45
|
—
|
—
|
5.75 Percentage of subjects
Interval 0.11 to 29.55
|
5.75 Percentage of subjects
Interval 0.11 to 29.55
|
|
Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 46
|
—
|
—
|
3.45 Percentage of subjects
Interval 0.0 to 56.0
|
3.45 Percentage of subjects
Interval 0.0 to 56.0
|
|
Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 47
|
—
|
—
|
5.88 Percentage of subjects
Interval 0.0 to 98.47
|
5.88 Percentage of subjects
Interval 0.0 to 98.47
|
|
Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 48
|
—
|
—
|
37.50 Percentage of subjects
Interval 0.19 to 97.69
|
37.50 Percentage of subjects
Interval 0.19 to 97.69
|
|
Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 40
|
—
|
7.69 Percentage of subjects
Interval 0.0 to 72.14
|
—
|
7.69 Percentage of subjects
Interval 0.0 to 72.14
|
|
Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 41
|
—
|
12.20 Percentage of subjects
Interval 3.66 to 27.56
|
—
|
12.20 Percentage of subjects
Interval 3.66 to 27.56
|
|
Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 41
|
—
|
4.00 Percentage of subjects
Interval 0.0 to 48.56
|
—
|
4.00 Percentage of subjects
Interval 0.0 to 48.56
|
|
Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 42
|
11.76 Percentage of subjects
Interval 0.0 to 99.87
|
6.90 Percentage of subjects
Interval 0.37 to 28.25
|
—
|
8.70 Percentage of subjects
Interval 2.19 to 21.73
|
|
Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 43
|
10.71 Percentage of subjects
Interval 2.27 to 28.23
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
—
|
7.89 Percentage of subjects
Interval 0.0 to 97.58
|
|
Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 44
|
17.14 Percentage of subjects
Interval 0.0 to 96.14
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
—
|
13.04 Percentage of subjects
Interval 0.16 to 59.6
|
|
Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 42
|
4.84 Percentage of subjects
Interval 1.8 to 10.23
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
—
|
4.35 Percentage of subjects
Interval 1.61 to 9.22
|
|
Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
33.33 Percentage of subjects
Interval 0.84 to 90.57
|
—
|
16.67 Percentage of subjects
Interval 0.0 to 100.0
|
|
Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
25.00 Percentage of subjects
Interval 0.63 to 80.59
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
10.00 Percentage of subjects
Interval 0.0 to 78.43
|
|
Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
12.50 Percentage of subjects
Interval 0.32 to 52.65
|
14.71 Percentage of subjects
Interval 7.28 to 25.39
|
13.92 Percentage of subjects
Interval 7.16 to 23.55
|
|
Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 46
|
—
|
28.57 Percentage of subjects
Interval 8.39 to 58.1
|
13.16 Percentage of subjects
Interval 4.41 to 28.09
|
17.31 Percentage of subjects
Interval 0.0 to 99.06
|
|
Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
100 Percentage of subjects
Interval 2.5 to 100.0
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
16.67 Percentage of subjects
Interval 0.0 to 96.87
|
|
Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 45
|
14.08 Percentage of subjects
Interval 0.51 to 54.36
|
10.00 Percentage of subjects
Interval 0.25 to 44.5
|
—
|
13.58 Percentage of subjects
Interval 6.73 to 23.52
|
|
Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 40
|
—
|
4.55 Percentage of subjects
Interval 0.56 to 15.47
|
—
|
4.55 Percentage of subjects
Interval 0.56 to 15.47
|
|
Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
|
Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as "6 months to 17 years", "18 to 65 years" and "\>65 years". All subjects who received the second dose of vaccine, were in the first age stratum: "6 months to 17 years". Please, refer to outcome n°52 for the overall (across age strata) post-dose 2 results.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 42
|
—
|
—
|
1.92 Percentage of subjects
Interval 0.05 to 10.26
|
1.92 Percentage of subjects
Interval 0.05 to 10.26
|
|
Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 43
|
—
|
—
|
5.13 Percentage of subjects
Interval 0.75 to 16.35
|
5.13 Percentage of subjects
Interval 0.75 to 16.35
|
|
Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 44
|
—
|
—
|
3.33 Percentage of subjects
Interval 0.0 to 34.01
|
3.33 Percentage of subjects
Interval 0.0 to 34.01
|
|
Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 45
|
—
|
—
|
1.15 Percentage of subjects
Interval 0.03 to 6.4
|
1.15 Percentage of subjects
Interval 0.03 to 6.4
|
|
Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 46
|
—
|
—
|
6.90 Percentage of subjects
Interval 0.11 to 35.38
|
6.90 Percentage of subjects
Interval 0.11 to 35.38
|
|
Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 47
|
—
|
—
|
5.88 Percentage of subjects
Interval 0.0 to 100.0
|
5.88 Percentage of subjects
Interval 0.0 to 100.0
|
|
Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
|
Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
|
Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.93
|
7.14 Percentage of subjects
Interval 0.0 to 99.99
|
—
|
0.72 Percentage of subjects
Interval 0.0 to 28.91
|
|
Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
|
Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 5.28
|
0.00 Percentage of subjects
Interval 0.0 to 4.56
|
|
Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 46
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
|
Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
|
Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 8.04
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 8.04
|
|
Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 7.11
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 7.11
|
|
Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
10.34 Percentage of subjects
Interval 0.51 to 40.58
|
—
|
6.52 Percentage of subjects
Interval 0.24 to 29.16
|
|
Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 12.34
|
10.00 Percentage of subjects
Interval 0.25 to 44.5
|
—
|
2.63 Percentage of subjects
Interval 0.0 to 99.98
|
|
Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 44
|
2.86 Percentage of subjects
Interval 0.0 to 82.04
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
—
|
2.17 Percentage of subjects
Interval 0.0 to 20.88
|
|
Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 45
|
1.41 Percentage of subjects
Interval 0.0 to 23.79
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
—
|
1.23 Percentage of subjects
Interval 0.03 to 6.69
|
|
Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 46
|
3.85 Percentage of subjects
Interval 0.1 to 19.64
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
—
|
2.63 Percentage of subjects
Interval 0.0 to 79.87
|
|
Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as "6 months to 17 years", "18 to 65 years" and "\>65 years". All subjects who received the second dose of vaccine, were in the first age stratum: "6 months to 17 years". Please, refer to outcome n°54 for the overall (across age strata) post-dose 2 results.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 42
|
—
|
—
|
26.92 Percentage of subjects
Interval 0.28 to 88.26
|
26.92 Percentage of subjects
Interval 0.28 to 88.26
|
|
Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 43
|
—
|
—
|
25.64 Percentage of subjects
Interval 16.42 to 36.79
|
25.64 Percentage of subjects
Interval 16.42 to 36.79
|
|
Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 44
|
—
|
—
|
18.33 Percentage of subjects
Interval 8.34 to 32.8
|
18.33 Percentage of subjects
Interval 8.34 to 32.8
|
|
Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 45
|
—
|
—
|
22.99 Percentage of subjects
Interval 2.17 to 65.07
|
22.99 Percentage of subjects
Interval 2.17 to 65.07
|
|
Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 46
|
—
|
—
|
17.24 Percentage of subjects
Interval 4.06 to 41.32
|
17.24 Percentage of subjects
Interval 4.06 to 41.32
|
|
Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 47
|
—
|
—
|
35.29 Percentage of subjects
Interval 0.0 to 100.0
|
35.29 Percentage of subjects
Interval 0.0 to 100.0
|
|
Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 48
|
—
|
—
|
31.25 Percentage of subjects
Interval 0.0 to 99.95
|
31.25 Percentage of subjects
Interval 0.0 to 99.95
|
|
Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 40
|
—
|
15.38 Percentage of subjects
Interval 0.0 to 94.7
|
—
|
15.38 Percentage of subjects
Interval 0.0 to 94.7
|
|
Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 41
|
—
|
17.07 Percentage of subjects
Interval 0.02 to 81.68
|
—
|
17.07 Percentage of subjects
Interval 0.02 to 81.68
|
|
Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 42
|
9.68 Percentage of subjects
Interval 5.1 to 16.29
|
14.29 Percentage of subjects
Interval 0.0 to 100.0
|
—
|
10.14 Percentage of subjects
Interval 4.97 to 17.88
|
|
Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 43
|
33.33 Percentage of subjects
Interval 0.84 to 90.57
|
33.33 Percentage of subjects
Interval 0.84 to 90.57
|
—
|
33.33 Percentage of subjects
Interval 4.33 to 77.72
|
|
Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
25.00 Percentage of subjects
Interval 0.63 to 80.59
|
20.00 Percentage of subjects
Interval 0.51 to 71.64
|
20.00 Percentage of subjects
Interval 2.52 to 55.61
|
|
Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
25.00 Percentage of subjects
Interval 3.19 to 65.09
|
19.12 Percentage of subjects
Interval 10.59 to 30.47
|
18.99 Percentage of subjects
Interval 11.03 to 29.38
|
|
Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 46
|
—
|
14.29 Percentage of subjects
Interval 1.78 to 42.81
|
23.68 Percentage of subjects
Interval 11.44 to 40.24
|
21.15 Percentage of subjects
Interval 0.09 to 84.06
|
|
Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
|
Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 40
|
—
|
4.55 Percentage of subjects
Interval 0.56 to 15.47
|
—
|
4.55 Percentage of subjects
Interval 0.56 to 15.47
|
|
Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 41
|
—
|
10.00 Percentage of subjects
Interval 0.65 to 37.24
|
—
|
10.00 Percentage of subjects
Interval 0.65 to 37.24
|
|
Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 42
|
11.76 Percentage of subjects
Interval 0.0 to 99.87
|
6.90 Percentage of subjects
Interval 0.37 to 28.25
|
—
|
8.70 Percentage of subjects
Interval 2.19 to 21.73
|
|
Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 43
|
17.86 Percentage of subjects
Interval 6.06 to 36.89
|
20.00 Percentage of subjects
Interval 2.52 to 55.61
|
—
|
18.42 Percentage of subjects
Interval 7.74 to 34.33
|
|
Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 44
|
25.71 Percentage of subjects
Interval 12.49 to 43.26
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
—
|
19.57 Percentage of subjects
Interval 1.2 to 62.87
|
|
Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 45
|
21.13 Percentage of subjects
Interval 5.9 to 46.18
|
20.00 Percentage of subjects
Interval 2.52 to 55.61
|
—
|
20.99 Percentage of subjects
Interval 12.73 to 31.46
|
|
Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 46
|
7.69 Percentage of subjects
Interval 0.95 to 25.13
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
—
|
5.26 Percentage of subjects
Interval 0.0 to 96.53
|
|
Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 47
|
10.53 Percentage of subjects
Interval 1.3 to 33.14
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
—
|
10.00 Percentage of subjects
Interval 1.23 to 31.7
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as "6 months to 17 years", "18 to 65 years" and "\>65 years". All subjects who received the second dose of vaccine, were in the first age stratum: "6 months to 17 years". Please, refer to outcome n°56 for the overall (across age strata) post-dose 2 results.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 46
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
|
Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 47
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
|
Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
|
Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
|
Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.93
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.64
|
|
Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
|
Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 5.28
|
0.00 Percentage of subjects
Interval 0.0 to 4.56
|
|
Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 46
|
—
|
7.14 Percentage of subjects
Interval 0.18 to 33.87
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
1.92 Percentage of subjects
Interval 0.0 to 99.8
|
|
Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
|
Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 40
|
—
|
4.55 Percentage of subjects
Interval 0.56 to 15.47
|
—
|
4.55 Percentage of subjects
Interval 0.56 to 15.47
|
|
Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 41
|
—
|
2.00 Percentage of subjects
Interval 0.0 to 27.58
|
—
|
2.00 Percentage of subjects
Interval 0.0 to 27.58
|
|
Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
3.45 Percentage of subjects
Interval 0.09 to 17.76
|
—
|
2.17 Percentage of subjects
Interval 0.06 to 11.53
|
|
Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 43
|
3.57 Percentage of subjects
Interval 0.09 to 18.35
|
10.00 Percentage of subjects
Interval 0.25 to 44.5
|
—
|
5.26 Percentage of subjects
Interval 0.0 to 85.52
|
|
Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 10.0
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 7.71
|
|
Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 45
|
7.04 Percentage of subjects
Interval 2.33 to 15.67
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
—
|
6.17 Percentage of subjects
Interval 2.03 to 13.82
|
|
Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
|
Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
|
Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 42
|
—
|
—
|
3.85 Percentage of subjects
Interval 0.11 to 19.24
|
3.85 Percentage of subjects
Interval 0.11 to 19.24
|
|
Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 43
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
|
Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 44
|
—
|
—
|
3.33 Percentage of subjects
Interval 0.0 to 33.03
|
3.33 Percentage of subjects
Interval 0.0 to 33.03
|
|
Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 45
|
—
|
—
|
2.30 Percentage of subjects
Interval 0.0 to 52.37
|
2.30 Percentage of subjects
Interval 0.0 to 52.37
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as "6 months to 17 years", "18 to 65 years" and "\>65 years". All subjects who received the second dose of vaccine, were in the first age stratum: "6 months to 17 years". Please, refer to outcome n°58 for the overall (across age strata) post-dose 2 results.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 10.0
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 7.71
|
|
Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 42
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
|
Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 43
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
|
Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 44
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.96
|
0.00 Percentage of subjects
Interval 0.0 to 5.96
|
|
Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 45
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 4.15
|
0.00 Percentage of subjects
Interval 0.0 to 4.15
|
|
Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 46
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
|
Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 47
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
|
Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 40
|
—
|
3.85 Percentage of subjects
Interval 0.0 to 45.2
|
—
|
3.85 Percentage of subjects
Interval 0.0 to 45.2
|
|
Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
|
Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.93
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.64
|
|
Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
|
Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 5.28
|
0.00 Percentage of subjects
Interval 0.0 to 4.56
|
|
Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 46
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
|
Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
|
Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 8.04
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 8.04
|
|
Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 7.11
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 7.11
|
|
Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 7.71
|
|
Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 12.34
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
|
Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 5.06
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 4.45
|
|
Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
|
Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as "6 months to 17 years", "18 to 65 years" and "\>65 years". All subjects who received the second dose of vaccine, were in the first age stratum: "6 months to 17 years". Please, refer to outcome n°60 for the overall (across age strata) post-dose 2 results.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 42
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
|
Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 43
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
|
Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 44
|
—
|
—
|
1.67 Percentage of subjects
Interval 0.04 to 8.94
|
1.67 Percentage of subjects
Interval 0.04 to 8.94
|
|
Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 45
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 4.15
|
0.00 Percentage of subjects
Interval 0.0 to 4.15
|
|
Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 46
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
|
Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 47
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
|
Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
|
Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 41
|
—
|
2.44 Percentage of subjects
Interval 0.0 to 24.59
|
—
|
2.44 Percentage of subjects
Interval 0.0 to 24.59
|
|
Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.93
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.64
|
|
Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
|
Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
25.00 Percentage of subjects
Interval 3.19 to 65.09
|
0.00 Percentage of subjects
Interval 0.0 to 5.28
|
2.53 Percentage of subjects
Interval 0.0 to 66.57
|
|
Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 46
|
—
|
7.14 Percentage of subjects
Interval 0.18 to 33.87
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
1.92 Percentage of subjects
Interval 0.0 to 99.8
|
|
Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
|
Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 8.04
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 8.04
|
|
Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 41
|
—
|
2.00 Percentage of subjects
Interval 0.0 to 27.58
|
—
|
2.00 Percentage of subjects
Interval 0.0 to 27.58
|
|
Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 7.71
|
|
Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 12.34
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
|
Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 44
|
2.86 Percentage of subjects
Interval 0.0 to 82.04
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
—
|
2.17 Percentage of subjects
Interval 0.0 to 20.88
|
|
Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 5.06
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 4.45
|
|
Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
|
Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as "6 months to 17 years", "18 to 65 years" and "\>65 years". All subjects who received the second dose of vaccine, were in the first age stratum: "6 months to 17 years". Please, refer to outcome n°62 for the overall (across age strata) post-dose 2 results.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 42
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
|
Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 43
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
|
Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 44
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.96
|
0.00 Percentage of subjects
Interval 0.0 to 5.96
|
|
Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 45
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 4.15
|
0.00 Percentage of subjects
Interval 0.0 to 4.15
|
|
Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 46
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
|
Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 47
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
|
Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
|
Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
|
Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.93
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.64
|
|
Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
|
Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 5.28
|
0.00 Percentage of subjects
Interval 0.0 to 4.56
|
|
Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 46
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
|
Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
|
Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 40
|
—
|
2.27 Percentage of subjects
Interval 0.06 to 12.02
|
—
|
2.27 Percentage of subjects
Interval 0.06 to 12.02
|
|
Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 7.11
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 7.11
|
|
Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
6.90 Percentage of subjects
Interval 0.37 to 28.25
|
—
|
4.35 Percentage of subjects
Interval 0.17 to 20.04
|
|
Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 12.34
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
|
Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 44
|
2.86 Percentage of subjects
Interval 0.0 to 82.04
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
—
|
2.17 Percentage of subjects
Interval 0.0 to 20.88
|
|
Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 5.06
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 4.45
|
|
Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
|
Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as "6 months to 17 years", "18 to 65 years" and "\>65 years". All subjects who received the second dose of vaccine, were in the first age stratum: "6 months to 17 years". Please, refer to outcome n°64 for the overall (across age strata) post-dose 2 results.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 42
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
|
Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 43
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
|
Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 44
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.96
|
0.00 Percentage of subjects
Interval 0.0 to 5.96
|
|
Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 45
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 4.15
|
0.00 Percentage of subjects
Interval 0.0 to 4.15
|
|
Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 46
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
|
Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 47
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
|
Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
|
Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
|
Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.93
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.64
|
|
Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
|
Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
12.50 Percentage of subjects
Interval 0.32 to 52.65
|
0.00 Percentage of subjects
Interval 0.0 to 5.28
|
1.27 Percentage of subjects
Interval 0.0 to 41.55
|
|
Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 46
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
|
Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
|
Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 8.04
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 8.04
|
|
Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 7.11
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 7.11
|
|
Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 7.71
|
|
Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 12.34
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
|
Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 10.0
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 7.71
|
|
Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 5.06
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 4.45
|
|
Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
|
Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as "6 months to 17 years", "18 to 65 years" and "\>65 years". All subjects who received the second dose of vaccine, were in the first age stratum: "6 months to 17 years". Please, refer to outcome n°66 for the overall (across age strata) post-dose 2 results.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 47
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
|
Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
|
Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
|
Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.93
|
7.14 Percentage of subjects
Interval 0.0 to 99.99
|
—
|
0.72 Percentage of subjects
Interval 0.0 to 28.91
|
|
Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
33.33 Percentage of subjects
Interval 0.84 to 90.57
|
—
|
16.67 Percentage of subjects
Interval 0.0 to 100.0
|
|
Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 5.28
|
0.00 Percentage of subjects
Interval 0.0 to 4.56
|
|
Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 46
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
|
Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
|
Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 8.04
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 8.04
|
|
Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 7.11
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 7.11
|
|
Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
3.45 Percentage of subjects
Interval 0.09 to 17.76
|
—
|
2.17 Percentage of subjects
Interval 0.06 to 11.53
|
|
Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 12.34
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
|
Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 10.0
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 7.71
|
|
Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 45
|
1.41 Percentage of subjects
Interval 0.0 to 23.79
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
—
|
1.23 Percentage of subjects
Interval 0.03 to 6.69
|
|
Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
|
Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
|
Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 42
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
|
Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 43
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
|
Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 44
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.96
|
0.00 Percentage of subjects
Interval 0.0 to 5.96
|
|
Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 45
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 4.15
|
0.00 Percentage of subjects
Interval 0.0 to 4.15
|
|
Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 46
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as "6 months to 17 years", "18 to 65 years" and "\>65 years". All subjects who received the second dose of vaccine, were in the first age stratum: "6 months to 17 years". Please, refer to outcome n°68 for the overall (across age strata) post-dose 2 results.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 42
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
|
Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 43
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
|
Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 44
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.96
|
0.00 Percentage of subjects
Interval 0.0 to 5.96
|
|
Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 45
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 4.15
|
0.00 Percentage of subjects
Interval 0.0 to 4.15
|
|
Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 46
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
|
Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 47
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
|
Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
6 months to 17 years,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
|
Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
|
Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 42
|
0.81 Percentage of subjects
Interval 0.02 to 4.41
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
—
|
0.72 Percentage of subjects
Interval 0.02 to 3.97
|
|
Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
|
Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 5.28
|
0.00 Percentage of subjects
Interval 0.0 to 4.56
|
|
Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 46
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
|
Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
18-65 years,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
|
Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 8.04
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 8.04
|
|
Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 7.11
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 7.11
|
|
Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 7.71
|
|
Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 12.34
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
|
Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 10.0
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 7.71
|
|
Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 5.06
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 4.45
|
|
Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
|
Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category
>65 years,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as "6 months to 17 years", "18 to 65 years" and "\>65 years". All subjects who received the second dose of vaccine, were in the first age stratum: "6 months to 17 years". Please, refer to outcome n°2 for the overall (across age strata) post-dose 2 results.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-42
|
—
|
—
|
44.23 Percentage of subjects
Interval 0.11 to 99.54
|
44.23 Percentage of subjects
Interval 0.11 to 99.54
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-43
|
—
|
—
|
46.15 Percentage of subjects
Interval 14.72 to 80.1
|
46.15 Percentage of subjects
Interval 14.72 to 80.1
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-44
|
—
|
—
|
42.11 Percentage of subjects
Interval 34.99 to 49.47
|
42.11 Percentage of subjects
Interval 34.99 to 49.47
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-45
|
—
|
—
|
43.68 Percentage of subjects
Interval 28.34 to 59.96
|
43.68 Percentage of subjects
Interval 28.34 to 59.96
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-46
|
—
|
—
|
42.48 Percentage of subjects
Interval 29.17 to 56.65
|
42.48 Percentage of subjects
Interval 29.17 to 56.65
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-47
|
—
|
—
|
43.96 Percentage of subjects
Interval 23.26 to 66.33
|
43.96 Percentage of subjects
Interval 23.26 to 66.33
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-48
|
—
|
—
|
45.72 Percentage of subjects
Interval 20.08 to 73.17
|
45.72 Percentage of subjects
Interval 20.08 to 73.17
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-49
|
—
|
—
|
45.72 Percentage of subjects
Interval 20.08 to 73.17
|
45.72 Percentage of subjects
Interval 20.08 to 73.17
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-50
|
—
|
—
|
45.72 Percentage of subjects
Interval 20.08 to 73.17
|
45.72 Percentage of subjects
Interval 20.08 to 73.17
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-51
|
—
|
—
|
45.72 Percentage of subjects
Interval 20.08 to 73.17
|
45.72 Percentage of subjects
Interval 20.08 to 73.17
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-52
|
—
|
—
|
45.72 Percentage of subjects
Interval 20.08 to 73.17
|
45.72 Percentage of subjects
Interval 20.08 to 73.17
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-40
|
—
|
46.15 Percentage of subjects
Interval 0.35 to 99.22
|
—
|
46.15 Percentage of subjects
Interval 0.35 to 99.22
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-41
|
—
|
43.28 Percentage of subjects
Interval 1.27 to 96.39
|
—
|
43.28 Percentage of subjects
Interval 1.27 to 96.39
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-42
|
47.58 Percentage of subjects
Interval 38.54 to 56.74
|
44.44 Percentage of subjects
Interval 4.39 to 91.64
|
—
|
46.34 Percentage of subjects
Interval 32.14 to 60.99
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-43
|
47.24 Percentage of subjects
Interval 38.32 to 56.3
|
44.05 Percentage of subjects
Interval 4.66 to 90.87
|
—
|
45.97 Percentage of subjects
Interval 34.03 to 58.26
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-44
|
46.88 Percentage of subjects
Interval 29.25 to 65.09
|
44.32 Percentage of subjects
Interval 5.76 to 89.45
|
60.00 Percentage of subjects
Interval 14.66 to 94.73
|
46.15 Percentage of subjects
Interval 35.85 to 56.7
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-45
|
45.80 Percentage of subjects
Interval 8.3 to 87.53
|
47.92 Percentage of subjects
Interval 10.13 to 87.69
|
56.16 Percentage of subjects
Interval 44.05 to 67.76
|
49.00 Percentage of subjects
Interval 39.73 to 58.32
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-46
|
45.80 Percentage of subjects
Interval 8.3 to 87.53
|
48.18 Percentage of subjects
Interval 13.61 to 84.15
|
52.25 Percentage of subjects
Interval 42.56 to 61.82
|
48.58 Percentage of subjects
Interval 41.21 to 55.99
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-47
|
46.62 Percentage of subjects
Interval 23.72 to 70.61
|
48.65 Percentage of subjects
Interval 13.91 to 84.42
|
52.63 Percentage of subjects
Interval 43.06 to 62.06
|
49.16 Percentage of subjects
Interval 41.99 to 56.36
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-48
|
46.62 Percentage of subjects
Interval 23.72 to 70.61
|
48.65 Percentage of subjects
Interval 13.91 to 84.42
|
52.63 Percentage of subjects
Interval 43.06 to 62.06
|
49.16 Percentage of subjects
Interval 41.99 to 56.36
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-49
|
46.62 Percentage of subjects
Interval 23.72 to 70.61
|
48.65 Percentage of subjects
Interval 13.91 to 84.42
|
52.63 Percentage of subjects
Interval 43.06 to 62.06
|
49.16 Percentage of subjects
Interval 41.99 to 56.36
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-50
|
46.62 Percentage of subjects
Interval 23.72 to 70.61
|
48.65 Percentage of subjects
Interval 13.91 to 84.42
|
52.63 Percentage of subjects
Interval 43.06 to 62.06
|
49.16 Percentage of subjects
Interval 41.99 to 56.36
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-51
|
46.62 Percentage of subjects
Interval 23.72 to 70.61
|
48.65 Percentage of subjects
Interval 13.91 to 84.42
|
52.63 Percentage of subjects
Interval 43.06 to 62.06
|
49.16 Percentage of subjects
Interval 41.99 to 56.36
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-52
|
46.62 Percentage of subjects
Interval 23.72 to 70.61
|
48.65 Percentage of subjects
Interval 13.91 to 84.42
|
52.63 Percentage of subjects
Interval 43.06 to 62.06
|
49.16 Percentage of subjects
Interval 41.99 to 56.36
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-40
|
—
|
25.00 Percentage of subjects
Interval 12.33 to 41.82
|
—
|
25.00 Percentage of subjects
Interval 12.33 to 41.82
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-41
|
—
|
28.72 Percentage of subjects
Interval 1.77 to 79.09
|
—
|
28.72 Percentage of subjects
Interval 1.77 to 79.09
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-42
|
29.41 Percentage of subjects
Interval 0.0 to 100.0
|
27.64 Percentage of subjects
Interval 4.41 to 66.54
|
—
|
27.86 Percentage of subjects
Interval 12.9 to 47.58
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-43
|
40.00 Percentage of subjects
Interval 0.0 to 99.97
|
28.57 Percentage of subjects
Interval 4.53 to 68.14
|
—
|
31.46 Percentage of subjects
Interval 15.89 to 50.84
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-44
|
47.50 Percentage of subjects
Interval 18.69 to 77.61
|
27.08 Percentage of subjects
Interval 7.02 to 57.93
|
—
|
34.38 Percentage of subjects
Interval 20.23 to 50.89
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-45
|
42.38 Percentage of subjects
Interval 18.45 to 69.29
|
28.57 Percentage of subjects
Interval 6.49 to 62.62
|
—
|
35.41 Percentage of subjects
Interval 24.11 to 48.04
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-46
|
40.11 Percentage of subjects
Interval 16.85 to 67.22
|
28.92 Percentage of subjects
Interval 7.25 to 61.51
|
—
|
34.69 Percentage of subjects
Interval 24.92 to 45.51
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-47
|
39.29 Percentage of subjects
Interval 17.18 to 65.18
|
28.74 Percentage of subjects
Interval 7.49 to 60.56
|
—
|
34.44 Percentage of subjects
Interval 25.25 to 44.56
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-48
|
39.29 Percentage of subjects
Interval 17.18 to 65.18
|
28.74 Percentage of subjects
Interval 7.49 to 60.56
|
—
|
34.44 Percentage of subjects
Interval 25.25 to 44.56
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-49
|
39.29 Percentage of subjects
Interval 17.18 to 65.18
|
28.74 Percentage of subjects
Interval 7.49 to 60.56
|
—
|
34.44 Percentage of subjects
Interval 25.25 to 44.56
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-50
|
39.29 Percentage of subjects
Interval 17.18 to 65.18
|
28.74 Percentage of subjects
Interval 7.49 to 60.56
|
—
|
34.44 Percentage of subjects
Interval 25.25 to 44.56
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-51
|
39.29 Percentage of subjects
Interval 17.18 to 65.18
|
28.74 Percentage of subjects
Interval 7.49 to 60.56
|
—
|
34.44 Percentage of subjects
Interval 25.25 to 44.56
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-52
|
39.29 Percentage of subjects
Interval 17.18 to 65.18
|
28.74 Percentage of subjects
Interval 7.49 to 60.56
|
—
|
34.44 Percentage of subjects
Interval 25.25 to 44.56
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as "6 months to 17 years", "18 to 65 years" and "\>65 years". All subjects who received the second dose of vaccine, were in the first age stratum: "6 months to 17 years". Please, refer to outcome n°4 for the overall (across age strata) post-dose 2 results.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-42
|
—
|
—
|
7.69 Percentage of subjects
Interval 0.19 to 36.17
|
7.69 Percentage of subjects
Interval 0.19 to 36.17
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-43
|
—
|
—
|
8.46 Percentage of subjects
Interval 3.32 to 17.07
|
8.46 Percentage of subjects
Interval 3.32 to 17.07
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-44
|
—
|
—
|
6.84 Percentage of subjects
Interval 3.69 to 11.42
|
6.84 Percentage of subjects
Interval 3.69 to 11.42
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-45
|
—
|
—
|
6.50 Percentage of subjects
Interval 3.9 to 10.08
|
6.50 Percentage of subjects
Interval 3.9 to 10.08
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-46
|
—
|
—
|
6.54 Percentage of subjects
Interval 3.28 to 11.46
|
6.54 Percentage of subjects
Interval 3.28 to 11.46
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-47
|
—
|
—
|
6.81 Percentage of subjects
Interval 3.04 to 12.85
|
6.81 Percentage of subjects
Interval 3.04 to 12.85
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-48
|
—
|
—
|
7.08 Percentage of subjects
Interval 2.85 to 14.16
|
7.08 Percentage of subjects
Interval 2.85 to 14.16
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-49
|
—
|
—
|
7.08 Percentage of subjects
Interval 2.85 to 14.16
|
7.08 Percentage of subjects
Interval 2.85 to 14.16
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-50
|
—
|
—
|
7.08 Percentage of subjects
Interval 2.85 to 14.16
|
7.08 Percentage of subjects
Interval 2.85 to 14.16
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-51
|
—
|
—
|
7.08 Percentage of subjects
Interval 2.85 to 14.16
|
7.08 Percentage of subjects
Interval 2.85 to 14.16
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-52
|
—
|
—
|
7.08 Percentage of subjects
Interval 2.85 to 14.16
|
7.08 Percentage of subjects
Interval 2.85 to 14.16
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-40
|
—
|
3.85 Percentage of subjects
Interval 0.0 to 45.2
|
—
|
3.85 Percentage of subjects
Interval 0.0 to 45.2
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-41
|
—
|
1.49 Percentage of subjects
Interval 0.01 to 10.39
|
—
|
1.49 Percentage of subjects
Interval 0.01 to 10.39
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-42
|
1.61 Percentage of subjects
Interval 0.2 to 5.7
|
3.70 Percentage of subjects
Interval 0.0 to 37.31
|
—
|
2.44 Percentage of subjects
Interval 0.21 to 9.46
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-43
|
1.57 Percentage of subjects
Interval 0.19 to 5.57
|
4.76 Percentage of subjects
Interval 0.0 to 51.14
|
—
|
2.84 Percentage of subjects
Interval 0.21 to 11.55
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-44
|
1.56 Percentage of subjects
Interval 0.19 to 5.53
|
5.68 Percentage of subjects
Interval 0.0 to 59.48
|
20.00 Percentage of subjects
Interval 0.51 to 71.64
|
3.62 Percentage of subjects
Interval 0.31 to 13.98
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-45
|
1.53 Percentage of subjects
Interval 0.19 to 5.41
|
7.29 Percentage of subjects
Interval 0.0 to 68.92
|
2.74 Percentage of subjects
Interval 0.33 to 9.55
|
3.67 Percentage of subjects
Interval 0.35 to 13.62
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-46
|
1.53 Percentage of subjects
Interval 0.19 to 5.41
|
7.27 Percentage of subjects
Interval 0.0 to 60.31
|
6.31 Percentage of subjects
Interval 2.57 to 12.56
|
4.83 Percentage of subjects
Interval 0.98 to 13.63
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-47
|
1.50 Percentage of subjects
Interval 0.08 to 6.8
|
7.21 Percentage of subjects
Interval 0.0 to 59.24
|
6.14 Percentage of subjects
Interval 2.5 to 12.24
|
4.75 Percentage of subjects
Interval 0.99 to 13.26
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-48
|
1.50 Percentage of subjects
Interval 0.08 to 6.8
|
7.21 Percentage of subjects
Interval 0.0 to 59.24
|
6.14 Percentage of subjects
Interval 2.5 to 12.24
|
4.75 Percentage of subjects
Interval 0.99 to 13.26
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-49
|
1.50 Percentage of subjects
Interval 0.08 to 6.8
|
7.21 Percentage of subjects
Interval 0.0 to 59.24
|
6.14 Percentage of subjects
Interval 2.5 to 12.24
|
4.75 Percentage of subjects
Interval 0.99 to 13.26
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-50
|
1.50 Percentage of subjects
Interval 0.08 to 6.8
|
7.21 Percentage of subjects
Interval 0.0 to 59.24
|
6.14 Percentage of subjects
Interval 2.5 to 12.24
|
4.75 Percentage of subjects
Interval 0.99 to 13.26
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-51
|
1.50 Percentage of subjects
Interval 0.08 to 6.8
|
7.21 Percentage of subjects
Interval 0.0 to 59.24
|
6.14 Percentage of subjects
Interval 2.5 to 12.24
|
4.75 Percentage of subjects
Interval 0.99 to 13.26
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-52
|
1.50 Percentage of subjects
Interval 0.08 to 6.8
|
7.21 Percentage of subjects
Interval 0.0 to 59.24
|
6.14 Percentage of subjects
Interval 2.5 to 12.24
|
4.75 Percentage of subjects
Interval 0.99 to 13.26
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-40
|
—
|
2.27 Percentage of subjects
Interval 0.06 to 12.02
|
—
|
2.27 Percentage of subjects
Interval 0.06 to 12.02
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-41
|
—
|
3.19 Percentage of subjects
Interval 0.24 to 12.75
|
—
|
3.19 Percentage of subjects
Interval 0.24 to 12.75
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-42
|
5.88 Percentage of subjects
Interval 0.0 to 94.68
|
4.88 Percentage of subjects
Interval 0.16 to 23.0
|
—
|
5.00 Percentage of subjects
Interval 1.42 to 12.14
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-43
|
8.89 Percentage of subjects
Interval 0.01 to 59.81
|
4.51 Percentage of subjects
Interval 0.33 to 17.92
|
—
|
5.62 Percentage of subjects
Interval 2.1 to 11.79
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-44
|
11.25 Percentage of subjects
Interval 3.2 to 26.18
|
4.17 Percentage of subjects
Interval 0.54 to 13.99
|
—
|
6.70 Percentage of subjects
Interval 2.88 to 12.9
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-45
|
10.60 Percentage of subjects
Interval 6.09 to 16.8
|
3.90 Percentage of subjects
Interval 0.72 to 11.49
|
—
|
7.21 Percentage of subjects
Interval 3.38 to 13.18
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-46
|
10.17 Percentage of subjects
Interval 5.8 to 16.22
|
3.61 Percentage of subjects
Interval 0.91 to 9.4
|
—
|
7.00 Percentage of subjects
Interval 3.24 to 12.89
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-47
|
10.20 Percentage of subjects
Interval 6.24 to 15.5
|
3.59 Percentage of subjects
Interval 0.92 to 9.26
|
—
|
7.16 Percentage of subjects
Interval 3.35 to 13.11
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-48
|
10.20 Percentage of subjects
Interval 6.24 to 15.5
|
3.59 Percentage of subjects
Interval 0.92 to 9.26
|
—
|
7.16 Percentage of subjects
Interval 3.35 to 13.11
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-49
|
10.20 Percentage of subjects
Interval 6.24 to 15.5
|
3.59 Percentage of subjects
Interval 0.92 to 9.26
|
—
|
7.16 Percentage of subjects
Interval 3.35 to 13.11
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-50
|
10.20 Percentage of subjects
Interval 6.24 to 15.5
|
3.59 Percentage of subjects
Interval 0.92 to 9.26
|
—
|
7.16 Percentage of subjects
Interval 3.35 to 13.11
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-51
|
10.20 Percentage of subjects
Interval 6.24 to 15.5
|
3.59 Percentage of subjects
Interval 0.92 to 9.26
|
—
|
7.16 Percentage of subjects
Interval 3.35 to 13.11
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-52
|
10.20 Percentage of subjects
Interval 6.24 to 15.5
|
3.59 Percentage of subjects
Interval 0.92 to 9.26
|
—
|
7.16 Percentage of subjects
Interval 3.35 to 13.11
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as "6 months to 17 years", "18 to 65 years" and "\>65 years". All subjects who received the second dose of vaccine, were in the first age stratum: "6 months to 17 years". Please, refer to outcome n°6 for the overall (across age strata) post-dose 2 results.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-42
|
—
|
—
|
26.92 Percentage of subjects
Interval 0.28 to 88.26
|
26.92 Percentage of subjects
Interval 0.28 to 88.26
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-43
|
—
|
—
|
26.92 Percentage of subjects
Interval 8.05 to 55.09
|
26.92 Percentage of subjects
Interval 8.05 to 55.09
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-44
|
—
|
—
|
23.68 Percentage of subjects
Interval 17.83 to 30.38
|
23.68 Percentage of subjects
Interval 17.83 to 30.38
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-45
|
—
|
—
|
23.83 Percentage of subjects
Interval 18.93 to 29.29
|
23.83 Percentage of subjects
Interval 18.93 to 29.29
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-46
|
—
|
—
|
23.86 Percentage of subjects
Interval 19.19 to 29.04
|
23.86 Percentage of subjects
Interval 19.19 to 29.04
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-47
|
—
|
—
|
25.08 Percentage of subjects
Interval 16.2 to 35.81
|
25.08 Percentage of subjects
Interval 16.2 to 35.81
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-48
|
—
|
—
|
26.84 Percentage of subjects
Interval 11.26 to 48.19
|
26.84 Percentage of subjects
Interval 11.26 to 48.19
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-49
|
—
|
—
|
26.84 Percentage of subjects
Interval 11.26 to 48.19
|
26.84 Percentage of subjects
Interval 11.26 to 48.19
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-50
|
—
|
—
|
26.84 Percentage of subjects
Interval 11.26 to 48.19
|
26.84 Percentage of subjects
Interval 11.26 to 48.19
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-51
|
—
|
—
|
26.84 Percentage of subjects
Interval 11.26 to 48.19
|
26.84 Percentage of subjects
Interval 11.26 to 48.19
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-52
|
—
|
—
|
26.84 Percentage of subjects
Interval 11.26 to 48.19
|
26.84 Percentage of subjects
Interval 11.26 to 48.19
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-40
|
—
|
42.31 Percentage of subjects
Interval 1.05 to 96.43
|
—
|
42.31 Percentage of subjects
Interval 1.05 to 96.43
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-41
|
—
|
38.81 Percentage of subjects
Interval 2.16 to 90.96
|
—
|
38.81 Percentage of subjects
Interval 2.16 to 90.96
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-42
|
33.06 Percentage of subjects
Interval 24.88 to 42.08
|
39.51 Percentage of subjects
Interval 5.87 to 83.54
|
—
|
35.61 Percentage of subjects
Interval 21.75 to 51.49
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-43
|
32.28 Percentage of subjects
Interval 14.53 to 54.8
|
39.29 Percentage of subjects
Interval 6.21 to 82.59
|
—
|
35.07 Percentage of subjects
Interval 23.64 to 47.91
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-44
|
32.03 Percentage of subjects
Interval 10.0 to 62.27
|
39.77 Percentage of subjects
Interval 7.76 to 80.48
|
40.00 Percentage of subjects
Interval 5.27 to 85.34
|
35.29 Percentage of subjects
Interval 25.26 to 46.38
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-45
|
31.30 Percentage of subjects
Interval 2.25 to 81.21
|
41.67 Percentage of subjects
Interval 11.84 to 77.0
|
43.84 Percentage of subjects
Interval 32.24 to 55.95
|
37.67 Percentage of subjects
Interval 28.0 to 48.11
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-46
|
31.30 Percentage of subjects
Interval 2.25 to 81.21
|
40.91 Percentage of subjects
Interval 13.91 to 72.76
|
39.64 Percentage of subjects
Interval 30.48 to 49.37
|
36.93 Percentage of subjects
Interval 29.42 to 44.94
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-47
|
32.33 Percentage of subjects
Interval 16.16 to 52.33
|
40.54 Percentage of subjects
Interval 13.6 to 72.56
|
40.35 Percentage of subjects
Interval 31.27 to 49.95
|
37.43 Percentage of subjects
Interval 30.02 to 45.3
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-48
|
32.33 Percentage of subjects
Interval 16.16 to 52.33
|
40.54 Percentage of subjects
Interval 13.6 to 72.56
|
40.35 Percentage of subjects
Interval 31.27 to 49.95
|
37.43 Percentage of subjects
Interval 30.02 to 45.3
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-49
|
32.33 Percentage of subjects
Interval 16.16 to 52.33
|
40.54 Percentage of subjects
Interval 13.6 to 72.56
|
40.35 Percentage of subjects
Interval 31.27 to 49.95
|
37.43 Percentage of subjects
Interval 30.02 to 45.3
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-50
|
32.33 Percentage of subjects
Interval 16.16 to 52.33
|
40.54 Percentage of subjects
Interval 13.6 to 72.56
|
40.35 Percentage of subjects
Interval 31.27 to 49.95
|
37.43 Percentage of subjects
Interval 30.02 to 45.3
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-51
|
32.33 Percentage of subjects
Interval 16.16 to 52.33
|
40.54 Percentage of subjects
Interval 13.6 to 72.56
|
40.35 Percentage of subjects
Interval 31.27 to 49.95
|
37.43 Percentage of subjects
Interval 30.02 to 45.3
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-52
|
32.33 Percentage of subjects
Interval 16.16 to 52.33
|
40.54 Percentage of subjects
Interval 13.6 to 72.56
|
40.35 Percentage of subjects
Interval 31.27 to 49.95
|
37.43 Percentage of subjects
Interval 30.02 to 45.3
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-40
|
—
|
15.91 Percentage of subjects
Interval 6.64 to 30.07
|
—
|
15.91 Percentage of subjects
Interval 6.64 to 30.07
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-41
|
—
|
20.21 Percentage of subjects
Interval 0.9 to 67.3
|
—
|
20.21 Percentage of subjects
Interval 0.9 to 67.3
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-42
|
17.65 Percentage of subjects
Interval 0.0 to 100.0
|
19.51 Percentage of subjects
Interval 2.47 to 54.52
|
—
|
19.29 Percentage of subjects
Interval 8.1 to 35.82
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-43
|
20.00 Percentage of subjects
Interval 0.0 to 91.7
|
18.80 Percentage of subjects
Interval 3.7 to 47.08
|
—
|
19.10 Percentage of subjects
Interval 10.71 to 30.22
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-44
|
30.00 Percentage of subjects
Interval 2.61 to 77.58
|
18.06 Percentage of subjects
Interval 5.08 to 40.25
|
—
|
22.32 Percentage of subjects
Interval 12.73 to 34.68
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-45
|
24.50 Percentage of subjects
Interval 2.22 to 68.32
|
19.48 Percentage of subjects
Interval 4.44 to 46.28
|
—
|
21.97 Percentage of subjects
Interval 13.2 to 33.06
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-46
|
23.16 Percentage of subjects
Interval 2.41 to 64.26
|
19.28 Percentage of subjects
Interval 5.31 to 42.95
|
—
|
21.28 Percentage of subjects
Interval 13.22 to 31.39
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-47
|
22.96 Percentage of subjects
Interval 3.15 to 60.38
|
19.16 Percentage of subjects
Interval 5.45 to 42.2
|
—
|
21.21 Percentage of subjects
Interval 13.6 to 30.64
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-48
|
22.96 Percentage of subjects
Interval 3.15 to 60.38
|
19.16 Percentage of subjects
Interval 5.45 to 42.2
|
—
|
21.21 Percentage of subjects
Interval 13.6 to 30.64
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-49
|
22.96 Percentage of subjects
Interval 3.15 to 60.38
|
19.16 Percentage of subjects
Interval 5.45 to 42.2
|
—
|
21.21 Percentage of subjects
Interval 13.6 to 30.64
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-50
|
22.96 Percentage of subjects
Interval 3.15 to 60.38
|
19.16 Percentage of subjects
Interval 5.45 to 42.2
|
—
|
21.21 Percentage of subjects
Interval 13.6 to 30.64
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-51
|
22.96 Percentage of subjects
Interval 3.15 to 60.38
|
19.16 Percentage of subjects
Interval 5.45 to 42.2
|
—
|
21.21 Percentage of subjects
Interval 13.6 to 30.64
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-52
|
22.96 Percentage of subjects
Interval 3.15 to 60.38
|
19.16 Percentage of subjects
Interval 5.45 to 42.2
|
—
|
21.21 Percentage of subjects
Interval 13.6 to 30.64
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as "6 months to 17 years", "18 to 65 years" and "\>65 years". All subjects who received the second dose of vaccine, were in the first age stratum: "6 months to 17 years". Please, refer to outcome n°8 for the overall (across age strata) post-dose 2 results.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-42
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
|
Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-43
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
|
Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-44
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.92
|
0.00 Percentage of subjects
Interval 0.0 to 1.92
|
|
Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-45
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
|
Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-46
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.2
|
0.00 Percentage of subjects
Interval 0.0 to 1.2
|
|
Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-47
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.14
|
0.00 Percentage of subjects
Interval 0.0 to 1.14
|
|
Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.08
|
0.00 Percentage of subjects
Interval 0.0 to 1.08
|
|
Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-49
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.08
|
0.00 Percentage of subjects
Interval 0.0 to 1.08
|
|
Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-50
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.08
|
0.00 Percentage of subjects
Interval 0.0 to 1.08
|
|
Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-51
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.08
|
0.00 Percentage of subjects
Interval 0.0 to 1.08
|
|
Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-52
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.08
|
0.00 Percentage of subjects
Interval 0.0 to 1.08
|
|
Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
|
Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
|
Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.93
|
0.00 Percentage of subjects
Interval 0.0 to 4.45
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.78
|
|
Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.86
|
0.00 Percentage of subjects
Interval 0.0 to 4.3
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.73
|
|
Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 2.84
|
0.00 Percentage of subjects
Interval 0.0 to 4.11
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 1.66
|
|
Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 2.78
|
0.00 Percentage of subjects
Interval 0.0 to 3.77
|
0.00 Percentage of subjects
Interval 0.0 to 4.93
|
0.00 Percentage of subjects
Interval 0.0 to 1.22
|
|
Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 2.78
|
0.00 Percentage of subjects
Interval 0.0 to 3.3
|
0.00 Percentage of subjects
Interval 0.0 to 3.27
|
0.00 Percentage of subjects
Interval 0.0 to 1.04
|
|
Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
0.00 Percentage of subjects
Interval 0.0 to 3.27
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.00 Percentage of subjects
Interval 0.0 to 1.03
|
|
Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
0.00 Percentage of subjects
Interval 0.0 to 3.27
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.00 Percentage of subjects
Interval 0.0 to 1.03
|
|
Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
0.00 Percentage of subjects
Interval 0.0 to 3.27
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.00 Percentage of subjects
Interval 0.0 to 1.03
|
|
Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
0.00 Percentage of subjects
Interval 0.0 to 3.27
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.00 Percentage of subjects
Interval 0.0 to 1.03
|
|
Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
0.00 Percentage of subjects
Interval 0.0 to 3.27
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.00 Percentage of subjects
Interval 0.0 to 1.03
|
|
Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
0.00 Percentage of subjects
Interval 0.0 to 3.27
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.00 Percentage of subjects
Interval 0.0 to 1.03
|
|
Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 8.04
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 8.04
|
|
Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.85
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.85
|
|
Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
0.00 Percentage of subjects
Interval 0.0 to 2.95
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.6
|
|
Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 7.87
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.05
|
|
Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 2.53
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.63
|
|
Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-45
|
0.66 Percentage of subjects
Interval 0.02 to 3.63
|
0.00 Percentage of subjects
Interval 0.0 to 2.37
|
—
|
0.33 Percentage of subjects
Interval 0.01 to 1.9
|
|
Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-46
|
0.56 Percentage of subjects
Interval 0.01 to 3.11
|
0.00 Percentage of subjects
Interval 0.0 to 2.2
|
—
|
0.29 Percentage of subjects
Interval 0.01 to 1.61
|
|
Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-47
|
0.51 Percentage of subjects
Interval 0.01 to 2.81
|
0.00 Percentage of subjects
Interval 0.0 to 2.18
|
—
|
0.28 Percentage of subjects
Interval 0.01 to 1.53
|
|
Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-48
|
0.51 Percentage of subjects
Interval 0.01 to 2.81
|
0.00 Percentage of subjects
Interval 0.0 to 2.18
|
—
|
0.28 Percentage of subjects
Interval 0.01 to 1.53
|
|
Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-49
|
0.51 Percentage of subjects
Interval 0.01 to 2.81
|
0.00 Percentage of subjects
Interval 0.0 to 2.18
|
—
|
0.28 Percentage of subjects
Interval 0.01 to 1.53
|
|
Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-50
|
0.51 Percentage of subjects
Interval 0.01 to 2.81
|
0.00 Percentage of subjects
Interval 0.0 to 2.18
|
—
|
0.28 Percentage of subjects
Interval 0.01 to 1.53
|
|
Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-51
|
0.51 Percentage of subjects
Interval 0.01 to 2.81
|
0.00 Percentage of subjects
Interval 0.0 to 2.18
|
—
|
0.28 Percentage of subjects
Interval 0.01 to 1.53
|
|
Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-52
|
0.51 Percentage of subjects
Interval 0.01 to 2.81
|
0.00 Percentage of subjects
Interval 0.0 to 2.18
|
—
|
0.28 Percentage of subjects
Interval 0.01 to 1.53
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as "6 months to 17 years", "18 to 65 years" and "\>65 years". All subjects who received the second dose of vaccine, were in the first age stratum: "6 months to 17 years". Please, refer to outcome n°10 for the overall (across age strata) post-dose 2 results.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-42
|
0.81 Percentage of subjects
Interval 0.02 to 4.41
|
9.88 Percentage of subjects
Interval 0.03 to 56.84
|
—
|
4.39 Percentage of subjects
Interval 0.0 to 35.51
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-43
|
0.79 Percentage of subjects
Interval 0.02 to 4.31
|
10.71 Percentage of subjects
Interval 0.12 to 52.31
|
—
|
4.74 Percentage of subjects
Interval 0.04 to 28.25
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-42
|
—
|
—
|
1.92 Percentage of subjects
Interval 0.05 to 10.26
|
1.92 Percentage of subjects
Interval 0.05 to 10.26
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-43
|
—
|
—
|
3.85 Percentage of subjects
Interval 0.3 to 15.16
|
3.85 Percentage of subjects
Interval 0.3 to 15.16
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-44
|
—
|
—
|
4.74 Percentage of subjects
Interval 1.21 to 12.12
|
4.74 Percentage of subjects
Interval 1.21 to 12.12
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-45
|
—
|
—
|
4.33 Percentage of subjects
Interval 0.7 to 13.42
|
4.33 Percentage of subjects
Interval 0.7 to 13.42
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-46
|
—
|
—
|
4.58 Percentage of subjects
Interval 0.31 to 18.44
|
4.58 Percentage of subjects
Interval 0.31 to 18.44
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-47
|
—
|
—
|
5.26 Percentage of subjects
Interval 0.12 to 26.68
|
5.26 Percentage of subjects
Interval 0.12 to 26.68
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-48
|
—
|
—
|
5.60 Percentage of subjects
Interval 0.09 to 29.71
|
5.60 Percentage of subjects
Interval 0.09 to 29.71
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-49
|
—
|
—
|
5.60 Percentage of subjects
Interval 0.09 to 29.71
|
5.60 Percentage of subjects
Interval 0.09 to 29.71
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-50
|
—
|
—
|
5.60 Percentage of subjects
Interval 0.09 to 29.71
|
5.60 Percentage of subjects
Interval 0.09 to 29.71
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-51
|
—
|
—
|
5.60 Percentage of subjects
Interval 0.09 to 29.71
|
5.60 Percentage of subjects
Interval 0.09 to 29.71
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-52
|
—
|
—
|
5.60 Percentage of subjects
Interval 0.09 to 29.71
|
5.60 Percentage of subjects
Interval 0.09 to 29.71
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-40
|
—
|
11.54 Percentage of subjects
Interval 0.0 to 87.11
|
—
|
11.54 Percentage of subjects
Interval 0.0 to 87.11
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-41
|
—
|
11.94 Percentage of subjects
Interval 0.31 to 50.82
|
—
|
11.94 Percentage of subjects
Interval 0.31 to 50.82
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-44
|
0.78 Percentage of subjects
Interval 0.02 to 4.28
|
11.36 Percentage of subjects
Interval 0.27 to 49.65
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
4.98 Percentage of subjects
Interval 0.13 to 24.63
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-45
|
0.76 Percentage of subjects
Interval 0.02 to 4.18
|
11.46 Percentage of subjects
Interval 0.46 to 45.77
|
8.22 Percentage of subjects
Interval 3.08 to 17.04
|
6.00 Percentage of subjects
Interval 0.79 to 19.61
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-46
|
0.76 Percentage of subjects
Interval 0.02 to 4.18
|
10.91 Percentage of subjects
Interval 0.7 to 40.17
|
9.01 Percentage of subjects
Interval 4.41 to 15.94
|
6.53 Percentage of subjects
Interval 1.32 to 18.21
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-47
|
0.75 Percentage of subjects
Interval 0.02 to 4.12
|
10.81 Percentage of subjects
Interval 0.69 to 39.88
|
8.77 Percentage of subjects
Interval 4.29 to 15.54
|
6.42 Percentage of subjects
Interval 1.33 to 17.73
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-48
|
0.75 Percentage of subjects
Interval 0.02 to 4.12
|
10.81 Percentage of subjects
Interval 0.69 to 39.88
|
8.77 Percentage of subjects
Interval 4.29 to 15.54
|
6.42 Percentage of subjects
Interval 1.33 to 17.73
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-49
|
0.75 Percentage of subjects
Interval 0.02 to 4.12
|
10.81 Percentage of subjects
Interval 0.69 to 39.88
|
8.77 Percentage of subjects
Interval 4.29 to 15.54
|
6.42 Percentage of subjects
Interval 1.33 to 17.73
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-50
|
0.75 Percentage of subjects
Interval 0.02 to 4.12
|
10.81 Percentage of subjects
Interval 0.69 to 39.88
|
8.77 Percentage of subjects
Interval 4.29 to 15.54
|
6.42 Percentage of subjects
Interval 1.33 to 17.73
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-51
|
0.75 Percentage of subjects
Interval 0.02 to 4.12
|
10.81 Percentage of subjects
Interval 0.69 to 39.88
|
8.77 Percentage of subjects
Interval 4.29 to 15.54
|
6.42 Percentage of subjects
Interval 1.33 to 17.73
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-52
|
0.75 Percentage of subjects
Interval 0.02 to 4.12
|
10.81 Percentage of subjects
Interval 0.69 to 39.88
|
8.77 Percentage of subjects
Interval 4.29 to 15.54
|
6.42 Percentage of subjects
Interval 1.33 to 17.73
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-40
|
—
|
6.82 Percentage of subjects
Interval 1.43 to 18.66
|
—
|
6.82 Percentage of subjects
Interval 1.43 to 18.66
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-41
|
—
|
6.38 Percentage of subjects
Interval 2.38 to 13.38
|
—
|
6.38 Percentage of subjects
Interval 2.38 to 13.38
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
6.50 Percentage of subjects
Interval 2.64 to 12.98
|
—
|
5.71 Percentage of subjects
Interval 2.5 to 10.95
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-43
|
4.44 Percentage of subjects
Interval 0.0 to 34.75
|
6.02 Percentage of subjects
Interval 2.63 to 11.51
|
—
|
5.62 Percentage of subjects
Interval 2.73 to 10.09
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-44
|
6.25 Percentage of subjects
Interval 2.06 to 13.99
|
5.56 Percentage of subjects
Interval 2.43 to 10.65
|
—
|
5.80 Percentage of subjects
Interval 3.13 to 9.72
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-45
|
7.95 Percentage of subjects
Interval 3.76 to 14.39
|
5.84 Percentage of subjects
Interval 2.71 to 10.8
|
—
|
6.89 Percentage of subjects
Interval 4.31 to 10.33
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-46
|
7.34 Percentage of subjects
Interval 3.12 to 14.25
|
6.02 Percentage of subjects
Interval 2.93 to 10.8
|
—
|
6.71 Percentage of subjects
Interval 4.3 to 9.89
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-47
|
7.14 Percentage of subjects
Interval 3.08 to 13.73
|
5.99 Percentage of subjects
Interval 2.91 to 10.74
|
—
|
6.61 Percentage of subjects
Interval 4.28 to 9.68
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-48
|
7.14 Percentage of subjects
Interval 3.08 to 13.73
|
5.99 Percentage of subjects
Interval 2.91 to 10.74
|
—
|
6.61 Percentage of subjects
Interval 4.28 to 9.68
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-49
|
7.14 Percentage of subjects
Interval 3.08 to 13.73
|
5.99 Percentage of subjects
Interval 2.91 to 10.74
|
—
|
6.61 Percentage of subjects
Interval 4.28 to 9.68
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-50
|
7.14 Percentage of subjects
Interval 3.08 to 13.73
|
5.99 Percentage of subjects
Interval 2.91 to 10.74
|
—
|
6.61 Percentage of subjects
Interval 4.28 to 9.68
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-51
|
7.14 Percentage of subjects
Interval 3.08 to 13.73
|
5.99 Percentage of subjects
Interval 2.91 to 10.74
|
—
|
6.61 Percentage of subjects
Interval 4.28 to 9.68
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-52
|
7.14 Percentage of subjects
Interval 3.08 to 13.73
|
5.99 Percentage of subjects
Interval 2.91 to 10.74
|
—
|
6.61 Percentage of subjects
Interval 4.28 to 9.68
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as "6 months to 17 years", "18 to 65 years" and "\>65 years". All subjects who received the second dose of vaccine, were in the first age stratum: "6 months to 17 years". Please, refer to outcome n°12 for the overall (across age strata) post-dose 2 results.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-47
|
—
|
—
|
6.50 Percentage of subjects
Interval 2.13 to 14.56
|
6.50 Percentage of subjects
Interval 2.13 to 14.56
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-48
|
—
|
—
|
6.78 Percentage of subjects
Interval 3.38 to 11.94
|
6.78 Percentage of subjects
Interval 3.38 to 11.94
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-49
|
—
|
—
|
6.78 Percentage of subjects
Interval 3.38 to 11.94
|
6.78 Percentage of subjects
Interval 3.38 to 11.94
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-50
|
—
|
—
|
6.78 Percentage of subjects
Interval 3.38 to 11.94
|
6.78 Percentage of subjects
Interval 3.38 to 11.94
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-51
|
—
|
—
|
6.78 Percentage of subjects
Interval 3.38 to 11.94
|
6.78 Percentage of subjects
Interval 3.38 to 11.94
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-52
|
—
|
—
|
6.78 Percentage of subjects
Interval 3.38 to 11.94
|
6.78 Percentage of subjects
Interval 3.38 to 11.94
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-41
|
—
|
1.49 Percentage of subjects
Interval 0.01 to 10.39
|
—
|
1.49 Percentage of subjects
Interval 0.01 to 10.39
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-42
|
0.81 Percentage of subjects
Interval 0.02 to 4.41
|
1.23 Percentage of subjects
Interval 0.0 to 12.57
|
—
|
0.98 Percentage of subjects
Interval 0.12 to 3.48
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-43
|
0.79 Percentage of subjects
Interval 0.02 to 4.31
|
1.19 Percentage of subjects
Interval 0.0 to 12.76
|
—
|
0.95 Percentage of subjects
Interval 0.11 to 3.38
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-44
|
0.78 Percentage of subjects
Interval 0.02 to 4.28
|
1.14 Percentage of subjects
Interval 0.0 to 13.03
|
20.00 Percentage of subjects
Interval 0.51 to 71.64
|
1.36 Percentage of subjects
Interval 0.23 to 4.22
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-45
|
0.76 Percentage of subjects
Interval 0.02 to 4.18
|
1.04 Percentage of subjects
Interval 0.0 to 13.56
|
1.37 Percentage of subjects
Interval 0.03 to 7.4
|
1.00 Percentage of subjects
Interval 0.21 to 2.89
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-46
|
0.76 Percentage of subjects
Interval 0.02 to 4.18
|
0.91 Percentage of subjects
Interval 0.0 to 14.27
|
0.90 Percentage of subjects
Interval 0.02 to 4.92
|
0.85 Percentage of subjects
Interval 0.18 to 2.47
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-47
|
0.75 Percentage of subjects
Interval 0.02 to 4.12
|
0.90 Percentage of subjects
Interval 0.0 to 14.3
|
0.88 Percentage of subjects
Interval 0.02 to 4.79
|
0.84 Percentage of subjects
Interval 0.17 to 2.43
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-48
|
0.75 Percentage of subjects
Interval 0.02 to 4.12
|
0.90 Percentage of subjects
Interval 0.0 to 14.3
|
0.88 Percentage of subjects
Interval 0.02 to 4.79
|
0.84 Percentage of subjects
Interval 0.17 to 2.43
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-49
|
0.75 Percentage of subjects
Interval 0.02 to 4.12
|
0.90 Percentage of subjects
Interval 0.0 to 14.3
|
0.88 Percentage of subjects
Interval 0.02 to 4.79
|
0.84 Percentage of subjects
Interval 0.17 to 2.43
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-50
|
0.75 Percentage of subjects
Interval 0.02 to 4.12
|
0.90 Percentage of subjects
Interval 0.0 to 14.3
|
0.88 Percentage of subjects
Interval 0.02 to 4.79
|
0.84 Percentage of subjects
Interval 0.17 to 2.43
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-51
|
0.75 Percentage of subjects
Interval 0.02 to 4.12
|
0.90 Percentage of subjects
Interval 0.0 to 14.3
|
0.88 Percentage of subjects
Interval 0.02 to 4.79
|
0.84 Percentage of subjects
Interval 0.17 to 2.43
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-52
|
0.75 Percentage of subjects
Interval 0.02 to 4.12
|
0.90 Percentage of subjects
Interval 0.0 to 14.3
|
0.88 Percentage of subjects
Interval 0.02 to 4.79
|
0.84 Percentage of subjects
Interval 0.17 to 2.43
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 8.04
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 8.04
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.85
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.85
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
0.00 Percentage of subjects
Interval 0.0 to 2.95
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.6
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 7.87
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.05
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-44
|
1.25 Percentage of subjects
Interval 0.0 to 27.29
|
0.00 Percentage of subjects
Interval 0.0 to 2.53
|
—
|
0.45 Percentage of subjects
Interval 0.0 to 4.19
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-45
|
2.65 Percentage of subjects
Interval 0.73 to 6.64
|
0.00 Percentage of subjects
Interval 0.0 to 2.37
|
—
|
1.31 Percentage of subjects
Interval 0.13 to 4.95
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-46
|
2.82 Percentage of subjects
Interval 0.92 to 6.47
|
0.00 Percentage of subjects
Interval 0.0 to 2.2
|
—
|
1.46 Percentage of subjects
Interval 0.15 to 5.49
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-47
|
3.06 Percentage of subjects
Interval 1.13 to 6.54
|
0.00 Percentage of subjects
Interval 0.0 to 2.18
|
—
|
1.65 Percentage of subjects
Interval 0.18 to 6.07
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-48
|
3.06 Percentage of subjects
Interval 1.13 to 6.54
|
0.00 Percentage of subjects
Interval 0.0 to 2.18
|
—
|
1.65 Percentage of subjects
Interval 0.18 to 6.07
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-49
|
3.06 Percentage of subjects
Interval 1.13 to 6.54
|
0.00 Percentage of subjects
Interval 0.0 to 2.18
|
—
|
1.65 Percentage of subjects
Interval 0.18 to 6.07
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-50
|
3.06 Percentage of subjects
Interval 1.13 to 6.54
|
0.00 Percentage of subjects
Interval 0.0 to 2.18
|
—
|
1.65 Percentage of subjects
Interval 0.18 to 6.07
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-51
|
3.06 Percentage of subjects
Interval 1.13 to 6.54
|
0.00 Percentage of subjects
Interval 0.0 to 2.18
|
—
|
1.65 Percentage of subjects
Interval 0.18 to 6.07
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-52
|
3.06 Percentage of subjects
Interval 1.13 to 6.54
|
0.00 Percentage of subjects
Interval 0.0 to 2.18
|
—
|
1.65 Percentage of subjects
Interval 0.18 to 6.07
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-46
|
—
|
—
|
6.86 Percentage of subjects
Interval 3.37 to 12.19
|
6.86 Percentage of subjects
Interval 3.37 to 12.19
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-42
|
—
|
—
|
3.85 Percentage of subjects
Interval 0.11 to 19.24
|
3.85 Percentage of subjects
Interval 0.11 to 19.24
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-43
|
—
|
—
|
8.46 Percentage of subjects
Interval 0.6 to 31.78
|
8.46 Percentage of subjects
Interval 0.6 to 31.78
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-44
|
—
|
—
|
7.89 Percentage of subjects
Interval 4.49 to 12.69
|
7.89 Percentage of subjects
Interval 4.49 to 12.69
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-45
|
—
|
—
|
7.58 Percentage of subjects
Interval 4.75 to 11.36
|
7.58 Percentage of subjects
Interval 4.75 to 11.36
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as "6 months to 17 years", "18 to 65 years" and "\>65 years". All subjects who received the second dose of vaccine, were in the first age stratum: "6 months to 17 years". Please, refer to outcome n°14 for the overall (across age strata) post-dose 2 results.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-42
|
—
|
—
|
7.69 Percentage of subjects
Interval 0.19 to 36.17
|
7.69 Percentage of subjects
Interval 0.19 to 36.17
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-43
|
—
|
—
|
7.69 Percentage of subjects
Interval 0.55 to 29.13
|
7.69 Percentage of subjects
Interval 0.55 to 29.13
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-44
|
—
|
—
|
5.79 Percentage of subjects
Interval 2.93 to 10.12
|
5.79 Percentage of subjects
Interval 2.93 to 10.12
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-45
|
—
|
—
|
5.05 Percentage of subjects
Interval 2.23 to 9.66
|
5.05 Percentage of subjects
Interval 2.23 to 9.66
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-46
|
—
|
—
|
4.90 Percentage of subjects
Interval 2.77 to 7.96
|
4.90 Percentage of subjects
Interval 2.77 to 7.96
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-47
|
—
|
—
|
4.95 Percentage of subjects
Interval 2.86 to 7.92
|
4.95 Percentage of subjects
Interval 2.86 to 7.92
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-48
|
—
|
—
|
6.49 Percentage of subjects
Interval 0.78 to 21.64
|
6.49 Percentage of subjects
Interval 0.78 to 21.64
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-49
|
—
|
—
|
6.49 Percentage of subjects
Interval 0.78 to 21.64
|
6.49 Percentage of subjects
Interval 0.78 to 21.64
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-50
|
—
|
—
|
6.49 Percentage of subjects
Interval 0.78 to 21.64
|
6.49 Percentage of subjects
Interval 0.78 to 21.64
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-51
|
—
|
—
|
6.49 Percentage of subjects
Interval 0.78 to 21.64
|
6.49 Percentage of subjects
Interval 0.78 to 21.64
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-52
|
—
|
—
|
6.49 Percentage of subjects
Interval 0.78 to 21.64
|
6.49 Percentage of subjects
Interval 0.78 to 21.64
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-40
|
—
|
3.85 Percentage of subjects
Interval 0.0 to 45.2
|
—
|
3.85 Percentage of subjects
Interval 0.0 to 45.2
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-41
|
—
|
8.96 Percentage of subjects
Interval 0.04 to 51.75
|
—
|
8.96 Percentage of subjects
Interval 0.04 to 51.75
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-42
|
12.90 Percentage of subjects
Interval 7.56 to 20.11
|
7.41 Percentage of subjects
Interval 0.0 to 58.57
|
—
|
10.73 Percentage of subjects
Interval 4.36 to 21.03
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-43
|
12.60 Percentage of subjects
Interval 6.09 to 22.2
|
7.14 Percentage of subjects
Interval 0.0 to 59.06
|
—
|
10.43 Percentage of subjects
Interval 4.67 to 19.37
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-44
|
12.50 Percentage of subjects
Interval 4.46 to 26.0
|
7.95 Percentage of subjects
Interval 0.02 to 49.34
|
20.00 Percentage of subjects
Interval 0.51 to 71.64
|
10.86 Percentage of subjects
Interval 6.15 to 17.39
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-45
|
12.21 Percentage of subjects
Interval 1.37 to 38.68
|
8.33 Percentage of subjects
Interval 0.1 to 42.9
|
15.07 Percentage of subjects
Interval 7.77 to 25.36
|
11.67 Percentage of subjects
Interval 7.78 to 16.61
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-46
|
12.21 Percentage of subjects
Interval 1.37 to 38.68
|
10.00 Percentage of subjects
Interval 0.82 to 35.33
|
14.41 Percentage of subjects
Interval 8.47 to 22.35
|
12.22 Percentage of subjects
Interval 8.98 to 16.1
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-47
|
12.03 Percentage of subjects
Interval 0.49 to 47.47
|
9.91 Percentage of subjects
Interval 0.83 to 34.92
|
14.04 Percentage of subjects
Interval 8.24 to 21.79
|
12.01 Percentage of subjects
Interval 8.83 to 15.84
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-48
|
12.03 Percentage of subjects
Interval 0.49 to 47.47
|
9.91 Percentage of subjects
Interval 0.83 to 34.92
|
14.04 Percentage of subjects
Interval 8.24 to 21.79
|
12.01 Percentage of subjects
Interval 8.83 to 15.84
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-49
|
12.03 Percentage of subjects
Interval 0.49 to 47.47
|
9.91 Percentage of subjects
Interval 0.83 to 34.92
|
14.04 Percentage of subjects
Interval 8.24 to 21.79
|
12.01 Percentage of subjects
Interval 8.83 to 15.84
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-50
|
12.03 Percentage of subjects
Interval 0.49 to 47.47
|
9.91 Percentage of subjects
Interval 0.83 to 34.92
|
14.04 Percentage of subjects
Interval 8.24 to 21.79
|
12.01 Percentage of subjects
Interval 8.83 to 15.84
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-51
|
12.03 Percentage of subjects
Interval 0.49 to 47.47
|
9.91 Percentage of subjects
Interval 0.83 to 34.92
|
14.04 Percentage of subjects
Interval 8.24 to 21.79
|
12.01 Percentage of subjects
Interval 8.83 to 15.84
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-52
|
12.03 Percentage of subjects
Interval 0.49 to 47.47
|
9.91 Percentage of subjects
Interval 0.83 to 34.92
|
14.04 Percentage of subjects
Interval 8.24 to 21.79
|
12.01 Percentage of subjects
Interval 8.83 to 15.84
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-40
|
—
|
6.82 Percentage of subjects
Interval 1.43 to 18.66
|
—
|
6.82 Percentage of subjects
Interval 1.43 to 18.66
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-41
|
—
|
5.32 Percentage of subjects
Interval 0.15 to 25.86
|
—
|
5.32 Percentage of subjects
Interval 0.15 to 25.86
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
4.88 Percentage of subjects
Interval 0.21 to 21.8
|
—
|
4.29 Percentage of subjects
Interval 0.85 to 12.27
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 7.87
|
6.77 Percentage of subjects
Interval 1.11 to 20.35
|
—
|
5.06 Percentage of subjects
Interval 0.88 to 15.13
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-44
|
8.75 Percentage of subjects
Interval 0.29 to 38.3
|
6.25 Percentage of subjects
Interval 1.27 to 17.39
|
—
|
7.14 Percentage of subjects
Interval 3.84 to 11.95
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-45
|
9.93 Percentage of subjects
Interval 2.03 to 26.68
|
7.14 Percentage of subjects
Interval 1.52 to 19.35
|
—
|
8.52 Percentage of subjects
Interval 5.44 to 12.59
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-46
|
10.17 Percentage of subjects
Interval 3.14 to 22.97
|
7.23 Percentage of subjects
Interval 1.76 to 18.52
|
—
|
8.75 Percentage of subjects
Interval 5.98 to 12.25
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-47
|
9.69 Percentage of subjects
Interval 2.88 to 22.35
|
7.19 Percentage of subjects
Interval 1.79 to 18.25
|
—
|
8.54 Percentage of subjects
Interval 5.88 to 11.9
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-48
|
9.69 Percentage of subjects
Interval 2.88 to 22.35
|
7.19 Percentage of subjects
Interval 1.79 to 18.25
|
—
|
8.54 Percentage of subjects
Interval 5.88 to 11.9
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-49
|
9.69 Percentage of subjects
Interval 2.88 to 22.35
|
7.19 Percentage of subjects
Interval 1.79 to 18.25
|
—
|
8.54 Percentage of subjects
Interval 5.88 to 11.9
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-50
|
9.69 Percentage of subjects
Interval 2.88 to 22.35
|
7.19 Percentage of subjects
Interval 1.79 to 18.25
|
—
|
8.54 Percentage of subjects
Interval 5.88 to 11.9
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-51
|
9.69 Percentage of subjects
Interval 2.88 to 22.35
|
7.19 Percentage of subjects
Interval 1.79 to 18.25
|
—
|
8.54 Percentage of subjects
Interval 5.88 to 11.9
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-52
|
9.69 Percentage of subjects
Interval 2.88 to 22.35
|
7.19 Percentage of subjects
Interval 1.79 to 18.25
|
—
|
8.54 Percentage of subjects
Interval 5.88 to 11.9
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as "6 months to 17 years", "18 to 65 years" and "\>65 years". All subjects who received the second dose of vaccine, were in the first age stratum: "6 months to 17 years". Please, refer to outcome n°16 for the overall (across age strata) post-dose 2 results.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-45
|
13.91 Percentage of subjects
Interval 8.82 to 20.47
|
4.55 Percentage of subjects
Interval 0.54 to 15.58
|
—
|
9.18 Percentage of subjects
Interval 3.83 to 17.86
|
|
Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-46
|
11.86 Percentage of subjects
Interval 6.25 to 19.87
|
4.22 Percentage of subjects
Interval 0.77 to 12.47
|
—
|
8.16 Percentage of subjects
Interval 3.8 to 14.93
|
|
Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-47
|
10.71 Percentage of subjects
Interval 4.56 to 20.47
|
4.19 Percentage of subjects
Interval 0.79 to 12.26
|
—
|
7.71 Percentage of subjects
Interval 3.95 to 13.29
|
|
Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-48
|
10.71 Percentage of subjects
Interval 4.56 to 20.47
|
4.19 Percentage of subjects
Interval 0.79 to 12.26
|
—
|
7.71 Percentage of subjects
Interval 3.95 to 13.29
|
|
Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-49
|
10.71 Percentage of subjects
Interval 4.56 to 20.47
|
4.19 Percentage of subjects
Interval 0.79 to 12.26
|
—
|
7.71 Percentage of subjects
Interval 3.95 to 13.29
|
|
Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-50
|
10.71 Percentage of subjects
Interval 4.56 to 20.47
|
4.19 Percentage of subjects
Interval 0.79 to 12.26
|
—
|
7.71 Percentage of subjects
Interval 3.95 to 13.29
|
|
Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-51
|
10.71 Percentage of subjects
Interval 4.56 to 20.47
|
4.19 Percentage of subjects
Interval 0.79 to 12.26
|
—
|
7.71 Percentage of subjects
Interval 3.95 to 13.29
|
|
Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-52
|
10.71 Percentage of subjects
Interval 4.56 to 20.47
|
4.19 Percentage of subjects
Interval 0.79 to 12.26
|
—
|
7.71 Percentage of subjects
Interval 3.95 to 13.29
|
|
Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-42
|
—
|
—
|
1.92 Percentage of subjects
Interval 0.05 to 10.26
|
1.92 Percentage of subjects
Interval 0.05 to 10.26
|
|
Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-43
|
—
|
—
|
5.38 Percentage of subjects
Interval 0.4 to 20.9
|
5.38 Percentage of subjects
Interval 0.4 to 20.9
|
|
Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-44
|
—
|
—
|
4.21 Percentage of subjects
Interval 1.84 to 8.13
|
4.21 Percentage of subjects
Interval 1.84 to 8.13
|
|
Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-45
|
—
|
—
|
4.69 Percentage of subjects
Interval 1.31 to 11.52
|
4.69 Percentage of subjects
Interval 1.31 to 11.52
|
|
Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-46
|
—
|
—
|
4.58 Percentage of subjects
Interval 1.86 to 9.19
|
4.58 Percentage of subjects
Interval 1.86 to 9.19
|
|
Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-47
|
—
|
—
|
4.64 Percentage of subjects
Interval 2.09 to 8.78
|
4.64 Percentage of subjects
Interval 2.09 to 8.78
|
|
Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-48
|
—
|
—
|
6.19 Percentage of subjects
Interval 1.88 to 14.44
|
6.19 Percentage of subjects
Interval 1.88 to 14.44
|
|
Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-49
|
—
|
—
|
6.19 Percentage of subjects
Interval 1.88 to 14.44
|
6.19 Percentage of subjects
Interval 1.88 to 14.44
|
|
Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-50
|
—
|
—
|
6.19 Percentage of subjects
Interval 1.88 to 14.44
|
6.19 Percentage of subjects
Interval 1.88 to 14.44
|
|
Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-51
|
—
|
—
|
6.19 Percentage of subjects
Interval 1.88 to 14.44
|
6.19 Percentage of subjects
Interval 1.88 to 14.44
|
|
Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-52
|
—
|
—
|
6.19 Percentage of subjects
Interval 1.88 to 14.44
|
6.19 Percentage of subjects
Interval 1.88 to 14.44
|
|
Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-40
|
—
|
7.69 Percentage of subjects
Interval 0.0 to 72.14
|
—
|
7.69 Percentage of subjects
Interval 0.0 to 72.14
|
|
Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-41
|
—
|
10.45 Percentage of subjects
Interval 3.7 to 22.05
|
—
|
10.45 Percentage of subjects
Interval 3.7 to 22.05
|
|
Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-42
|
4.84 Percentage of subjects
Interval 1.8 to 10.23
|
8.64 Percentage of subjects
Interval 1.19 to 26.97
|
—
|
6.34 Percentage of subjects
Interval 2.11 to 14.1
|
|
Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-43
|
4.72 Percentage of subjects
Interval 1.75 to 10.0
|
9.52 Percentage of subjects
Interval 1.88 to 26.03
|
—
|
6.64 Percentage of subjects
Interval 2.66 to 13.33
|
|
Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-44
|
4.69 Percentage of subjects
Interval 1.73 to 9.94
|
10.23 Percentage of subjects
Interval 2.02 to 27.74
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
6.79 Percentage of subjects
Interval 2.9 to 13.13
|
|
Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-45
|
4.58 Percentage of subjects
Interval 0.58 to 15.42
|
10.42 Percentage of subjects
Interval 2.36 to 26.81
|
13.70 Percentage of subjects
Interval 6.77 to 23.75
|
8.67 Percentage of subjects
Interval 3.62 to 16.87
|
|
Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-46
|
4.58 Percentage of subjects
Interval 0.58 to 15.42
|
12.73 Percentage of subjects
Interval 1.62 to 38.68
|
13.51 Percentage of subjects
Interval 7.77 to 21.31
|
9.94 Percentage of subjects
Interval 4.2 to 19.15
|
|
Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-47
|
4.51 Percentage of subjects
Interval 0.22 to 19.67
|
13.51 Percentage of subjects
Interval 1.25 to 44.07
|
13.16 Percentage of subjects
Interval 7.56 to 20.77
|
10.06 Percentage of subjects
Interval 4.19 to 19.5
|
|
Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-48
|
4.51 Percentage of subjects
Interval 0.22 to 19.67
|
13.51 Percentage of subjects
Interval 1.25 to 44.07
|
13.16 Percentage of subjects
Interval 7.56 to 20.77
|
10.06 Percentage of subjects
Interval 4.19 to 19.5
|
|
Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-49
|
4.51 Percentage of subjects
Interval 0.22 to 19.67
|
13.51 Percentage of subjects
Interval 1.25 to 44.07
|
13.16 Percentage of subjects
Interval 7.56 to 20.77
|
10.06 Percentage of subjects
Interval 4.19 to 19.5
|
|
Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-50
|
4.51 Percentage of subjects
Interval 0.22 to 19.67
|
13.51 Percentage of subjects
Interval 1.25 to 44.07
|
13.16 Percentage of subjects
Interval 7.56 to 20.77
|
10.06 Percentage of subjects
Interval 4.19 to 19.5
|
|
Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-51
|
4.51 Percentage of subjects
Interval 0.22 to 19.67
|
13.51 Percentage of subjects
Interval 1.25 to 44.07
|
13.16 Percentage of subjects
Interval 7.56 to 20.77
|
10.06 Percentage of subjects
Interval 4.19 to 19.5
|
|
Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-52
|
4.51 Percentage of subjects
Interval 0.22 to 19.67
|
13.51 Percentage of subjects
Interval 1.25 to 44.07
|
13.16 Percentage of subjects
Interval 7.56 to 20.77
|
10.06 Percentage of subjects
Interval 4.19 to 19.5
|
|
Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-40
|
—
|
4.55 Percentage of subjects
Interval 0.56 to 15.47
|
—
|
4.55 Percentage of subjects
Interval 0.56 to 15.47
|
|
Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-41
|
—
|
4.26 Percentage of subjects
Interval 0.11 to 21.52
|
—
|
4.26 Percentage of subjects
Interval 0.11 to 21.52
|
|
Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-42
|
11.76 Percentage of subjects
Interval 0.0 to 99.87
|
4.88 Percentage of subjects
Interval 0.16 to 23.0
|
—
|
5.71 Percentage of subjects
Interval 1.58 to 13.99
|
|
Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-43
|
11.11 Percentage of subjects
Interval 0.01 to 69.27
|
4.51 Percentage of subjects
Interval 0.33 to 17.92
|
—
|
6.18 Percentage of subjects
Interval 1.89 to 14.38
|
|
Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-44
|
13.75 Percentage of subjects
Interval 3.37 to 33.39
|
4.17 Percentage of subjects
Interval 0.54 to 13.99
|
—
|
7.59 Percentage of subjects
Interval 2.74 to 16.09
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as "6 months to 17 years", "18 to 65 years" and "\>65 years". All subjects who received the second dose of vaccine, were in the first age stratum: "6 months to 17 years". Please, refer to outcome n°18 for the overall (across age strata) post-dose 2 results.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-51
|
—
|
—
|
3.24 Percentage of subjects
Interval 1.63 to 5.73
|
3.24 Percentage of subjects
Interval 1.63 to 5.73
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-52
|
—
|
—
|
3.24 Percentage of subjects
Interval 1.63 to 5.73
|
3.24 Percentage of subjects
Interval 1.63 to 5.73
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.93
|
1.23 Percentage of subjects
Interval 0.0 to 31.16
|
—
|
0.49 Percentage of subjects
Interval 0.0 to 8.75
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.86
|
1.19 Percentage of subjects
Interval 0.0 to 28.59
|
—
|
0.47 Percentage of subjects
Interval 0.0 to 6.21
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 2.84
|
1.14 Percentage of subjects
Interval 0.0 to 25.56
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.45 Percentage of subjects
Interval 0.0 to 4.86
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 2.78
|
1.04 Percentage of subjects
Interval 0.0 to 20.63
|
0.00 Percentage of subjects
Interval 0.0 to 4.93
|
0.33 Percentage of subjects
Interval 0.0 to 3.33
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 2.78
|
0.91 Percentage of subjects
Interval 0.0 to 14.64
|
0.00 Percentage of subjects
Interval 0.0 to 3.27
|
0.28 Percentage of subjects
Interval 0.0 to 2.72
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
0.90 Percentage of subjects
Interval 0.0 to 14.3
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.28 Percentage of subjects
Interval 0.0 to 2.66
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
0.90 Percentage of subjects
Interval 0.0 to 14.3
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.28 Percentage of subjects
Interval 0.0 to 2.66
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
0.90 Percentage of subjects
Interval 0.0 to 14.3
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.28 Percentage of subjects
Interval 0.0 to 2.66
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
0.90 Percentage of subjects
Interval 0.0 to 14.3
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.28 Percentage of subjects
Interval 0.0 to 2.66
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
0.90 Percentage of subjects
Interval 0.0 to 14.3
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.28 Percentage of subjects
Interval 0.0 to 2.66
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
0.90 Percentage of subjects
Interval 0.0 to 14.3
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.28 Percentage of subjects
Interval 0.0 to 2.66
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 8.04
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 8.04
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.85
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.85
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
2.44 Percentage of subjects
Interval 0.0 to 34.95
|
—
|
2.14 Percentage of subjects
Interval 0.01 to 14.95
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 7.87
|
3.01 Percentage of subjects
Interval 0.0 to 37.3
|
—
|
2.25 Percentage of subjects
Interval 0.01 to 15.77
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-44
|
1.25 Percentage of subjects
Interval 0.0 to 27.29
|
2.78 Percentage of subjects
Interval 0.0 to 31.28
|
—
|
2.23 Percentage of subjects
Interval 0.12 to 9.95
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-45
|
1.32 Percentage of subjects
Interval 0.05 to 6.55
|
2.60 Percentage of subjects
Interval 0.0 to 26.85
|
—
|
1.97 Percentage of subjects
Interval 0.24 to 6.92
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-46
|
1.69 Percentage of subjects
Interval 0.35 to 4.87
|
2.41 Percentage of subjects
Interval 0.0 to 22.57
|
—
|
2.04 Percentage of subjects
Interval 0.5 to 5.4
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-47
|
1.53 Percentage of subjects
Interval 0.32 to 4.41
|
2.40 Percentage of subjects
Interval 0.0 to 22.26
|
—
|
1.93 Percentage of subjects
Interval 0.44 to 5.32
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-48
|
1.53 Percentage of subjects
Interval 0.32 to 4.41
|
2.40 Percentage of subjects
Interval 0.0 to 22.26
|
—
|
1.93 Percentage of subjects
Interval 0.44 to 5.32
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-49
|
1.53 Percentage of subjects
Interval 0.32 to 4.41
|
2.40 Percentage of subjects
Interval 0.0 to 22.26
|
—
|
1.93 Percentage of subjects
Interval 0.44 to 5.32
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-50
|
1.53 Percentage of subjects
Interval 0.32 to 4.41
|
2.40 Percentage of subjects
Interval 0.0 to 22.26
|
—
|
1.93 Percentage of subjects
Interval 0.44 to 5.32
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-51
|
1.53 Percentage of subjects
Interval 0.32 to 4.41
|
2.40 Percentage of subjects
Interval 0.0 to 22.26
|
—
|
1.93 Percentage of subjects
Interval 0.44 to 5.32
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-52
|
1.53 Percentage of subjects
Interval 0.32 to 4.41
|
2.40 Percentage of subjects
Interval 0.0 to 22.26
|
—
|
1.93 Percentage of subjects
Interval 0.44 to 5.32
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-42
|
—
|
—
|
1.92 Percentage of subjects
Interval 0.05 to 10.26
|
1.92 Percentage of subjects
Interval 0.05 to 10.26
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-43
|
—
|
—
|
3.85 Percentage of subjects
Interval 0.3 to 15.16
|
3.85 Percentage of subjects
Interval 0.3 to 15.16
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-44
|
—
|
—
|
3.68 Percentage of subjects
Interval 1.23 to 8.3
|
3.68 Percentage of subjects
Interval 1.23 to 8.3
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-45
|
—
|
—
|
2.89 Percentage of subjects
Interval 1.25 to 5.64
|
2.89 Percentage of subjects
Interval 1.25 to 5.64
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-46
|
—
|
—
|
3.27 Percentage of subjects
Interval 1.58 to 5.93
|
3.27 Percentage of subjects
Interval 1.58 to 5.93
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-47
|
—
|
—
|
3.41 Percentage of subjects
Interval 1.59 to 6.3
|
3.41 Percentage of subjects
Interval 1.59 to 6.3
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-48
|
—
|
—
|
3.24 Percentage of subjects
Interval 1.63 to 5.73
|
3.24 Percentage of subjects
Interval 1.63 to 5.73
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-49
|
—
|
—
|
3.24 Percentage of subjects
Interval 1.63 to 5.73
|
3.24 Percentage of subjects
Interval 1.63 to 5.73
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-50
|
—
|
—
|
3.24 Percentage of subjects
Interval 1.63 to 5.73
|
3.24 Percentage of subjects
Interval 1.63 to 5.73
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as "6 months to 17 years", "18 to 65 years" and "\>65 years". All subjects who received the second dose of vaccine, were in the first age stratum: "6 months to 17 years". Please, refer to outcome n°20 for the overall (across age strata) post-dose 2 results.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-42
|
—
|
—
|
26.92 Percentage of subjects
Interval 0.28 to 88.26
|
26.92 Percentage of subjects
Interval 0.28 to 88.26
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-43
|
—
|
—
|
26.15 Percentage of subjects
Interval 8.21 to 52.91
|
26.15 Percentage of subjects
Interval 8.21 to 52.91
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-44
|
—
|
—
|
23.68 Percentage of subjects
Interval 17.83 to 30.38
|
23.68 Percentage of subjects
Interval 17.83 to 30.38
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-45
|
—
|
—
|
23.47 Percentage of subjects
Interval 15.58 to 32.98
|
23.47 Percentage of subjects
Interval 15.58 to 32.98
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-46
|
—
|
—
|
22.88 Percentage of subjects
Interval 14.93 to 32.55
|
22.88 Percentage of subjects
Interval 14.93 to 32.55
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-47
|
—
|
—
|
23.53 Percentage of subjects
Interval 12.19 to 38.53
|
23.53 Percentage of subjects
Interval 12.19 to 38.53
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-48
|
—
|
—
|
23.89 Percentage of subjects
Interval 11.55 to 40.56
|
23.89 Percentage of subjects
Interval 11.55 to 40.56
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-49
|
—
|
—
|
23.89 Percentage of subjects
Interval 11.55 to 40.56
|
23.89 Percentage of subjects
Interval 11.55 to 40.56
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-50
|
—
|
—
|
23.89 Percentage of subjects
Interval 11.55 to 40.56
|
23.89 Percentage of subjects
Interval 11.55 to 40.56
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-51
|
—
|
—
|
23.89 Percentage of subjects
Interval 11.55 to 40.56
|
23.89 Percentage of subjects
Interval 11.55 to 40.56
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-52
|
—
|
—
|
23.89 Percentage of subjects
Interval 11.55 to 40.56
|
23.89 Percentage of subjects
Interval 11.55 to 40.56
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-40
|
—
|
15.38 Percentage of subjects
Interval 0.0 to 94.7
|
—
|
15.38 Percentage of subjects
Interval 0.0 to 94.7
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-41
|
—
|
16.42 Percentage of subjects
Interval 0.23 to 67.81
|
—
|
16.42 Percentage of subjects
Interval 0.23 to 67.81
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-42
|
9.68 Percentage of subjects
Interval 5.1 to 16.29
|
16.05 Percentage of subjects
Interval 0.15 to 69.39
|
—
|
12.20 Percentage of subjects
Interval 3.14 to 29.38
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-43
|
10.24 Percentage of subjects
Interval 1.2 to 32.87
|
16.67 Percentage of subjects
Interval 0.26 to 67.84
|
—
|
12.80 Percentage of subjects
Interval 4.4 to 27.04
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-44
|
10.16 Percentage of subjects
Interval 1.84 to 28.43
|
17.05 Percentage of subjects
Interval 0.38 to 65.95
|
20.00 Percentage of subjects
Interval 0.51 to 71.64
|
13.12 Percentage of subjects
Interval 5.29 to 25.56
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-45
|
9.92 Percentage of subjects
Interval 4.86 to 17.51
|
17.71 Percentage of subjects
Interval 0.69 to 62.94
|
19.18 Percentage of subjects
Interval 10.9 to 30.08
|
14.67 Percentage of subjects
Interval 7.13 to 25.61
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-46
|
9.92 Percentage of subjects
Interval 4.86 to 17.51
|
17.27 Percentage of subjects
Interval 1.28 to 55.73
|
20.72 Percentage of subjects
Interval 13.61 to 29.45
|
15.63 Percentage of subjects
Interval 7.93 to 26.51
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-47
|
9.77 Percentage of subjects
Interval 5.31 to 16.13
|
17.12 Percentage of subjects
Interval 1.31 to 55.05
|
20.18 Percentage of subjects
Interval 13.24 to 28.72
|
15.36 Percentage of subjects
Interval 7.98 to 25.72
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-48
|
9.77 Percentage of subjects
Interval 5.31 to 16.13
|
17.12 Percentage of subjects
Interval 1.31 to 55.05
|
20.18 Percentage of subjects
Interval 13.24 to 28.72
|
15.36 Percentage of subjects
Interval 7.98 to 25.72
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-49
|
9.77 Percentage of subjects
Interval 5.31 to 16.13
|
17.12 Percentage of subjects
Interval 1.31 to 55.05
|
20.18 Percentage of subjects
Interval 13.24 to 28.72
|
15.36 Percentage of subjects
Interval 7.98 to 25.72
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-50
|
9.77 Percentage of subjects
Interval 5.31 to 16.13
|
17.12 Percentage of subjects
Interval 1.31 to 55.05
|
20.18 Percentage of subjects
Interval 13.24 to 28.72
|
15.36 Percentage of subjects
Interval 7.98 to 25.72
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-51
|
9.77 Percentage of subjects
Interval 5.31 to 16.13
|
17.12 Percentage of subjects
Interval 1.31 to 55.05
|
20.18 Percentage of subjects
Interval 13.24 to 28.72
|
15.36 Percentage of subjects
Interval 7.98 to 25.72
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-52
|
9.77 Percentage of subjects
Interval 5.31 to 16.13
|
17.12 Percentage of subjects
Interval 1.31 to 55.05
|
20.18 Percentage of subjects
Interval 13.24 to 28.72
|
15.36 Percentage of subjects
Interval 7.98 to 25.72
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-40
|
—
|
4.55 Percentage of subjects
Interval 0.56 to 15.47
|
—
|
4.55 Percentage of subjects
Interval 0.56 to 15.47
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-41
|
—
|
7.45 Percentage of subjects
Interval 0.99 to 23.82
|
—
|
7.45 Percentage of subjects
Interval 0.99 to 23.82
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-42
|
11.76 Percentage of subjects
Interval 0.0 to 99.87
|
7.32 Percentage of subjects
Interval 1.65 to 19.37
|
—
|
7.86 Percentage of subjects
Interval 3.83 to 13.99
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-43
|
15.56 Percentage of subjects
Interval 0.01 to 83.16
|
8.27 Percentage of subjects
Interval 1.15 to 25.83
|
—
|
10.11 Percentage of subjects
Interval 4.17 to 19.71
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-44
|
20.00 Percentage of subjects
Interval 10.76 to 32.37
|
7.64 Percentage of subjects
Interval 1.89 to 19.37
|
—
|
12.05 Percentage of subjects
Interval 5.32 to 22.44
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-45
|
20.53 Percentage of subjects
Interval 14.4 to 27.86
|
8.44 Percentage of subjects
Interval 1.56 to 23.86
|
—
|
14.43 Percentage of subjects
Interval 6.84 to 25.58
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-46
|
18.64 Percentage of subjects
Interval 13.19 to 25.17
|
7.83 Percentage of subjects
Interval 2.26 to 18.54
|
—
|
13.41 Percentage of subjects
Interval 6.75 to 23.02
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-47
|
17.86 Percentage of subjects
Interval 12.76 to 23.95
|
7.78 Percentage of subjects
Interval 2.31 to 18.17
|
—
|
13.22 Percentage of subjects
Interval 7.02 to 21.97
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-48
|
17.86 Percentage of subjects
Interval 12.76 to 23.95
|
7.78 Percentage of subjects
Interval 2.31 to 18.17
|
—
|
13.22 Percentage of subjects
Interval 7.02 to 21.97
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-49
|
17.86 Percentage of subjects
Interval 12.76 to 23.95
|
7.78 Percentage of subjects
Interval 2.31 to 18.17
|
—
|
13.22 Percentage of subjects
Interval 7.02 to 21.97
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-50
|
17.86 Percentage of subjects
Interval 12.76 to 23.95
|
7.78 Percentage of subjects
Interval 2.31 to 18.17
|
—
|
13.22 Percentage of subjects
Interval 7.02 to 21.97
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-51
|
17.86 Percentage of subjects
Interval 12.76 to 23.95
|
7.78 Percentage of subjects
Interval 2.31 to 18.17
|
—
|
13.22 Percentage of subjects
Interval 7.02 to 21.97
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-52
|
17.86 Percentage of subjects
Interval 12.76 to 23.95
|
7.78 Percentage of subjects
Interval 2.31 to 18.17
|
—
|
13.22 Percentage of subjects
Interval 7.02 to 21.97
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as "6 months to 17 years", "18 to 65 years" and "\>65 years". All subjects who received the second dose of vaccine, were in the first age stratum: "6 months to 17 years". Please, refer to outcome n°22 for the overall (across age strata) post-dose 2 results.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-42
|
—
|
—
|
3.85 Percentage of subjects
Interval 0.11 to 19.24
|
3.85 Percentage of subjects
Interval 0.11 to 19.24
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-43
|
—
|
—
|
1.54 Percentage of subjects
Interval 0.12 to 6.2
|
1.54 Percentage of subjects
Interval 0.12 to 6.2
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-44
|
—
|
—
|
2.11 Percentage of subjects
Interval 0.25 to 7.46
|
2.11 Percentage of subjects
Interval 0.25 to 7.46
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-45
|
—
|
—
|
2.17 Percentage of subjects
Interval 0.0 to 19.17
|
2.17 Percentage of subjects
Interval 0.0 to 19.17
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-46
|
—
|
—
|
1.96 Percentage of subjects
Interval 0.0 to 15.98
|
1.96 Percentage of subjects
Interval 0.0 to 15.98
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-47
|
—
|
—
|
1.86 Percentage of subjects
Interval 0.01 to 13.26
|
1.86 Percentage of subjects
Interval 0.01 to 13.26
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-48
|
—
|
—
|
1.77 Percentage of subjects
Interval 0.01 to 11.97
|
1.77 Percentage of subjects
Interval 0.01 to 11.97
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-49
|
—
|
—
|
1.77 Percentage of subjects
Interval 0.01 to 11.97
|
1.77 Percentage of subjects
Interval 0.01 to 11.97
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-50
|
—
|
—
|
1.77 Percentage of subjects
Interval 0.01 to 11.97
|
1.77 Percentage of subjects
Interval 0.01 to 11.97
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-51
|
—
|
—
|
1.77 Percentage of subjects
Interval 0.01 to 11.97
|
1.77 Percentage of subjects
Interval 0.01 to 11.97
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-52
|
—
|
—
|
1.77 Percentage of subjects
Interval 0.01 to 11.97
|
1.77 Percentage of subjects
Interval 0.01 to 11.97
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.93
|
0.00 Percentage of subjects
Interval 0.0 to 4.45
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.78
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.86
|
0.00 Percentage of subjects
Interval 0.0 to 4.3
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.73
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 2.84
|
0.00 Percentage of subjects
Interval 0.0 to 4.11
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 1.66
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 2.78
|
0.00 Percentage of subjects
Interval 0.0 to 3.77
|
0.00 Percentage of subjects
Interval 0.0 to 4.93
|
0.00 Percentage of subjects
Interval 0.0 to 1.22
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 2.78
|
0.91 Percentage of subjects
Interval 0.0 to 14.64
|
0.00 Percentage of subjects
Interval 0.0 to 3.27
|
0.28 Percentage of subjects
Interval 0.0 to 2.72
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
0.90 Percentage of subjects
Interval 0.0 to 14.3
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.28 Percentage of subjects
Interval 0.0 to 2.66
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
0.90 Percentage of subjects
Interval 0.0 to 14.3
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.28 Percentage of subjects
Interval 0.0 to 2.66
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
0.90 Percentage of subjects
Interval 0.0 to 14.3
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.28 Percentage of subjects
Interval 0.0 to 2.66
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
0.90 Percentage of subjects
Interval 0.0 to 14.3
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.28 Percentage of subjects
Interval 0.0 to 2.66
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
0.90 Percentage of subjects
Interval 0.0 to 14.3
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.28 Percentage of subjects
Interval 0.0 to 2.66
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
0.90 Percentage of subjects
Interval 0.0 to 14.3
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.28 Percentage of subjects
Interval 0.0 to 2.66
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-40
|
—
|
4.55 Percentage of subjects
Interval 0.56 to 15.47
|
—
|
4.55 Percentage of subjects
Interval 0.56 to 15.47
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-41
|
—
|
3.19 Percentage of subjects
Interval 0.24 to 12.75
|
—
|
3.19 Percentage of subjects
Interval 0.24 to 12.75
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
3.25 Percentage of subjects
Interval 0.46 to 10.67
|
—
|
2.86 Percentage of subjects
Interval 0.78 to 7.15
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-43
|
2.22 Percentage of subjects
Interval 0.0 to 18.7
|
3.76 Percentage of subjects
Interval 0.52 to 12.38
|
—
|
3.37 Percentage of subjects
Interval 1.25 to 7.19
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-44
|
1.25 Percentage of subjects
Interval 0.0 to 9.31
|
3.47 Percentage of subjects
Interval 0.69 to 10.0
|
—
|
2.68 Percentage of subjects
Interval 0.99 to 5.74
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-45
|
3.97 Percentage of subjects
Interval 1.47 to 8.45
|
3.25 Percentage of subjects
Interval 0.78 to 8.63
|
—
|
3.61 Percentage of subjects
Interval 1.81 to 6.36
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-46
|
3.39 Percentage of subjects
Interval 1.25 to 7.23
|
3.01 Percentage of subjects
Interval 0.81 to 7.61
|
—
|
3.21 Percentage of subjects
Interval 1.61 to 5.67
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-47
|
3.06 Percentage of subjects
Interval 1.13 to 6.54
|
2.99 Percentage of subjects
Interval 0.81 to 7.55
|
—
|
3.03 Percentage of subjects
Interval 1.52 to 5.36
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-48
|
3.06 Percentage of subjects
Interval 1.13 to 6.54
|
2.99 Percentage of subjects
Interval 0.81 to 7.55
|
—
|
3.03 Percentage of subjects
Interval 1.52 to 5.36
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-49
|
3.06 Percentage of subjects
Interval 1.13 to 6.54
|
2.99 Percentage of subjects
Interval 0.81 to 7.55
|
—
|
3.03 Percentage of subjects
Interval 1.52 to 5.36
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-50
|
3.06 Percentage of subjects
Interval 1.13 to 6.54
|
2.99 Percentage of subjects
Interval 0.81 to 7.55
|
—
|
3.03 Percentage of subjects
Interval 1.52 to 5.36
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-51
|
3.06 Percentage of subjects
Interval 1.13 to 6.54
|
2.99 Percentage of subjects
Interval 0.81 to 7.55
|
—
|
3.03 Percentage of subjects
Interval 1.52 to 5.36
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-52
|
3.06 Percentage of subjects
Interval 1.13 to 6.54
|
2.99 Percentage of subjects
Interval 0.81 to 7.55
|
—
|
3.03 Percentage of subjects
Interval 1.52 to 5.36
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as "6 months to 17 years", "18 to 65 years" and "\>65 years". All subjects who received the second dose of vaccine, were in the first age stratum: "6 months to 17 years". Please, refer to outcome n°24 for the overall (across age strata) post-dose 2 results.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-42
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
|
Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-43
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
|
Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-44
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.92
|
0.00 Percentage of subjects
Interval 0.0 to 1.92
|
|
Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-45
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
|
Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-46
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.2
|
0.00 Percentage of subjects
Interval 0.0 to 1.2
|
|
Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-47
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.14
|
0.00 Percentage of subjects
Interval 0.0 to 1.14
|
|
Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.08
|
0.00 Percentage of subjects
Interval 0.0 to 1.08
|
|
Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-49
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.08
|
0.00 Percentage of subjects
Interval 0.0 to 1.08
|
|
Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-50
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.08
|
0.00 Percentage of subjects
Interval 0.0 to 1.08
|
|
Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-51
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.08
|
0.00 Percentage of subjects
Interval 0.0 to 1.08
|
|
Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-52
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.08
|
0.00 Percentage of subjects
Interval 0.0 to 1.08
|
|
Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-40
|
—
|
3.85 Percentage of subjects
Interval 0.0 to 45.2
|
—
|
3.85 Percentage of subjects
Interval 0.0 to 45.2
|
|
Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-41
|
—
|
1.49 Percentage of subjects
Interval 0.01 to 10.39
|
—
|
1.49 Percentage of subjects
Interval 0.01 to 10.39
|
|
Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.93
|
1.23 Percentage of subjects
Interval 0.0 to 12.57
|
—
|
0.49 Percentage of subjects
Interval 0.0 to 7.05
|
|
Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.86
|
1.19 Percentage of subjects
Interval 0.0 to 12.76
|
—
|
0.47 Percentage of subjects
Interval 0.0 to 5.15
|
|
Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 2.84
|
1.14 Percentage of subjects
Interval 0.0 to 13.03
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.45 Percentage of subjects
Interval 0.0 to 4.17
|
|
Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 2.78
|
1.04 Percentage of subjects
Interval 0.0 to 13.56
|
0.00 Percentage of subjects
Interval 0.0 to 4.93
|
0.33 Percentage of subjects
Interval 0.0 to 3.08
|
|
Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 2.78
|
0.91 Percentage of subjects
Interval 0.0 to 14.27
|
0.00 Percentage of subjects
Interval 0.0 to 3.27
|
0.28 Percentage of subjects
Interval 0.0 to 2.71
|
|
Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
0.90 Percentage of subjects
Interval 0.0 to 14.3
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.28 Percentage of subjects
Interval 0.0 to 2.66
|
|
Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
0.90 Percentage of subjects
Interval 0.0 to 14.3
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.28 Percentage of subjects
Interval 0.0 to 2.66
|
|
Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
0.90 Percentage of subjects
Interval 0.0 to 14.3
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.28 Percentage of subjects
Interval 0.0 to 2.66
|
|
Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
0.90 Percentage of subjects
Interval 0.0 to 14.3
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.28 Percentage of subjects
Interval 0.0 to 2.66
|
|
Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
0.90 Percentage of subjects
Interval 0.0 to 14.3
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.28 Percentage of subjects
Interval 0.0 to 2.66
|
|
Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
0.90 Percentage of subjects
Interval 0.0 to 14.3
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.28 Percentage of subjects
Interval 0.0 to 2.66
|
|
Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 8.04
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 8.04
|
|
Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.85
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.85
|
|
Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
0.00 Percentage of subjects
Interval 0.0 to 2.95
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.6
|
|
Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 7.87
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.05
|
|
Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 2.53
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.63
|
|
Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 2.41
|
0.00 Percentage of subjects
Interval 0.0 to 2.37
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.2
|
|
Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 2.06
|
0.00 Percentage of subjects
Interval 0.0 to 2.2
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.07
|
|
Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 1.86
|
0.00 Percentage of subjects
Interval 0.0 to 2.18
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.01
|
|
Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 1.86
|
0.00 Percentage of subjects
Interval 0.0 to 2.18
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.01
|
|
Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 1.86
|
0.00 Percentage of subjects
Interval 0.0 to 2.18
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.01
|
|
Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 1.86
|
0.00 Percentage of subjects
Interval 0.0 to 2.18
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.01
|
|
Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 1.86
|
0.00 Percentage of subjects
Interval 0.0 to 2.18
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.01
|
|
Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 1.86
|
0.00 Percentage of subjects
Interval 0.0 to 2.18
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.01
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as "6 months to 17 years", "18 to 65 years" and "\>65 years". All subjects who received the second dose of vaccine, were in the first age stratum: "6 months to 17 years". Please, refer to outcome n°26 for the overall (across age strata) post-dose 2 results.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-52
|
—
|
—
|
0.29 Percentage of subjects
Interval 0.01 to 1.63
|
0.29 Percentage of subjects
Interval 0.01 to 1.63
|
|
Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
|
Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-41
|
—
|
1.49 Percentage of subjects
Interval 0.01 to 10.39
|
—
|
1.49 Percentage of subjects
Interval 0.01 to 10.39
|
|
Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.93
|
1.23 Percentage of subjects
Interval 0.0 to 12.57
|
—
|
0.49 Percentage of subjects
Interval 0.0 to 7.05
|
|
Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.86
|
1.19 Percentage of subjects
Interval 0.0 to 12.76
|
—
|
0.47 Percentage of subjects
Interval 0.0 to 5.15
|
|
Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 2.84
|
1.14 Percentage of subjects
Interval 0.0 to 13.03
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.45 Percentage of subjects
Interval 0.0 to 4.17
|
|
Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 2.78
|
3.13 Percentage of subjects
Interval 0.01 to 22.01
|
0.00 Percentage of subjects
Interval 0.0 to 4.93
|
1.00 Percentage of subjects
Interval 0.01 to 6.32
|
|
Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 2.78
|
3.64 Percentage of subjects
Interval 0.02 to 24.24
|
0.00 Percentage of subjects
Interval 0.0 to 3.27
|
1.14 Percentage of subjects
Interval 0.01 to 7.51
|
|
Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
3.60 Percentage of subjects
Interval 0.02 to 23.59
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
1.12 Percentage of subjects
Interval 0.01 to 7.36
|
|
Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
3.60 Percentage of subjects
Interval 0.02 to 23.59
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
1.12 Percentage of subjects
Interval 0.01 to 7.36
|
|
Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
3.60 Percentage of subjects
Interval 0.02 to 23.59
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
1.12 Percentage of subjects
Interval 0.01 to 7.36
|
|
Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
3.60 Percentage of subjects
Interval 0.02 to 23.59
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
1.12 Percentage of subjects
Interval 0.01 to 7.36
|
|
Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
3.60 Percentage of subjects
Interval 0.02 to 23.59
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
1.12 Percentage of subjects
Interval 0.01 to 7.36
|
|
Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
3.60 Percentage of subjects
Interval 0.02 to 23.59
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
1.12 Percentage of subjects
Interval 0.01 to 7.36
|
|
Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 8.04
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 8.04
|
|
Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-41
|
—
|
1.06 Percentage of subjects
Interval 0.0 to 24.79
|
—
|
1.06 Percentage of subjects
Interval 0.0 to 24.79
|
|
Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
0.81 Percentage of subjects
Interval 0.0 to 13.06
|
—
|
0.71 Percentage of subjects
Interval 0.0 to 5.16
|
|
Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 7.87
|
0.75 Percentage of subjects
Interval 0.0 to 10.68
|
—
|
0.56 Percentage of subjects
Interval 0.0 to 4.11
|
|
Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-44
|
1.25 Percentage of subjects
Interval 0.0 to 27.29
|
0.69 Percentage of subjects
Interval 0.0 to 8.71
|
—
|
0.89 Percentage of subjects
Interval 0.07 to 3.63
|
|
Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-45
|
0.66 Percentage of subjects
Interval 0.0 to 18.74
|
0.65 Percentage of subjects
Interval 0.0 to 7.33
|
—
|
0.66 Percentage of subjects
Interval 0.04 to 3.0
|
|
Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-46
|
0.56 Percentage of subjects
Interval 0.0 to 17.67
|
0.60 Percentage of subjects
Interval 0.0 to 6.05
|
—
|
0.58 Percentage of subjects
Interval 0.03 to 2.79
|
|
Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-47
|
0.51 Percentage of subjects
Interval 0.0 to 16.86
|
0.60 Percentage of subjects
Interval 0.0 to 5.96
|
—
|
0.55 Percentage of subjects
Interval 0.02 to 2.78
|
|
Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-48
|
0.51 Percentage of subjects
Interval 0.0 to 16.86
|
0.60 Percentage of subjects
Interval 0.0 to 5.96
|
—
|
0.55 Percentage of subjects
Interval 0.02 to 2.78
|
|
Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-49
|
0.51 Percentage of subjects
Interval 0.0 to 16.86
|
0.60 Percentage of subjects
Interval 0.0 to 5.96
|
—
|
0.55 Percentage of subjects
Interval 0.02 to 2.78
|
|
Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-50
|
0.51 Percentage of subjects
Interval 0.0 to 16.86
|
0.60 Percentage of subjects
Interval 0.0 to 5.96
|
—
|
0.55 Percentage of subjects
Interval 0.02 to 2.78
|
|
Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-51
|
0.51 Percentage of subjects
Interval 0.0 to 16.86
|
0.60 Percentage of subjects
Interval 0.0 to 5.96
|
—
|
0.55 Percentage of subjects
Interval 0.02 to 2.78
|
|
Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-52
|
0.51 Percentage of subjects
Interval 0.0 to 16.86
|
0.60 Percentage of subjects
Interval 0.0 to 5.96
|
—
|
0.55 Percentage of subjects
Interval 0.02 to 2.78
|
|
Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-42
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
|
Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-43
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
|
Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-44
|
—
|
—
|
0.53 Percentage of subjects
Interval 0.01 to 2.9
|
0.53 Percentage of subjects
Interval 0.01 to 2.9
|
|
Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-45
|
—
|
—
|
0.36 Percentage of subjects
Interval 0.01 to 1.99
|
0.36 Percentage of subjects
Interval 0.01 to 1.99
|
|
Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-46
|
—
|
—
|
0.33 Percentage of subjects
Interval 0.01 to 1.81
|
0.33 Percentage of subjects
Interval 0.01 to 1.81
|
|
Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-47
|
—
|
—
|
0.31 Percentage of subjects
Interval 0.01 to 1.71
|
0.31 Percentage of subjects
Interval 0.01 to 1.71
|
|
Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-48
|
—
|
—
|
0.29 Percentage of subjects
Interval 0.01 to 1.63
|
0.29 Percentage of subjects
Interval 0.01 to 1.63
|
|
Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-49
|
—
|
—
|
0.29 Percentage of subjects
Interval 0.01 to 1.63
|
0.29 Percentage of subjects
Interval 0.01 to 1.63
|
|
Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-50
|
—
|
—
|
0.29 Percentage of subjects
Interval 0.01 to 1.63
|
0.29 Percentage of subjects
Interval 0.01 to 1.63
|
|
Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-51
|
—
|
—
|
0.29 Percentage of subjects
Interval 0.01 to 1.63
|
0.29 Percentage of subjects
Interval 0.01 to 1.63
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as "6 months to 17 years", "18 to 65 years" and "\>65 years". All subjects who received the second dose of vaccine, were in the first age stratum: "6 months to 17 years". Please, refer to outcome n°28 for the overall (across age strata) post-dose 2 results.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-42
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-43
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-44
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.92
|
0.00 Percentage of subjects
Interval 0.0 to 1.92
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-45
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-46
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.2
|
0.00 Percentage of subjects
Interval 0.0 to 1.2
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-47
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.14
|
0.00 Percentage of subjects
Interval 0.0 to 1.14
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.08
|
0.00 Percentage of subjects
Interval 0.0 to 1.08
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-49
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.08
|
0.00 Percentage of subjects
Interval 0.0 to 1.08
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-50
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.08
|
0.00 Percentage of subjects
Interval 0.0 to 1.08
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-51
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.08
|
0.00 Percentage of subjects
Interval 0.0 to 1.08
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-52
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.08
|
0.00 Percentage of subjects
Interval 0.0 to 1.08
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.93
|
0.00 Percentage of subjects
Interval 0.0 to 4.45
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.78
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.86
|
0.00 Percentage of subjects
Interval 0.0 to 4.3
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.73
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 2.84
|
0.00 Percentage of subjects
Interval 0.0 to 4.11
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 1.66
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 2.78
|
0.00 Percentage of subjects
Interval 0.0 to 3.77
|
0.00 Percentage of subjects
Interval 0.0 to 4.93
|
0.00 Percentage of subjects
Interval 0.0 to 1.22
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 2.78
|
0.00 Percentage of subjects
Interval 0.0 to 3.3
|
0.00 Percentage of subjects
Interval 0.0 to 3.27
|
0.00 Percentage of subjects
Interval 0.0 to 1.04
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
0.00 Percentage of subjects
Interval 0.0 to 3.27
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.00 Percentage of subjects
Interval 0.0 to 1.03
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
0.00 Percentage of subjects
Interval 0.0 to 3.27
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.00 Percentage of subjects
Interval 0.0 to 1.03
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
0.00 Percentage of subjects
Interval 0.0 to 3.27
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.00 Percentage of subjects
Interval 0.0 to 1.03
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
0.00 Percentage of subjects
Interval 0.0 to 3.27
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.00 Percentage of subjects
Interval 0.0 to 1.03
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
0.00 Percentage of subjects
Interval 0.0 to 3.27
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.00 Percentage of subjects
Interval 0.0 to 1.03
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
0.00 Percentage of subjects
Interval 0.0 to 3.27
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.00 Percentage of subjects
Interval 0.0 to 1.03
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-40
|
—
|
2.27 Percentage of subjects
Interval 0.06 to 12.02
|
—
|
2.27 Percentage of subjects
Interval 0.06 to 12.02
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-41
|
—
|
1.06 Percentage of subjects
Interval 0.0 to 10.65
|
—
|
1.06 Percentage of subjects
Interval 0.0 to 10.65
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
2.44 Percentage of subjects
Interval 0.09 to 11.91
|
—
|
2.14 Percentage of subjects
Interval 0.4 to 6.41
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 7.87
|
2.26 Percentage of subjects
Interval 0.17 to 9.17
|
—
|
1.69 Percentage of subjects
Interval 0.22 to 5.8
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-44
|
1.25 Percentage of subjects
Interval 0.0 to 27.29
|
2.08 Percentage of subjects
Interval 0.28 to 7.1
|
—
|
1.79 Percentage of subjects
Interval 0.48 to 4.54
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-45
|
0.66 Percentage of subjects
Interval 0.0 to 18.74
|
1.95 Percentage of subjects
Interval 0.37 to 5.8
|
—
|
1.31 Percentage of subjects
Interval 0.18 to 4.43
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-46
|
0.56 Percentage of subjects
Interval 0.0 to 17.67
|
1.81 Percentage of subjects
Interval 0.37 to 5.19
|
—
|
1.17 Percentage of subjects
Interval 0.13 to 4.22
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-47
|
0.51 Percentage of subjects
Interval 0.0 to 16.86
|
1.80 Percentage of subjects
Interval 0.37 to 5.16
|
—
|
1.10 Percentage of subjects
Interval 0.1 to 4.29
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-48
|
0.51 Percentage of subjects
Interval 0.0 to 16.86
|
1.80 Percentage of subjects
Interval 0.37 to 5.16
|
—
|
1.10 Percentage of subjects
Interval 0.1 to 4.29
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-49
|
0.51 Percentage of subjects
Interval 0.0 to 16.86
|
1.80 Percentage of subjects
Interval 0.37 to 5.16
|
—
|
1.10 Percentage of subjects
Interval 0.1 to 4.29
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-50
|
0.51 Percentage of subjects
Interval 0.0 to 16.86
|
1.80 Percentage of subjects
Interval 0.37 to 5.16
|
—
|
1.10 Percentage of subjects
Interval 0.1 to 4.29
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-51
|
0.51 Percentage of subjects
Interval 0.0 to 16.86
|
1.80 Percentage of subjects
Interval 0.37 to 5.16
|
—
|
1.10 Percentage of subjects
Interval 0.1 to 4.29
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-52
|
0.51 Percentage of subjects
Interval 0.0 to 16.86
|
1.80 Percentage of subjects
Interval 0.37 to 5.16
|
—
|
1.10 Percentage of subjects
Interval 0.1 to 4.29
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as "6 months to 17 years", "18 to 65 years" and "\>65 years". All subjects who received the second dose of vaccine, were in the first age stratum: "6 months to 17 years". Please, refer to outcome n°30 for the overall (across age strata) post-dose 2 results.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-42
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
|
Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-43
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
|
Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-44
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.92
|
0.00 Percentage of subjects
Interval 0.0 to 1.92
|
|
Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-45
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
|
Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-46
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.2
|
0.00 Percentage of subjects
Interval 0.0 to 1.2
|
|
Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-47
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.14
|
0.00 Percentage of subjects
Interval 0.0 to 1.14
|
|
Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.08
|
0.00 Percentage of subjects
Interval 0.0 to 1.08
|
|
Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-49
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.08
|
0.00 Percentage of subjects
Interval 0.0 to 1.08
|
|
Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-50
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.08
|
0.00 Percentage of subjects
Interval 0.0 to 1.08
|
|
Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-51
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.08
|
0.00 Percentage of subjects
Interval 0.0 to 1.08
|
|
Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-52
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.08
|
0.00 Percentage of subjects
Interval 0.0 to 1.08
|
|
Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
|
Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
|
Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.93
|
0.00 Percentage of subjects
Interval 0.0 to 4.45
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.78
|
|
Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.86
|
0.00 Percentage of subjects
Interval 0.0 to 4.3
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.73
|
|
Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 2.84
|
0.00 Percentage of subjects
Interval 0.0 to 4.11
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 1.66
|
|
Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 2.78
|
1.04 Percentage of subjects
Interval 0.0 to 20.63
|
0.00 Percentage of subjects
Interval 0.0 to 4.93
|
0.33 Percentage of subjects
Interval 0.0 to 3.33
|
|
Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 2.78
|
0.91 Percentage of subjects
Interval 0.0 to 14.64
|
0.00 Percentage of subjects
Interval 0.0 to 3.27
|
0.28 Percentage of subjects
Interval 0.0 to 2.72
|
|
Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
0.90 Percentage of subjects
Interval 0.0 to 14.3
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.28 Percentage of subjects
Interval 0.0 to 2.66
|
|
Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
0.90 Percentage of subjects
Interval 0.0 to 14.3
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.28 Percentage of subjects
Interval 0.0 to 2.66
|
|
Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
0.90 Percentage of subjects
Interval 0.0 to 14.3
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.28 Percentage of subjects
Interval 0.0 to 2.66
|
|
Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
0.90 Percentage of subjects
Interval 0.0 to 14.3
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.28 Percentage of subjects
Interval 0.0 to 2.66
|
|
Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
0.90 Percentage of subjects
Interval 0.0 to 14.3
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.28 Percentage of subjects
Interval 0.0 to 2.66
|
|
Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
0.90 Percentage of subjects
Interval 0.0 to 14.3
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.28 Percentage of subjects
Interval 0.0 to 2.66
|
|
Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 8.04
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 8.04
|
|
Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.85
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.85
|
|
Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
0.00 Percentage of subjects
Interval 0.0 to 2.95
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.6
|
|
Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 7.87
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.05
|
|
Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 2.53
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.63
|
|
Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 2.41
|
0.00 Percentage of subjects
Interval 0.0 to 2.37
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.2
|
|
Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 2.06
|
0.00 Percentage of subjects
Interval 0.0 to 2.2
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.07
|
|
Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 1.86
|
0.00 Percentage of subjects
Interval 0.0 to 2.18
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.01
|
|
Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 1.86
|
0.00 Percentage of subjects
Interval 0.0 to 2.18
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.01
|
|
Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 1.86
|
0.00 Percentage of subjects
Interval 0.0 to 2.18
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.01
|
|
Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 1.86
|
0.00 Percentage of subjects
Interval 0.0 to 2.18
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.01
|
|
Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 1.86
|
0.00 Percentage of subjects
Interval 0.0 to 2.18
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.01
|
|
Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 1.86
|
0.00 Percentage of subjects
Interval 0.0 to 2.18
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.01
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as "6 months to 17 years", "18 to 65 years" and "\>65 years". All subjects who received the second dose of vaccine, were in the first age stratum: "6 months to 17 years". Please, refer to outcome n°32 for the overall (across age strata) post-dose 2 results.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-42
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
|
Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-43
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
|
Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-44
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.92
|
0.00 Percentage of subjects
Interval 0.0 to 1.92
|
|
Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-45
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
|
Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-46
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.2
|
0.00 Percentage of subjects
Interval 0.0 to 1.2
|
|
Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-47
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.14
|
0.00 Percentage of subjects
Interval 0.0 to 1.14
|
|
Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.08
|
0.00 Percentage of subjects
Interval 0.0 to 1.08
|
|
Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-49
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.08
|
0.00 Percentage of subjects
Interval 0.0 to 1.08
|
|
Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-50
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.08
|
0.00 Percentage of subjects
Interval 0.0 to 1.08
|
|
Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-51
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.08
|
0.00 Percentage of subjects
Interval 0.0 to 1.08
|
|
Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-52
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.08
|
0.00 Percentage of subjects
Interval 0.0 to 1.08
|
|
Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
|
Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
|
Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.93
|
1.23 Percentage of subjects
Interval 0.0 to 31.16
|
—
|
0.49 Percentage of subjects
Interval 0.0 to 8.75
|
|
Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.86
|
2.38 Percentage of subjects
Interval 0.0 to 49.63
|
—
|
0.95 Percentage of subjects
Interval 0.0 to 12.11
|
|
Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 2.84
|
2.27 Percentage of subjects
Interval 0.0 to 45.15
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.90 Percentage of subjects
Interval 0.0 to 9.53
|
|
Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 2.78
|
2.08 Percentage of subjects
Interval 0.0 to 37.46
|
0.00 Percentage of subjects
Interval 0.0 to 4.93
|
0.67 Percentage of subjects
Interval 0.0 to 6.57
|
|
Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 2.78
|
1.82 Percentage of subjects
Interval 0.0 to 27.44
|
0.00 Percentage of subjects
Interval 0.0 to 3.27
|
0.57 Percentage of subjects
Interval 0.0 to 5.38
|
|
Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
1.80 Percentage of subjects
Interval 0.0 to 26.86
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.56 Percentage of subjects
Interval 0.0 to 5.28
|
|
Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
1.80 Percentage of subjects
Interval 0.0 to 26.86
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.56 Percentage of subjects
Interval 0.0 to 5.28
|
|
Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
1.80 Percentage of subjects
Interval 0.0 to 26.86
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.56 Percentage of subjects
Interval 0.0 to 5.28
|
|
Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
1.80 Percentage of subjects
Interval 0.0 to 26.86
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.56 Percentage of subjects
Interval 0.0 to 5.28
|
|
Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
1.80 Percentage of subjects
Interval 0.0 to 26.86
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.56 Percentage of subjects
Interval 0.0 to 5.28
|
|
Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
1.80 Percentage of subjects
Interval 0.0 to 26.86
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.56 Percentage of subjects
Interval 0.0 to 5.28
|
|
Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 8.04
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 8.04
|
|
Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.85
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.85
|
|
Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
0.81 Percentage of subjects
Interval 0.0 to 13.06
|
—
|
0.71 Percentage of subjects
Interval 0.0 to 5.16
|
|
Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 7.87
|
0.75 Percentage of subjects
Interval 0.0 to 10.68
|
—
|
0.56 Percentage of subjects
Interval 0.0 to 4.11
|
|
Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 4.51
|
0.69 Percentage of subjects
Interval 0.0 to 8.71
|
—
|
0.45 Percentage of subjects
Interval 0.01 to 2.85
|
|
Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-45
|
0.66 Percentage of subjects
Interval 0.02 to 3.63
|
0.65 Percentage of subjects
Interval 0.0 to 7.33
|
—
|
0.66 Percentage of subjects
Interval 0.08 to 2.35
|
|
Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-46
|
0.56 Percentage of subjects
Interval 0.01 to 3.11
|
0.60 Percentage of subjects
Interval 0.0 to 6.05
|
—
|
0.58 Percentage of subjects
Interval 0.07 to 2.09
|
|
Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-47
|
0.51 Percentage of subjects
Interval 0.01 to 2.81
|
0.60 Percentage of subjects
Interval 0.0 to 5.96
|
—
|
0.55 Percentage of subjects
Interval 0.07 to 1.98
|
|
Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-48
|
0.51 Percentage of subjects
Interval 0.01 to 2.81
|
0.60 Percentage of subjects
Interval 0.0 to 5.96
|
—
|
0.55 Percentage of subjects
Interval 0.07 to 1.98
|
|
Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-49
|
0.51 Percentage of subjects
Interval 0.01 to 2.81
|
0.60 Percentage of subjects
Interval 0.0 to 5.96
|
—
|
0.55 Percentage of subjects
Interval 0.07 to 1.98
|
|
Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-50
|
0.51 Percentage of subjects
Interval 0.01 to 2.81
|
0.60 Percentage of subjects
Interval 0.0 to 5.96
|
—
|
0.55 Percentage of subjects
Interval 0.07 to 1.98
|
|
Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-51
|
0.51 Percentage of subjects
Interval 0.01 to 2.81
|
0.60 Percentage of subjects
Interval 0.0 to 5.96
|
—
|
0.55 Percentage of subjects
Interval 0.07 to 1.98
|
|
Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-52
|
0.51 Percentage of subjects
Interval 0.01 to 2.81
|
0.60 Percentage of subjects
Interval 0.0 to 5.96
|
—
|
0.55 Percentage of subjects
Interval 0.07 to 1.98
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as "6 months to 17 years", "18 to 65 years" and "\>65 years". All subjects who received the second dose of vaccine, were in the first age stratum: "6 months to 17 years". Please, refer to outcome n°34 for the overall (across age strata) post-dose 2 results.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-42
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
|
Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-43
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
|
Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-44
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.92
|
0.00 Percentage of subjects
Interval 0.0 to 1.92
|
|
Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-45
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
|
Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-46
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.2
|
0.00 Percentage of subjects
Interval 0.0 to 1.2
|
|
Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-47
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.14
|
0.00 Percentage of subjects
Interval 0.0 to 1.14
|
|
Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.08
|
0.00 Percentage of subjects
Interval 0.0 to 1.08
|
|
Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-49
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.08
|
0.00 Percentage of subjects
Interval 0.0 to 1.08
|
|
Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-50
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.08
|
0.00 Percentage of subjects
Interval 0.0 to 1.08
|
|
Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-51
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.08
|
0.00 Percentage of subjects
Interval 0.0 to 1.08
|
|
Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
6 months to 17 years,Weeks 40-52
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.08
|
0.00 Percentage of subjects
Interval 0.0 to 1.08
|
|
Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
|
Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
|
Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-42
|
0.81 Percentage of subjects
Interval 0.02 to 4.41
|
0.00 Percentage of subjects
Interval 0.0 to 4.45
|
—
|
0.49 Percentage of subjects
Interval 0.01 to 2.69
|
|
Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-43
|
0.79 Percentage of subjects
Interval 0.02 to 4.31
|
0.00 Percentage of subjects
Interval 0.0 to 4.3
|
—
|
0.47 Percentage of subjects
Interval 0.01 to 2.61
|
|
Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-44
|
0.78 Percentage of subjects
Interval 0.02 to 4.28
|
0.00 Percentage of subjects
Interval 0.0 to 4.11
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.45 Percentage of subjects
Interval 0.01 to 2.5
|
|
Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-45
|
0.76 Percentage of subjects
Interval 0.02 to 4.18
|
0.00 Percentage of subjects
Interval 0.0 to 3.77
|
0.00 Percentage of subjects
Interval 0.0 to 4.93
|
0.33 Percentage of subjects
Interval 0.01 to 1.84
|
|
Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-46
|
0.76 Percentage of subjects
Interval 0.02 to 4.18
|
0.00 Percentage of subjects
Interval 0.0 to 3.3
|
0.00 Percentage of subjects
Interval 0.0 to 3.27
|
0.28 Percentage of subjects
Interval 0.0 to 1.72
|
|
Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-47
|
0.75 Percentage of subjects
Interval 0.02 to 4.12
|
0.00 Percentage of subjects
Interval 0.0 to 3.27
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.28 Percentage of subjects
Interval 0.0 to 1.71
|
|
Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-48
|
0.75 Percentage of subjects
Interval 0.02 to 4.12
|
0.00 Percentage of subjects
Interval 0.0 to 3.27
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.28 Percentage of subjects
Interval 0.0 to 1.71
|
|
Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-49
|
0.75 Percentage of subjects
Interval 0.02 to 4.12
|
0.00 Percentage of subjects
Interval 0.0 to 3.27
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.28 Percentage of subjects
Interval 0.0 to 1.71
|
|
Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-50
|
0.75 Percentage of subjects
Interval 0.02 to 4.12
|
0.00 Percentage of subjects
Interval 0.0 to 3.27
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.28 Percentage of subjects
Interval 0.0 to 1.71
|
|
Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-51
|
0.75 Percentage of subjects
Interval 0.02 to 4.12
|
0.00 Percentage of subjects
Interval 0.0 to 3.27
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.28 Percentage of subjects
Interval 0.0 to 1.71
|
|
Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
18-65 years,Weeks 40-52
|
0.75 Percentage of subjects
Interval 0.02 to 4.12
|
0.00 Percentage of subjects
Interval 0.0 to 3.27
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.28 Percentage of subjects
Interval 0.0 to 1.71
|
|
Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 8.04
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 8.04
|
|
Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.85
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.85
|
|
Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
0.00 Percentage of subjects
Interval 0.0 to 2.95
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.6
|
|
Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 7.87
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.05
|
|
Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 2.53
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.63
|
|
Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 2.41
|
0.00 Percentage of subjects
Interval 0.0 to 2.37
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.2
|
|
Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 2.06
|
0.00 Percentage of subjects
Interval 0.0 to 2.2
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.07
|
|
Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 1.86
|
0.00 Percentage of subjects
Interval 0.0 to 2.18
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.01
|
|
Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 1.86
|
0.00 Percentage of subjects
Interval 0.0 to 2.18
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.01
|
|
Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 1.86
|
0.00 Percentage of subjects
Interval 0.0 to 2.18
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.01
|
|
Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 1.86
|
0.00 Percentage of subjects
Interval 0.0 to 2.18
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.01
|
|
Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 1.86
|
0.00 Percentage of subjects
Interval 0.0 to 2.18
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.01
|
|
Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category
>65 years,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 1.86
|
0.00 Percentage of subjects
Interval 0.0 to 2.18
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.01
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 41
|
—
|
36.36 Percentage of subjects
Interval 0.0 to 100.0
|
—
|
36.36 Percentage of subjects
Interval 0.0 to 100.0
|
|
Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 42
|
56.25 Percentage of subjects
Interval 0.0 to 100.0
|
30.30 Percentage of subjects
Interval 0.0 to 99.55
|
56.25 Percentage of subjects
Interval 0.73 to 99.82
|
43.08 Percentage of subjects
Interval 23.7 to 64.14
|
|
Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 43
|
45.16 Percentage of subjects
Interval 27.32 to 63.97
|
40.00 Percentage of subjects
Interval 12.16 to 73.76
|
47.62 Percentage of subjects
Interval 6.49 to 91.59
|
45.16 Percentage of subjects
Interval 32.48 to 58.32
|
|
Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 44
|
55.56 Percentage of subjects
Interval 0.01 to 100.0
|
25.00 Percentage of subjects
Interval 5.49 to 57.19
|
34.78 Percentage of subjects
Interval 4.15 to 80.55
|
43.66 Percentage of subjects
Interval 21.31 to 68.08
|
|
Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 45
|
35.14 Percentage of subjects
Interval 0.51 to 94.16
|
58.33 Percentage of subjects
Interval 27.67 to 84.83
|
52.17 Percentage of subjects
Interval 17.17 to 85.61
|
45.51 Percentage of subjects
Interval 27.09 to 64.87
|
|
Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 46
|
26.92 Percentage of subjects
Interval 11.57 to 47.79
|
38.89 Percentage of subjects
Interval 17.3 to 64.25
|
39.58 Percentage of subjects
Interval 20.92 to 60.77
|
35.87 Percentage of subjects
Interval 23.69 to 49.55
|
|
Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 47
|
38.10 Percentage of subjects
Interval 18.11 to 61.56
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
70.00 Percentage of subjects
Interval 0.0 to 100.0
|
46.88 Percentage of subjects
Interval 18.94 to 76.35
|
|
Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 48
|
—
|
—
|
76.92 Percentage of subjects
Interval 23.37 to 99.35
|
76.92 Percentage of subjects
Interval 23.37 to 99.35
|
|
Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 40
|
—
|
34.33 Percentage of subjects
Interval 22.95 to 47.19
|
—
|
34.33 Percentage of subjects
Interval 22.95 to 47.19
|
|
Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 41
|
—
|
36.17 Percentage of subjects
Interval 0.29 to 96.34
|
—
|
36.17 Percentage of subjects
Interval 0.29 to 96.34
|
|
Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 42
|
44.00 Percentage of subjects
Interval 35.14 to 53.16
|
40.00 Percentage of subjects
Interval 0.0 to 100.0
|
38.89 Percentage of subjects
Interval 0.08 to 98.92
|
42.69 Percentage of subjects
Interval 35.17 to 50.47
|
|
Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 43
|
—
|
33.33 Percentage of subjects
Interval 0.84 to 90.57
|
47.37 Percentage of subjects
Interval 24.16 to 71.45
|
46.67 Percentage of subjects
Interval 33.67 to 60.0
|
|
Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 44
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
35.71 Percentage of subjects
Interval 0.83 to 92.88
|
33.33 Percentage of subjects
Interval 6.2 to 72.97
|
|
Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 45
|
—
|
83.33 Percentage of subjects
Interval 35.88 to 99.58
|
49.21 Percentage of subjects
Interval 32.01 to 66.54
|
52.17 Percentage of subjects
Interval 33.89 to 70.04
|
|
Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 46
|
—
|
50.00 Percentage of subjects
Interval 15.7 to 84.3
|
36.84 Percentage of subjects
Interval 15.96 to 62.13
|
40.74 Percentage of subjects
Interval 22.39 to 61.2
|
|
Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 47
|
—
|
100 Percentage of subjects
Interval 2.5 to 100.0
|
70.00 Percentage of subjects
Interval 0.76 to 100.0
|
72.73 Percentage of subjects
Interval 39.03 to 93.98
|
|
Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 48
|
—
|
—
|
100 Percentage of subjects
Interval 29.24 to 100.0
|
100 Percentage of subjects
Interval 29.24 to 100.0
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=139 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 47
|
66.67 Percentage of subjects
Interval 0.0 to 100.0
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 48
|
50.00 Percentage of subjects
Interval 11.81 to 88.19
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 49
|
15.38 Percentage of subjects
Interval 1.02 to 52.27
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 50
|
18.18 Percentage of subjects
Interval 0.46 to 67.75
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 51
|
25.00 Percentage of subjects
Interval 0.0 to 100.0
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 52
|
33.33 Percentage of subjects
Interval 0.84 to 90.57
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 46
|
50.00 Percentage of subjects
Interval 1.26 to 98.74
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 47
|
38.46 Percentage of subjects
Interval 0.0 to 100.0
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 48
|
42.11 Percentage of subjects
Interval 20.25 to 66.5
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 49
|
9.52 Percentage of subjects
Interval 0.0 to 65.04
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 50
|
6.45 Percentage of subjects
Interval 0.0 to 68.83
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 51
|
25.00 Percentage of subjects
Interval 0.63 to 80.59
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 52
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 41
|
—
|
2.27 Percentage of subjects
Interval 0.0 to 99.42
|
—
|
2.27 Percentage of subjects
Interval 0.0 to 99.42
|
|
Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 42
|
12.50 Percentage of subjects
Interval 0.0 to 99.41
|
15.15 Percentage of subjects
Interval 0.0 to 85.7
|
6.25 Percentage of subjects
Interval 0.16 to 30.23
|
12.31 Percentage of subjects
Interval 5.47 to 22.82
|
|
Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 43
|
9.68 Percentage of subjects
Interval 2.04 to 25.75
|
10.00 Percentage of subjects
Interval 0.25 to 44.5
|
4.76 Percentage of subjects
Interval 0.0 to 100.0
|
8.06 Percentage of subjects
Interval 1.24 to 24.4
|
|
Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 44
|
13.89 Percentage of subjects
Interval 0.0 to 87.39
|
8.33 Percentage of subjects
Interval 0.21 to 38.48
|
13.04 Percentage of subjects
Interval 0.0 to 91.75
|
12.68 Percentage of subjects
Interval 5.96 to 22.7
|
|
Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 45
|
9.46 Percentage of subjects
Interval 3.89 to 18.52
|
8.33 Percentage of subjects
Interval 0.21 to 38.48
|
3.26 Percentage of subjects
Interval 0.02 to 21.52
|
6.18 Percentage of subjects
Interval 1.73 to 14.97
|
|
Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 46
|
7.69 Percentage of subjects
Interval 0.95 to 25.13
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
10.42 Percentage of subjects
Interval 2.04 to 28.3
|
7.61 Percentage of subjects
Interval 2.29 to 17.67
|
|
Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 47
|
9.52 Percentage of subjects
Interval 1.17 to 30.38
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
10.00 Percentage of subjects
Interval 0.0 to 99.13
|
9.38 Percentage of subjects
Interval 1.98 to 25.02
|
|
Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 48
|
—
|
—
|
15.38 Percentage of subjects
Interval 0.58 to 57.61
|
15.38 Percentage of subjects
Interval 0.58 to 57.61
|
|
Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 40
|
—
|
2.99 Percentage of subjects
Interval 0.36 to 10.37
|
—
|
2.99 Percentage of subjects
Interval 0.36 to 10.37
|
|
Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 41
|
—
|
2.13 Percentage of subjects
Interval 0.01 to 16.09
|
—
|
2.13 Percentage of subjects
Interval 0.01 to 16.09
|
|
Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 42
|
0.80 Percentage of subjects
Interval 0.02 to 4.38
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
8.33 Percentage of subjects
Interval 0.13 to 41.57
|
2.34 Percentage of subjects
Interval 0.02 to 15.22
|
|
Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 43
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
10.53 Percentage of subjects
Interval 3.96 to 21.52
|
10.00 Percentage of subjects
Interval 3.76 to 20.51
|
|
Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 44
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
0.00 Percentage of subjects
Interval 0.0 to 7.87
|
|
Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 45
|
—
|
16.67 Percentage of subjects
Interval 0.42 to 64.12
|
4.76 Percentage of subjects
Interval 0.38 to 18.32
|
5.80 Percentage of subjects
Interval 1.37 to 15.21
|
|
Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 46
|
—
|
12.50 Percentage of subjects
Interval 0.32 to 52.65
|
10.53 Percentage of subjects
Interval 0.0 to 68.41
|
11.11 Percentage of subjects
Interval 1.36 to 34.82
|
|
Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 47
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
10.00 Percentage of subjects
Interval 0.0 to 88.98
|
9.09 Percentage of subjects
Interval 0.23 to 41.28
|
|
Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were diarrhoea, nausea, and vomiting. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=139 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 47
|
16.67 Percentage of subjects
Interval 0.0 to 100.0
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 49
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 50
|
9.09 Percentage of subjects
Interval 0.0 to 92.61
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 51
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 52
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 46
|
50.00 Percentage of subjects
Interval 1.26 to 98.74
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 47
|
7.69 Percentage of subjects
Interval 0.0 to 90.25
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 49
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 50
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 51
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 52
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 47
|
28.57 Percentage of subjects
Interval 11.28 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
50.00 Percentage of subjects
Interval 0.01 to 99.99
|
34.38 Percentage of subjects
Interval 13.93 to 60.22
|
|
Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 47
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
50.00 Percentage of subjects
Interval 18.71 to 81.29
|
45.45 Percentage of subjects
Interval 16.75 to 76.62
|
|
Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 41
|
—
|
27.27 Percentage of subjects
Interval 0.0 to 100.0
|
—
|
27.27 Percentage of subjects
Interval 0.0 to 100.0
|
|
Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 42
|
37.50 Percentage of subjects
Interval 0.0 to 100.0
|
24.24 Percentage of subjects
Interval 0.0 to 97.62
|
43.75 Percentage of subjects
Interval 1.42 to 96.32
|
32.31 Percentage of subjects
Interval 18.33 to 49.06
|
|
Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 43
|
19.35 Percentage of subjects
Interval 7.45 to 37.47
|
20.00 Percentage of subjects
Interval 2.52 to 55.61
|
23.81 Percentage of subjects
Interval 2.15 to 67.11
|
20.97 Percentage of subjects
Interval 11.66 to 33.18
|
|
Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 44
|
41.67 Percentage of subjects
Interval 0.0 to 100.0
|
25.00 Percentage of subjects
Interval 5.49 to 57.19
|
17.39 Percentage of subjects
Interval 0.43 to 66.04
|
30.99 Percentage of subjects
Interval 10.3 to 59.46
|
|
Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 45
|
17.57 Percentage of subjects
Interval 0.0 to 96.81
|
50.00 Percentage of subjects
Interval 21.09 to 78.91
|
35.87 Percentage of subjects
Interval 2.46 to 86.88
|
29.21 Percentage of subjects
Interval 9.25 to 57.67
|
|
Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 46
|
15.38 Percentage of subjects
Interval 4.36 to 34.87
|
27.78 Percentage of subjects
Interval 9.69 to 53.48
|
29.17 Percentage of subjects
Interval 3.75 to 71.88
|
25.00 Percentage of subjects
Interval 10.41 to 45.43
|
|
Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 48
|
—
|
—
|
61.54 Percentage of subjects
Interval 3.6 to 99.52
|
61.54 Percentage of subjects
Interval 3.6 to 99.52
|
|
Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 40
|
—
|
26.87 Percentage of subjects
Interval 11.49 to 47.81
|
—
|
26.87 Percentage of subjects
Interval 11.49 to 47.81
|
|
Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 41
|
—
|
31.91 Percentage of subjects
Interval 0.49 to 91.5
|
—
|
31.91 Percentage of subjects
Interval 0.49 to 91.5
|
|
Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 42
|
30.40 Percentage of subjects
Interval 22.49 to 39.26
|
30.00 Percentage of subjects
Interval 0.0 to 100.0
|
19.44 Percentage of subjects
Interval 0.18 to 77.39
|
28.07 Percentage of subjects
Interval 20.48 to 36.71
|
|
Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 43
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
28.07 Percentage of subjects
Interval 16.56 to 42.15
|
26.67 Percentage of subjects
Interval 15.72 to 40.2
|
|
Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 44
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
19.05 Percentage of subjects
Interval 1.16 to 61.85
|
17.78 Percentage of subjects
Interval 4.5 to 41.33
|
|
Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 45
|
—
|
50.00 Percentage of subjects
Interval 11.81 to 88.19
|
28.57 Percentage of subjects
Interval 17.89 to 41.35
|
30.43 Percentage of subjects
Interval 19.92 to 42.69
|
|
Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 46
|
—
|
25.00 Percentage of subjects
Interval 3.19 to 65.09
|
26.32 Percentage of subjects
Interval 0.24 to 88.0
|
25.93 Percentage of subjects
Interval 5.65 to 58.91
|
|
Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 48
|
—
|
—
|
66.67 Percentage of subjects
Interval 9.43 to 99.16
|
66.67 Percentage of subjects
Interval 9.43 to 99.16
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=139 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 47
|
33.33 Percentage of subjects
Interval 4.33 to 77.72
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 49
|
7.69 Percentage of subjects
Interval 0.07 to 41.92
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 50
|
9.09 Percentage of subjects
Interval 0.23 to 41.28
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 51
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 52
|
33.33 Percentage of subjects
Interval 0.84 to 90.57
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 47
|
38.46 Percentage of subjects
Interval 0.0 to 100.0
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 48
|
5.26 Percentage of subjects
Interval 0.13 to 26.03
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 49
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 50
|
3.23 Percentage of subjects
Interval 0.0 to 42.56
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 51
|
25.00 Percentage of subjects
Interval 0.63 to 80.59
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 52
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 8.04
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 8.04
|
|
Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 10.58
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
|
Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
|
Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
0.00 Percentage of subjects
Interval 0.0 to 14.82
|
0.00 Percentage of subjects
Interval 0.0 to 5.06
|
|
Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 45
|
1.35 Percentage of subjects
Interval 0.0 to 21.52
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
0.00 Percentage of subjects
Interval 0.0 to 3.93
|
0.56 Percentage of subjects
Interval 0.01 to 3.45
|
|
Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.00 Percentage of subjects
Interval 0.0 to 7.4
|
0.00 Percentage of subjects
Interval 0.0 to 3.93
|
|
Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 10.89
|
|
Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
|
Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
|
Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
|
Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 2.13
|
|
Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 43
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 6.27
|
0.00 Percentage of subjects
Interval 0.0 to 5.96
|
|
Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 44
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
0.00 Percentage of subjects
Interval 0.0 to 7.87
|
|
Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 45
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
0.00 Percentage of subjects
Interval 0.0 to 5.21
|
|
Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 46
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
0.00 Percentage of subjects
Interval 0.0 to 12.77
|
|
Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 47
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
|
Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was to be performed on the enrolled subjects vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine, and who returned the ADR card, i.e.: only Fluarix Tetra Group subjects who received the second dose. As no AEs were reported for the MedDRA Class considered, the "by risk status" analysis could not be performed.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 41
|
—
|
9.09 Percentage of subjects
Interval 0.0 to 99.98
|
—
|
9.09 Percentage of subjects
Interval 0.0 to 99.98
|
|
Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
6.06 Percentage of subjects
Interval 0.0 to 48.84
|
6.25 Percentage of subjects
Interval 0.16 to 30.23
|
4.62 Percentage of subjects
Interval 0.96 to 12.9
|
|
Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 43
|
6.45 Percentage of subjects
Interval 0.79 to 21.42
|
10.00 Percentage of subjects
Interval 0.25 to 44.5
|
4.76 Percentage of subjects
Interval 0.0 to 47.5
|
6.45 Percentage of subjects
Interval 1.79 to 15.7
|
|
Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 44
|
8.33 Percentage of subjects
Interval 1.75 to 22.47
|
8.33 Percentage of subjects
Interval 0.21 to 38.48
|
4.35 Percentage of subjects
Interval 0.0 to 56.7
|
7.04 Percentage of subjects
Interval 2.33 to 15.67
|
|
Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 45
|
9.46 Percentage of subjects
Interval 0.0 to 69.82
|
8.33 Percentage of subjects
Interval 0.21 to 38.48
|
6.52 Percentage of subjects
Interval 1.82 to 15.81
|
7.87 Percentage of subjects
Interval 4.37 to 12.84
|
|
Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 46
|
3.85 Percentage of subjects
Interval 0.1 to 19.64
|
11.11 Percentage of subjects
Interval 1.38 to 34.71
|
10.42 Percentage of subjects
Interval 0.85 to 36.63
|
8.70 Percentage of subjects
Interval 2.61 to 20.07
|
|
Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 47
|
4.76 Percentage of subjects
Interval 0.12 to 23.82
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
10.00 Percentage of subjects
Interval 0.0 to 99.13
|
6.25 Percentage of subjects
Interval 0.77 to 20.81
|
|
Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 48
|
—
|
—
|
15.38 Percentage of subjects
Interval 0.0 to 100.0
|
15.38 Percentage of subjects
Interval 0.0 to 100.0
|
|
Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 40
|
—
|
8.96 Percentage of subjects
Interval 3.36 to 18.48
|
—
|
8.96 Percentage of subjects
Interval 3.36 to 18.48
|
|
Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 41
|
—
|
8.51 Percentage of subjects
Interval 0.02 to 53.58
|
—
|
8.51 Percentage of subjects
Interval 0.02 to 53.58
|
|
Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 42
|
0.80 Percentage of subjects
Interval 0.02 to 4.38
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.58 Percentage of subjects
Interval 0.01 to 3.22
|
|
Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 43
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
5.26 Percentage of subjects
Interval 1.1 to 14.62
|
5.00 Percentage of subjects
Interval 1.04 to 13.92
|
|
Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 44
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
7.14 Percentage of subjects
Interval 0.0 to 61.63
|
6.67 Percentage of subjects
Interval 0.07 to 36.62
|
|
Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 45
|
—
|
16.67 Percentage of subjects
Interval 0.42 to 64.12
|
4.76 Percentage of subjects
Interval 0.0 to 55.81
|
5.80 Percentage of subjects
Interval 0.04 to 34.97
|
|
Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 46
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
5.26 Percentage of subjects
Interval 0.0 to 73.64
|
3.70 Percentage of subjects
Interval 0.0 to 40.23
|
|
Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 47
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
20.00 Percentage of subjects
Interval 0.0 to 99.56
|
18.18 Percentage of subjects
Interval 1.13 to 59.63
|
|
Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=139 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 48
|
50.00 Percentage of subjects
Interval 11.81 to 88.19
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 49
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 50
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 51
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 52
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 49
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 50
|
3.23 Percentage of subjects
Interval 0.0 to 42.56
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 51
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 52
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 8.04
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 8.04
|
|
Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 42
|
6.25 Percentage of subjects
Interval 0.0 to 100.0
|
0.00 Percentage of subjects
Interval 0.0 to 10.58
|
6.25 Percentage of subjects
Interval 0.16 to 30.23
|
3.08 Percentage of subjects
Interval 0.07 to 16.12
|
|
Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
4.76 Percentage of subjects
Interval 0.0 to 47.5
|
1.61 Percentage of subjects
Interval 0.0 to 17.38
|
|
Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 44
|
2.78 Percentage of subjects
Interval 0.0 to 84.65
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
17.39 Percentage of subjects
Interval 0.43 to 66.04
|
7.04 Percentage of subjects
Interval 0.78 to 23.94
|
|
Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 45
|
4.05 Percentage of subjects
Interval 0.0 to 53.08
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
4.35 Percentage of subjects
Interval 0.0 to 62.93
|
3.93 Percentage of subjects
Interval 0.46 to 13.64
|
|
Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 46
|
3.85 Percentage of subjects
Interval 0.1 to 19.64
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.00 Percentage of subjects
Interval 0.0 to 7.4
|
1.09 Percentage of subjects
Interval 0.0 to 8.84
|
|
Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 47
|
4.76 Percentage of subjects
Interval 0.12 to 23.82
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
3.13 Percentage of subjects
Interval 0.08 to 16.22
|
|
Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 48
|
—
|
—
|
15.38 Percentage of subjects
Interval 0.58 to 57.61
|
15.38 Percentage of subjects
Interval 0.58 to 57.61
|
|
Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
|
Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 41
|
—
|
2.13 Percentage of subjects
Interval 0.01 to 16.09
|
—
|
2.13 Percentage of subjects
Interval 0.01 to 16.09
|
|
Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
2.78 Percentage of subjects
Interval 0.05 to 15.34
|
0.58 Percentage of subjects
Interval 0.0 to 7.25
|
|
Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 43
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
14.04 Percentage of subjects
Interval 6.26 to 25.79
|
13.33 Percentage of subjects
Interval 5.94 to 24.59
|
|
Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 44
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
2.38 Percentage of subjects
Interval 0.06 to 12.57
|
2.22 Percentage of subjects
Interval 0.06 to 11.77
|
|
Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 45
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
3.17 Percentage of subjects
Interval 0.04 to 18.51
|
2.90 Percentage of subjects
Interval 0.26 to 11.06
|
|
Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 46
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
0.00 Percentage of subjects
Interval 0.0 to 12.77
|
|
Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 47
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
|
Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=139 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 49
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 50
|
9.09 Percentage of subjects
Interval 0.23 to 41.28
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 51
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 52
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 47
|
7.69 Percentage of subjects
Interval 0.0 to 90.25
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 48
|
5.26 Percentage of subjects
Interval 0.13 to 26.03
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 49
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 50
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 51
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 52
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 41
|
—
|
2.27 Percentage of subjects
Interval 0.0 to 99.42
|
—
|
2.27 Percentage of subjects
Interval 0.0 to 99.42
|
|
Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 42
|
6.25 Percentage of subjects
Interval 0.0 to 100.0
|
3.03 Percentage of subjects
Interval 0.0 to 27.44
|
12.50 Percentage of subjects
Interval 1.15 to 41.43
|
6.15 Percentage of subjects
Interval 1.09 to 18.08
|
|
Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
20.00 Percentage of subjects
Interval 2.52 to 55.61
|
4.76 Percentage of subjects
Interval 0.0 to 47.5
|
4.84 Percentage of subjects
Interval 0.01 to 34.5
|
|
Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 44
|
19.44 Percentage of subjects
Interval 0.05 to 83.92
|
8.33 Percentage of subjects
Interval 0.21 to 38.48
|
4.35 Percentage of subjects
Interval 0.0 to 100.0
|
12.68 Percentage of subjects
Interval 2.83 to 32.16
|
|
Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 45
|
10.81 Percentage of subjects
Interval 0.08 to 55.52
|
16.67 Percentage of subjects
Interval 2.09 to 48.41
|
8.70 Percentage of subjects
Interval 0.09 to 45.17
|
10.11 Percentage of subjects
Interval 5.74 to 16.19
|
|
Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 46
|
11.54 Percentage of subjects
Interval 2.45 to 30.15
|
11.11 Percentage of subjects
Interval 1.38 to 34.71
|
8.33 Percentage of subjects
Interval 0.71 to 29.93
|
9.78 Percentage of subjects
Interval 4.57 to 17.76
|
|
Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 47
|
4.76 Percentage of subjects
Interval 0.12 to 23.82
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
3.13 Percentage of subjects
Interval 0.08 to 16.22
|
|
Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 48
|
—
|
—
|
46.15 Percentage of subjects
Interval 0.32 to 99.28
|
46.15 Percentage of subjects
Interval 0.32 to 99.28
|
|
Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 40
|
—
|
5.97 Percentage of subjects
Interval 1.65 to 14.59
|
—
|
5.97 Percentage of subjects
Interval 1.65 to 14.59
|
|
Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 41
|
—
|
12.77 Percentage of subjects
Interval 0.02 to 70.77
|
—
|
12.77 Percentage of subjects
Interval 0.02 to 70.77
|
|
Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 42
|
12.00 Percentage of subjects
Interval 6.87 to 19.02
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
5.56 Percentage of subjects
Interval 0.1 to 29.18
|
9.94 Percentage of subjects
Interval 5.24 to 16.73
|
|
Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 43
|
—
|
33.33 Percentage of subjects
Interval 0.84 to 90.57
|
8.77 Percentage of subjects
Interval 2.91 to 19.3
|
10.00 Percentage of subjects
Interval 3.56 to 21.08
|
|
Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 44
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
2.38 Percentage of subjects
Interval 0.0 to 63.98
|
2.22 Percentage of subjects
Interval 0.0 to 37.2
|
|
Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 45
|
—
|
16.67 Percentage of subjects
Interval 0.42 to 64.12
|
7.94 Percentage of subjects
Interval 1.25 to 23.87
|
8.70 Percentage of subjects
Interval 3.21 to 18.1
|
|
Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 46
|
—
|
25.00 Percentage of subjects
Interval 3.19 to 65.09
|
10.53 Percentage of subjects
Interval 0.25 to 46.86
|
14.81 Percentage of subjects
Interval 2.87 to 38.77
|
|
Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 47
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
10.00 Percentage of subjects
Interval 0.0 to 88.98
|
9.09 Percentage of subjects
Interval 0.23 to 41.28
|
|
Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=139 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 49
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 50
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 51
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 52
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 47
|
7.69 Percentage of subjects
Interval 0.0 to 90.25
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 49
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 50
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 51
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 52
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 41
|
—
|
9.09 Percentage of subjects
Interval 0.0 to 99.98
|
—
|
9.09 Percentage of subjects
Interval 0.0 to 99.98
|
|
Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 42
|
25.00 Percentage of subjects
Interval 0.0 to 100.0
|
6.06 Percentage of subjects
Interval 0.0 to 48.84
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
9.23 Percentage of subjects
Interval 1.8 to 25.43
|
|
Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 43
|
9.68 Percentage of subjects
Interval 2.04 to 25.75
|
10.00 Percentage of subjects
Interval 0.25 to 44.5
|
9.52 Percentage of subjects
Interval 0.0 to 75.08
|
9.68 Percentage of subjects
Interval 3.63 to 19.88
|
|
Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 44
|
16.67 Percentage of subjects
Interval 0.0 to 98.03
|
8.33 Percentage of subjects
Interval 0.21 to 38.48
|
4.35 Percentage of subjects
Interval 0.0 to 56.7
|
11.27 Percentage of subjects
Interval 2.71 to 28.13
|
|
Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 45
|
13.51 Percentage of subjects
Interval 0.84 to 47.92
|
8.33 Percentage of subjects
Interval 0.21 to 38.48
|
7.61 Percentage of subjects
Interval 0.09 to 40.43
|
10.11 Percentage of subjects
Interval 5.06 to 17.59
|
|
Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
11.11 Percentage of subjects
Interval 1.38 to 34.71
|
8.33 Percentage of subjects
Interval 0.71 to 29.93
|
6.52 Percentage of subjects
Interval 0.91 to 20.73
|
|
Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 10.89
|
|
Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 48
|
—
|
—
|
38.46 Percentage of subjects
Interval 0.48 to 96.4
|
38.46 Percentage of subjects
Interval 0.48 to 96.4
|
|
Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 40
|
—
|
5.97 Percentage of subjects
Interval 1.65 to 14.59
|
—
|
5.97 Percentage of subjects
Interval 1.65 to 14.59
|
|
Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 41
|
—
|
6.38 Percentage of subjects
Interval 0.01 to 42.76
|
—
|
6.38 Percentage of subjects
Interval 0.01 to 42.76
|
|
Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 42
|
3.20 Percentage of subjects
Interval 0.88 to 7.99
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
2.78 Percentage of subjects
Interval 0.05 to 15.34
|
2.92 Percentage of subjects
Interval 0.96 to 6.69
|
|
Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 43
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
7.02 Percentage of subjects
Interval 1.95 to 17.0
|
6.67 Percentage of subjects
Interval 1.85 to 16.2
|
|
Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 44
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
0.00 Percentage of subjects
Interval 0.0 to 7.87
|
|
Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 45
|
—
|
16.67 Percentage of subjects
Interval 0.42 to 64.12
|
12.70 Percentage of subjects
Interval 2.19 to 35.21
|
13.04 Percentage of subjects
Interval 5.2 to 25.57
|
|
Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 46
|
—
|
25.00 Percentage of subjects
Interval 3.19 to 65.09
|
10.53 Percentage of subjects
Interval 0.25 to 46.86
|
14.81 Percentage of subjects
Interval 2.87 to 38.77
|
|
Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 47
|
—
|
100 Percentage of subjects
Interval 2.5 to 100.0
|
10.00 Percentage of subjects
Interval 0.0 to 88.98
|
18.18 Percentage of subjects
Interval 0.07 to 79.3
|
|
Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 48
|
—
|
—
|
33.33 Percentage of subjects
Interval 0.84 to 90.57
|
33.33 Percentage of subjects
Interval 0.84 to 90.57
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was to be performed on the enrolled subjects vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine, and who returned the ADR card, i.e.: only Fluarix Tetra Group subjects who received the second dose. As no AEs were reported for the MedDRA Class considered, the "by risk status" analysis could not be performed.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 45
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
1.59 Percentage of subjects
Interval 0.0 to 12.8
|
1.45 Percentage of subjects
Interval 0.04 to 7.82
|
|
Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 8.04
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 8.04
|
|
Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
12.12 Percentage of subjects
Interval 0.0 to 77.14
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
6.15 Percentage of subjects
Interval 0.26 to 26.98
|
|
Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
10.00 Percentage of subjects
Interval 0.25 to 44.5
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
1.61 Percentage of subjects
Interval 0.0 to 21.62
|
|
Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 44
|
2.78 Percentage of subjects
Interval 0.0 to 84.65
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
4.35 Percentage of subjects
Interval 0.0 to 56.7
|
2.82 Percentage of subjects
Interval 0.34 to 9.81
|
|
Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 45
|
1.35 Percentage of subjects
Interval 0.0 to 21.52
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
0.00 Percentage of subjects
Interval 0.0 to 3.93
|
0.56 Percentage of subjects
Interval 0.01 to 3.45
|
|
Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 46
|
3.85 Percentage of subjects
Interval 0.1 to 19.64
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
2.08 Percentage of subjects
Interval 0.0 to 51.95
|
2.17 Percentage of subjects
Interval 0.05 to 11.78
|
|
Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
10.00 Percentage of subjects
Interval 0.0 to 99.13
|
3.13 Percentage of subjects
Interval 0.0 to 37.12
|
|
Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
|
Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
|
Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
|
Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
2.78 Percentage of subjects
Interval 0.05 to 15.34
|
0.58 Percentage of subjects
Interval 0.0 to 7.25
|
|
Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 43
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
7.02 Percentage of subjects
Interval 1.95 to 17.0
|
6.67 Percentage of subjects
Interval 1.85 to 16.2
|
|
Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 44
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
2.38 Percentage of subjects
Interval 0.0 to 63.98
|
2.22 Percentage of subjects
Interval 0.0 to 37.2
|
|
Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 46
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
5.26 Percentage of subjects
Interval 0.0 to 73.64
|
3.70 Percentage of subjects
Interval 0.0 to 40.23
|
|
Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 47
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
|
Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=139 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 49
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 50
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 51
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 52
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 48
|
10.53 Percentage of subjects
Interval 1.3 to 33.14
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 49
|
9.52 Percentage of subjects
Interval 0.0 to 65.04
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 50
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 51
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 52
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 48
|
—
|
—
|
23.08 Percentage of subjects
Interval 0.65 to 76.63
|
23.08 Percentage of subjects
Interval 0.65 to 76.63
|
|
Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 43
|
19.35 Percentage of subjects
Interval 7.45 to 37.47
|
30.00 Percentage of subjects
Interval 6.67 to 65.25
|
28.57 Percentage of subjects
Interval 0.0 to 99.8
|
24.19 Percentage of subjects
Interval 11.6 to 41.2
|
|
Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 44
|
25.00 Percentage of subjects
Interval 12.12 to 42.2
|
8.33 Percentage of subjects
Interval 0.21 to 38.48
|
21.74 Percentage of subjects
Interval 0.0 to 99.72
|
21.13 Percentage of subjects
Interval 12.2 to 32.66
|
|
Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 40
|
—
|
8.96 Percentage of subjects
Interval 3.36 to 18.48
|
—
|
8.96 Percentage of subjects
Interval 3.36 to 18.48
|
|
Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 41
|
—
|
17.02 Percentage of subjects
Interval 0.45 to 64.71
|
—
|
17.02 Percentage of subjects
Interval 0.45 to 64.71
|
|
Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 42
|
9.60 Percentage of subjects
Interval 5.06 to 16.17
|
10.00 Percentage of subjects
Interval 0.0 to 100.0
|
25.00 Percentage of subjects
Interval 0.16 to 87.94
|
12.87 Percentage of subjects
Interval 3.84 to 29.01
|
|
Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 43
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
24.56 Percentage of subjects
Interval 2.2 to 68.56
|
23.33 Percentage of subjects
Interval 13.38 to 36.04
|
|
Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 44
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
16.67 Percentage of subjects
Interval 0.35 to 65.58
|
15.56 Percentage of subjects
Interval 2.47 to 42.95
|
|
Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 45
|
20.27 Percentage of subjects
Interval 7.81 to 39.06
|
25.00 Percentage of subjects
Interval 5.49 to 57.19
|
20.65 Percentage of subjects
Interval 4.48 to 49.35
|
20.79 Percentage of subjects
Interval 15.05 to 27.54
|
|
Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 45
|
—
|
16.67 Percentage of subjects
Interval 0.42 to 64.12
|
22.22 Percentage of subjects
Interval 1.15 to 69.94
|
21.74 Percentage of subjects
Interval 4.99 to 50.53
|
|
Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 41
|
—
|
9.09 Percentage of subjects
Interval 0.0 to 99.98
|
—
|
9.09 Percentage of subjects
Interval 0.0 to 99.98
|
|
Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 42
|
12.50 Percentage of subjects
Interval 0.0 to 99.41
|
9.09 Percentage of subjects
Interval 0.0 to 65.12
|
31.25 Percentage of subjects
Interval 1.75 to 83.28
|
15.38 Percentage of subjects
Interval 4.58 to 34.16
|
|
Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 46
|
7.69 Percentage of subjects
Interval 0.95 to 25.13
|
11.11 Percentage of subjects
Interval 1.38 to 34.71
|
20.83 Percentage of subjects
Interval 10.47 to 34.99
|
15.22 Percentage of subjects
Interval 6.17 to 29.29
|
|
Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 47
|
9.52 Percentage of subjects
Interval 1.17 to 30.38
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
30.00 Percentage of subjects
Interval 0.0 to 100.0
|
15.63 Percentage of subjects
Interval 1.42 to 49.58
|
|
Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 46
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
21.05 Percentage of subjects
Interval 6.05 to 45.57
|
14.81 Percentage of subjects
Interval 2.31 to 41.47
|
|
Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 47
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
30.00 Percentage of subjects
Interval 0.0 to 100.0
|
27.27 Percentage of subjects
Interval 1.29 to 79.3
|
|
Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 48
|
—
|
—
|
66.67 Percentage of subjects
Interval 9.43 to 99.16
|
66.67 Percentage of subjects
Interval 9.43 to 99.16
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=139 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 50
|
3.23 Percentage of subjects
Interval 0.0 to 42.56
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 51
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 52
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 47
|
33.33 Percentage of subjects
Interval 0.0 to 100.0
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 48
|
33.33 Percentage of subjects
Interval 4.33 to 77.72
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 49
|
15.38 Percentage of subjects
Interval 1.02 to 52.27
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 50
|
9.09 Percentage of subjects
Interval 0.23 to 41.28
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 51
|
25.00 Percentage of subjects
Interval 0.0 to 100.0
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 52
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 47
|
7.69 Percentage of subjects
Interval 0.0 to 90.25
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 48
|
36.84 Percentage of subjects
Interval 16.29 to 61.64
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 49
|
4.76 Percentage of subjects
Interval 0.0 to 86.58
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.00 Percentage of subjects
Interval 0.0 to 7.4
|
0.00 Percentage of subjects
Interval 0.0 to 3.93
|
|
Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 10.89
|
|
Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
|
Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 45
|
6.76 Percentage of subjects
Interval 1.9 to 16.31
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
2.17 Percentage of subjects
Interval 0.0 to 57.57
|
3.93 Percentage of subjects
Interval 0.4 to 14.32
|
|
Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 46
|
—
|
12.50 Percentage of subjects
Interval 0.32 to 52.65
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
3.70 Percentage of subjects
Interval 0.0 to 31.71
|
|
Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 47
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
|
Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 40
|
—
|
2.99 Percentage of subjects
Interval 0.36 to 10.37
|
—
|
2.99 Percentage of subjects
Interval 0.36 to 10.37
|
|
Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
|
Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 2.13
|
|
Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 43
|
—
|
33.33 Percentage of subjects
Interval 0.84 to 90.57
|
0.00 Percentage of subjects
Interval 0.0 to 6.27
|
1.67 Percentage of subjects
Interval 0.0 to 54.99
|
|
Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 44
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
2.38 Percentage of subjects
Interval 0.0 to 63.98
|
2.22 Percentage of subjects
Interval 0.0 to 37.2
|
|
Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 45
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
0.00 Percentage of subjects
Interval 0.0 to 5.21
|
|
Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 41
|
—
|
2.27 Percentage of subjects
Interval 0.0 to 99.42
|
—
|
2.27 Percentage of subjects
Interval 0.0 to 99.42
|
|
Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
3.03 Percentage of subjects
Interval 0.0 to 27.44
|
12.50 Percentage of subjects
Interval 1.15 to 41.43
|
4.62 Percentage of subjects
Interval 0.56 to 15.72
|
|
Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 43
|
3.23 Percentage of subjects
Interval 0.08 to 16.7
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
1.61 Percentage of subjects
Interval 0.02 to 9.93
|
|
Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
4.35 Percentage of subjects
Interval 0.0 to 56.7
|
1.41 Percentage of subjects
Interval 0.0 to 11.12
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=139 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 49
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 50
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 51
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 52
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 48
|
5.26 Percentage of subjects
Interval 0.13 to 26.03
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 49
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 50
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 51
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 52
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 8.04
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 8.04
|
|
Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 10.58
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
|
Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
|
Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
0.00 Percentage of subjects
Interval 0.0 to 14.82
|
0.00 Percentage of subjects
Interval 0.0 to 5.06
|
|
Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
0.00 Percentage of subjects
Interval 0.0 to 3.93
|
0.00 Percentage of subjects
Interval 0.0 to 2.05
|
|
Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.00 Percentage of subjects
Interval 0.0 to 7.4
|
0.00 Percentage of subjects
Interval 0.0 to 3.93
|
|
Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 10.89
|
|
Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
|
Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 40
|
—
|
1.49 Percentage of subjects
Interval 0.04 to 8.04
|
—
|
1.49 Percentage of subjects
Interval 0.04 to 8.04
|
|
Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
|
Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 2.13
|
|
Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 43
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 6.27
|
0.00 Percentage of subjects
Interval 0.0 to 5.96
|
|
Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 44
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
0.00 Percentage of subjects
Interval 0.0 to 7.87
|
|
Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 45
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
0.00 Percentage of subjects
Interval 0.0 to 5.21
|
|
Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 46
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
0.00 Percentage of subjects
Interval 0.0 to 12.77
|
|
Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 47
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
|
Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was to be performed on the enrolled subjects vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine, and who returned the ADR card, i.e.: only Fluarix Tetra Group subjects who received the second dose. As no AEs were reported for the MedDRA Class considered, the "by risk status" analysis could not be performed.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 44
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
0.00 Percentage of subjects
Interval 0.0 to 7.87
|
|
Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 45
|
—
|
16.67 Percentage of subjects
Interval 0.42 to 64.12
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
1.45 Percentage of subjects
Interval 0.0 to 21.94
|
|
Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 46
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
0.00 Percentage of subjects
Interval 0.0 to 12.77
|
|
Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 47
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
|
Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 41
|
—
|
2.27 Percentage of subjects
Interval 0.0 to 99.42
|
—
|
2.27 Percentage of subjects
Interval 0.0 to 99.42
|
|
Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 10.58
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
|
Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
|
Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 44
|
2.78 Percentage of subjects
Interval 0.0 to 84.65
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
4.35 Percentage of subjects
Interval 0.0 to 56.7
|
2.82 Percentage of subjects
Interval 0.34 to 9.81
|
|
Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
8.33 Percentage of subjects
Interval 0.21 to 38.48
|
0.00 Percentage of subjects
Interval 0.0 to 3.93
|
0.56 Percentage of subjects
Interval 0.0 to 5.76
|
|
Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
5.56 Percentage of subjects
Interval 0.14 to 27.29
|
0.00 Percentage of subjects
Interval 0.0 to 7.4
|
1.09 Percentage of subjects
Interval 0.0 to 10.42
|
|
Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 10.89
|
|
Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
|
Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
|
Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 41
|
—
|
2.13 Percentage of subjects
Interval 0.01 to 16.09
|
—
|
2.13 Percentage of subjects
Interval 0.01 to 16.09
|
|
Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 2.13
|
|
Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 43
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 6.27
|
0.00 Percentage of subjects
Interval 0.0 to 5.96
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was to be performed on the enrolled subjects vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine, and who returned the ADR card, i.e.: only Fluarix Tetra Group subjects who received the second dose. As no AEs were reported for the MedDRA Class considered, the "by risk status" analysis could not be performed.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were diarrhoea, nausea, and vomiting. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 8.04
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 8.04
|
|
Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
6.06 Percentage of subjects
Interval 0.0 to 48.84
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
3.08 Percentage of subjects
Interval 0.14 to 14.05
|
|
Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
|
Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 44
|
2.78 Percentage of subjects
Interval 0.0 to 84.65
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
0.00 Percentage of subjects
Interval 0.0 to 14.82
|
1.41 Percentage of subjects
Interval 0.01 to 9.48
|
|
Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
0.00 Percentage of subjects
Interval 0.0 to 3.93
|
0.00 Percentage of subjects
Interval 0.0 to 2.05
|
|
Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.00 Percentage of subjects
Interval 0.0 to 7.4
|
0.00 Percentage of subjects
Interval 0.0 to 3.93
|
|
Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 10.89
|
|
Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
|
Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 40
|
—
|
1.49 Percentage of subjects
Interval 0.04 to 8.04
|
—
|
1.49 Percentage of subjects
Interval 0.04 to 8.04
|
|
Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
|
Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 2.13
|
|
Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 43
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 6.27
|
0.00 Percentage of subjects
Interval 0.0 to 5.96
|
|
Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 44
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
0.00 Percentage of subjects
Interval 0.0 to 7.87
|
|
Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 45
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
0.00 Percentage of subjects
Interval 0.0 to 5.21
|
|
Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 46
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
0.00 Percentage of subjects
Interval 0.0 to 12.77
|
|
Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 47
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
|
Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=139 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 47
|
16.67 Percentage of subjects
Interval 0.0 to 100.0
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 49
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 50
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 51
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Week 52
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 47
|
7.69 Percentage of subjects
Interval 0.0 to 90.25
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 49
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 50
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 51
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
—
|
—
|
—
|
|
Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Week 52
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 10.89
|
|
Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
|
Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
|
Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
|
Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 2.13
|
|
Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 43
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 6.27
|
0.00 Percentage of subjects
Interval 0.0 to 5.96
|
|
Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 44
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
0.00 Percentage of subjects
Interval 0.0 to 7.87
|
|
Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 45
|
—
|
16.67 Percentage of subjects
Interval 0.42 to 64.12
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
1.45 Percentage of subjects
Interval 0.0 to 21.94
|
|
Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 46
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
0.00 Percentage of subjects
Interval 0.0 to 12.77
|
|
Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 47
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
|
Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 8.04
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 8.04
|
|
Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 10.58
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
|
Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
|
Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
0.00 Percentage of subjects
Interval 0.0 to 14.82
|
0.00 Percentage of subjects
Interval 0.0 to 5.06
|
|
Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
0.00 Percentage of subjects
Interval 0.0 to 3.93
|
0.00 Percentage of subjects
Interval 0.0 to 2.05
|
|
Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.00 Percentage of subjects
Interval 0.0 to 7.4
|
0.00 Percentage of subjects
Interval 0.0 to 3.93
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was to be performed on the enrolled subjects vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine, and who returned the ADR card, i.e.: only Fluarix Tetra Group subjects who received the second dose. As no AEs were reported for the MedDRA Class considered, the "by risk status" analysis could not be performed.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were diarrhoea, nausea, and vomiting. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 8.04
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 8.04
|
|
Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
6.06 Percentage of subjects
Interval 0.0 to 48.84
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
3.08 Percentage of subjects
Interval 0.14 to 14.05
|
|
Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
10.00 Percentage of subjects
Interval 0.25 to 44.5
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
1.61 Percentage of subjects
Interval 0.0 to 21.62
|
|
Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
0.00 Percentage of subjects
Interval 0.0 to 14.82
|
0.00 Percentage of subjects
Interval 0.0 to 5.06
|
|
Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 45
|
1.35 Percentage of subjects
Interval 0.0 to 21.52
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
0.00 Percentage of subjects
Interval 0.0 to 3.93
|
0.56 Percentage of subjects
Interval 0.01 to 3.45
|
|
Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.00 Percentage of subjects
Interval 0.0 to 7.4
|
0.00 Percentage of subjects
Interval 0.0 to 3.93
|
|
Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 10.89
|
|
Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
|
Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
|
Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
|
Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 2.13
|
|
Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 43
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 6.27
|
0.00 Percentage of subjects
Interval 0.0 to 5.96
|
|
Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 44
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
0.00 Percentage of subjects
Interval 0.0 to 7.87
|
|
Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 45
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
0.00 Percentage of subjects
Interval 0.0 to 5.21
|
|
Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 46
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
0.00 Percentage of subjects
Interval 0.0 to 12.77
|
|
Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 47
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
|
Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was to be performed on the enrolled subjects vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine, and who returned the ADR card, i.e.: only Fluarix Tetra Group subjects who received the second dose. As no AEs were reported for the MedDRA Class considered, the "by risk status" analysis could not be performed.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 8.04
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 8.04
|
|
Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 10.58
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
|
Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
|
Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
0.00 Percentage of subjects
Interval 0.0 to 14.82
|
0.00 Percentage of subjects
Interval 0.0 to 5.06
|
|
Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
0.00 Percentage of subjects
Interval 0.0 to 3.93
|
0.00 Percentage of subjects
Interval 0.0 to 2.05
|
|
Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 18.53
|
0.00 Percentage of subjects
Interval 0.0 to 7.4
|
0.00 Percentage of subjects
Interval 0.0 to 3.93
|
|
Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 10.89
|
|
Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
|
Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
|
Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
|
Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 42
|
0.80 Percentage of subjects
Interval 0.02 to 4.38
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.58 Percentage of subjects
Interval 0.01 to 3.22
|
|
Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 43
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 6.27
|
0.00 Percentage of subjects
Interval 0.0 to 5.96
|
|
Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 44
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
0.00 Percentage of subjects
Interval 0.0 to 7.87
|
|
Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 45
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
0.00 Percentage of subjects
Interval 0.0 to 5.21
|
|
Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 46
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
0.00 Percentage of subjects
Interval 0.0 to 12.77
|
|
Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 47
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
|
Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Week 48
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was to be performed on the enrolled subjects vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine, and who returned the ADR card, i.e.: only Fluarix Tetra Group subjects who received the second dose. As no AEs were reported for the MedDRA Class considered, the "by risk status" analysis could not be performed.
The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-41
|
—
|
34.04 Percentage of subjects
Interval 0.0 to 100.0
|
—
|
34.04 Percentage of subjects
Interval 0.0 to 100.0
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-42
|
56.25 Percentage of subjects
Interval 0.0 to 100.0
|
32.50 Percentage of subjects
Interval 0.0 to 100.0
|
56.25 Percentage of subjects
Interval 0.73 to 99.82
|
39.29 Percentage of subjects
Interval 16.38 to 66.3
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-43
|
48.94 Percentage of subjects
Interval 0.01 to 99.99
|
33.33 Percentage of subjects
Interval 0.0 to 100.0
|
51.35 Percentage of subjects
Interval 1.45 to 98.86
|
41.38 Percentage of subjects
Interval 24.45 to 59.95
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-44
|
51.81 Percentage of subjects
Interval 17.11 to 85.22
|
32.35 Percentage of subjects
Interval 0.0 to 100.0
|
45.00 Percentage of subjects
Interval 27.96 to 62.94
|
42.04 Percentage of subjects
Interval 30.32 to 54.46
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-45
|
43.95 Percentage of subjects
Interval 14.48 to 77.03
|
35.09 Percentage of subjects
Interval 0.0 to 100.0
|
49.34 Percentage of subjects
Interval 27.42 to 71.45
|
43.50 Percentage of subjects
Interval 34.29 to 53.05
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-46
|
41.53 Percentage of subjects
Interval 13.31 to 74.68
|
35.61 Percentage of subjects
Interval 0.0 to 100.0
|
47.00 Percentage of subjects
Interval 30.32 to 64.18
|
42.14 Percentage of subjects
Interval 33.74 to 50.88
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-47
|
41.18 Percentage of subjects
Interval 15.0 to 71.71
|
35.34 Percentage of subjects
Interval 0.0 to 100.0
|
48.10 Percentage of subjects
Interval 29.39 to 67.2
|
42.41 Percentage of subjects
Interval 33.83 to 51.34
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-48
|
41.18 Percentage of subjects
Interval 15.0 to 71.71
|
35.34 Percentage of subjects
Interval 0.0 to 100.0
|
49.78 Percentage of subjects
Interval 27.91 to 71.7
|
43.21 Percentage of subjects
Interval 33.66 to 53.15
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-49
|
41.18 Percentage of subjects
Interval 15.0 to 71.71
|
35.34 Percentage of subjects
Interval 0.0 to 100.0
|
49.78 Percentage of subjects
Interval 27.91 to 71.7
|
43.21 Percentage of subjects
Interval 33.66 to 53.15
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-50
|
41.18 Percentage of subjects
Interval 15.0 to 71.71
|
35.34 Percentage of subjects
Interval 0.0 to 100.0
|
49.78 Percentage of subjects
Interval 27.91 to 71.7
|
43.21 Percentage of subjects
Interval 33.66 to 53.15
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-51
|
41.18 Percentage of subjects
Interval 15.0 to 71.71
|
35.34 Percentage of subjects
Interval 0.0 to 100.0
|
49.78 Percentage of subjects
Interval 27.91 to 71.7
|
43.21 Percentage of subjects
Interval 33.66 to 53.15
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-52
|
41.18 Percentage of subjects
Interval 15.0 to 71.71
|
35.34 Percentage of subjects
Interval 0.0 to 100.0
|
49.78 Percentage of subjects
Interval 27.91 to 71.7
|
43.21 Percentage of subjects
Interval 33.66 to 53.15
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-40
|
—
|
34.33 Percentage of subjects
Interval 22.95 to 47.19
|
—
|
34.33 Percentage of subjects
Interval 22.95 to 47.19
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-41
|
—
|
35.09 Percentage of subjects
Interval 12.54 to 63.98
|
—
|
35.09 Percentage of subjects
Interval 12.54 to 63.98
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-42
|
44.00 Percentage of subjects
Interval 35.14 to 53.16
|
35.48 Percentage of subjects
Interval 16.02 to 59.26
|
38.89 Percentage of subjects
Interval 0.08 to 98.92
|
39.65 Percentage of subjects
Interval 32.94 to 46.66
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-43
|
44.00 Percentage of subjects
Interval 35.14 to 53.16
|
35.43 Percentage of subjects
Interval 16.17 to 58.94
|
44.09 Percentage of subjects
Interval 23.52 to 66.26
|
40.87 Percentage of subjects
Interval 35.21 to 46.71
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-44
|
44.00 Percentage of subjects
Interval 35.14 to 53.16
|
34.62 Percentage of subjects
Interval 12.67 to 62.8
|
41.48 Percentage of subjects
Interval 27.8 to 56.2
|
40.00 Percentage of subjects
Interval 34.92 to 45.24
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-45
|
44.00 Percentage of subjects
Interval 35.14 to 53.16
|
36.76 Percentage of subjects
Interval 23.53 to 51.64
|
43.94 Percentage of subjects
Interval 26.87 to 62.13
|
41.83 Percentage of subjects
Interval 37.27 to 46.49
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-46
|
44.00 Percentage of subjects
Interval 35.14 to 53.16
|
37.50 Percentage of subjects
Interval 26.97 to 48.98
|
43.32 Percentage of subjects
Interval 29.56 to 57.88
|
41.77 Percentage of subjects
Interval 37.34 to 46.3
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-47
|
44.00 Percentage of subjects
Interval 35.14 to 53.16
|
37.93 Percentage of subjects
Interval 28.18 to 48.46
|
44.49 Percentage of subjects
Interval 24.73 to 65.62
|
42.45 Percentage of subjects
Interval 38.02 to 46.98
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-48
|
44.00 Percentage of subjects
Interval 35.14 to 53.16
|
37.93 Percentage of subjects
Interval 28.18 to 48.46
|
45.22 Percentage of subjects
Interval 21.68 to 70.45
|
42.80 Percentage of subjects
Interval 37.59 to 48.14
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-49
|
44.00 Percentage of subjects
Interval 35.14 to 53.16
|
37.93 Percentage of subjects
Interval 28.18 to 48.46
|
45.22 Percentage of subjects
Interval 21.68 to 70.45
|
42.80 Percentage of subjects
Interval 37.59 to 48.14
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-50
|
44.00 Percentage of subjects
Interval 35.14 to 53.16
|
37.93 Percentage of subjects
Interval 28.18 to 48.46
|
45.22 Percentage of subjects
Interval 21.68 to 70.45
|
42.80 Percentage of subjects
Interval 37.59 to 48.14
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-51
|
44.00 Percentage of subjects
Interval 35.14 to 53.16
|
37.93 Percentage of subjects
Interval 28.18 to 48.46
|
45.22 Percentage of subjects
Interval 21.68 to 70.45
|
42.80 Percentage of subjects
Interval 37.59 to 48.14
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-52
|
44.00 Percentage of subjects
Interval 35.14 to 53.16
|
37.93 Percentage of subjects
Interval 28.18 to 48.46
|
45.22 Percentage of subjects
Interval 21.68 to 70.45
|
42.80 Percentage of subjects
Interval 37.59 to 48.14
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=139 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-47
|
57.14 Percentage of subjects
Interval 0.0 to 100.0
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-48
|
53.85 Percentage of subjects
Interval 0.0 to 100.0
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-49
|
34.62 Percentage of subjects
Interval 2.53 to 85.04
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-50
|
29.73 Percentage of subjects
Interval 1.34 to 83.06
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-51
|
28.89 Percentage of subjects
Interval 0.63 to 86.72
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-52
|
29.17 Percentage of subjects
Interval 1.05 to 83.94
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-46
|
50.00 Percentage of subjects
Interval 1.26 to 98.74
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-47
|
40.00 Percentage of subjects
Interval 0.0 to 100.0
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-48
|
41.18 Percentage of subjects
Interval 0.03 to 99.64
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-49
|
29.09 Percentage of subjects
Interval 13.83 to 48.83
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-50
|
20.93 Percentage of subjects
Interval 7.66 to 41.13
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-51
|
21.11 Percentage of subjects
Interval 8.16 to 40.43
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-52
|
20.88 Percentage of subjects
Interval 8.2 to 39.75
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-48
|
10.29 Percentage of subjects
Interval 5.05 to 18.12
|
6.77 Percentage of subjects
Interval 0.0 to 95.72
|
7.17 Percentage of subjects
Interval 2.28 to 16.25
|
8.21 Percentage of subjects
Interval 6.01 to 10.9
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-49
|
10.29 Percentage of subjects
Interval 5.05 to 18.12
|
6.77 Percentage of subjects
Interval 0.0 to 95.72
|
7.17 Percentage of subjects
Interval 2.28 to 16.25
|
8.21 Percentage of subjects
Interval 6.01 to 10.9
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-50
|
10.29 Percentage of subjects
Interval 5.05 to 18.12
|
6.77 Percentage of subjects
Interval 0.0 to 95.72
|
7.17 Percentage of subjects
Interval 2.28 to 16.25
|
8.21 Percentage of subjects
Interval 6.01 to 10.9
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-41
|
—
|
2.13 Percentage of subjects
Interval 0.0 to 99.46
|
—
|
2.13 Percentage of subjects
Interval 0.0 to 99.46
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-42
|
12.50 Percentage of subjects
Interval 0.0 to 99.41
|
7.50 Percentage of subjects
Interval 0.0 to 99.99
|
6.25 Percentage of subjects
Interval 0.16 to 30.23
|
8.04 Percentage of subjects
Interval 1.56 to 22.38
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-43
|
10.64 Percentage of subjects
Interval 0.0 to 69.52
|
7.78 Percentage of subjects
Interval 0.0 to 99.96
|
5.41 Percentage of subjects
Interval 0.0 to 99.49
|
8.05 Percentage of subjects
Interval 2.68 to 17.73
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-44
|
12.05 Percentage of subjects
Interval 2.62 to 31.07
|
7.84 Percentage of subjects
Interval 0.0 to 99.8
|
8.33 Percentage of subjects
Interval 0.41 to 34.04
|
9.39 Percentage of subjects
Interval 5.25 to 15.2
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-45
|
10.83 Percentage of subjects
Interval 4.92 to 19.92
|
7.89 Percentage of subjects
Interval 0.0 to 99.36
|
5.26 Percentage of subjects
Interval 0.6 to 18.2
|
8.04 Percentage of subjects
Interval 4.73 to 12.6
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-46
|
10.38 Percentage of subjects
Interval 4.74 to 19.08
|
6.82 Percentage of subjects
Interval 0.0 to 96.02
|
6.50 Percentage of subjects
Interval 1.41 to 17.58
|
7.96 Percentage of subjects
Interval 5.4 to 11.23
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-47
|
10.29 Percentage of subjects
Interval 5.05 to 18.12
|
6.77 Percentage of subjects
Interval 0.0 to 95.72
|
6.67 Percentage of subjects
Interval 1.89 to 16.02
|
8.04 Percentage of subjects
Interval 5.68 to 11.0
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-51
|
10.29 Percentage of subjects
Interval 5.05 to 18.12
|
6.77 Percentage of subjects
Interval 0.0 to 95.72
|
7.17 Percentage of subjects
Interval 2.28 to 16.25
|
8.21 Percentage of subjects
Interval 6.01 to 10.9
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-52
|
10.29 Percentage of subjects
Interval 5.05 to 18.12
|
6.77 Percentage of subjects
Interval 0.0 to 95.72
|
7.17 Percentage of subjects
Interval 2.28 to 16.25
|
8.21 Percentage of subjects
Interval 6.01 to 10.9
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-40
|
—
|
2.99 Percentage of subjects
Interval 0.36 to 10.37
|
—
|
2.99 Percentage of subjects
Interval 0.36 to 10.37
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-41
|
—
|
2.63 Percentage of subjects
Interval 0.49 to 7.85
|
—
|
2.63 Percentage of subjects
Interval 0.49 to 7.85
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-42
|
0.80 Percentage of subjects
Interval 0.02 to 4.38
|
2.42 Percentage of subjects
Interval 0.17 to 10.03
|
8.33 Percentage of subjects
Interval 0.13 to 41.57
|
2.46 Percentage of subjects
Interval 0.38 to 7.86
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-43
|
0.80 Percentage of subjects
Interval 0.02 to 4.38
|
2.36 Percentage of subjects
Interval 0.12 to 10.64
|
9.68 Percentage of subjects
Interval 2.05 to 25.7
|
3.77 Percentage of subjects
Interval 0.35 to 14.12
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-44
|
0.80 Percentage of subjects
Interval 0.02 to 4.38
|
2.31 Percentage of subjects
Interval 0.09 to 11.25
|
6.67 Percentage of subjects
Interval 3.09 to 12.28
|
3.33 Percentage of subjects
Interval 0.6 to 10.01
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-45
|
0.80 Percentage of subjects
Interval 0.02 to 4.38
|
2.94 Percentage of subjects
Interval 0.81 to 7.36
|
6.06 Percentage of subjects
Interval 2.54 to 11.91
|
3.70 Percentage of subjects
Interval 1.0 to 9.28
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-46
|
0.80 Percentage of subjects
Interval 0.02 to 4.38
|
3.47 Percentage of subjects
Interval 0.85 to 9.16
|
6.45 Percentage of subjects
Interval 3.57 to 10.59
|
4.12 Percentage of subjects
Interval 1.5 to 8.83
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-47
|
0.80 Percentage of subjects
Interval 0.02 to 4.38
|
3.45 Percentage of subjects
Interval 0.89 to 8.87
|
6.61 Percentage of subjects
Interval 3.75 to 10.66
|
4.23 Percentage of subjects
Interval 1.63 to 8.77
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-48
|
0.80 Percentage of subjects
Interval 0.02 to 4.38
|
3.45 Percentage of subjects
Interval 0.89 to 8.87
|
6.52 Percentage of subjects
Interval 3.7 to 10.53
|
4.20 Percentage of subjects
Interval 1.62 to 8.71
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-49
|
0.80 Percentage of subjects
Interval 0.02 to 4.38
|
3.45 Percentage of subjects
Interval 0.89 to 8.87
|
6.52 Percentage of subjects
Interval 3.7 to 10.53
|
4.20 Percentage of subjects
Interval 1.62 to 8.71
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-50
|
0.80 Percentage of subjects
Interval 0.02 to 4.38
|
3.45 Percentage of subjects
Interval 0.89 to 8.87
|
6.52 Percentage of subjects
Interval 3.7 to 10.53
|
4.20 Percentage of subjects
Interval 1.62 to 8.71
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-51
|
0.80 Percentage of subjects
Interval 0.02 to 4.38
|
3.45 Percentage of subjects
Interval 0.89 to 8.87
|
6.52 Percentage of subjects
Interval 3.7 to 10.53
|
4.20 Percentage of subjects
Interval 1.62 to 8.71
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-52
|
0.80 Percentage of subjects
Interval 0.02 to 4.38
|
3.45 Percentage of subjects
Interval 0.89 to 8.87
|
6.52 Percentage of subjects
Interval 3.7 to 10.53
|
4.20 Percentage of subjects
Interval 1.62 to 8.71
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=139 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-47
|
14.29 Percentage of subjects
Interval 0.0 to 100.0
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-48
|
7.69 Percentage of subjects
Interval 0.0 to 100.0
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-49
|
3.85 Percentage of subjects
Interval 0.0 to 66.83
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-50
|
5.41 Percentage of subjects
Interval 0.0 to 81.93
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-51
|
4.44 Percentage of subjects
Interval 0.0 to 77.39
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-52
|
4.17 Percentage of subjects
Interval 0.0 to 76.38
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-46
|
50.00 Percentage of subjects
Interval 1.26 to 98.74
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-47
|
13.33 Percentage of subjects
Interval 0.0 to 97.21
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-48
|
5.88 Percentage of subjects
Interval 0.07 to 32.75
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-49
|
3.64 Percentage of subjects
Interval 0.44 to 12.53
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-50
|
2.33 Percentage of subjects
Interval 0.28 to 8.15
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-51
|
2.22 Percentage of subjects
Interval 0.27 to 7.8
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-52
|
2.20 Percentage of subjects
Interval 0.27 to 7.71
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e. week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-41
|
—
|
25.53 Percentage of subjects
Interval 0.0 to 100.0
|
—
|
25.53 Percentage of subjects
Interval 0.0 to 100.0
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-42
|
37.50 Percentage of subjects
Interval 0.0 to 100.0
|
25.00 Percentage of subjects
Interval 0.0 to 100.0
|
43.75 Percentage of subjects
Interval 1.42 to 96.32
|
29.46 Percentage of subjects
Interval 13.05 to 51.01
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-43
|
25.53 Percentage of subjects
Interval 0.0 to 99.94
|
24.44 Percentage of subjects
Interval 0.0 to 100.0
|
32.43 Percentage of subjects
Interval 14.38 to 55.36
|
26.44 Percentage of subjects
Interval 15.77 to 39.59
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-44
|
32.53 Percentage of subjects
Interval 1.71 to 85.31
|
24.51 Percentage of subjects
Interval 0.0 to 99.96
|
26.67 Percentage of subjects
Interval 16.07 to 39.66
|
27.76 Percentage of subjects
Interval 19.07 to 37.87
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-45
|
25.48 Percentage of subjects
Interval 1.4 to 75.12
|
27.19 Percentage of subjects
Interval 0.0 to 99.99
|
32.24 Percentage of subjects
Interval 3.7 to 77.68
|
28.37 Percentage of subjects
Interval 17.36 to 41.65
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-46
|
24.04 Percentage of subjects
Interval 1.58 to 70.96
|
27.27 Percentage of subjects
Interval 0.0 to 99.9
|
31.50 Percentage of subjects
Interval 4.13 to 75.09
|
27.77 Percentage of subjects
Interval 16.9 to 40.95
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-47
|
24.51 Percentage of subjects
Interval 2.85 to 65.37
|
27.07 Percentage of subjects
Interval 0.0 to 99.87
|
32.38 Percentage of subjects
Interval 4.15 to 76.58
|
28.15 Percentage of subjects
Interval 17.34 to 41.19
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-48
|
24.51 Percentage of subjects
Interval 2.85 to 65.37
|
27.07 Percentage of subjects
Interval 0.0 to 99.87
|
34.08 Percentage of subjects
Interval 4.26 to 79.14
|
28.93 Percentage of subjects
Interval 17.28 to 43.04
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-49
|
24.51 Percentage of subjects
Interval 2.85 to 65.37
|
27.07 Percentage of subjects
Interval 0.0 to 99.87
|
34.08 Percentage of subjects
Interval 4.26 to 79.14
|
28.93 Percentage of subjects
Interval 17.28 to 43.04
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-50
|
24.51 Percentage of subjects
Interval 2.85 to 65.37
|
27.07 Percentage of subjects
Interval 0.0 to 99.87
|
34.08 Percentage of subjects
Interval 4.26 to 79.14
|
28.93 Percentage of subjects
Interval 17.28 to 43.04
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-51
|
24.51 Percentage of subjects
Interval 2.85 to 65.37
|
27.07 Percentage of subjects
Interval 0.0 to 99.87
|
34.08 Percentage of subjects
Interval 4.26 to 79.14
|
28.93 Percentage of subjects
Interval 17.28 to 43.04
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-52
|
24.51 Percentage of subjects
Interval 2.85 to 65.37
|
27.07 Percentage of subjects
Interval 0.0 to 99.87
|
34.08 Percentage of subjects
Interval 4.26 to 79.14
|
28.93 Percentage of subjects
Interval 17.28 to 43.04
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-40
|
—
|
26.87 Percentage of subjects
Interval 11.49 to 47.81
|
—
|
26.87 Percentage of subjects
Interval 11.49 to 47.81
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-41
|
—
|
28.95 Percentage of subjects
Interval 12.83 to 50.22
|
—
|
28.95 Percentage of subjects
Interval 12.83 to 50.22
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-42
|
30.40 Percentage of subjects
Interval 22.49 to 39.26
|
29.03 Percentage of subjects
Interval 14.04 to 48.34
|
19.44 Percentage of subjects
Interval 0.18 to 77.39
|
28.42 Percentage of subjects
Interval 23.06 to 34.27
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-43
|
30.40 Percentage of subjects
Interval 22.49 to 39.26
|
28.35 Percentage of subjects
Interval 10.83 to 52.51
|
24.73 Percentage of subjects
Interval 4.38 to 60.02
|
28.12 Percentage of subjects
Interval 23.18 to 33.47
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-44
|
30.40 Percentage of subjects
Interval 22.49 to 39.26
|
27.69 Percentage of subjects
Interval 8.22 to 56.49
|
22.96 Percentage of subjects
Interval 16.17 to 30.98
|
26.92 Percentage of subjects
Interval 20.63 to 33.98
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-45
|
30.40 Percentage of subjects
Interval 22.49 to 39.26
|
28.68 Percentage of subjects
Interval 13.37 to 48.65
|
24.75 Percentage of subjects
Interval 18.9 to 31.36
|
27.45 Percentage of subjects
Interval 22.67 to 32.65
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-46
|
30.40 Percentage of subjects
Interval 22.49 to 39.26
|
28.47 Percentage of subjects
Interval 13.11 to 48.63
|
24.88 Percentage of subjects
Interval 19.28 to 31.19
|
27.37 Percentage of subjects
Interval 23.07 to 31.99
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-47
|
30.40 Percentage of subjects
Interval 22.49 to 39.26
|
28.28 Percentage of subjects
Interval 12.28 to 49.64
|
25.99 Percentage of subjects
Interval 18.71 to 34.4
|
27.77 Percentage of subjects
Interval 23.41 to 32.46
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-48
|
30.40 Percentage of subjects
Interval 22.49 to 39.26
|
28.28 Percentage of subjects
Interval 12.28 to 49.64
|
26.52 Percentage of subjects
Interval 16.53 to 38.66
|
28.00 Percentage of subjects
Interval 23.48 to 32.87
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-49
|
30.40 Percentage of subjects
Interval 22.49 to 39.26
|
28.28 Percentage of subjects
Interval 12.28 to 49.64
|
26.52 Percentage of subjects
Interval 16.53 to 38.66
|
28.00 Percentage of subjects
Interval 23.48 to 32.87
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-50
|
30.40 Percentage of subjects
Interval 22.49 to 39.26
|
28.28 Percentage of subjects
Interval 12.28 to 49.64
|
26.52 Percentage of subjects
Interval 16.53 to 38.66
|
28.00 Percentage of subjects
Interval 23.48 to 32.87
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-51
|
30.40 Percentage of subjects
Interval 22.49 to 39.26
|
28.28 Percentage of subjects
Interval 12.28 to 49.64
|
26.52 Percentage of subjects
Interval 16.53 to 38.66
|
28.00 Percentage of subjects
Interval 23.48 to 32.87
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-52
|
30.40 Percentage of subjects
Interval 22.49 to 39.26
|
28.28 Percentage of subjects
Interval 12.28 to 49.64
|
26.52 Percentage of subjects
Interval 16.53 to 38.66
|
28.00 Percentage of subjects
Interval 23.48 to 32.87
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=139 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-47
|
28.57 Percentage of subjects
Interval 2.18 to 76.83
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-48
|
15.38 Percentage of subjects
Interval 0.0 to 99.93
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-49
|
11.54 Percentage of subjects
Interval 2.45 to 30.15
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-50
|
10.81 Percentage of subjects
Interval 3.03 to 25.42
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-51
|
8.89 Percentage of subjects
Interval 2.48 to 21.22
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-52
|
10.42 Percentage of subjects
Interval 3.47 to 22.66
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-47
|
33.33 Percentage of subjects
Interval 0.0 to 100.0
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-48
|
17.65 Percentage of subjects
Interval 0.11 to 75.84
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-49
|
10.91 Percentage of subjects
Interval 4.11 to 22.25
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-50
|
8.14 Percentage of subjects
Interval 2.45 to 18.83
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-51
|
8.89 Percentage of subjects
Interval 2.85 to 19.86
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-52
|
8.79 Percentage of subjects
Interval 2.87 to 19.49
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-47
|
0.49 Percentage of subjects
Interval 0.01 to 2.7
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
0.00 Percentage of subjects
Interval 0.0 to 1.74
|
0.18 Percentage of subjects
Interval 0.0 to 1.01
|
|
Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-48
|
0.49 Percentage of subjects
Interval 0.01 to 2.7
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
0.00 Percentage of subjects
Interval 0.0 to 1.64
|
0.18 Percentage of subjects
Interval 0.0 to 1.0
|
|
Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
|
Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 3.24
|
|
Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
0.00 Percentage of subjects
Interval 0.0 to 4.02
|
0.00 Percentage of subjects
Interval 0.0 to 9.49
|
0.00 Percentage of subjects
Interval 0.0 to 2.1
|
|
Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 4.35
|
0.00 Percentage of subjects
Interval 0.0 to 3.55
|
0.00 Percentage of subjects
Interval 0.0 to 5.96
|
0.00 Percentage of subjects
Interval 0.0 to 1.49
|
|
Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-45
|
0.64 Percentage of subjects
Interval 0.02 to 3.5
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.00 Percentage of subjects
Interval 0.0 to 2.4
|
0.24 Percentage of subjects
Interval 0.01 to 1.35
|
|
Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-46
|
0.55 Percentage of subjects
Interval 0.01 to 3.01
|
0.00 Percentage of subjects
Interval 0.0 to 2.76
|
0.00 Percentage of subjects
Interval 0.0 to 1.83
|
0.19 Percentage of subjects
Interval 0.0 to 1.11
|
|
Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-49
|
0.49 Percentage of subjects
Interval 0.01 to 2.7
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
0.00 Percentage of subjects
Interval 0.0 to 1.64
|
0.18 Percentage of subjects
Interval 0.0 to 1.0
|
|
Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-50
|
0.49 Percentage of subjects
Interval 0.01 to 2.7
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
0.00 Percentage of subjects
Interval 0.0 to 1.64
|
0.18 Percentage of subjects
Interval 0.0 to 1.0
|
|
Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-51
|
0.49 Percentage of subjects
Interval 0.01 to 2.7
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
0.00 Percentage of subjects
Interval 0.0 to 1.64
|
0.18 Percentage of subjects
Interval 0.0 to 1.0
|
|
Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-52
|
0.49 Percentage of subjects
Interval 0.01 to 2.7
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
0.00 Percentage of subjects
Interval 0.0 to 1.64
|
0.18 Percentage of subjects
Interval 0.0 to 1.0
|
|
Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
|
Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.00 Percentage of subjects
Interval 0.0 to 2.93
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 1.29
|
|
Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.00 Percentage of subjects
Interval 0.0 to 2.86
|
0.00 Percentage of subjects
Interval 0.0 to 3.89
|
0.00 Percentage of subjects
Interval 0.0 to 1.06
|
|
Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.00 Percentage of subjects
Interval 0.0 to 2.7
|
0.00 Percentage of subjects
Interval 0.0 to 0.94
|
|
Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.00 Percentage of subjects
Interval 0.0 to 2.68
|
0.00 Percentage of subjects
Interval 0.0 to 1.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.8
|
|
Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.00 Percentage of subjects
Interval 0.0 to 2.53
|
0.00 Percentage of subjects
Interval 0.0 to 1.69
|
0.00 Percentage of subjects
Interval 0.0 to 0.76
|
|
Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
0.00 Percentage of subjects
Interval 0.0 to 1.61
|
0.00 Percentage of subjects
Interval 0.0 to 0.74
|
|
Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
0.00 Percentage of subjects
Interval 0.0 to 1.59
|
0.00 Percentage of subjects
Interval 0.0 to 0.74
|
|
Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
0.00 Percentage of subjects
Interval 0.0 to 1.59
|
0.00 Percentage of subjects
Interval 0.0 to 0.74
|
|
Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
0.00 Percentage of subjects
Interval 0.0 to 1.59
|
0.00 Percentage of subjects
Interval 0.0 to 0.74
|
|
Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
0.00 Percentage of subjects
Interval 0.0 to 1.59
|
0.00 Percentage of subjects
Interval 0.0 to 0.74
|
|
Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
0.00 Percentage of subjects
Interval 0.0 to 1.59
|
0.00 Percentage of subjects
Interval 0.0 to 0.74
|
|
Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was to be performed on the enrolled subjects vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine, and who returned the ADR card, i.e.: only Fluarix Tetra Group subjects who received the second dose. As no AEs were reported for the MedDRA Class considered, the "by risk status" analysis could not be performed.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-41
|
—
|
8.51 Percentage of subjects
Interval 0.0 to 99.99
|
—
|
8.51 Percentage of subjects
Interval 0.0 to 99.99
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
7.50 Percentage of subjects
Interval 0.0 to 97.14
|
6.25 Percentage of subjects
Interval 0.16 to 30.23
|
6.25 Percentage of subjects
Interval 1.56 to 15.94
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-43
|
4.26 Percentage of subjects
Interval 0.06 to 23.84
|
7.78 Percentage of subjects
Interval 0.0 to 95.5
|
5.41 Percentage of subjects
Interval 0.01 to 39.15
|
6.32 Percentage of subjects
Interval 2.58 to 12.6
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-44
|
6.02 Percentage of subjects
Interval 1.98 to 13.5
|
7.84 Percentage of subjects
Interval 0.0 to 91.81
|
5.00 Percentage of subjects
Interval 1.04 to 13.92
|
6.53 Percentage of subjects
Interval 3.78 to 10.39
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-45
|
7.64 Percentage of subjects
Interval 3.22 to 14.85
|
7.89 Percentage of subjects
Interval 0.0 to 87.38
|
5.92 Percentage of subjects
Interval 2.35 to 12.0
|
7.09 Percentage of subjects
Interval 4.84 to 9.97
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-46
|
7.10 Percentage of subjects
Interval 2.74 to 14.57
|
8.33 Percentage of subjects
Interval 0.0 to 83.24
|
7.00 Percentage of subjects
Interval 1.01 to 21.89
|
7.38 Percentage of subjects
Interval 5.11 to 10.24
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-47
|
6.86 Percentage of subjects
Interval 2.67 to 14.01
|
8.27 Percentage of subjects
Interval 0.0 to 82.34
|
7.14 Percentage of subjects
Interval 0.9 to 23.32
|
7.31 Percentage of subjects
Interval 4.99 to 10.26
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-48
|
6.86 Percentage of subjects
Interval 2.67 to 14.01
|
8.27 Percentage of subjects
Interval 0.0 to 82.34
|
7.62 Percentage of subjects
Interval 1.62 to 20.61
|
7.50 Percentage of subjects
Interval 5.26 to 10.31
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-49
|
6.86 Percentage of subjects
Interval 2.67 to 14.01
|
8.27 Percentage of subjects
Interval 0.0 to 82.34
|
7.62 Percentage of subjects
Interval 1.62 to 20.61
|
7.50 Percentage of subjects
Interval 5.26 to 10.31
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-50
|
6.86 Percentage of subjects
Interval 2.67 to 14.01
|
8.27 Percentage of subjects
Interval 0.0 to 82.34
|
7.62 Percentage of subjects
Interval 1.62 to 20.61
|
7.50 Percentage of subjects
Interval 5.26 to 10.31
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-51
|
6.86 Percentage of subjects
Interval 2.67 to 14.01
|
8.27 Percentage of subjects
Interval 0.0 to 82.34
|
7.62 Percentage of subjects
Interval 1.62 to 20.61
|
7.50 Percentage of subjects
Interval 5.26 to 10.31
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-52
|
6.86 Percentage of subjects
Interval 2.67 to 14.01
|
8.27 Percentage of subjects
Interval 0.0 to 82.34
|
7.62 Percentage of subjects
Interval 1.62 to 20.61
|
7.50 Percentage of subjects
Interval 5.26 to 10.31
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-40
|
—
|
8.96 Percentage of subjects
Interval 3.36 to 18.48
|
—
|
8.96 Percentage of subjects
Interval 3.36 to 18.48
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-41
|
—
|
8.77 Percentage of subjects
Interval 1.53 to 25.26
|
—
|
8.77 Percentage of subjects
Interval 1.53 to 25.26
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-42
|
0.80 Percentage of subjects
Interval 0.02 to 4.38
|
8.06 Percentage of subjects
Interval 0.5 to 31.4
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
3.86 Percentage of subjects
Interval 0.09 to 19.92
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-43
|
0.80 Percentage of subjects
Interval 0.02 to 4.38
|
7.87 Percentage of subjects
Interval 0.35 to 33.05
|
3.23 Percentage of subjects
Interval 0.67 to 9.14
|
4.06 Percentage of subjects
Interval 0.34 to 15.55
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-44
|
0.80 Percentage of subjects
Interval 0.02 to 4.38
|
7.69 Percentage of subjects
Interval 0.24 to 34.68
|
4.44 Percentage of subjects
Interval 0.25 to 18.85
|
4.36 Percentage of subjects
Interval 0.76 to 13.14
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-45
|
0.80 Percentage of subjects
Interval 0.02 to 4.38
|
8.09 Percentage of subjects
Interval 0.76 to 28.36
|
4.55 Percentage of subjects
Interval 0.02 to 30.67
|
4.58 Percentage of subjects
Interval 1.01 to 12.49
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-46
|
0.80 Percentage of subjects
Interval 0.02 to 4.38
|
7.64 Percentage of subjects
Interval 0.36 to 31.76
|
4.61 Percentage of subjects
Interval 0.02 to 30.12
|
4.53 Percentage of subjects
Interval 1.07 to 12.02
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-47
|
0.80 Percentage of subjects
Interval 0.02 to 4.38
|
7.59 Percentage of subjects
Interval 0.33 to 32.18
|
5.29 Percentage of subjects
Interval 0.01 to 38.99
|
4.83 Percentage of subjects
Interval 1.16 to 12.69
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-48
|
0.80 Percentage of subjects
Interval 0.02 to 4.38
|
7.59 Percentage of subjects
Interval 0.33 to 32.18
|
5.22 Percentage of subjects
Interval 0.01 to 37.3
|
4.80 Percentage of subjects
Interval 1.17 to 12.53
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-49
|
0.80 Percentage of subjects
Interval 0.02 to 4.38
|
7.59 Percentage of subjects
Interval 0.33 to 32.18
|
5.22 Percentage of subjects
Interval 0.01 to 37.3
|
4.80 Percentage of subjects
Interval 1.17 to 12.53
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-50
|
0.80 Percentage of subjects
Interval 0.02 to 4.38
|
7.59 Percentage of subjects
Interval 0.33 to 32.18
|
5.22 Percentage of subjects
Interval 0.01 to 37.3
|
4.80 Percentage of subjects
Interval 1.17 to 12.53
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-51
|
0.80 Percentage of subjects
Interval 0.02 to 4.38
|
7.59 Percentage of subjects
Interval 0.33 to 32.18
|
5.22 Percentage of subjects
Interval 0.01 to 37.3
|
4.80 Percentage of subjects
Interval 1.17 to 12.53
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-52
|
0.80 Percentage of subjects
Interval 0.02 to 4.38
|
7.59 Percentage of subjects
Interval 0.33 to 32.18
|
5.22 Percentage of subjects
Interval 0.01 to 37.3
|
4.80 Percentage of subjects
Interval 1.17 to 12.53
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=139 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-52
|
6.25 Percentage of subjects
Interval 0.37 to 25.31
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-48
|
23.08 Percentage of subjects
Interval 0.0 to 99.99
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-49
|
11.54 Percentage of subjects
Interval 0.21 to 51.85
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-50
|
8.11 Percentage of subjects
Interval 0.2 to 37.89
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-51
|
6.67 Percentage of subjects
Interval 0.29 to 28.75
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 10.28
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 6.49
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-50
|
1.16 Percentage of subjects
Interval 0.03 to 6.31
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-51
|
1.11 Percentage of subjects
Interval 0.03 to 6.04
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-52
|
1.10 Percentage of subjects
Interval 0.03 to 5.97
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-42
|
6.25 Percentage of subjects
Interval 0.0 to 100.0
|
0.00 Percentage of subjects
Interval 0.0 to 4.51
|
6.25 Percentage of subjects
Interval 0.16 to 30.23
|
1.79 Percentage of subjects
Interval 0.02 to 11.2
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-43
|
2.13 Percentage of subjects
Interval 0.0 to 100.0
|
0.00 Percentage of subjects
Interval 0.0 to 4.02
|
5.41 Percentage of subjects
Interval 0.01 to 39.15
|
1.72 Percentage of subjects
Interval 0.03 to 9.75
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-44
|
2.41 Percentage of subjects
Interval 0.0 to 38.72
|
0.00 Percentage of subjects
Interval 0.0 to 3.55
|
10.00 Percentage of subjects
Interval 3.76 to 20.51
|
3.27 Percentage of subjects
Interval 0.31 to 12.24
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-45
|
3.18 Percentage of subjects
Interval 0.56 to 9.64
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
6.58 Percentage of subjects
Interval 0.02 to 41.41
|
3.55 Percentage of subjects
Interval 0.76 to 9.87
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-46
|
3.28 Percentage of subjects
Interval 0.88 to 8.28
|
0.00 Percentage of subjects
Interval 0.0 to 2.76
|
5.00 Percentage of subjects
Interval 0.0 to 43.12
|
3.11 Percentage of subjects
Interval 0.7 to 8.49
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-47
|
3.43 Percentage of subjects
Interval 1.21 to 7.51
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
4.76 Percentage of subjects
Interval 0.0 to 43.22
|
3.11 Percentage of subjects
Interval 0.78 to 8.12
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-48
|
3.43 Percentage of subjects
Interval 1.21 to 7.51
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
5.38 Percentage of subjects
Interval 0.05 to 31.59
|
3.39 Percentage of subjects
Interval 1.11 to 7.74
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-49
|
3.43 Percentage of subjects
Interval 1.21 to 7.51
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
5.38 Percentage of subjects
Interval 0.05 to 31.59
|
3.39 Percentage of subjects
Interval 1.11 to 7.74
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-50
|
3.43 Percentage of subjects
Interval 1.21 to 7.51
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
5.38 Percentage of subjects
Interval 0.05 to 31.59
|
3.39 Percentage of subjects
Interval 1.11 to 7.74
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-51
|
3.43 Percentage of subjects
Interval 1.21 to 7.51
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
5.38 Percentage of subjects
Interval 0.05 to 31.59
|
3.39 Percentage of subjects
Interval 1.11 to 7.74
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-52
|
3.43 Percentage of subjects
Interval 1.21 to 7.51
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
5.38 Percentage of subjects
Interval 0.05 to 31.59
|
3.39 Percentage of subjects
Interval 1.11 to 7.74
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-41
|
—
|
0.88 Percentage of subjects
Interval 0.02 to 4.79
|
—
|
0.88 Percentage of subjects
Interval 0.02 to 4.79
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.81 Percentage of subjects
Interval 0.02 to 4.41
|
2.78 Percentage of subjects
Interval 0.05 to 15.34
|
0.70 Percentage of subjects
Interval 0.04 to 3.25
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.79 Percentage of subjects
Interval 0.02 to 4.31
|
9.68 Percentage of subjects
Interval 2.05 to 25.7
|
2.90 Percentage of subjects
Interval 0.04 to 17.14
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.77 Percentage of subjects
Interval 0.02 to 4.21
|
7.41 Percentage of subjects
Interval 3.61 to 13.2
|
2.82 Percentage of subjects
Interval 0.1 to 13.63
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.74 Percentage of subjects
Interval 0.01 to 4.27
|
6.06 Percentage of subjects
Interval 2.54 to 11.91
|
2.83 Percentage of subjects
Interval 0.23 to 11.23
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.69 Percentage of subjects
Interval 0.0 to 4.82
|
5.53 Percentage of subjects
Interval 1.33 to 14.44
|
2.67 Percentage of subjects
Interval 0.21 to 10.65
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.69 Percentage of subjects
Interval 0.0 to 4.89
|
5.29 Percentage of subjects
Interval 0.9 to 15.88
|
2.62 Percentage of subjects
Interval 0.2 to 10.48
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.69 Percentage of subjects
Interval 0.0 to 4.89
|
5.22 Percentage of subjects
Interval 0.8 to 16.29
|
2.60 Percentage of subjects
Interval 0.2 to 10.44
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.69 Percentage of subjects
Interval 0.0 to 4.89
|
5.22 Percentage of subjects
Interval 0.8 to 16.29
|
2.60 Percentage of subjects
Interval 0.2 to 10.44
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.69 Percentage of subjects
Interval 0.0 to 4.89
|
5.22 Percentage of subjects
Interval 0.8 to 16.29
|
2.60 Percentage of subjects
Interval 0.2 to 10.44
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.69 Percentage of subjects
Interval 0.0 to 4.89
|
5.22 Percentage of subjects
Interval 0.8 to 16.29
|
2.60 Percentage of subjects
Interval 0.2 to 10.44
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.69 Percentage of subjects
Interval 0.0 to 4.89
|
5.22 Percentage of subjects
Interval 0.8 to 16.29
|
2.60 Percentage of subjects
Interval 0.2 to 10.44
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=139 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-50
|
2.70 Percentage of subjects
Interval 0.07 to 14.16
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-51
|
2.22 Percentage of subjects
Interval 0.06 to 11.77
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-52
|
2.08 Percentage of subjects
Interval 0.05 to 11.07
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-47
|
6.67 Percentage of subjects
Interval 0.0 to 79.41
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-48
|
5.88 Percentage of subjects
Interval 0.07 to 32.75
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-49
|
3.64 Percentage of subjects
Interval 0.44 to 12.53
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-50
|
2.33 Percentage of subjects
Interval 0.28 to 8.15
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-51
|
2.22 Percentage of subjects
Interval 0.27 to 7.8
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-52
|
2.20 Percentage of subjects
Interval 0.27 to 7.71
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-41
|
—
|
2.13 Percentage of subjects
Interval 0.0 to 99.46
|
—
|
2.13 Percentage of subjects
Interval 0.0 to 99.46
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-42
|
6.25 Percentage of subjects
Interval 0.0 to 100.0
|
2.50 Percentage of subjects
Interval 0.0 to 94.21
|
12.50 Percentage of subjects
Interval 1.15 to 41.43
|
4.46 Percentage of subjects
Interval 0.7 to 13.97
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-43
|
2.13 Percentage of subjects
Interval 0.0 to 100.0
|
4.44 Percentage of subjects
Interval 0.0 to 98.48
|
8.11 Percentage of subjects
Interval 0.01 to 53.94
|
4.60 Percentage of subjects
Interval 0.84 to 13.55
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-44
|
9.64 Percentage of subjects
Interval 0.23 to 43.7
|
4.90 Percentage of subjects
Interval 0.0 to 97.43
|
6.67 Percentage of subjects
Interval 1.21 to 19.31
|
6.94 Percentage of subjects
Interval 3.68 to 11.72
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-45
|
10.19 Percentage of subjects
Interval 1.52 to 30.44
|
6.14 Percentage of subjects
Interval 0.0 to 97.75
|
7.89 Percentage of subjects
Interval 0.1 to 41.07
|
8.27 Percentage of subjects
Interval 4.86 to 12.98
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-46
|
10.38 Percentage of subjects
Interval 2.47 to 26.2
|
6.82 Percentage of subjects
Interval 0.0 to 96.02
|
8.00 Percentage of subjects
Interval 0.15 to 39.06
|
8.54 Percentage of subjects
Interval 5.32 to 12.85
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-47
|
9.80 Percentage of subjects
Interval 2.2 to 25.43
|
6.77 Percentage of subjects
Interval 0.0 to 95.72
|
7.62 Percentage of subjects
Interval 0.19 to 35.69
|
8.23 Percentage of subjects
Interval 5.26 to 12.13
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-48
|
9.80 Percentage of subjects
Interval 2.2 to 25.43
|
6.77 Percentage of subjects
Interval 0.0 to 95.72
|
9.87 Percentage of subjects
Interval 0.11 to 49.43
|
9.11 Percentage of subjects
Interval 5.02 to 14.91
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-49
|
9.80 Percentage of subjects
Interval 2.2 to 25.43
|
6.77 Percentage of subjects
Interval 0.0 to 95.72
|
9.87 Percentage of subjects
Interval 0.11 to 49.43
|
9.11 Percentage of subjects
Interval 5.02 to 14.91
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-50
|
9.80 Percentage of subjects
Interval 2.2 to 25.43
|
6.77 Percentage of subjects
Interval 0.0 to 95.72
|
9.87 Percentage of subjects
Interval 0.11 to 49.43
|
9.11 Percentage of subjects
Interval 5.02 to 14.91
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-51
|
9.80 Percentage of subjects
Interval 2.2 to 25.43
|
6.77 Percentage of subjects
Interval 0.0 to 95.72
|
9.87 Percentage of subjects
Interval 0.11 to 49.43
|
9.11 Percentage of subjects
Interval 5.02 to 14.91
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-52
|
9.80 Percentage of subjects
Interval 2.2 to 25.43
|
6.77 Percentage of subjects
Interval 0.0 to 95.72
|
9.87 Percentage of subjects
Interval 0.11 to 49.43
|
9.11 Percentage of subjects
Interval 5.02 to 14.91
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-40
|
—
|
5.97 Percentage of subjects
Interval 1.65 to 14.59
|
—
|
5.97 Percentage of subjects
Interval 1.65 to 14.59
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-41
|
—
|
8.77 Percentage of subjects
Interval 1.53 to 25.26
|
—
|
8.77 Percentage of subjects
Interval 1.53 to 25.26
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-42
|
12.00 Percentage of subjects
Interval 6.87 to 19.02
|
8.06 Percentage of subjects
Interval 0.5 to 31.4
|
5.56 Percentage of subjects
Interval 0.1 to 29.18
|
9.47 Percentage of subjects
Interval 5.8 to 14.4
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-43
|
12.00 Percentage of subjects
Interval 6.87 to 19.02
|
8.66 Percentage of subjects
Interval 1.55 to 24.72
|
7.53 Percentage of subjects
Interval 1.63 to 20.21
|
9.57 Percentage of subjects
Interval 6.57 to 13.33
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-44
|
12.00 Percentage of subjects
Interval 6.87 to 19.02
|
8.46 Percentage of subjects
Interval 1.25 to 25.87
|
5.93 Percentage of subjects
Interval 2.59 to 11.34
|
8.72 Percentage of subjects
Interval 4.96 to 13.98
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-45
|
12.00 Percentage of subjects
Interval 6.87 to 19.02
|
8.82 Percentage of subjects
Interval 2.16 to 22.28
|
6.57 Percentage of subjects
Interval 1.95 to 15.45
|
8.71 Percentage of subjects
Interval 5.28 to 13.36
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-46
|
12.00 Percentage of subjects
Interval 6.87 to 19.02
|
9.72 Percentage of subjects
Interval 3.93 to 19.2
|
6.91 Percentage of subjects
Interval 2.02 to 16.36
|
9.05 Percentage of subjects
Interval 5.64 to 13.6
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-47
|
12.00 Percentage of subjects
Interval 6.87 to 19.02
|
9.66 Percentage of subjects
Interval 3.9 to 19.08
|
7.05 Percentage of subjects
Interval 2.32 to 15.7
|
9.05 Percentage of subjects
Interval 5.74 to 13.43
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-48
|
12.00 Percentage of subjects
Interval 6.87 to 19.02
|
9.66 Percentage of subjects
Interval 3.9 to 19.08
|
6.96 Percentage of subjects
Interval 2.38 to 15.22
|
9.00 Percentage of subjects
Interval 5.7 to 13.36
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-49
|
12.00 Percentage of subjects
Interval 6.87 to 19.02
|
9.66 Percentage of subjects
Interval 3.9 to 19.08
|
6.96 Percentage of subjects
Interval 2.38 to 15.22
|
9.00 Percentage of subjects
Interval 5.7 to 13.36
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-50
|
12.00 Percentage of subjects
Interval 6.87 to 19.02
|
9.66 Percentage of subjects
Interval 3.9 to 19.08
|
6.96 Percentage of subjects
Interval 2.38 to 15.22
|
9.00 Percentage of subjects
Interval 5.7 to 13.36
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-51
|
12.00 Percentage of subjects
Interval 6.87 to 19.02
|
9.66 Percentage of subjects
Interval 3.9 to 19.08
|
6.96 Percentage of subjects
Interval 2.38 to 15.22
|
9.00 Percentage of subjects
Interval 5.7 to 13.36
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-52
|
12.00 Percentage of subjects
Interval 6.87 to 19.02
|
9.66 Percentage of subjects
Interval 3.9 to 19.08
|
6.96 Percentage of subjects
Interval 2.38 to 15.22
|
9.00 Percentage of subjects
Interval 5.7 to 13.36
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=139 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 9.49
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 7.87
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 7.4
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-47
|
6.67 Percentage of subjects
Interval 0.0 to 79.41
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-48
|
2.94 Percentage of subjects
Interval 0.04 to 17.37
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-49
|
1.82 Percentage of subjects
Interval 0.05 to 9.72
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-50
|
1.16 Percentage of subjects
Interval 0.03 to 6.31
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-51
|
1.11 Percentage of subjects
Interval 0.03 to 6.04
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-52
|
1.10 Percentage of subjects
Interval 0.03 to 5.97
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-41
|
—
|
8.51 Percentage of subjects
Interval 0.0 to 99.99
|
—
|
8.51 Percentage of subjects
Interval 0.0 to 99.99
|
|
Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-42
|
25.00 Percentage of subjects
Interval 0.0 to 100.0
|
7.50 Percentage of subjects
Interval 0.0 to 97.14
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
8.93 Percentage of subjects
Interval 2.7 to 20.53
|
|
Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-43
|
14.89 Percentage of subjects
Interval 0.0 to 99.25
|
7.78 Percentage of subjects
Interval 0.0 to 95.5
|
5.41 Percentage of subjects
Interval 0.01 to 39.15
|
9.20 Percentage of subjects
Interval 4.72 to 15.77
|
|
Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-44
|
15.66 Percentage of subjects
Interval 1.96 to 46.07
|
7.84 Percentage of subjects
Interval 0.0 to 91.81
|
5.00 Percentage of subjects
Interval 1.04 to 13.92
|
9.80 Percentage of subjects
Interval 5.67 to 15.49
|
|
Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-45
|
14.65 Percentage of subjects
Interval 6.92 to 26.01
|
7.89 Percentage of subjects
Interval 0.0 to 87.38
|
6.58 Percentage of subjects
Interval 0.29 to 28.35
|
9.93 Percentage of subjects
Interval 6.23 to 14.81
|
|
Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-46
|
12.57 Percentage of subjects
Interval 4.16 to 27.09
|
8.33 Percentage of subjects
Interval 0.0 to 83.24
|
7.00 Percentage of subjects
Interval 0.26 to 31.01
|
9.32 Percentage of subjects
Interval 6.33 to 13.11
|
|
Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-47
|
11.27 Percentage of subjects
Interval 2.87 to 27.49
|
8.27 Percentage of subjects
Interval 0.0 to 82.34
|
6.67 Percentage of subjects
Interval 0.32 to 28.17
|
8.78 Percentage of subjects
Interval 6.11 to 12.11
|
|
Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-48
|
11.27 Percentage of subjects
Interval 2.87 to 27.49
|
8.27 Percentage of subjects
Interval 0.0 to 82.34
|
8.52 Percentage of subjects
Interval 0.18 to 40.41
|
9.46 Percentage of subjects
Interval 6.25 to 13.6
|
|
Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-49
|
11.27 Percentage of subjects
Interval 2.87 to 27.49
|
8.27 Percentage of subjects
Interval 0.0 to 82.34
|
8.52 Percentage of subjects
Interval 0.18 to 40.41
|
9.46 Percentage of subjects
Interval 6.25 to 13.6
|
|
Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-50
|
11.27 Percentage of subjects
Interval 2.87 to 27.49
|
8.27 Percentage of subjects
Interval 0.0 to 82.34
|
8.52 Percentage of subjects
Interval 0.18 to 40.41
|
9.46 Percentage of subjects
Interval 6.25 to 13.6
|
|
Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-51
|
11.27 Percentage of subjects
Interval 2.87 to 27.49
|
8.27 Percentage of subjects
Interval 0.0 to 82.34
|
8.52 Percentage of subjects
Interval 0.18 to 40.41
|
9.46 Percentage of subjects
Interval 6.25 to 13.6
|
|
Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-52
|
11.27 Percentage of subjects
Interval 2.87 to 27.49
|
8.27 Percentage of subjects
Interval 0.0 to 82.34
|
8.52 Percentage of subjects
Interval 0.18 to 40.41
|
9.46 Percentage of subjects
Interval 6.25 to 13.6
|
|
Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-40
|
—
|
5.97 Percentage of subjects
Interval 1.65 to 14.59
|
—
|
5.97 Percentage of subjects
Interval 1.65 to 14.59
|
|
Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-41
|
—
|
6.14 Percentage of subjects
Interval 1.1 to 17.96
|
—
|
6.14 Percentage of subjects
Interval 1.1 to 17.96
|
|
Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-42
|
3.20 Percentage of subjects
Interval 0.88 to 7.99
|
5.65 Percentage of subjects
Interval 0.37 to 22.59
|
2.78 Percentage of subjects
Interval 0.05 to 15.34
|
4.21 Percentage of subjects
Interval 1.49 to 9.18
|
|
Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-43
|
3.20 Percentage of subjects
Interval 0.88 to 7.99
|
5.51 Percentage of subjects
Interval 0.26 to 23.86
|
5.38 Percentage of subjects
Interval 1.19 to 14.58
|
4.64 Percentage of subjects
Interval 2.2 to 8.47
|
|
Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-44
|
3.20 Percentage of subjects
Interval 0.88 to 7.99
|
5.38 Percentage of subjects
Interval 0.18 to 25.12
|
3.70 Percentage of subjects
Interval 1.21 to 8.43
|
4.10 Percentage of subjects
Interval 2.04 to 7.27
|
|
Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-45
|
3.20 Percentage of subjects
Interval 0.88 to 7.99
|
5.88 Percentage of subjects
Interval 0.94 to 18.02
|
6.57 Percentage of subjects
Interval 1.95 to 15.45
|
5.45 Percentage of subjects
Interval 3.22 to 8.56
|
|
Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-46
|
3.20 Percentage of subjects
Interval 0.88 to 7.99
|
6.94 Percentage of subjects
Interval 2.86 to 13.71
|
6.91 Percentage of subjects
Interval 2.02 to 16.36
|
5.97 Percentage of subjects
Interval 3.71 to 9.02
|
|
Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-47
|
3.20 Percentage of subjects
Interval 0.88 to 7.99
|
7.59 Percentage of subjects
Interval 2.56 to 16.67
|
7.05 Percentage of subjects
Interval 2.32 to 15.7
|
6.24 Percentage of subjects
Interval 3.86 to 9.45
|
|
Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-48
|
3.20 Percentage of subjects
Interval 0.88 to 7.99
|
7.59 Percentage of subjects
Interval 2.56 to 16.67
|
7.39 Percentage of subjects
Interval 2.13 to 17.55
|
6.40 Percentage of subjects
Interval 3.95 to 9.72
|
|
Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-49
|
3.20 Percentage of subjects
Interval 0.88 to 7.99
|
7.59 Percentage of subjects
Interval 2.56 to 16.67
|
7.39 Percentage of subjects
Interval 2.13 to 17.55
|
6.40 Percentage of subjects
Interval 3.95 to 9.72
|
|
Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-50
|
3.20 Percentage of subjects
Interval 0.88 to 7.99
|
7.59 Percentage of subjects
Interval 2.56 to 16.67
|
7.39 Percentage of subjects
Interval 2.13 to 17.55
|
6.40 Percentage of subjects
Interval 3.95 to 9.72
|
|
Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-51
|
3.20 Percentage of subjects
Interval 0.88 to 7.99
|
7.59 Percentage of subjects
Interval 2.56 to 16.67
|
7.39 Percentage of subjects
Interval 2.13 to 17.55
|
6.40 Percentage of subjects
Interval 3.95 to 9.72
|
|
Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-52
|
3.20 Percentage of subjects
Interval 0.88 to 7.99
|
7.59 Percentage of subjects
Interval 2.56 to 16.67
|
7.39 Percentage of subjects
Interval 2.13 to 17.55
|
6.40 Percentage of subjects
Interval 3.95 to 9.72
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was to be performed on the enrolled subjects vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine, and who returned the ADR card, i.e.: only Fluarix Tetra Group subjects who received the second dose. As no AEs were reported for the MedDRA Class considered, the "by risk status" analysis could not be performed.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
5.00 Percentage of subjects
Interval 0.0 to 99.75
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
3.57 Percentage of subjects
Interval 0.1 to 18.07
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
5.56 Percentage of subjects
Interval 0.0 to 99.52
|
0.00 Percentage of subjects
Interval 0.0 to 9.49
|
2.87 Percentage of subjects
Interval 0.03 to 17.26
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-44
|
1.20 Percentage of subjects
Interval 0.0 to 27.53
|
4.90 Percentage of subjects
Interval 0.0 to 97.43
|
1.67 Percentage of subjects
Interval 0.04 to 8.94
|
2.86 Percentage of subjects
Interval 0.4 to 9.44
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-45
|
1.27 Percentage of subjects
Interval 0.04 to 6.71
|
4.39 Percentage of subjects
Interval 0.0 to 92.73
|
0.66 Percentage of subjects
Interval 0.0 to 8.8
|
1.89 Percentage of subjects
Interval 0.3 to 6.08
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-46
|
1.64 Percentage of subjects
Interval 0.34 to 4.72
|
3.79 Percentage of subjects
Interval 0.0 to 81.65
|
1.00 Percentage of subjects
Interval 0.0 to 16.86
|
1.94 Percentage of subjects
Interval 0.53 to 4.92
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-47
|
1.47 Percentage of subjects
Interval 0.3 to 4.24
|
3.76 Percentage of subjects
Interval 0.0 to 80.95
|
1.43 Percentage of subjects
Interval 0.06 to 6.92
|
2.01 Percentage of subjects
Interval 0.7 to 4.46
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-48
|
1.47 Percentage of subjects
Interval 0.3 to 4.24
|
3.76 Percentage of subjects
Interval 0.0 to 80.95
|
1.35 Percentage of subjects
Interval 0.03 to 7.32
|
1.96 Percentage of subjects
Interval 0.66 to 4.43
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-49
|
1.47 Percentage of subjects
Interval 0.3 to 4.24
|
3.76 Percentage of subjects
Interval 0.0 to 80.95
|
1.35 Percentage of subjects
Interval 0.03 to 7.32
|
1.96 Percentage of subjects
Interval 0.66 to 4.43
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-50
|
1.47 Percentage of subjects
Interval 0.3 to 4.24
|
3.76 Percentage of subjects
Interval 0.0 to 80.95
|
1.35 Percentage of subjects
Interval 0.03 to 7.32
|
1.96 Percentage of subjects
Interval 0.66 to 4.43
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-51
|
1.47 Percentage of subjects
Interval 0.3 to 4.24
|
3.76 Percentage of subjects
Interval 0.0 to 80.95
|
1.35 Percentage of subjects
Interval 0.03 to 7.32
|
1.96 Percentage of subjects
Interval 0.66 to 4.43
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-52
|
1.47 Percentage of subjects
Interval 0.3 to 4.24
|
3.76 Percentage of subjects
Interval 0.0 to 80.95
|
1.35 Percentage of subjects
Interval 0.03 to 7.32
|
1.96 Percentage of subjects
Interval 0.66 to 4.43
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.00 Percentage of subjects
Interval 0.0 to 2.93
|
2.78 Percentage of subjects
Interval 0.05 to 15.34
|
0.35 Percentage of subjects
Interval 0.0 to 3.52
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.00 Percentage of subjects
Interval 0.0 to 2.86
|
5.38 Percentage of subjects
Interval 1.19 to 14.58
|
1.45 Percentage of subjects
Interval 0.01 to 10.7
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
4.44 Percentage of subjects
Interval 1.28 to 10.75
|
1.54 Percentage of subjects
Interval 0.07 to 7.33
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.00 Percentage of subjects
Interval 0.0 to 2.68
|
3.54 Percentage of subjects
Interval 1.43 to 7.15
|
1.53 Percentage of subjects
Interval 0.1 to 6.6
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.00 Percentage of subjects
Interval 0.0 to 2.53
|
3.69 Percentage of subjects
Interval 1.6 to 7.13
|
1.65 Percentage of subjects
Interval 0.19 to 5.97
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
3.52 Percentage of subjects
Interval 1.53 to 6.83
|
1.61 Percentage of subjects
Interval 0.18 to 5.83
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
3.48 Percentage of subjects
Interval 1.51 to 6.74
|
1.60 Percentage of subjects
Interval 0.18 to 5.79
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
3.48 Percentage of subjects
Interval 1.51 to 6.74
|
1.60 Percentage of subjects
Interval 0.18 to 5.79
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
3.48 Percentage of subjects
Interval 1.51 to 6.74
|
1.60 Percentage of subjects
Interval 0.18 to 5.79
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
3.48 Percentage of subjects
Interval 1.51 to 6.74
|
1.60 Percentage of subjects
Interval 0.18 to 5.79
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
3.48 Percentage of subjects
Interval 1.51 to 6.74
|
1.60 Percentage of subjects
Interval 0.18 to 5.79
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=139 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 9.49
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 7.87
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 7.4
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-48
|
5.88 Percentage of subjects
Interval 0.07 to 32.75
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-49
|
7.27 Percentage of subjects
Interval 0.65 to 26.14
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-50
|
4.65 Percentage of subjects
Interval 0.39 to 17.73
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-51
|
4.44 Percentage of subjects
Interval 0.37 to 17.05
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-52
|
4.40 Percentage of subjects
Interval 0.36 to 16.89
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-41
|
—
|
8.51 Percentage of subjects
Interval 0.0 to 99.99
|
—
|
8.51 Percentage of subjects
Interval 0.0 to 99.99
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-42
|
12.50 Percentage of subjects
Interval 0.0 to 99.41
|
8.75 Percentage of subjects
Interval 0.0 to 99.35
|
31.25 Percentage of subjects
Interval 1.75 to 83.28
|
12.50 Percentage of subjects
Interval 3.59 to 28.74
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-43
|
17.02 Percentage of subjects
Interval 0.13 to 73.09
|
11.11 Percentage of subjects
Interval 0.0 to 99.86
|
29.73 Percentage of subjects
Interval 0.0 to 98.65
|
16.67 Percentage of subjects
Interval 6.65 to 32.12
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-44
|
20.48 Percentage of subjects
Interval 12.41 to 30.76
|
10.78 Percentage of subjects
Interval 0.0 to 99.23
|
26.67 Percentage of subjects
Interval 7.84 to 54.97
|
17.96 Percentage of subjects
Interval 9.63 to 29.3
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-45
|
20.38 Percentage of subjects
Interval 14.38 to 27.54
|
12.28 Percentage of subjects
Interval 0.0 to 99.36
|
23.03 Percentage of subjects
Interval 4.14 to 56.68
|
19.15 Percentage of subjects
Interval 13.3 to 26.21
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-46
|
18.58 Percentage of subjects
Interval 13.22 to 24.98
|
12.12 Percentage of subjects
Interval 0.0 to 97.62
|
22.50 Percentage of subjects
Interval 7.16 to 46.4
|
18.45 Percentage of subjects
Interval 13.7 to 24.01
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-47
|
17.65 Percentage of subjects
Interval 12.68 to 23.58
|
12.03 Percentage of subjects
Interval 0.0 to 97.36
|
22.86 Percentage of subjects
Interval 6.62 to 48.7
|
18.28 Percentage of subjects
Interval 13.54 to 23.84
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-48
|
17.65 Percentage of subjects
Interval 12.68 to 23.58
|
12.03 Percentage of subjects
Interval 0.0 to 97.36
|
22.87 Percentage of subjects
Interval 7.69 to 46.03
|
18.39 Percentage of subjects
Interval 13.8 to 23.75
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-49
|
17.65 Percentage of subjects
Interval 12.68 to 23.58
|
12.03 Percentage of subjects
Interval 0.0 to 97.36
|
22.87 Percentage of subjects
Interval 7.69 to 46.03
|
18.39 Percentage of subjects
Interval 13.8 to 23.75
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-50
|
17.65 Percentage of subjects
Interval 12.68 to 23.58
|
12.03 Percentage of subjects
Interval 0.0 to 97.36
|
22.87 Percentage of subjects
Interval 7.69 to 46.03
|
18.39 Percentage of subjects
Interval 13.8 to 23.75
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-51
|
17.65 Percentage of subjects
Interval 12.68 to 23.58
|
12.03 Percentage of subjects
Interval 0.0 to 97.36
|
22.87 Percentage of subjects
Interval 7.69 to 46.03
|
18.39 Percentage of subjects
Interval 13.8 to 23.75
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-52
|
17.65 Percentage of subjects
Interval 12.68 to 23.58
|
12.03 Percentage of subjects
Interval 0.0 to 97.36
|
22.87 Percentage of subjects
Interval 7.69 to 46.03
|
18.39 Percentage of subjects
Interval 13.8 to 23.75
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-40
|
—
|
8.96 Percentage of subjects
Interval 3.36 to 18.48
|
—
|
8.96 Percentage of subjects
Interval 3.36 to 18.48
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-41
|
—
|
12.28 Percentage of subjects
Interval 4.45 to 25.38
|
—
|
12.28 Percentage of subjects
Interval 4.45 to 25.38
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-42
|
9.60 Percentage of subjects
Interval 5.06 to 16.17
|
12.10 Percentage of subjects
Interval 3.48 to 27.87
|
25.00 Percentage of subjects
Interval 0.16 to 87.94
|
12.63 Percentage of subjects
Interval 6.85 to 20.72
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-43
|
9.60 Percentage of subjects
Interval 5.06 to 16.17
|
11.81 Percentage of subjects
Interval 3.08 to 28.4
|
24.73 Percentage of subjects
Interval 16.37 to 34.76
|
14.49 Percentage of subjects
Interval 6.58 to 26.33
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-44
|
9.60 Percentage of subjects
Interval 5.06 to 16.17
|
11.54 Percentage of subjects
Interval 2.65 to 29.25
|
22.22 Percentage of subjects
Interval 14.01 to 32.4
|
14.62 Percentage of subjects
Interval 8.24 to 23.28
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-45
|
9.60 Percentage of subjects
Interval 5.06 to 16.17
|
11.76 Percentage of subjects
Interval 3.37 to 27.2
|
22.22 Percentage of subjects
Interval 8.23 to 43.14
|
15.69 Percentage of subjects
Interval 9.73 to 23.39
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-46
|
9.60 Percentage of subjects
Interval 5.06 to 16.17
|
11.11 Percentage of subjects
Interval 2.28 to 29.5
|
22.12 Percentage of subjects
Interval 9.18 to 40.79
|
15.64 Percentage of subjects
Interval 9.72 to 23.28
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-47
|
9.60 Percentage of subjects
Interval 5.06 to 16.17
|
11.03 Percentage of subjects
Interval 2.15 to 29.85
|
22.47 Percentage of subjects
Interval 8.39 to 43.4
|
15.90 Percentage of subjects
Interval 9.76 to 23.85
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-48
|
9.60 Percentage of subjects
Interval 5.06 to 16.17
|
11.03 Percentage of subjects
Interval 2.15 to 29.85
|
23.04 Percentage of subjects
Interval 6.94 to 48.35
|
16.20 Percentage of subjects
Interval 9.72 to 24.69
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-49
|
9.60 Percentage of subjects
Interval 5.06 to 16.17
|
11.03 Percentage of subjects
Interval 2.15 to 29.85
|
23.04 Percentage of subjects
Interval 6.94 to 48.35
|
16.20 Percentage of subjects
Interval 9.72 to 24.69
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-50
|
9.60 Percentage of subjects
Interval 5.06 to 16.17
|
11.03 Percentage of subjects
Interval 2.15 to 29.85
|
23.04 Percentage of subjects
Interval 6.94 to 48.35
|
16.20 Percentage of subjects
Interval 9.72 to 24.69
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-51
|
9.60 Percentage of subjects
Interval 5.06 to 16.17
|
11.03 Percentage of subjects
Interval 2.15 to 29.85
|
23.04 Percentage of subjects
Interval 6.94 to 48.35
|
16.20 Percentage of subjects
Interval 9.72 to 24.69
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-52
|
9.60 Percentage of subjects
Interval 5.06 to 16.17
|
11.03 Percentage of subjects
Interval 2.15 to 29.85
|
23.04 Percentage of subjects
Interval 6.94 to 48.35
|
16.20 Percentage of subjects
Interval 9.72 to 24.69
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=139 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-47
|
28.57 Percentage of subjects
Interval 0.0 to 100.0
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-48
|
30.77 Percentage of subjects
Interval 0.0 to 100.0
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-49
|
23.08 Percentage of subjects
Interval 0.7 to 76.09
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-50
|
18.92 Percentage of subjects
Interval 1.97 to 55.63
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-51
|
20.00 Percentage of subjects
Interval 0.96 to 66.16
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-52
|
18.75 Percentage of subjects
Interval 0.67 to 66.08
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-47
|
6.67 Percentage of subjects
Interval 0.0 to 79.41
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-48
|
23.53 Percentage of subjects
Interval 0.1 to 87.82
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-49
|
16.36 Percentage of subjects
Interval 7.0 to 30.49
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-50
|
11.63 Percentage of subjects
Interval 4.28 to 23.93
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-51
|
11.11 Percentage of subjects
Interval 4.26 to 22.44
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-52
|
10.99 Percentage of subjects
Interval 4.25 to 22.1
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-41
|
—
|
2.13 Percentage of subjects
Interval 0.0 to 99.46
|
—
|
2.13 Percentage of subjects
Interval 0.0 to 99.46
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
2.50 Percentage of subjects
Interval 0.0 to 94.21
|
12.50 Percentage of subjects
Interval 1.15 to 41.43
|
3.57 Percentage of subjects
Interval 0.42 to 12.48
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-43
|
2.13 Percentage of subjects
Interval 0.03 to 12.41
|
2.22 Percentage of subjects
Interval 0.0 to 86.59
|
5.41 Percentage of subjects
Interval 0.01 to 39.15
|
2.87 Percentage of subjects
Interval 0.94 to 6.58
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-44
|
1.20 Percentage of subjects
Interval 0.01 to 8.25
|
1.96 Percentage of subjects
Interval 0.0 to 75.07
|
5.00 Percentage of subjects
Interval 1.04 to 13.92
|
2.45 Percentage of subjects
Interval 0.8 to 5.62
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-45
|
3.82 Percentage of subjects
Interval 1.42 to 8.13
|
1.75 Percentage of subjects
Interval 0.0 to 63.29
|
3.29 Percentage of subjects
Interval 0.0 to 29.73
|
3.07 Percentage of subjects
Interval 1.42 to 5.73
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-46
|
3.28 Percentage of subjects
Interval 1.21 to 7.0
|
1.52 Percentage of subjects
Interval 0.0 to 47.97
|
2.50 Percentage of subjects
Interval 0.0 to 28.45
|
2.52 Percentage of subjects
Interval 1.05 to 5.03
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-47
|
2.94 Percentage of subjects
Interval 1.09 to 6.29
|
1.50 Percentage of subjects
Interval 0.0 to 47.23
|
2.38 Percentage of subjects
Interval 0.0 to 27.72
|
2.38 Percentage of subjects
Interval 1.02 to 4.65
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-48
|
2.94 Percentage of subjects
Interval 1.09 to 6.29
|
1.50 Percentage of subjects
Interval 0.0 to 47.23
|
2.24 Percentage of subjects
Interval 0.0 to 27.87
|
2.32 Percentage of subjects
Interval 0.95 to 4.7
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-49
|
2.94 Percentage of subjects
Interval 1.09 to 6.29
|
1.50 Percentage of subjects
Interval 0.0 to 47.23
|
2.24 Percentage of subjects
Interval 0.0 to 27.87
|
2.32 Percentage of subjects
Interval 0.95 to 4.7
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-50
|
2.94 Percentage of subjects
Interval 1.09 to 6.29
|
1.50 Percentage of subjects
Interval 0.0 to 47.23
|
2.24 Percentage of subjects
Interval 0.0 to 27.87
|
2.32 Percentage of subjects
Interval 0.95 to 4.7
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-51
|
2.94 Percentage of subjects
Interval 1.09 to 6.29
|
1.50 Percentage of subjects
Interval 0.0 to 47.23
|
2.24 Percentage of subjects
Interval 0.0 to 27.87
|
2.32 Percentage of subjects
Interval 0.95 to 4.7
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-52
|
2.94 Percentage of subjects
Interval 1.09 to 6.29
|
1.50 Percentage of subjects
Interval 0.0 to 47.23
|
2.24 Percentage of subjects
Interval 0.0 to 27.87
|
2.32 Percentage of subjects
Interval 0.95 to 4.7
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-40
|
—
|
2.99 Percentage of subjects
Interval 0.36 to 10.37
|
—
|
2.99 Percentage of subjects
Interval 0.36 to 10.37
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-41
|
—
|
1.75 Percentage of subjects
Interval 0.21 to 6.19
|
—
|
1.75 Percentage of subjects
Interval 0.21 to 6.19
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
1.61 Percentage of subjects
Interval 0.12 to 6.74
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.70 Percentage of subjects
Interval 0.01 to 4.79
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
2.36 Percentage of subjects
Interval 0.38 to 7.46
|
0.00 Percentage of subjects
Interval 0.0 to 3.89
|
0.87 Percentage of subjects
Interval 0.03 to 4.43
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
2.31 Percentage of subjects
Interval 0.47 to 6.65
|
0.74 Percentage of subjects
Interval 0.0 to 30.06
|
1.03 Percentage of subjects
Interval 0.07 to 4.33
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
2.21 Percentage of subjects
Interval 0.46 to 6.31
|
0.51 Percentage of subjects
Interval 0.0 to 19.03
|
0.87 Percentage of subjects
Interval 0.06 to 3.7
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
2.78 Percentage of subjects
Interval 0.17 to 11.91
|
0.46 Percentage of subjects
Interval 0.0 to 16.65
|
1.03 Percentage of subjects
Interval 0.07 to 4.31
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
2.76 Percentage of subjects
Interval 0.18 to 11.54
|
0.44 Percentage of subjects
Interval 0.0 to 14.95
|
1.01 Percentage of subjects
Interval 0.08 to 4.15
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
2.76 Percentage of subjects
Interval 0.18 to 11.54
|
0.43 Percentage of subjects
Interval 0.0 to 14.44
|
1.00 Percentage of subjects
Interval 0.08 to 4.1
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
2.76 Percentage of subjects
Interval 0.18 to 11.54
|
0.43 Percentage of subjects
Interval 0.0 to 14.44
|
1.00 Percentage of subjects
Interval 0.08 to 4.1
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
2.76 Percentage of subjects
Interval 0.18 to 11.54
|
0.43 Percentage of subjects
Interval 0.0 to 14.44
|
1.00 Percentage of subjects
Interval 0.08 to 4.1
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
2.76 Percentage of subjects
Interval 0.18 to 11.54
|
0.43 Percentage of subjects
Interval 0.0 to 14.44
|
1.00 Percentage of subjects
Interval 0.08 to 4.1
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
2.76 Percentage of subjects
Interval 0.18 to 11.54
|
0.43 Percentage of subjects
Interval 0.0 to 14.44
|
1.00 Percentage of subjects
Interval 0.08 to 4.1
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=139 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 9.49
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 7.87
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 7.4
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-48
|
2.94 Percentage of subjects
Interval 0.04 to 17.37
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-49
|
1.82 Percentage of subjects
Interval 0.05 to 9.72
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-50
|
1.16 Percentage of subjects
Interval 0.03 to 6.31
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-51
|
1.11 Percentage of subjects
Interval 0.03 to 6.04
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-52
|
1.10 Percentage of subjects
Interval 0.03 to 5.97
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
|
Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 3.24
|
|
Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
0.00 Percentage of subjects
Interval 0.0 to 4.02
|
0.00 Percentage of subjects
Interval 0.0 to 9.49
|
0.00 Percentage of subjects
Interval 0.0 to 2.1
|
|
Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 4.35
|
0.00 Percentage of subjects
Interval 0.0 to 3.55
|
0.00 Percentage of subjects
Interval 0.0 to 5.96
|
0.00 Percentage of subjects
Interval 0.0 to 1.49
|
|
Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 2.32
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.00 Percentage of subjects
Interval 0.0 to 2.4
|
0.00 Percentage of subjects
Interval 0.0 to 0.87
|
|
Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 2.0
|
0.00 Percentage of subjects
Interval 0.0 to 2.76
|
0.00 Percentage of subjects
Interval 0.0 to 1.83
|
0.00 Percentage of subjects
Interval 0.0 to 0.71
|
|
Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
0.00 Percentage of subjects
Interval 0.0 to 1.74
|
0.00 Percentage of subjects
Interval 0.0 to 0.67
|
|
Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
0.00 Percentage of subjects
Interval 0.0 to 1.64
|
0.00 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
0.00 Percentage of subjects
Interval 0.0 to 1.64
|
0.00 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
0.00 Percentage of subjects
Interval 0.0 to 1.64
|
0.00 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
0.00 Percentage of subjects
Interval 0.0 to 1.64
|
0.00 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
0.00 Percentage of subjects
Interval 0.0 to 1.64
|
0.00 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-40
|
—
|
1.49 Percentage of subjects
Interval 0.04 to 8.04
|
—
|
1.49 Percentage of subjects
Interval 0.04 to 8.04
|
|
Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-41
|
—
|
0.88 Percentage of subjects
Interval 0.02 to 4.79
|
—
|
0.88 Percentage of subjects
Interval 0.02 to 4.79
|
|
Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.81 Percentage of subjects
Interval 0.02 to 4.41
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.35 Percentage of subjects
Interval 0.0 to 2.41
|
|
Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.79 Percentage of subjects
Interval 0.02 to 4.31
|
0.00 Percentage of subjects
Interval 0.0 to 3.89
|
0.29 Percentage of subjects
Interval 0.0 to 2.16
|
|
Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.77 Percentage of subjects
Interval 0.02 to 4.21
|
0.00 Percentage of subjects
Interval 0.0 to 2.7
|
0.26 Percentage of subjects
Interval 0.0 to 1.83
|
|
Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.74 Percentage of subjects
Interval 0.01 to 4.27
|
0.00 Percentage of subjects
Interval 0.0 to 1.85
|
0.22 Percentage of subjects
Interval 0.0 to 1.64
|
|
Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.69 Percentage of subjects
Interval 0.0 to 4.82
|
0.00 Percentage of subjects
Interval 0.0 to 1.69
|
0.21 Percentage of subjects
Interval 0.0 to 1.56
|
|
Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.69 Percentage of subjects
Interval 0.0 to 4.89
|
0.00 Percentage of subjects
Interval 0.0 to 1.61
|
0.20 Percentage of subjects
Interval 0.0 to 1.52
|
|
Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.69 Percentage of subjects
Interval 0.0 to 4.89
|
0.00 Percentage of subjects
Interval 0.0 to 1.59
|
0.20 Percentage of subjects
Interval 0.0 to 1.51
|
|
Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.69 Percentage of subjects
Interval 0.0 to 4.89
|
0.00 Percentage of subjects
Interval 0.0 to 1.59
|
0.20 Percentage of subjects
Interval 0.0 to 1.51
|
|
Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.69 Percentage of subjects
Interval 0.0 to 4.89
|
0.00 Percentage of subjects
Interval 0.0 to 1.59
|
0.20 Percentage of subjects
Interval 0.0 to 1.51
|
|
Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.69 Percentage of subjects
Interval 0.0 to 4.89
|
0.00 Percentage of subjects
Interval 0.0 to 1.59
|
0.20 Percentage of subjects
Interval 0.0 to 1.51
|
|
Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.69 Percentage of subjects
Interval 0.0 to 4.89
|
0.00 Percentage of subjects
Interval 0.0 to 1.59
|
0.20 Percentage of subjects
Interval 0.0 to 1.51
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was to be performed on the enrolled subjects vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine, and who returned the ADR card, i.e.: only Fluarix Tetra Group subjects who received the second dose. As no AEs were reported for the MedDRA Class considered, the "by risk status" analysis could not be performed.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-41
|
—
|
2.13 Percentage of subjects
Interval 0.0 to 99.46
|
—
|
2.13 Percentage of subjects
Interval 0.0 to 99.46
|
|
Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
1.25 Percentage of subjects
Interval 0.0 to 75.19
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.89 Percentage of subjects
Interval 0.02 to 4.87
|
|
Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
1.11 Percentage of subjects
Interval 0.0 to 62.7
|
0.00 Percentage of subjects
Interval 0.0 to 9.49
|
0.57 Percentage of subjects
Interval 0.01 to 3.61
|
|
Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-44
|
1.20 Percentage of subjects
Interval 0.0 to 27.53
|
0.98 Percentage of subjects
Interval 0.0 to 49.52
|
1.67 Percentage of subjects
Interval 0.04 to 8.94
|
1.22 Percentage of subjects
Interval 0.25 to 3.54
|
|
Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-45
|
0.64 Percentage of subjects
Interval 0.0 to 18.63
|
1.75 Percentage of subjects
Interval 0.0 to 63.29
|
0.66 Percentage of subjects
Interval 0.0 to 8.8
|
0.95 Percentage of subjects
Interval 0.16 to 2.98
|
|
Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-46
|
0.55 Percentage of subjects
Interval 0.0 to 17.51
|
2.27 Percentage of subjects
Interval 0.0 to 62.91
|
0.50 Percentage of subjects
Interval 0.0 to 8.76
|
0.97 Percentage of subjects
Interval 0.11 to 3.52
|
|
Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-47
|
0.49 Percentage of subjects
Interval 0.0 to 16.62
|
2.26 Percentage of subjects
Interval 0.0 to 62.1
|
0.48 Percentage of subjects
Interval 0.0 to 8.76
|
0.91 Percentage of subjects
Interval 0.09 to 3.45
|
|
Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-48
|
0.49 Percentage of subjects
Interval 0.0 to 16.62
|
2.26 Percentage of subjects
Interval 0.0 to 62.1
|
0.45 Percentage of subjects
Interval 0.0 to 8.85
|
0.89 Percentage of subjects
Interval 0.09 to 3.42
|
|
Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-49
|
0.49 Percentage of subjects
Interval 0.0 to 16.62
|
2.26 Percentage of subjects
Interval 0.0 to 62.1
|
0.45 Percentage of subjects
Interval 0.0 to 8.85
|
0.89 Percentage of subjects
Interval 0.09 to 3.42
|
|
Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-50
|
0.49 Percentage of subjects
Interval 0.0 to 16.62
|
2.26 Percentage of subjects
Interval 0.0 to 62.1
|
0.45 Percentage of subjects
Interval 0.0 to 8.85
|
0.89 Percentage of subjects
Interval 0.09 to 3.42
|
|
Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-51
|
0.49 Percentage of subjects
Interval 0.0 to 16.62
|
2.26 Percentage of subjects
Interval 0.0 to 62.1
|
0.45 Percentage of subjects
Interval 0.0 to 8.85
|
0.89 Percentage of subjects
Interval 0.09 to 3.42
|
|
Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-52
|
0.49 Percentage of subjects
Interval 0.0 to 16.62
|
2.26 Percentage of subjects
Interval 0.0 to 62.1
|
0.45 Percentage of subjects
Interval 0.0 to 8.85
|
0.89 Percentage of subjects
Interval 0.09 to 3.42
|
|
Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
|
Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-41
|
—
|
0.88 Percentage of subjects
Interval 0.02 to 4.79
|
—
|
0.88 Percentage of subjects
Interval 0.02 to 4.79
|
|
Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.81 Percentage of subjects
Interval 0.02 to 4.41
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.35 Percentage of subjects
Interval 0.0 to 2.41
|
|
Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.79 Percentage of subjects
Interval 0.02 to 4.31
|
0.00 Percentage of subjects
Interval 0.0 to 3.89
|
0.29 Percentage of subjects
Interval 0.0 to 2.16
|
|
Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.77 Percentage of subjects
Interval 0.02 to 4.21
|
0.00 Percentage of subjects
Interval 0.0 to 2.7
|
0.26 Percentage of subjects
Interval 0.0 to 1.83
|
|
Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
1.47 Percentage of subjects
Interval 0.04 to 7.88
|
0.00 Percentage of subjects
Interval 0.0 to 1.85
|
0.44 Percentage of subjects
Interval 0.02 to 2.21
|
|
Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
1.39 Percentage of subjects
Interval 0.09 to 6.05
|
0.00 Percentage of subjects
Interval 0.0 to 1.69
|
0.41 Percentage of subjects
Interval 0.02 to 2.04
|
|
Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
1.38 Percentage of subjects
Interval 0.09 to 5.86
|
0.00 Percentage of subjects
Interval 0.0 to 1.61
|
0.40 Percentage of subjects
Interval 0.02 to 1.98
|
|
Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
1.38 Percentage of subjects
Interval 0.09 to 5.86
|
0.00 Percentage of subjects
Interval 0.0 to 1.59
|
0.40 Percentage of subjects
Interval 0.02 to 1.97
|
|
Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
1.38 Percentage of subjects
Interval 0.09 to 5.86
|
0.00 Percentage of subjects
Interval 0.0 to 1.59
|
0.40 Percentage of subjects
Interval 0.02 to 1.97
|
|
Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
1.38 Percentage of subjects
Interval 0.09 to 5.86
|
0.00 Percentage of subjects
Interval 0.0 to 1.59
|
0.40 Percentage of subjects
Interval 0.02 to 1.97
|
|
Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
1.38 Percentage of subjects
Interval 0.09 to 5.86
|
0.00 Percentage of subjects
Interval 0.0 to 1.59
|
0.40 Percentage of subjects
Interval 0.02 to 1.97
|
|
Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
1.38 Percentage of subjects
Interval 0.09 to 5.86
|
0.00 Percentage of subjects
Interval 0.0 to 1.59
|
0.40 Percentage of subjects
Interval 0.02 to 1.97
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was to be performed on the enrolled subjects vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine, and who returned the ADR card, i.e.: only Fluarix Tetra Group subjects who received the second dose. As no AEs were reported for the MedDRA Class considered, the "by risk status" analysis could not be performed.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
2.50 Percentage of subjects
Interval 0.0 to 94.21
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
1.79 Percentage of subjects
Interval 0.05 to 9.29
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
2.22 Percentage of subjects
Interval 0.0 to 86.59
|
0.00 Percentage of subjects
Interval 0.0 to 9.49
|
1.15 Percentage of subjects
Interval 0.01 to 7.15
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-44
|
1.20 Percentage of subjects
Interval 0.0 to 27.53
|
1.96 Percentage of subjects
Interval 0.0 to 75.07
|
0.00 Percentage of subjects
Interval 0.0 to 5.96
|
1.22 Percentage of subjects
Interval 0.13 to 4.52
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-45
|
0.64 Percentage of subjects
Interval 0.0 to 18.63
|
1.75 Percentage of subjects
Interval 0.0 to 63.29
|
0.00 Percentage of subjects
Interval 0.0 to 2.4
|
0.71 Percentage of subjects
Interval 0.04 to 3.13
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-46
|
0.55 Percentage of subjects
Interval 0.0 to 17.51
|
1.52 Percentage of subjects
Interval 0.0 to 47.97
|
0.00 Percentage of subjects
Interval 0.0 to 1.83
|
0.58 Percentage of subjects
Interval 0.03 to 2.63
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-47
|
0.49 Percentage of subjects
Interval 0.0 to 16.62
|
1.50 Percentage of subjects
Interval 0.0 to 47.23
|
0.00 Percentage of subjects
Interval 0.0 to 1.74
|
0.55 Percentage of subjects
Interval 0.03 to 2.55
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-48
|
0.49 Percentage of subjects
Interval 0.0 to 16.62
|
1.50 Percentage of subjects
Interval 0.0 to 47.23
|
0.00 Percentage of subjects
Interval 0.0 to 1.64
|
0.54 Percentage of subjects
Interval 0.03 to 2.52
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-49
|
0.49 Percentage of subjects
Interval 0.0 to 16.62
|
1.50 Percentage of subjects
Interval 0.0 to 47.23
|
0.00 Percentage of subjects
Interval 0.0 to 1.64
|
0.54 Percentage of subjects
Interval 0.03 to 2.52
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-50
|
0.49 Percentage of subjects
Interval 0.0 to 16.62
|
1.50 Percentage of subjects
Interval 0.0 to 47.23
|
0.00 Percentage of subjects
Interval 0.0 to 1.64
|
0.54 Percentage of subjects
Interval 0.03 to 2.52
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-51
|
0.49 Percentage of subjects
Interval 0.0 to 16.62
|
1.50 Percentage of subjects
Interval 0.0 to 47.23
|
0.00 Percentage of subjects
Interval 0.0 to 1.64
|
0.54 Percentage of subjects
Interval 0.03 to 2.52
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-52
|
0.49 Percentage of subjects
Interval 0.0 to 16.62
|
1.50 Percentage of subjects
Interval 0.0 to 47.23
|
0.00 Percentage of subjects
Interval 0.0 to 1.64
|
0.54 Percentage of subjects
Interval 0.03 to 2.52
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-40
|
—
|
1.49 Percentage of subjects
Interval 0.04 to 8.04
|
—
|
1.49 Percentage of subjects
Interval 0.04 to 8.04
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-41
|
—
|
0.88 Percentage of subjects
Interval 0.02 to 4.79
|
—
|
0.88 Percentage of subjects
Interval 0.02 to 4.79
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.81 Percentage of subjects
Interval 0.02 to 4.41
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.35 Percentage of subjects
Interval 0.0 to 2.41
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.79 Percentage of subjects
Interval 0.02 to 4.31
|
0.00 Percentage of subjects
Interval 0.0 to 3.89
|
0.29 Percentage of subjects
Interval 0.0 to 2.16
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.77 Percentage of subjects
Interval 0.02 to 4.21
|
0.00 Percentage of subjects
Interval 0.0 to 2.7
|
0.26 Percentage of subjects
Interval 0.0 to 1.83
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.74 Percentage of subjects
Interval 0.01 to 4.27
|
0.00 Percentage of subjects
Interval 0.0 to 1.85
|
0.22 Percentage of subjects
Interval 0.0 to 1.64
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.69 Percentage of subjects
Interval 0.0 to 4.82
|
0.00 Percentage of subjects
Interval 0.0 to 1.69
|
0.21 Percentage of subjects
Interval 0.0 to 1.56
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.69 Percentage of subjects
Interval 0.0 to 4.89
|
0.00 Percentage of subjects
Interval 0.0 to 1.61
|
0.20 Percentage of subjects
Interval 0.0 to 1.52
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.69 Percentage of subjects
Interval 0.0 to 4.89
|
0.00 Percentage of subjects
Interval 0.0 to 1.59
|
0.20 Percentage of subjects
Interval 0.0 to 1.51
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.69 Percentage of subjects
Interval 0.0 to 4.89
|
0.00 Percentage of subjects
Interval 0.0 to 1.59
|
0.20 Percentage of subjects
Interval 0.0 to 1.51
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.69 Percentage of subjects
Interval 0.0 to 4.89
|
0.00 Percentage of subjects
Interval 0.0 to 1.59
|
0.20 Percentage of subjects
Interval 0.0 to 1.51
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.69 Percentage of subjects
Interval 0.0 to 4.89
|
0.00 Percentage of subjects
Interval 0.0 to 1.59
|
0.20 Percentage of subjects
Interval 0.0 to 1.51
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.69 Percentage of subjects
Interval 0.0 to 4.89
|
0.00 Percentage of subjects
Interval 0.0 to 1.59
|
0.20 Percentage of subjects
Interval 0.0 to 1.51
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=139 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-47
|
14.29 Percentage of subjects
Interval 0.0 to 100.0
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-48
|
7.69 Percentage of subjects
Interval 0.0 to 90.25
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-49
|
3.85 Percentage of subjects
Interval 0.1 to 19.72
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-50
|
2.70 Percentage of subjects
Interval 0.07 to 14.16
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-51
|
2.22 Percentage of subjects
Interval 0.06 to 11.77
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-47
|
6.67 Percentage of subjects
Interval 0.0 to 79.41
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
At risk,Weeks 40-52
|
2.08 Percentage of subjects
Interval 0.05 to 11.07
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-48
|
2.94 Percentage of subjects
Interval 0.04 to 17.37
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-49
|
1.82 Percentage of subjects
Interval 0.05 to 9.72
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-50
|
1.16 Percentage of subjects
Interval 0.03 to 6.31
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-51
|
1.11 Percentage of subjects
Interval 0.03 to 6.04
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-52
|
1.10 Percentage of subjects
Interval 0.03 to 5.97
|
—
|
—
|
—
|
|
Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status
Not at risk,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
|
Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 3.24
|
|
Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
0.00 Percentage of subjects
Interval 0.0 to 4.02
|
0.00 Percentage of subjects
Interval 0.0 to 9.49
|
0.00 Percentage of subjects
Interval 0.0 to 2.1
|
|
Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 4.35
|
0.00 Percentage of subjects
Interval 0.0 to 3.55
|
0.00 Percentage of subjects
Interval 0.0 to 5.96
|
0.00 Percentage of subjects
Interval 0.0 to 1.49
|
|
Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 2.32
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.00 Percentage of subjects
Interval 0.0 to 2.4
|
0.00 Percentage of subjects
Interval 0.0 to 0.87
|
|
Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 2.0
|
0.00 Percentage of subjects
Interval 0.0 to 2.76
|
0.00 Percentage of subjects
Interval 0.0 to 1.83
|
0.00 Percentage of subjects
Interval 0.0 to 0.71
|
|
Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
0.00 Percentage of subjects
Interval 0.0 to 1.74
|
0.00 Percentage of subjects
Interval 0.0 to 0.67
|
|
Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
0.00 Percentage of subjects
Interval 0.0 to 1.64
|
0.00 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
0.00 Percentage of subjects
Interval 0.0 to 1.64
|
0.00 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
0.00 Percentage of subjects
Interval 0.0 to 1.64
|
0.00 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
0.00 Percentage of subjects
Interval 0.0 to 1.64
|
0.00 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
0.00 Percentage of subjects
Interval 0.0 to 1.64
|
0.00 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
|
Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
|
Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.00 Percentage of subjects
Interval 0.0 to 2.93
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 1.29
|
|
Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.00 Percentage of subjects
Interval 0.0 to 2.86
|
0.00 Percentage of subjects
Interval 0.0 to 3.89
|
0.00 Percentage of subjects
Interval 0.0 to 1.06
|
|
Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.00 Percentage of subjects
Interval 0.0 to 2.7
|
0.00 Percentage of subjects
Interval 0.0 to 0.94
|
|
Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.74 Percentage of subjects
Interval 0.0 to 20.74
|
0.00 Percentage of subjects
Interval 0.0 to 1.85
|
0.22 Percentage of subjects
Interval 0.0 to 2.05
|
|
Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.69 Percentage of subjects
Interval 0.0 to 17.92
|
0.00 Percentage of subjects
Interval 0.0 to 1.69
|
0.21 Percentage of subjects
Interval 0.0 to 1.88
|
|
Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.69 Percentage of subjects
Interval 0.0 to 17.61
|
0.00 Percentage of subjects
Interval 0.0 to 1.61
|
0.20 Percentage of subjects
Interval 0.0 to 1.83
|
|
Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.69 Percentage of subjects
Interval 0.0 to 17.61
|
0.00 Percentage of subjects
Interval 0.0 to 1.59
|
0.20 Percentage of subjects
Interval 0.0 to 1.82
|
|
Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.69 Percentage of subjects
Interval 0.0 to 17.61
|
0.00 Percentage of subjects
Interval 0.0 to 1.59
|
0.20 Percentage of subjects
Interval 0.0 to 1.82
|
|
Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.69 Percentage of subjects
Interval 0.0 to 17.61
|
0.00 Percentage of subjects
Interval 0.0 to 1.59
|
0.20 Percentage of subjects
Interval 0.0 to 1.82
|
|
Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.69 Percentage of subjects
Interval 0.0 to 17.61
|
0.00 Percentage of subjects
Interval 0.0 to 1.59
|
0.20 Percentage of subjects
Interval 0.0 to 1.82
|
|
Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.69 Percentage of subjects
Interval 0.0 to 17.61
|
0.00 Percentage of subjects
Interval 0.0 to 1.59
|
0.20 Percentage of subjects
Interval 0.0 to 1.82
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was to be performed on the enrolled subjects vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine, and who returned the ADR card, i.e.: only Fluarix Tetra Group subjects who received the second dose. As no AEs were reported for the MedDRA Class considered, the "by risk status" analysis could not be performed.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
|
Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
2.50 Percentage of subjects
Interval 0.0 to 94.21
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
1.79 Percentage of subjects
Interval 0.05 to 9.29
|
|
Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
3.33 Percentage of subjects
Interval 0.0 to 95.38
|
0.00 Percentage of subjects
Interval 0.0 to 9.49
|
1.72 Percentage of subjects
Interval 0.02 to 10.6
|
|
Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 4.35
|
2.94 Percentage of subjects
Interval 0.0 to 87.98
|
0.00 Percentage of subjects
Interval 0.0 to 5.96
|
1.22 Percentage of subjects
Interval 0.02 to 6.96
|
|
Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-45
|
0.64 Percentage of subjects
Interval 0.02 to 3.5
|
2.63 Percentage of subjects
Interval 0.0 to 78.24
|
0.00 Percentage of subjects
Interval 0.0 to 2.4
|
0.95 Percentage of subjects
Interval 0.07 to 3.9
|
|
Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-46
|
0.55 Percentage of subjects
Interval 0.01 to 3.01
|
2.27 Percentage of subjects
Interval 0.0 to 62.91
|
0.00 Percentage of subjects
Interval 0.0 to 1.83
|
0.78 Percentage of subjects
Interval 0.06 to 3.23
|
|
Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-47
|
0.49 Percentage of subjects
Interval 0.01 to 2.7
|
2.26 Percentage of subjects
Interval 0.0 to 62.1
|
0.00 Percentage of subjects
Interval 0.0 to 1.74
|
0.73 Percentage of subjects
Interval 0.05 to 3.09
|
|
Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-48
|
0.49 Percentage of subjects
Interval 0.01 to 2.7
|
2.26 Percentage of subjects
Interval 0.0 to 62.1
|
0.00 Percentage of subjects
Interval 0.0 to 1.64
|
0.71 Percentage of subjects
Interval 0.05 to 3.06
|
|
Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-49
|
0.49 Percentage of subjects
Interval 0.01 to 2.7
|
2.26 Percentage of subjects
Interval 0.0 to 62.1
|
0.00 Percentage of subjects
Interval 0.0 to 1.64
|
0.71 Percentage of subjects
Interval 0.05 to 3.06
|
|
Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-50
|
0.49 Percentage of subjects
Interval 0.01 to 2.7
|
2.26 Percentage of subjects
Interval 0.0 to 62.1
|
0.00 Percentage of subjects
Interval 0.0 to 1.64
|
0.71 Percentage of subjects
Interval 0.05 to 3.06
|
|
Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-51
|
0.49 Percentage of subjects
Interval 0.01 to 2.7
|
2.26 Percentage of subjects
Interval 0.0 to 62.1
|
0.00 Percentage of subjects
Interval 0.0 to 1.64
|
0.71 Percentage of subjects
Interval 0.05 to 3.06
|
|
Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-52
|
0.49 Percentage of subjects
Interval 0.01 to 2.7
|
2.26 Percentage of subjects
Interval 0.0 to 62.1
|
0.00 Percentage of subjects
Interval 0.0 to 1.64
|
0.71 Percentage of subjects
Interval 0.05 to 3.06
|
|
Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
|
Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
|
Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.00 Percentage of subjects
Interval 0.0 to 2.93
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.00 Percentage of subjects
Interval 0.0 to 1.29
|
|
Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.00 Percentage of subjects
Interval 0.0 to 2.86
|
0.00 Percentage of subjects
Interval 0.0 to 3.89
|
0.00 Percentage of subjects
Interval 0.0 to 1.06
|
|
Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.00 Percentage of subjects
Interval 0.0 to 2.7
|
0.00 Percentage of subjects
Interval 0.0 to 0.94
|
|
Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.00 Percentage of subjects
Interval 0.0 to 2.68
|
0.00 Percentage of subjects
Interval 0.0 to 1.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.8
|
|
Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.00 Percentage of subjects
Interval 0.0 to 2.53
|
0.00 Percentage of subjects
Interval 0.0 to 1.69
|
0.00 Percentage of subjects
Interval 0.0 to 0.76
|
|
Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
0.00 Percentage of subjects
Interval 0.0 to 1.61
|
0.00 Percentage of subjects
Interval 0.0 to 0.74
|
|
Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
0.00 Percentage of subjects
Interval 0.0 to 1.59
|
0.00 Percentage of subjects
Interval 0.0 to 0.74
|
|
Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
0.00 Percentage of subjects
Interval 0.0 to 1.59
|
0.00 Percentage of subjects
Interval 0.0 to 0.74
|
|
Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
0.00 Percentage of subjects
Interval 0.0 to 1.59
|
0.00 Percentage of subjects
Interval 0.0 to 0.74
|
|
Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
0.00 Percentage of subjects
Interval 0.0 to 1.59
|
0.00 Percentage of subjects
Interval 0.0 to 0.74
|
|
Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
0.00 Percentage of subjects
Interval 0.0 to 1.59
|
0.00 Percentage of subjects
Interval 0.0 to 0.74
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was to be performed on the enrolled subjects vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine, and who returned the ADR card, i.e.: only Fluarix Tetra Group subjects who received the second dose. As no AEs were reported for the MedDRA Class considered, the "by risk status" analysis could not be performed.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK's quadrivalent seasonal influenza vaccine and who returned the ADR card.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Outcome measures
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 Participants
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 Participants
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 Participants
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
Total Group
n=1060 Participants
Volunteered male and female subjects from Vaccinated\_AlphaRix Tetra Group, Vaccinated\_Influsplit Tetra Group and Vaccinated\_Fluarix Tetra Group were pooled into the Total Group. Therefore, subjects included in the Total Group received GSK's quadrivalent seasonal influenza vaccine, as follows: one dose of AlphaRix Tetra vaccine (first group) or one dose of Influsplit Tetra (second group) or one or two dose(s) of Fluarix Tetra vaccine (third group), between 1 October and 31 December 2018.
|
|---|---|---|---|---|
|
Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
|
Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-42
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 3.24
|
|
Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-43
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
0.00 Percentage of subjects
Interval 0.0 to 4.02
|
0.00 Percentage of subjects
Interval 0.0 to 9.49
|
0.00 Percentage of subjects
Interval 0.0 to 2.1
|
|
Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-44
|
0.00 Percentage of subjects
Interval 0.0 to 4.35
|
0.00 Percentage of subjects
Interval 0.0 to 3.55
|
0.00 Percentage of subjects
Interval 0.0 to 5.96
|
0.00 Percentage of subjects
Interval 0.0 to 1.49
|
|
Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-45
|
0.00 Percentage of subjects
Interval 0.0 to 2.32
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.00 Percentage of subjects
Interval 0.0 to 2.4
|
0.00 Percentage of subjects
Interval 0.0 to 0.87
|
|
Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-46
|
0.00 Percentage of subjects
Interval 0.0 to 2.0
|
0.00 Percentage of subjects
Interval 0.0 to 2.76
|
0.00 Percentage of subjects
Interval 0.0 to 1.83
|
0.00 Percentage of subjects
Interval 0.0 to 0.71
|
|
Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-47
|
0.00 Percentage of subjects
Interval 0.0 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
0.00 Percentage of subjects
Interval 0.0 to 1.74
|
0.00 Percentage of subjects
Interval 0.0 to 0.67
|
|
Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-48
|
0.00 Percentage of subjects
Interval 0.0 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
0.00 Percentage of subjects
Interval 0.0 to 1.64
|
0.00 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-49
|
0.00 Percentage of subjects
Interval 0.0 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
0.00 Percentage of subjects
Interval 0.0 to 1.64
|
0.00 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-50
|
0.00 Percentage of subjects
Interval 0.0 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
0.00 Percentage of subjects
Interval 0.0 to 1.64
|
0.00 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-51
|
0.00 Percentage of subjects
Interval 0.0 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
0.00 Percentage of subjects
Interval 0.0 to 1.64
|
0.00 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
At risk,Weeks 40-52
|
0.00 Percentage of subjects
Interval 0.0 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
0.00 Percentage of subjects
Interval 0.0 to 1.64
|
0.00 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-40
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 5.36
|
|
Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-41
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
|
Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-42
|
0.80 Percentage of subjects
Interval 0.02 to 4.38
|
0.00 Percentage of subjects
Interval 0.0 to 2.93
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
0.35 Percentage of subjects
Interval 0.01 to 1.94
|
|
Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-43
|
0.80 Percentage of subjects
Interval 0.02 to 4.38
|
0.00 Percentage of subjects
Interval 0.0 to 2.86
|
0.00 Percentage of subjects
Interval 0.0 to 3.89
|
0.29 Percentage of subjects
Interval 0.0 to 1.75
|
|
Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-44
|
0.80 Percentage of subjects
Interval 0.02 to 4.38
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
0.00 Percentage of subjects
Interval 0.0 to 2.7
|
0.26 Percentage of subjects
Interval 0.0 to 1.55
|
|
Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-45
|
0.80 Percentage of subjects
Interval 0.02 to 4.38
|
0.00 Percentage of subjects
Interval 0.0 to 2.68
|
0.00 Percentage of subjects
Interval 0.0 to 1.85
|
0.22 Percentage of subjects
Interval 0.0 to 1.43
|
|
Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-46
|
0.80 Percentage of subjects
Interval 0.02 to 4.38
|
0.00 Percentage of subjects
Interval 0.0 to 2.53
|
0.00 Percentage of subjects
Interval 0.0 to 1.69
|
0.21 Percentage of subjects
Interval 0.0 to 1.37
|
|
Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-47
|
0.80 Percentage of subjects
Interval 0.02 to 4.38
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
0.00 Percentage of subjects
Interval 0.0 to 1.61
|
0.20 Percentage of subjects
Interval 0.0 to 1.35
|
|
Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-48
|
0.80 Percentage of subjects
Interval 0.02 to 4.38
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
0.00 Percentage of subjects
Interval 0.0 to 1.59
|
0.20 Percentage of subjects
Interval 0.0 to 1.34
|
|
Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-49
|
0.80 Percentage of subjects
Interval 0.02 to 4.38
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
0.00 Percentage of subjects
Interval 0.0 to 1.59
|
0.20 Percentage of subjects
Interval 0.0 to 1.34
|
|
Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-50
|
0.80 Percentage of subjects
Interval 0.02 to 4.38
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
0.00 Percentage of subjects
Interval 0.0 to 1.59
|
0.20 Percentage of subjects
Interval 0.0 to 1.34
|
|
Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-51
|
0.80 Percentage of subjects
Interval 0.02 to 4.38
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
0.00 Percentage of subjects
Interval 0.0 to 1.59
|
0.20 Percentage of subjects
Interval 0.0 to 1.34
|
|
Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status
Not at risk,Weeks 40-52
|
0.80 Percentage of subjects
Interval 0.02 to 4.38
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
0.00 Percentage of subjects
Interval 0.0 to 1.59
|
0.20 Percentage of subjects
Interval 0.0 to 1.34
|
SECONDARY outcome
Timeframe: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 daysPopulation: Analysis was to be performed on the enrolled subjects vaccinated with a second dose of GSK's quadrivalent seasonal influenza vaccine, and who returned the ADR card, i.e.: only Fluarix Tetra Group subjects who received the second dose. As no AEs were reported for the MedDRA Class considered, the "by risk status" analysis could not be performed.
The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.
Outcome measures
Outcome data not reported
Adverse Events
Vaccinated_AlphaRix Tetra Group
Serious events: 0 serious events
Other events: 139 other events
Deaths: 0 deaths
Vaccinated_Influsplit Tetra Group
Serious events: 0 serious events
Other events: 102 other events
Deaths: 0 deaths
Vaccinated_Fluarix Tetra Group
Serious events: 0 serious events
Other events: 227 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Vaccinated_AlphaRix Tetra Group
n=329 participants at risk
Volunteered male and female subjects, 18 years of age and above, who received in Belgium one dose of GlaxoSmithKline's (GSK's) quadrivalent seasonal influenza vaccine (AlphaRix Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Influsplit Tetra Group
n=278 participants at risk
Volunteered subjects male and female subjects, 18 years of age and above, who received in Germany one dose of GSK's quadrivalent seasonal influenza vaccine (Influsplit Tetra) between 01 October and 31 December 2018.
|
Vaccinated_Fluarix Tetra Group
n=453 participants at risk
Volunteered male and female subjects, between 6 months and 65 years of age, who received in Spain one or two dose(s) of GSK's quadrivalent seasonal influenza vaccine (Fluarix Tetra) between 01 October and 31 December 2018.
|
|---|---|---|---|
|
Ear and labyrinth disorders
Ear haemorrhage
|
0.00%
0/329 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.36%
1/278 • Number of events 1 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/453 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/329 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.36%
1/278 • Number of events 1 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.22%
1/453 • Number of events 1 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
Ear and labyrinth disorders
Ear pruritus
|
0.30%
1/329 • Number of events 1 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/278 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/453 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/329 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.36%
1/278 • Number of events 1 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/453 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/329 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.72%
2/278 • Number of events 2 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/453 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
Eye disorders
Eye discharge
|
0.00%
0/329 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.36%
1/278 • Number of events 1 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/453 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
Eye disorders
Eye pruritus
|
0.00%
0/329 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.36%
1/278 • Number of events 1 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.44%
2/453 • Number of events 2 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/329 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.36%
1/278 • Number of events 1 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/453 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
Eye disorders
Swelling of eyelid
|
0.30%
1/329 • Number of events 1 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/278 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/453 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/329 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/278 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.22%
1/453 • Number of events 1 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/329 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/278 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.88%
4/453 • Number of events 4 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
Gastrointestinal disorders
Diarrhoea
|
1.8%
6/329 • Number of events 6 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
3.2%
9/278 • Number of events 9 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
4.0%
18/453 • Number of events 20 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/329 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.36%
1/278 • Number of events 1 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/453 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/329 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.36%
1/278 • Number of events 1 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/453 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
Gastrointestinal disorders
Nausea
|
4.3%
14/329 • Number of events 14 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
1.8%
5/278 • Number of events 5 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
2.9%
13/453 • Number of events 13 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/329 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.36%
1/278 • Number of events 1 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/453 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
Gastrointestinal disorders
Tongue discomfort
|
0.00%
0/329 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.36%
1/278 • Number of events 1 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/453 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
Gastrointestinal disorders
Vomiting
|
1.5%
5/329 • Number of events 5 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/278 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
3.3%
15/453 • Number of events 15 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
General disorders
Chills
|
1.5%
5/329 • Number of events 5 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
2.5%
7/278 • Number of events 7 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
2.9%
13/453 • Number of events 13 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
General disorders
Discomfort
|
0.00%
0/329 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/278 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.22%
1/453 • Number of events 1 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
General disorders
Face oedema
|
0.30%
1/329 • Number of events 1 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/278 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.22%
1/453 • Number of events 1 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
General disorders
Fatigue
|
4.0%
13/329 • Number of events 13 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
7.9%
22/278 • Number of events 22 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
7.5%
34/453 • Number of events 36 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
General disorders
Feeling cold
|
0.30%
1/329 • Number of events 1 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/278 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/453 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
General disorders
Feeling hot
|
0.30%
1/329 • Number of events 1 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/278 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/453 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
General disorders
Influenza like illness
|
0.30%
1/329 • Number of events 1 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/278 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.22%
1/453 • Number of events 1 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
General disorders
Injection site erythema
|
3.0%
10/329 • Number of events 10 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
7.6%
21/278 • Number of events 21 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
5.5%
25/453 • Number of events 25 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
General disorders
Injection site haematoma
|
0.00%
0/329 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.36%
1/278 • Number of events 1 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/453 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
General disorders
Injection site pain
|
19.8%
65/329 • Number of events 65 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
16.5%
46/278 • Number of events 46 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
18.1%
82/453 • Number of events 83 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
General disorders
Injection site pruritus
|
0.30%
1/329 • Number of events 1 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
1.1%
3/278 • Number of events 3 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.22%
1/453 • Number of events 1 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
General disorders
Injection site swelling
|
5.2%
17/329 • Number of events 17 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
10.8%
30/278 • Number of events 30 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
7.3%
33/453 • Number of events 33 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
General disorders
Injection site warmth
|
0.30%
1/329 • Number of events 1 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/278 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/453 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
General disorders
Malaise
|
0.00%
0/329 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.36%
1/278 • Number of events 1 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/453 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
General disorders
Mucous membrane disorder
|
0.00%
0/329 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/278 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.44%
2/453 • Number of events 2 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
General disorders
Peripheral swelling
|
0.30%
1/329 • Number of events 1 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/278 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.22%
1/453 • Number of events 1 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
General disorders
Pyrexia
|
0.61%
2/329 • Number of events 2 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.72%
2/278 • Number of events 2 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
7.7%
35/453 • Number of events 36 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
Immune system disorders
Hypersensitivity
|
0.30%
1/329 • Number of events 1 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/278 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/453 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/329 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/278 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.22%
1/453 • Number of events 1 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
Infections and infestations
Conjunctivitis
|
3.6%
12/329 • Number of events 12 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
4.0%
11/278 • Number of events 11 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
3.5%
16/453 • Number of events 16 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
Infections and infestations
Ear infection
|
0.00%
0/329 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/278 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.22%
1/453 • Number of events 1 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/329 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.36%
1/278 • Number of events 1 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/453 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
Infections and infestations
Hordeolum
|
0.00%
0/329 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/278 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.22%
1/453 • Number of events 1 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
Infections and infestations
Laryngitis
|
0.00%
0/329 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/278 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.22%
1/453 • Number of events 1 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/329 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/278 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.22%
1/453 • Number of events 1 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
Infections and infestations
Oral herpes
|
0.00%
0/329 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.36%
1/278 • Number of events 1 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/453 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
Infections and infestations
Rhinitis
|
1.8%
6/329 • Number of events 6 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
4.7%
13/278 • Number of events 13 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
3.1%
14/453 • Number of events 14 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/329 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/278 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.22%
1/453 • Number of events 1 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/329 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.36%
1/278 • Number of events 1 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/453 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
Investigations
Heart rate increased
|
0.30%
1/329 • Number of events 1 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
1.1%
3/278 • Number of events 3 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/453 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.1%
7/329 • Number of events 7 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.36%
1/278 • Number of events 1 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
5.7%
26/453 • Number of events 27 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
3.3%
11/329 • Number of events 11 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
3.6%
10/278 • Number of events 10 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
2.4%
11/453 • Number of events 11 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/329 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.36%
1/278 • Number of events 1 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/453 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/329 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.36%
1/278 • Number of events 1 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/453 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.2%
27/329 • Number of events 27 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
5.4%
15/278 • Number of events 15 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
7.1%
32/453 • Number of events 32 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/329 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.72%
2/278 • Number of events 2 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.22%
1/453 • Number of events 1 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
Musculoskeletal and connective tissue disorders
Rheumatic disorder
|
0.00%
0/329 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.72%
2/278 • Number of events 2 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/453 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/329 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/278 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.22%
1/453 • Number of events 1 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
Nervous system disorders
Aphonia
|
0.00%
0/329 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/278 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.22%
1/453 • Number of events 1 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
Nervous system disorders
Dizziness
|
0.91%
3/329 • Number of events 3 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/278 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.22%
1/453 • Number of events 1 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
Nervous system disorders
Headache
|
7.3%
24/329 • Number of events 24 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
7.6%
21/278 • Number of events 21 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
7.3%
33/453 • Number of events 34 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
Nervous system disorders
Poor quality sleep
|
0.00%
0/329 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.36%
1/278 • Number of events 1 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/453 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
Nervous system disorders
Somnolence
|
0.00%
0/329 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/278 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.22%
1/453 • Number of events 1 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
Nervous system disorders
Tremor
|
0.30%
1/329 • Number of events 1 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/278 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/453 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/329 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.36%
1/278 • Number of events 1 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/453 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
Psychiatric disorders
Irritability
|
0.91%
3/329 • Number of events 3 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
1.4%
4/278 • Number of events 4 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
2.9%
13/453 • Number of events 15 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
Psychiatric disorders
Mood swings
|
0.00%
0/329 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/278 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.22%
1/453 • Number of events 1 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/329 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.36%
1/278 • Number of events 1 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/453 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.6%
12/329 • Number of events 12 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
4.0%
11/278 • Number of events 11 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
12.6%
57/453 • Number of events 61 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.30%
1/329 • Number of events 1 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/278 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/453 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
1.2%
4/329 • Number of events 4 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
3.2%
9/278 • Number of events 9 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
2.9%
13/453 • Number of events 13 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/329 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
1.1%
3/278 • Number of events 4 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/453 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.30%
1/329 • Number of events 1 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
1.4%
4/278 • Number of events 4 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
1.1%
5/453 • Number of events 5 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
Respiratory, thoracic and mediastinal disorders
Increased upper airway secretion
|
0.00%
0/329 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/278 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.22%
1/453 • Number of events 1 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.0%
10/329 • Number of events 10 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
3.6%
10/278 • Number of events 10 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
8.8%
40/453 • Number of events 41 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.0%
10/329 • Number of events 10 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
5.4%
15/278 • Number of events 15 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
5.7%
26/453 • Number of events 26 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
9.1%
30/329 • Number of events 30 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
5.4%
15/278 • Number of events 15 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
11.5%
52/453 • Number of events 57 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.30%
1/329 • Number of events 1 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/278 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.66%
3/453 • Number of events 3 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
Respiratory, thoracic and mediastinal disorders
Throat clearing
|
0.00%
0/329 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/278 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.22%
1/453 • Number of events 1 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.30%
1/329 • Number of events 1 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
1.1%
3/278 • Number of events 3 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.88%
4/453 • Number of events 4 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/329 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/278 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.44%
2/453 • Number of events 2 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.30%
1/329 • Number of events 1 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/278 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/453 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.91%
3/329 • Number of events 3 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
1.8%
5/278 • Number of events 5 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/453 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.61%
2/329 • Number of events 2 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/278 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/453 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.30%
1/329 • Number of events 1 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.36%
1/278 • Number of events 1 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
1.1%
5/453 • Number of events 5 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/329 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.36%
1/278 • Number of events 1 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/453 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
Vascular disorders
Hot flush
|
0.30%
1/329 • Number of events 1 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/278 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/453 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/329 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.36%
1/278 • Number of events 1 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
0.00%
0/453 • Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).
|
Additional Information
Enhanced safety surveillance of GSK's quadrivalent seasonal influenza vaccines
GlaxoSmithKline
Phone: 877-379-3718
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests 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