Trial Outcomes & Findings for Post-authorisation Passive Enhanced Safety Surveillance of Seasonal Influenza Vaccines: Pilot Study in England (NCT NCT03278067)
NCT ID: NCT03278067
Last Updated: 2020-01-13
Results Overview
The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Recruitment status
COMPLETED
Target enrollment
23939 participants
Primary outcome timeframe
Within 7 days post vaccination
Results posted on
2020-01-13
Participant Flow
One study General Practitioner (GP2) did not follow the procedure as per protocol in distributing, handling of the returned cards and the unused Adverse Drug Reaction (ADR) cards, therefore the data from that GP were excluded from the analysis.
Participant milestones
| Measure |
Vaccinated_Fluarix Tetra Group
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Overall Study
STARTED
|
16433
|
3310
|
4196
|
|
Overall Study
COMPLETED
|
16433
|
3310
|
4196
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Post-authorisation Passive Enhanced Safety Surveillance of Seasonal Influenza Vaccines: Pilot Study in England
Baseline characteristics by cohort
| Measure |
Vaccinated_Fluarix Tetra Group
n=16433 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=3310 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=4196 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Total
n=23939 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
65.9 Years
STANDARD_DEVIATION 16.3 • n=5 Participants
|
23.6 Years
STANDARD_DEVIATION 27.4 • n=7 Participants
|
52.2 Years
STANDARD_DEVIATION 28.0 • n=5 Participants
|
57.67 Years
STANDARD_DEVIATION 25.21 • n=4 Participants
|
|
Sex: Female, Male
Female
|
9177 Participants
n=5 Participants
|
1696 Participants
n=7 Participants
|
2330 Participants
n=5 Participants
|
13203 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
7256 Participants
n=5 Participants
|
1614 Participants
n=7 Participants
|
1866 Participants
n=5 Participants
|
10736 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
393 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
554 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black
|
84 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
127 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
11697 Participants
n=5 Participants
|
2121 Participants
n=7 Participants
|
2880 Participants
n=5 Participants
|
16698 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Mixed
|
57 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
101 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
25 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Missing
|
4177 Participants
n=5 Participants
|
1076 Participants
n=7 Participants
|
1163 Participants
n=5 Participants
|
6416 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in electronic health record (EHR), using card-based ADR reporting system during the safety follow-up (FU) period (from vaccination up to 7 days post-vaccination).
The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16387 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=2946 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=546 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Weekly Incidence Rates of Any Adverse Events of Interest (AEIs) Reported Via Adverse Drug Reaction (ADR) Card, by Vaccine Group
Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of Any Adverse Events of Interest (AEIs) Reported Via Adverse Drug Reaction (ADR) Card, by Vaccine Group
Week 38
|
7.69 Percentage of subjects
Interval 5.94 to 9.77
|
14.29 Percentage of subjects
Interval 0.0 to 90.97
|
12.50 Percentage of subjects
Interval 1.5 to 38.73
|
|
Weekly Incidence Rates of Any Adverse Events of Interest (AEIs) Reported Via Adverse Drug Reaction (ADR) Card, by Vaccine Group
Week 46
|
4.29 Percentage of subjects
Interval 1.59 to 9.1
|
1.89 Percentage of subjects
Interval 0.08 to 9.13
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Weekly Incidence Rates of Any Adverse Events of Interest (AEIs) Reported Via Adverse Drug Reaction (ADR) Card, by Vaccine Group
Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of Any Adverse Events of Interest (AEIs) Reported Via Adverse Drug Reaction (ADR) Card, by Vaccine Group
Week 37
|
10.10 Percentage of subjects
Interval 8.53 to 11.84
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
12.50 Percentage of subjects
Interval 1.55 to 38.35
|
|
Weekly Incidence Rates of Any Adverse Events of Interest (AEIs) Reported Via Adverse Drug Reaction (ADR) Card, by Vaccine Group
Week 39
|
7.97 Percentage of subjects
Interval 7.16 to 8.84
|
0.00 Percentage of subjects
Interval 0.0 to 3.85
|
4.17 Percentage of subjects
Interval 0.11 to 21.12
|
|
Weekly Incidence Rates of Any Adverse Events of Interest (AEIs) Reported Via Adverse Drug Reaction (ADR) Card, by Vaccine Group
Week 40
|
8.22 Percentage of subjects
Interval 4.92 to 12.73
|
4.75 Percentage of subjects
Interval 2.74 to 7.6
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Weekly Incidence Rates of Any Adverse Events of Interest (AEIs) Reported Via Adverse Drug Reaction (ADR) Card, by Vaccine Group
Week 41
|
6.40 Percentage of subjects
Interval 4.45 to 8.86
|
3.25 Percentage of subjects
Interval 1.08 to 7.37
|
1.79 Percentage of subjects
Interval 0.05 to 9.55
|
|
Weekly Incidence Rates of Any Adverse Events of Interest (AEIs) Reported Via Adverse Drug Reaction (ADR) Card, by Vaccine Group
Week 42
|
3.74 Percentage of subjects
Interval 1.74 to 6.93
|
1.25 Percentage of subjects
Interval 0.36 to 3.06
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
|
Weekly Incidence Rates of Any Adverse Events of Interest (AEIs) Reported Via Adverse Drug Reaction (ADR) Card, by Vaccine Group
Week 43
|
4.64 Percentage of subjects
Interval 1.86 to 9.38
|
2.65 Percentage of subjects
Interval 0.69 to 6.81
|
0.00 Percentage of subjects
Interval 0.0 to 15.44
|
|
Weekly Incidence Rates of Any Adverse Events of Interest (AEIs) Reported Via Adverse Drug Reaction (ADR) Card, by Vaccine Group
Week 44
|
4.40 Percentage of subjects
Interval 1.33 to 10.39
|
3.66 Percentage of subjects
Interval 0.7 to 10.72
|
0.00 Percentage of subjects
Interval 0.0 to 11.57
|
|
Weekly Incidence Rates of Any Adverse Events of Interest (AEIs) Reported Via Adverse Drug Reaction (ADR) Card, by Vaccine Group
Week 45
|
3.75 Percentage of subjects
Interval 1.64 to 7.25
|
2.24 Percentage of subjects
Interval 0.2 to 8.71
|
1.92 Percentage of subjects
Interval 0.62 to 4.41
|
|
Weekly Incidence Rates of Any Adverse Events of Interest (AEIs) Reported Via Adverse Drug Reaction (ADR) Card, by Vaccine Group
Week 47
|
1.55 Percentage of subjects
Interval 0.22 to 5.19
|
0.64 Percentage of subjects
Interval 0.02 to 3.5
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
PRIMARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start, up to end of the week of interest and were registered in EHR, using card-based ADR reporting system during the safety FU period (from vaccination up to 7 days post-vaccination).
The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16387 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=2946 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=546 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group
Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group
Week 35-37
|
10.09 Percentage of subjects
Interval 8.52 to 11.84
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
10.53 Percentage of subjects
Interval 1.3 to 33.14
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group
Week 35-41
|
8.15 Percentage of subjects
Interval 7.0 to 9.43
|
3.59 Percentage of subjects
Interval 1.96 to 5.98
|
4.11 Percentage of subjects
Interval 1.52 to 8.73
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group
Week 35-43
|
7.75 Percentage of subjects
Interval 6.54 to 9.12
|
2.76 Percentage of subjects
Interval 1.38 to 4.9
|
3.24 Percentage of subjects
Interval 1.2 to 6.93
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group
Week 35-45
|
7.48 Percentage of subjects
Interval 6.25 to 8.86
|
2.85 Percentage of subjects
Interval 1.32 to 5.3
|
2.31 Percentage of subjects
Interval 1.16 to 4.1
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group
Week 35-48
|
7.25 Percentage of subjects
Interval 5.95 to 8.73
|
2.55 Percentage of subjects
Interval 1.01 to 5.23
|
2.01 Percentage of subjects
Interval 1.01 to 3.58
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group
Week 35-38
|
8.83 Percentage of subjects
Interval 7.25 to 10.63
|
9.09 Percentage of subjects
Interval 0.08 to 47.67
|
11.43 Percentage of subjects
Interval 3.2 to 26.74
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group
Week 35-39
|
8.45 Percentage of subjects
Interval 7.37 to 9.64
|
0.95 Percentage of subjects
Interval 0.02 to 5.19
|
8.47 Percentage of subjects
Interval 2.81 to 18.68
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group
Week 35-40
|
8.41 Percentage of subjects
Interval 7.29 to 9.63
|
3.85 Percentage of subjects
Interval 2.14 to 6.33
|
5.56 Percentage of subjects
Interval 1.83 to 12.49
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group
Week 35-42
|
7.87 Percentage of subjects
Interval 6.68 to 9.19
|
2.79 Percentage of subjects
Interval 1.49 to 4.74
|
3.68 Percentage of subjects
Interval 1.36 to 7.84
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group
Week 35-44
|
7.59 Percentage of subjects
Interval 6.36 to 8.97
|
2.97 Percentage of subjects
Interval 1.29 to 5.75
|
2.79 Percentage of subjects
Interval 1.03 to 5.97
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group
Week 35-46
|
7.41 Percentage of subjects
Interval 6.13 to 8.86
|
2.75 Percentage of subjects
Interval 1.14 to 5.52
|
2.22 Percentage of subjects
Interval 1.11 to 3.94
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group
Week 35-47
|
7.31 Percentage of subjects
Interval 6.03 to 8.78
|
2.64 Percentage of subjects
Interval 1.05 to 5.39
|
2.05 Percentage of subjects
Interval 1.03 to 3.64
|
PRIMARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in electronic health record (EHR), using card-based ADR reporting system during the safety follow-up (FU) period (from vaccination up to 7 days post-vaccination).
Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16387 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=2946 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=546 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group
Week 37
|
0.45 Percentage of subjects
Interval 0.2 to 0.85
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group
Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group
Week 38
|
0.51 Percentage of subjects
Interval 0.15 to 1.26
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group
Week 39
|
0.46 Percentage of subjects
Interval 0.2 to 0.92
|
0.00 Percentage of subjects
Interval 0.0 to 3.85
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group
Week 40
|
0.34 Percentage of subjects
Interval 0.12 to 0.77
|
1.19 Percentage of subjects
Interval 0.09 to 4.96
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group
Week 41
|
0.36 Percentage of subjects
Interval 0.13 to 0.79
|
0.59 Percentage of subjects
Interval 0.07 to 2.12
|
0.00 Percentage of subjects
Interval 0.0 to 6.38
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group
Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 0.4
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group
Week 43
|
0.40 Percentage of subjects
Interval 0.05 to 1.47
|
0.00 Percentage of subjects
Interval 0.0 to 0.97
|
0.00 Percentage of subjects
Interval 0.0 to 15.44
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group
Week 44
|
0.27 Percentage of subjects
Interval 0.02 to 1.2
|
0.43 Percentage of subjects
Interval 0.05 to 1.55
|
0.00 Percentage of subjects
Interval 0.0 to 11.57
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group
Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.00 Percentage of subjects
Interval 0.0 to 0.91
|
0.38 Percentage of subjects
Interval 0.01 to 2.12
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group
Week 46
|
0.57 Percentage of subjects
Interval 0.03 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.39
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group
Week 47
|
0.39 Percentage of subjects
Interval 0.0 to 2.82
|
0.00 Percentage of subjects
Interval 0.0 to 2.32
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group
Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
PRIMARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start, up to end of the week of interest and were registered in EHR, using card-based ADR reporting system during the safety FU period (from vaccination up to 7 days post-vaccination).
Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16387 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=2946 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=546 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group
Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group
Week 35-37
|
0.45 Percentage of subjects
Interval 0.2 to 0.85
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group
Week 35-38
|
0.48 Percentage of subjects
Interval 0.26 to 0.8
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
0.00 Percentage of subjects
Interval 0.0 to 10.0
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group
Week 35-39
|
0.47 Percentage of subjects
Interval 0.24 to 0.83
|
0.00 Percentage of subjects
Interval 0.0 to 3.45
|
0.00 Percentage of subjects
Interval 0.0 to 6.06
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group
Week 35-40
|
0.45 Percentage of subjects
Interval 0.25 to 0.73
|
0.90 Percentage of subjects
Interval 0.03 to 4.68
|
0.00 Percentage of subjects
Interval 0.0 to 4.02
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group
Week 35-41
|
0.44 Percentage of subjects
Interval 0.27 to 0.68
|
0.77 Percentage of subjects
Interval 0.16 to 2.23
|
0.00 Percentage of subjects
Interval 0.0 to 2.49
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group
Week 35-42
|
0.41 Percentage of subjects
Interval 0.24 to 0.65
|
0.51 Percentage of subjects
Interval 0.08 to 1.67
|
0.00 Percentage of subjects
Interval 0.0 to 2.24
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group
Week 35-43
|
0.41 Percentage of subjects
Interval 0.24 to 0.64
|
0.38 Percentage of subjects
Interval 0.05 to 1.38
|
0.00 Percentage of subjects
Interval 0.0 to 1.97
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group
Week 35-44
|
0.40 Percentage of subjects
Interval 0.24 to 0.63
|
0.40 Percentage of subjects
Interval 0.09 to 1.08
|
0.00 Percentage of subjects
Interval 0.0 to 1.7
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group
Week 35-45
|
0.39 Percentage of subjects
Interval 0.23 to 0.62
|
0.33 Percentage of subjects
Interval 0.07 to 0.94
|
0.21 Percentage of subjects
Interval 0.01 to 1.16
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group
Week 35-46
|
0.39 Percentage of subjects
Interval 0.23 to 0.64
|
0.30 Percentage of subjects
Interval 0.06 to 0.87
|
0.20 Percentage of subjects
Interval 0.01 to 1.12
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group
Week 35-47
|
0.39 Percentage of subjects
Interval 0.23 to 0.63
|
0.28 Percentage of subjects
Interval 0.06 to 0.83
|
0.19 Percentage of subjects
Interval 0.0 to 1.04
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group
Week 35-48
|
0.39 Percentage of subjects
Interval 0.23 to 0.62
|
0.27 Percentage of subjects
Interval 0.05 to 0.8
|
0.18 Percentage of subjects
Interval 0.0 to 1.02
|
PRIMARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in electronic health record (EHR), using card-based ADR reporting system during the safety follow-up (FU) period (from vaccination up to 7 days post-vaccination).
Local symptoms include local erythema. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16387 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=2946 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=546 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group
Week 38
|
1.61 Percentage of subjects
Interval 0.84 to 2.79
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group
Week 46
|
1.43 Percentage of subjects
Interval 0.2 to 4.82
|
1.14 Percentage of subjects
Interval 0.09 to 4.61
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group
Week 44
|
1.20 Percentage of subjects
Interval 0.25 to 3.43
|
0.65 Percentage of subjects
Interval 0.08 to 2.28
|
0.00 Percentage of subjects
Interval 0.0 to 11.57
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group
Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group
Week 37
|
1.87 Percentage of subjects
Interval 0.78 to 3.72
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
6.25 Percentage of subjects
Interval 0.16 to 30.23
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group
Week 39
|
1.90 Percentage of subjects
Interval 1.23 to 2.79
|
0.00 Percentage of subjects
Interval 0.0 to 3.85
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group
Week 40
|
1.95 Percentage of subjects
Interval 0.77 to 4.02
|
0.30 Percentage of subjects
Interval 0.0 to 1.82
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group
Week 41
|
1.45 Percentage of subjects
Interval 0.93 to 2.15
|
0.89 Percentage of subjects
Interval 0.15 to 2.82
|
0.00 Percentage of subjects
Interval 0.0 to 6.38
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group
Week 42
|
0.55 Percentage of subjects
Interval 0.09 to 1.78
|
0.50 Percentage of subjects
Interval 0.06 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group
Week 43
|
0.40 Percentage of subjects
Interval 0.04 to 1.5
|
0.79 Percentage of subjects
Interval 0.06 to 3.28
|
0.00 Percentage of subjects
Interval 0.0 to 15.44
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group
Week 45
|
0.66 Percentage of subjects
Interval 0.05 to 2.76
|
0.50 Percentage of subjects
Interval 0.0 to 3.52
|
0.00 Percentage of subjects
Interval 0.0 to 1.4
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group
Week 47
|
1.16 Percentage of subjects
Interval 0.06 to 5.45
|
0.00 Percentage of subjects
Interval 0.0 to 2.32
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group
Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
PRIMARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start, up to end of the week of interest and were registered in EHR, using card-based ADR reporting system during the safety FU period (from vaccination up to 7 days post-vaccination).
Local symptoms include local erythema. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16387 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=2946 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=546 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group
Week 35-47
|
1.59 Percentage of subjects
Interval 1.17 to 2.12
|
0.60 Percentage of subjects
Interval 0.12 to 1.74
|
0.19 Percentage of subjects
Interval 0.0 to 1.59
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group
Week 35-48
|
1.58 Percentage of subjects
Interval 1.16 to 2.1
|
0.58 Percentage of subjects
Interval 0.12 to 1.68
|
0.18 Percentage of subjects
Interval 0.0 to 1.57
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group
Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group
Week 35-37
|
1.86 Percentage of subjects
Interval 0.78 to 3.72
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
5.26 Percentage of subjects
Interval 0.13 to 26.03
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group
Week 35-38
|
1.73 Percentage of subjects
Interval 0.99 to 2.81
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
2.86 Percentage of subjects
Interval 0.07 to 14.92
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group
Week 35-39
|
1.80 Percentage of subjects
Interval 1.14 to 2.71
|
0.00 Percentage of subjects
Interval 0.0 to 3.45
|
1.69 Percentage of subjects
Interval 0.02 to 10.67
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group
Week 35-40
|
1.83 Percentage of subjects
Interval 1.17 to 2.71
|
0.23 Percentage of subjects
Interval 0.01 to 1.25
|
1.11 Percentage of subjects
Interval 0.02 to 6.81
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group
Week 35-41
|
1.78 Percentage of subjects
Interval 1.2 to 2.54
|
0.51 Percentage of subjects
Interval 0.04 to 2.05
|
0.68 Percentage of subjects
Interval 0.01 to 4.24
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group
Week 35-42
|
1.70 Percentage of subjects
Interval 1.19 to 2.36
|
0.51 Percentage of subjects
Interval 0.06 to 1.89
|
0.61 Percentage of subjects
Interval 0.01 to 3.64
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group
Week 35-43
|
1.66 Percentage of subjects
Interval 1.17 to 2.28
|
0.58 Percentage of subjects
Interval 0.06 to 2.17
|
0.54 Percentage of subjects
Interval 0.01 to 3.14
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group
Week 35-44
|
1.63 Percentage of subjects
Interval 1.17 to 2.21
|
0.59 Percentage of subjects
Interval 0.08 to 2.05
|
0.47 Percentage of subjects
Interval 0.01 to 2.73
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group
Week 35-45
|
1.61 Percentage of subjects
Interval 1.16 to 2.17
|
0.58 Percentage of subjects
Interval 0.12 to 1.65
|
0.21 Percentage of subjects
Interval 0.0 to 1.82
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group
Week 35-46
|
1.60 Percentage of subjects
Interval 1.17 to 2.14
|
0.63 Percentage of subjects
Interval 0.13 to 1.83
|
0.20 Percentage of subjects
Interval 0.0 to 1.74
|
PRIMARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in electronic health record (EHR), using card-based ADR reporting system during the safety follow-up (FU) period (from vaccination up to 7 days post-vaccination).
General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16387 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=2946 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=546 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Any, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Any, Week 40
|
2.43 Percentage of subjects
Interval 1.76 to 3.27
|
1.48 Percentage of subjects
Interval 0.36 to 4.0
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Any, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Drowsiness, Week 38
|
0.81 Percentage of subjects
Interval 0.29 to 1.76
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Drowsiness, Week 39
|
0.63 Percentage of subjects
Interval 0.32 to 1.12
|
0.00 Percentage of subjects
Interval 0.0 to 3.85
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Fatigue, Week 38
|
1.79 Percentage of subjects
Interval 1.16 to 2.65
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Fatigue, Week 40
|
1.12 Percentage of subjects
Interval 0.54 to 2.05
|
0.59 Percentage of subjects
Interval 0.01 to 3.61
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Headache, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Headache, Week 37
|
2.19 Percentage of subjects
Interval 1.65 to 2.85
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Headache, Week 38
|
1.79 Percentage of subjects
Interval 0.9 to 3.18
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Headache, Week 39
|
1.68 Percentage of subjects
Interval 1.22 to 2.25
|
0.00 Percentage of subjects
Interval 0.0 to 3.85
|
4.17 Percentage of subjects
Interval 0.11 to 21.12
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Headache, Week 44
|
1.33 Percentage of subjects
Interval 0.52 to 2.78
|
0.65 Percentage of subjects
Interval 0.1 to 2.08
|
0.00 Percentage of subjects
Interval 0.0 to 11.57
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Headache, Week 46
|
0.29 Percentage of subjects
Interval 0.0 to 2.15
|
0.38 Percentage of subjects
Interval 0.0 to 2.63
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Irritability, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 1.42
|
0.00 Percentage of subjects
Interval 0.0 to 2.32
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Malaise, Week 37
|
0.04 Percentage of subjects
Interval 0.0 to 0.25
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Malaise, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.00 Percentage of subjects
Interval 0.0 to 1.39
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Any, Week 41
|
1.75 Percentage of subjects
Interval 1.18 to 2.5
|
1.18 Percentage of subjects
Interval 0.19 to 3.76
|
0.00 Percentage of subjects
Interval 0.0 to 6.38
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Any, Week 37
|
3.89 Percentage of subjects
Interval 3.16 to 4.74
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
6.25 Percentage of subjects
Interval 0.03 to 39.17
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Any, Week 38
|
2.97 Percentage of subjects
Interval 2.02 to 4.19
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Any, Week 39
|
2.94 Percentage of subjects
Interval 2.41 to 3.55
|
0.00 Percentage of subjects
Interval 0.0 to 3.85
|
4.17 Percentage of subjects
Interval 0.11 to 21.12
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Any, Week 42
|
1.54 Percentage of subjects
Interval 0.53 to 3.43
|
0.25 Percentage of subjects
Interval 0.01 to 1.38
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Any, Week 43
|
1.81 Percentage of subjects
Interval 0.54 to 4.39
|
1.06 Percentage of subjects
Interval 0.08 to 4.36
|
0.00 Percentage of subjects
Interval 0.0 to 15.44
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Any, Week 44
|
1.60 Percentage of subjects
Interval 0.67 to 3.18
|
1.29 Percentage of subjects
Interval 0.09 to 5.42
|
0.00 Percentage of subjects
Interval 0.0 to 11.57
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Drowsiness, Week 43
|
0.81 Percentage of subjects
Interval 0.01 to 5.29
|
0.26 Percentage of subjects
Interval 0.01 to 1.47
|
0.00 Percentage of subjects
Interval 0.0 to 15.44
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Any, Week 45
|
1.10 Percentage of subjects
Interval 0.19 to 3.43
|
1.00 Percentage of subjects
Interval 0.15 to 3.24
|
0.38 Percentage of subjects
Interval 0.01 to 2.12
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Any, Week 46
|
0.57 Percentage of subjects
Interval 0.03 to 2.58
|
0.76 Percentage of subjects
Interval 0.01 to 5.22
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Any, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 1.42
|
0.00 Percentage of subjects
Interval 0.0 to 2.32
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Drowsiness, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Drowsiness, Week 37
|
1.05 Percentage of subjects
Interval 0.62 to 1.68
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Drowsiness, Week 40
|
0.68 Percentage of subjects
Interval 0.37 to 1.14
|
0.30 Percentage of subjects
Interval 0.01 to 1.64
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Drowsiness, Week 41
|
0.48 Percentage of subjects
Interval 0.2 to 0.98
|
0.59 Percentage of subjects
Interval 0.07 to 2.12
|
0.00 Percentage of subjects
Interval 0.0 to 6.38
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Drowsiness, Week 42
|
0.33 Percentage of subjects
Interval 0.02 to 1.52
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Drowsiness, Week 44
|
0.27 Percentage of subjects
Interval 0.02 to 1.18
|
0.43 Percentage of subjects
Interval 0.01 to 2.52
|
0.00 Percentage of subjects
Interval 0.0 to 11.57
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Drowsiness, Week 45
|
0.22 Percentage of subjects
Interval 0.0 to 1.58
|
0.00 Percentage of subjects
Interval 0.0 to 0.91
|
0.00 Percentage of subjects
Interval 0.0 to 1.4
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Drowsiness, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.38 Percentage of subjects
Interval 0.0 to 2.63
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Drowsiness, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 1.42
|
0.00 Percentage of subjects
Interval 0.0 to 2.32
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Drowsiness, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Fatigue, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Fatigue, Week 37
|
2.11 Percentage of subjects
Interval 1.58 to 2.76
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
6.25 Percentage of subjects
Interval 0.03 to 39.17
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Fatigue, Week 39
|
1.58 Percentage of subjects
Interval 1.22 to 2.01
|
0.00 Percentage of subjects
Interval 0.0 to 3.85
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Irritability, Week 43
|
0.20 Percentage of subjects
Interval 0.0 to 1.34
|
0.26 Percentage of subjects
Interval 0.01 to 1.47
|
0.00 Percentage of subjects
Interval 0.0 to 15.44
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Irritability, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 0.49
|
0.43 Percentage of subjects
Interval 0.01 to 2.52
|
0.00 Percentage of subjects
Interval 0.0 to 11.57
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Irritability, Week 45
|
0.22 Percentage of subjects
Interval 0.0 to 1.58
|
0.00 Percentage of subjects
Interval 0.0 to 0.91
|
0.00 Percentage of subjects
Interval 0.0 to 1.4
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Irritability, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.00 Percentage of subjects
Interval 0.0 to 1.39
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Irritability, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Malaise, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Malaise, Week 38
|
0.00 Percentage of subjects
Interval 0.0 to 0.14
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Malaise, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 0.09
|
0.00 Percentage of subjects
Interval 0.0 to 3.85
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Fatigue, Week 41
|
1.09 Percentage of subjects
Interval 0.65 to 1.71
|
0.30 Percentage of subjects
Interval 0.01 to 1.64
|
0.00 Percentage of subjects
Interval 0.0 to 6.38
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Malaise, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 0.49
|
0.00 Percentage of subjects
Interval 0.0 to 0.79
|
0.00 Percentage of subjects
Interval 0.0 to 11.57
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Fatigue, Week 42
|
0.77 Percentage of subjects
Interval 0.08 to 2.92
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Fatigue, Week 43
|
0.81 Percentage of subjects
Interval 0.14 to 2.53
|
0.53 Percentage of subjects
Interval 0.04 to 2.19
|
0.00 Percentage of subjects
Interval 0.0 to 15.44
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Fatigue, Week 44
|
0.53 Percentage of subjects
Interval 0.15 to 1.36
|
0.65 Percentage of subjects
Interval 0.1 to 2.08
|
0.00 Percentage of subjects
Interval 0.0 to 11.57
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Fatigue, Week 45
|
0.88 Percentage of subjects
Interval 0.15 to 2.77
|
0.50 Percentage of subjects
Interval 0.02 to 2.39
|
0.38 Percentage of subjects
Interval 0.01 to 2.12
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Fatigue, Week 46
|
0.57 Percentage of subjects
Interval 0.03 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.39
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Fatigue, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 1.42
|
0.00 Percentage of subjects
Interval 0.0 to 2.32
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Fatigue, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Malaise, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 0.18
|
0.00 Percentage of subjects
Interval 0.0 to 1.09
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Malaise, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 0.22
|
0.00 Percentage of subjects
Interval 0.0 to 1.09
|
0.00 Percentage of subjects
Interval 0.0 to 6.38
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Malaise, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.00 Percentage of subjects
Interval 0.0 to 0.91
|
0.00 Percentage of subjects
Interval 0.0 to 1.4
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Malaise, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 0.4
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Malaise, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 0.74
|
0.00 Percentage of subjects
Interval 0.0 to 0.97
|
0.00 Percentage of subjects
Interval 0.0 to 15.44
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Malaise, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 1.42
|
0.00 Percentage of subjects
Interval 0.0 to 2.32
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Malaise, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Headache, Week 43
|
1.21 Percentage of subjects
Interval 0.27 to 3.36
|
0.79 Percentage of subjects
Interval 0.06 to 3.28
|
0.00 Percentage of subjects
Interval 0.0 to 15.44
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Headache, Week 40
|
1.41 Percentage of subjects
Interval 0.88 to 2.14
|
0.89 Percentage of subjects
Interval 0.06 to 3.8
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Headache, Week 41
|
0.91 Percentage of subjects
Interval 0.51 to 1.49
|
0.89 Percentage of subjects
Interval 0.15 to 2.82
|
0.00 Percentage of subjects
Interval 0.0 to 6.38
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Headache, Week 42
|
0.77 Percentage of subjects
Interval 0.24 to 1.82
|
0.25 Percentage of subjects
Interval 0.01 to 1.38
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Headache, Week 45
|
0.88 Percentage of subjects
Interval 0.07 to 3.62
|
0.75 Percentage of subjects
Interval 0.07 to 2.91
|
0.38 Percentage of subjects
Interval 0.01 to 2.12
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Headache, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 1.42
|
0.00 Percentage of subjects
Interval 0.0 to 2.32
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Headache, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Irritability, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Irritability, Week 37
|
0.36 Percentage of subjects
Interval 0.14 to 0.76
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Irritability, Week 38
|
0.26 Percentage of subjects
Interval 0.09 to 0.56
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Irritability, Week 39
|
0.34 Percentage of subjects
Interval 0.12 to 0.76
|
0.00 Percentage of subjects
Interval 0.0 to 3.85
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Irritability, Week 40
|
0.15 Percentage of subjects
Interval 0.03 to 0.43
|
0.00 Percentage of subjects
Interval 0.0 to 1.09
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Irritability, Week 41
|
0.12 Percentage of subjects
Interval 0.01 to 0.44
|
0.00 Percentage of subjects
Interval 0.0 to 1.09
|
0.00 Percentage of subjects
Interval 0.0 to 6.38
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Irritability, Week 42
|
0.11 Percentage of subjects
Interval 0.0 to 0.8
|
0.25 Percentage of subjects
Interval 0.01 to 1.38
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
PRIMARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start, up to end of the week of interest and were registered in EHR, using card-based ADR reporting system during the safety FU period (from vaccination up to 7 days post-vaccination).
General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16387 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=2946 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=546 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Any, Week 35-38
|
3.41 Percentage of subjects
Interval 2.58 to 4.4
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
2.86 Percentage of subjects
Interval 0.02 to 18.52
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Any, Week 35-40
|
3.06 Percentage of subjects
Interval 2.39 to 3.85
|
1.13 Percentage of subjects
Interval 0.37 to 2.62
|
2.22 Percentage of subjects
Interval 0.27 to 7.8
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Drowsiness, Week 35-48
|
0.65 Percentage of subjects
Interval 0.32 to 1.16
|
0.24 Percentage of subjects
Interval 0.03 to 0.83
|
0.00 Percentage of subjects
Interval 0.0 to 0.67
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Fatigue, Week 35-41
|
1.59 Percentage of subjects
Interval 1.2 to 2.06
|
0.38 Percentage of subjects
Interval 0.03 to 1.54
|
0.68 Percentage of subjects
Interval 0.02 to 3.76
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Headache, Week 35-40
|
1.77 Percentage of subjects
Interval 1.24 to 2.44
|
0.68 Percentage of subjects
Interval 0.08 to 2.44
|
1.11 Percentage of subjects
Interval 0.03 to 6.04
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Irritability, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Irritability, Week 35-37
|
0.36 Percentage of subjects
Interval 0.14 to 0.76
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Irritability, Week 35-44
|
0.24 Percentage of subjects
Interval 0.12 to 0.44
|
0.20 Percentage of subjects
Interval 0.02 to 0.82
|
0.00 Percentage of subjects
Interval 0.0 to 1.7
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Any, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Any, Week 35-37
|
3.89 Percentage of subjects
Interval 3.15 to 4.74
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
5.26 Percentage of subjects
Interval 0.06 to 29.55
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Any, Week 35-39
|
3.20 Percentage of subjects
Interval 2.47 to 4.07
|
0.00 Percentage of subjects
Interval 0.0 to 3.45
|
3.39 Percentage of subjects
Interval 0.41 to 11.71
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Any, Week 35-42
|
2.81 Percentage of subjects
Interval 2.14 to 3.6
|
0.85 Percentage of subjects
Interval 0.27 to 2.0
|
1.23 Percentage of subjects
Interval 0.15 to 4.36
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Any, Week 35-41
|
2.89 Percentage of subjects
Interval 2.24 to 3.67
|
1.15 Percentage of subjects
Interval 0.34 to 2.8
|
1.37 Percentage of subjects
Interval 0.17 to 4.86
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Any, Week 35-43
|
2.77 Percentage of subjects
Interval 2.1 to 3.59
|
0.90 Percentage of subjects
Interval 0.21 to 2.44
|
1.08 Percentage of subjects
Interval 0.13 to 3.85
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Any, Week 35-44
|
2.71 Percentage of subjects
Interval 2.04 to 3.54
|
0.99 Percentage of subjects
Interval 0.19 to 2.96
|
0.93 Percentage of subjects
Interval 0.11 to 3.32
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Any, Week 35-45
|
2.67 Percentage of subjects
Interval 2.0 to 3.47
|
0.99 Percentage of subjects
Interval 0.27 to 2.5
|
0.63 Percentage of subjects
Interval 0.13 to 1.83
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Any, Week 35-46
|
2.62 Percentage of subjects
Interval 1.95 to 3.45
|
0.97 Percentage of subjects
Interval 0.22 to 2.68
|
0.61 Percentage of subjects
Interval 0.13 to 1.76
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Any, Week 35-47
|
2.58 Percentage of subjects
Interval 1.91 to 3.41
|
0.91 Percentage of subjects
Interval 0.2 to 2.56
|
0.56 Percentage of subjects
Interval 0.12 to 1.63
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Any, Week 35-48
|
2.56 Percentage of subjects
Interval 1.89 to 3.38
|
0.88 Percentage of subjects
Interval 0.2 to 2.48
|
0.55 Percentage of subjects
Interval 0.11 to 1.6
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Drowsiness, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Drowsiness, Week 35-37
|
1.05 Percentage of subjects
Interval 0.62 to 1.68
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Drowsiness, Week 35-38
|
0.92 Percentage of subjects
Interval 0.49 to 1.59
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
0.00 Percentage of subjects
Interval 0.0 to 10.0
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Drowsiness, Week 35-39
|
0.79 Percentage of subjects
Interval 0.42 to 1.36
|
0.00 Percentage of subjects
Interval 0.0 to 3.45
|
0.00 Percentage of subjects
Interval 0.0 to 6.06
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Drowsiness, Week 35-40
|
0.77 Percentage of subjects
Interval 0.43 to 1.28
|
0.23 Percentage of subjects
Interval 0.01 to 1.25
|
0.00 Percentage of subjects
Interval 0.0 to 4.02
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Drowsiness, Week 35-41
|
0.74 Percentage of subjects
Interval 0.41 to 1.23
|
0.38 Percentage of subjects
Interval 0.08 to 1.12
|
0.00 Percentage of subjects
Interval 0.0 to 2.49
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Drowsiness, Week 35-42
|
0.71 Percentage of subjects
Interval 0.38 to 1.21
|
0.25 Percentage of subjects
Interval 0.05 to 0.74
|
0.00 Percentage of subjects
Interval 0.0 to 2.24
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Drowsiness, Week 35-43
|
0.71 Percentage of subjects
Interval 0.36 to 1.26
|
0.26 Percentage of subjects
Interval 0.07 to 0.66
|
0.00 Percentage of subjects
Interval 0.0 to 1.97
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Drowsiness, Week 35-44
|
0.69 Percentage of subjects
Interval 0.34 to 1.24
|
0.30 Percentage of subjects
Interval 0.06 to 0.89
|
0.00 Percentage of subjects
Interval 0.0 to 1.7
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Drowsiness, Week 35-45
|
0.68 Percentage of subjects
Interval 0.34 to 1.21
|
0.25 Percentage of subjects
Interval 0.04 to 0.78
|
0.00 Percentage of subjects
Interval 0.0 to 0.77
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Drowsiness, Week 35-46
|
0.66 Percentage of subjects
Interval 0.33 to 1.19
|
0.26 Percentage of subjects
Interval 0.04 to 0.9
|
0.00 Percentage of subjects
Interval 0.0 to 0.74
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Drowsiness, Week 35-47
|
0.65 Percentage of subjects
Interval 0.32 to 1.17
|
0.25 Percentage of subjects
Interval 0.03 to 0.86
|
0.00 Percentage of subjects
Interval 0.0 to 0.69
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Fatigue, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Fatigue, Week 35-37
|
2.11 Percentage of subjects
Interval 1.58 to 2.76
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
5.26 Percentage of subjects
Interval 0.06 to 29.55
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Fatigue, Week 35-38
|
1.94 Percentage of subjects
Interval 1.46 to 2.54
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
2.86 Percentage of subjects
Interval 0.02 to 18.52
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Fatigue, Week 35-39
|
1.78 Percentage of subjects
Interval 1.37 to 2.28
|
0.00 Percentage of subjects
Interval 0.0 to 3.45
|
1.69 Percentage of subjects
Interval 0.01 to 12.12
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Fatigue, Week 35-40
|
1.66 Percentage of subjects
Interval 1.27 to 2.13
|
0.45 Percentage of subjects
Interval 0.01 to 2.35
|
1.11 Percentage of subjects
Interval 0.01 to 7.73
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Fatigue, Week 35-42
|
1.54 Percentage of subjects
Interval 1.14 to 2.02
|
0.25 Percentage of subjects
Interval 0.03 to 0.95
|
0.61 Percentage of subjects
Interval 0.02 to 3.37
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Fatigue, Week 35-43
|
1.51 Percentage of subjects
Interval 1.13 to 1.98
|
0.32 Percentage of subjects
Interval 0.03 to 1.21
|
0.54 Percentage of subjects
Interval 0.01 to 2.97
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Fatigue, Week 35-44
|
1.46 Percentage of subjects
Interval 1.09 to 1.92
|
0.40 Percentage of subjects
Interval 0.06 to 1.3
|
0.47 Percentage of subjects
Interval 0.01 to 2.56
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Fatigue, Week 35-45
|
1.45 Percentage of subjects
Interval 1.09 to 1.88
|
0.41 Percentage of subjects
Interval 0.14 to 0.95
|
0.42 Percentage of subjects
Interval 0.05 to 1.51
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Fatigue, Week 35-46
|
1.43 Percentage of subjects
Interval 1.05 to 1.89
|
0.37 Percentage of subjects
Interval 0.11 to 0.91
|
0.40 Percentage of subjects
Interval 0.05 to 1.45
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Fatigue, Week 35-47
|
1.40 Percentage of subjects
Interval 1.03 to 1.86
|
0.35 Percentage of subjects
Interval 0.1 to 0.87
|
0.37 Percentage of subjects
Interval 0.05 to 1.34
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Fatigue, Week 35-48
|
1.39 Percentage of subjects
Interval 1.02 to 1.85
|
0.34 Percentage of subjects
Interval 0.1 to 0.84
|
0.37 Percentage of subjects
Interval 0.04 to 1.32
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Headache, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Headache, Week 35-37
|
2.19 Percentage of subjects
Interval 1.64 to 2.85
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Headache, Week 35-38
|
1.98 Percentage of subjects
Interval 1.25 to 2.97
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
0.00 Percentage of subjects
Interval 0.0 to 10.0
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Headache, Week 35-39
|
1.85 Percentage of subjects
Interval 1.24 to 2.64
|
0.00 Percentage of subjects
Interval 0.0 to 3.45
|
1.69 Percentage of subjects
Interval 0.04 to 9.09
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Headache, Week 35-41
|
1.66 Percentage of subjects
Interval 1.16 to 2.29
|
0.77 Percentage of subjects
Interval 0.14 to 2.32
|
0.68 Percentage of subjects
Interval 0.01 to 4.4
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Headache, Week 35-42
|
1.60 Percentage of subjects
Interval 1.12 to 2.21
|
0.59 Percentage of subjects
Interval 0.13 to 1.69
|
0.61 Percentage of subjects
Interval 0.01 to 4.02
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Headache, Week 35-43
|
1.59 Percentage of subjects
Interval 1.11 to 2.2
|
0.64 Percentage of subjects
Interval 0.12 to 1.95
|
0.54 Percentage of subjects
Interval 0.0 to 3.67
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Irritability, Week 35-40
|
0.29 Percentage of subjects
Interval 0.16 to 0.47
|
0.00 Percentage of subjects
Interval 0.0 to 0.83
|
0.00 Percentage of subjects
Interval 0.0 to 4.02
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Headache, Week 35-44
|
1.57 Percentage of subjects
Interval 1.1 to 2.19
|
0.64 Percentage of subjects
Interval 0.12 to 1.93
|
0.47 Percentage of subjects
Interval 0.0 to 3.34
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Headache, Week 35-45
|
1.55 Percentage of subjects
Interval 1.09 to 2.15
|
0.66 Percentage of subjects
Interval 0.17 to 1.73
|
0.42 Percentage of subjects
Interval 0.05 to 1.51
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Headache, Week 35-46
|
1.53 Percentage of subjects
Interval 1.06 to 2.12
|
0.63 Percentage of subjects
Interval 0.14 to 1.78
|
0.40 Percentage of subjects
Interval 0.05 to 1.45
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Headache, Week 35-47
|
1.50 Percentage of subjects
Interval 1.04 to 2.09
|
0.60 Percentage of subjects
Interval 0.13 to 1.7
|
0.37 Percentage of subjects
Interval 0.05 to 1.34
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Headache, Week 35-48
|
1.49 Percentage of subjects
Interval 1.03 to 2.08
|
0.58 Percentage of subjects
Interval 0.13 to 1.64
|
0.37 Percentage of subjects
Interval 0.04 to 1.32
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Irritability, Week 35-41
|
0.27 Percentage of subjects
Interval 0.15 to 0.45
|
0.00 Percentage of subjects
Interval 0.0 to 0.47
|
0.00 Percentage of subjects
Interval 0.0 to 2.49
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Irritability, Week 35-38
|
0.31 Percentage of subjects
Interval 0.14 to 0.6
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
0.00 Percentage of subjects
Interval 0.0 to 10.0
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Irritability, Week 35-39
|
0.32 Percentage of subjects
Interval 0.17 to 0.56
|
0.00 Percentage of subjects
Interval 0.0 to 3.45
|
0.00 Percentage of subjects
Interval 0.0 to 6.06
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Irritability, Week 35-42
|
0.26 Percentage of subjects
Interval 0.14 to 0.45
|
0.08 Percentage of subjects
Interval 0.0 to 0.47
|
0.00 Percentage of subjects
Interval 0.0 to 2.24
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Irritability, Week 35-43
|
0.26 Percentage of subjects
Interval 0.13 to 0.46
|
0.13 Percentage of subjects
Interval 0.01 to 0.48
|
0.00 Percentage of subjects
Interval 0.0 to 1.97
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Irritability, Week 35-45
|
0.24 Percentage of subjects
Interval 0.13 to 0.42
|
0.16 Percentage of subjects
Interval 0.01 to 0.71
|
0.00 Percentage of subjects
Interval 0.0 to 0.77
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Irritability, Week 35-46
|
0.24 Percentage of subjects
Interval 0.12 to 0.42
|
0.15 Percentage of subjects
Interval 0.01 to 0.67
|
0.00 Percentage of subjects
Interval 0.0 to 0.74
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Irritability, Week 35-47
|
0.23 Percentage of subjects
Interval 0.12 to 0.41
|
0.14 Percentage of subjects
Interval 0.01 to 0.64
|
0.00 Percentage of subjects
Interval 0.0 to 0.69
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Irritability, Week 35-48
|
0.23 Percentage of subjects
Interval 0.12 to 0.41
|
0.14 Percentage of subjects
Interval 0.01 to 0.62
|
0.00 Percentage of subjects
Interval 0.0 to 0.67
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Malaise, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Malaise, Week 35-37
|
0.04 Percentage of subjects
Interval 0.0 to 0.25
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Malaise, Week 35-38
|
0.02 Percentage of subjects
Interval 0.0 to 0.12
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
0.00 Percentage of subjects
Interval 0.0 to 10.0
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Malaise, Week 35-39
|
0.01 Percentage of subjects
Interval 0.0 to 0.07
|
0.00 Percentage of subjects
Interval 0.0 to 3.45
|
0.00 Percentage of subjects
Interval 0.0 to 6.06
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Malaise, Week 35-40
|
0.01 Percentage of subjects
Interval 0.0 to 0.06
|
0.00 Percentage of subjects
Interval 0.0 to 0.83
|
0.00 Percentage of subjects
Interval 0.0 to 4.02
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Malaise, Week 35-41
|
0.01 Percentage of subjects
Interval 0.0 to 0.05
|
0.00 Percentage of subjects
Interval 0.0 to 0.47
|
0.00 Percentage of subjects
Interval 0.0 to 2.49
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Malaise, Week 35-42
|
0.01 Percentage of subjects
Interval 0.0 to 0.05
|
0.00 Percentage of subjects
Interval 0.0 to 0.31
|
0.00 Percentage of subjects
Interval 0.0 to 2.24
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Malaise, Week 35-43
|
0.01 Percentage of subjects
Interval 0.0 to 0.04
|
0.00 Percentage of subjects
Interval 0.0 to 0.24
|
0.00 Percentage of subjects
Interval 0.0 to 1.97
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Malaise, Week 35-44
|
0.01 Percentage of subjects
Interval 0.0 to 0.04
|
0.00 Percentage of subjects
Interval 0.0 to 0.18
|
0.00 Percentage of subjects
Interval 0.0 to 1.7
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Malaise, Week 35-45
|
0.01 Percentage of subjects
Interval 0.0 to 0.04
|
0.00 Percentage of subjects
Interval 0.0 to 0.15
|
0.00 Percentage of subjects
Interval 0.0 to 0.77
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Malaise, Week 35-46
|
0.01 Percentage of subjects
Interval 0.0 to 0.04
|
0.00 Percentage of subjects
Interval 0.0 to 0.14
|
0.00 Percentage of subjects
Interval 0.0 to 0.74
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Malaise, Week 35-47
|
0.01 Percentage of subjects
Interval 0.0 to 0.04
|
0.00 Percentage of subjects
Interval 0.0 to 0.13
|
0.00 Percentage of subjects
Interval 0.0 to 0.69
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group
Malaise, Week 35-48
|
0.01 Percentage of subjects
Interval 0.0 to 0.04
|
0.00 Percentage of subjects
Interval 0.0 to 0.13
|
0.00 Percentage of subjects
Interval 0.0 to 0.67
|
PRIMARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in electronic health record (EHR), using card-based ADR reporting system during the safety follow-up (FU) period (from vaccination up to 7 days post-vaccination).
Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16387 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=2946 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=546 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 45
|
1.77 Percentage of subjects
Interval 0.54 to 4.23
|
1.00 Percentage of subjects
Interval 0.01 to 6.97
|
1.92 Percentage of subjects
Interval 0.62 to 4.41
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 39
|
4.23 Percentage of subjects
Interval 3.63 to 4.89
|
0.00 Percentage of subjects
Interval 0.0 to 3.85
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 40
|
4.57 Percentage of subjects
Interval 2.77 to 7.05
|
2.67 Percentage of subjects
Interval 0.48 to 8.06
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 47
|
1.55 Percentage of subjects
Interval 0.22 to 5.19
|
0.64 Percentage of subjects
Interval 0.02 to 3.5
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 37
|
5.76 Percentage of subjects
Interval 4.81 to 6.83
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 38
|
3.88 Percentage of subjects
Interval 2.99 to 4.95
|
14.29 Percentage of subjects
Interval 0.0 to 90.97
|
6.25 Percentage of subjects
Interval 0.16 to 30.23
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 41
|
3.32 Percentage of subjects
Interval 2.19 to 4.81
|
2.07 Percentage of subjects
Interval 0.75 to 4.49
|
0.00 Percentage of subjects
Interval 0.0 to 6.38
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 42
|
2.09 Percentage of subjects
Interval 0.95 to 3.94
|
0.50 Percentage of subjects
Interval 0.06 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 43
|
2.62 Percentage of subjects
Interval 0.83 to 6.1
|
1.85 Percentage of subjects
Interval 0.66 to 4.07
|
0.00 Percentage of subjects
Interval 0.0 to 15.44
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 44
|
2.40 Percentage of subjects
Interval 0.64 to 6.09
|
2.16 Percentage of subjects
Interval 0.63 to 5.25
|
0.00 Percentage of subjects
Interval 0.0 to 11.57
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 46
|
1.43 Percentage of subjects
Interval 0.41 to 3.52
|
1.14 Percentage of subjects
Interval 0.01 to 7.76
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
PRIMARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start, up to end of the week of interest and were registered in EHR, using card-based ADR reporting system during the safety FU period (from vaccination up to 7 days post-vaccination).
Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16387 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=2946 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=546 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 35-37
|
5.76 Percentage of subjects
Interval 4.81 to 6.83
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 35-38
|
4.77 Percentage of subjects
Interval 3.99 to 5.65
|
9.09 Percentage of subjects
Interval 0.08 to 47.67
|
2.86 Percentage of subjects
Interval 0.05 to 16.1
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 35-40
|
4.54 Percentage of subjects
Interval 3.88 to 5.27
|
2.26 Percentage of subjects
Interval 0.44 to 6.66
|
1.11 Percentage of subjects
Interval 0.03 to 6.04
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 35-41
|
4.38 Percentage of subjects
Interval 3.71 to 5.14
|
2.18 Percentage of subjects
Interval 0.8 to 4.71
|
0.68 Percentage of subjects
Interval 0.01 to 4.4
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 35-42
|
4.23 Percentage of subjects
Interval 3.53 to 5.03
|
1.61 Percentage of subjects
Interval 0.58 to 3.5
|
0.61 Percentage of subjects
Interval 0.01 to 4.02
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 35-43
|
4.18 Percentage of subjects
Interval 3.44 to 5.02
|
1.67 Percentage of subjects
Interval 0.84 to 2.95
|
0.54 Percentage of subjects
Interval 0.0 to 3.67
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 35-44
|
4.09 Percentage of subjects
Interval 3.35 to 4.94
|
1.78 Percentage of subjects
Interval 0.96 to 2.99
|
0.47 Percentage of subjects
Interval 0.0 to 3.34
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 35-45
|
4.02 Percentage of subjects
Interval 3.28 to 4.88
|
1.65 Percentage of subjects
Interval 0.83 to 2.91
|
1.26 Percentage of subjects
Interval 0.46 to 2.72
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 35-46
|
3.97 Percentage of subjects
Interval 3.19 to 4.86
|
1.60 Percentage of subjects
Interval 0.8 to 2.85
|
1.21 Percentage of subjects
Interval 0.45 to 2.62
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 35-48
|
3.89 Percentage of subjects
Interval 3.12 to 4.79
|
1.49 Percentage of subjects
Interval 0.73 to 2.69
|
1.10 Percentage of subjects
Interval 0.4 to 2.38
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 35-39
|
4.53 Percentage of subjects
Interval 3.96 to 5.16
|
0.95 Percentage of subjects
Interval 0.02 to 5.19
|
1.69 Percentage of subjects
Interval 0.04 to 9.09
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 35-47
|
3.93 Percentage of subjects
Interval 3.16 to 4.82
|
1.55 Percentage of subjects
Interval 0.77 to 2.77
|
1.12 Percentage of subjects
Interval 0.41 to 2.42
|
PRIMARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in electronic health record (EHR), using card-based ADR reporting system during the safety follow-up (FU) period (from vaccination up to 7 days post-vaccination).
Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhea, nausea, and vomiting. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16387 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=2946 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=546 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 37
|
2.03 Percentage of subjects
Interval 1.29 to 3.03
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
6.25 Percentage of subjects
Interval 0.03 to 39.17
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 38
|
1.65 Percentage of subjects
Interval 0.95 to 2.65
|
14.29 Percentage of subjects
Interval 0.0 to 90.97
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 40
|
1.36 Percentage of subjects
Interval 0.8 to 2.16
|
1.19 Percentage of subjects
Interval 0.32 to 3.01
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 41
|
1.15 Percentage of subjects
Interval 0.62 to 1.94
|
0.59 Percentage of subjects
Interval 0.07 to 2.12
|
0.00 Percentage of subjects
Interval 0.0 to 6.38
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 43
|
0.40 Percentage of subjects
Interval 0.04 to 1.61
|
0.00 Percentage of subjects
Interval 0.0 to 0.97
|
0.00 Percentage of subjects
Interval 0.0 to 15.44
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 44
|
0.40 Percentage of subjects
Interval 0.08 to 1.16
|
0.43 Percentage of subjects
Interval 0.01 to 2.52
|
0.00 Percentage of subjects
Interval 0.0 to 11.57
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 46
|
0.86 Percentage of subjects
Interval 0.06 to 3.72
|
0.00 Percentage of subjects
Interval 0.0 to 1.39
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 39
|
1.34 Percentage of subjects
Interval 0.81 to 2.08
|
0.00 Percentage of subjects
Interval 0.0 to 3.85
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 42
|
0.66 Percentage of subjects
Interval 0.19 to 1.63
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 45
|
1.32 Percentage of subjects
Interval 0.22 to 4.18
|
1.00 Percentage of subjects
Interval 0.15 to 3.24
|
0.38 Percentage of subjects
Interval 0.01 to 2.12
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 1.42
|
0.00 Percentage of subjects
Interval 0.0 to 2.32
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
PRIMARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start, up to end of the week of interest and were registered in EHR, using card-based ADR reporting system during the safety FU period (from vaccination up to 7 days post-vaccination).
Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhea, nausea and, vomiting. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16387 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=2946 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=546 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 35-37
|
2.03 Percentage of subjects
Interval 1.29 to 3.03
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
5.26 Percentage of subjects
Interval 0.06 to 29.55
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 35-39
|
1.61 Percentage of subjects
Interval 1.11 to 2.26
|
0.95 Percentage of subjects
Interval 0.02 to 5.19
|
1.69 Percentage of subjects
Interval 0.01 to 12.12
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 35-40
|
1.57 Percentage of subjects
Interval 1.15 to 2.07
|
1.13 Percentage of subjects
Interval 0.37 to 2.62
|
1.11 Percentage of subjects
Interval 0.01 to 7.73
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 35-38
|
1.83 Percentage of subjects
Interval 1.33 to 2.44
|
9.09 Percentage of subjects
Interval 0.08 to 47.67
|
2.86 Percentage of subjects
Interval 0.02 to 18.52
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 35-41
|
1.51 Percentage of subjects
Interval 1.12 to 1.99
|
0.90 Percentage of subjects
Interval 0.35 to 1.87
|
0.68 Percentage of subjects
Interval 0.02 to 3.76
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 35-42
|
1.46 Percentage of subjects
Interval 1.09 to 1.91
|
0.59 Percentage of subjects
Interval 0.24 to 1.23
|
0.61 Percentage of subjects
Interval 0.02 to 3.37
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 35-43
|
1.42 Percentage of subjects
Interval 1.05 to 1.88
|
0.45 Percentage of subjects
Interval 0.16 to 1.01
|
0.54 Percentage of subjects
Interval 0.01 to 2.97
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 35-44
|
1.37 Percentage of subjects
Interval 1.01 to 1.81
|
0.44 Percentage of subjects
Interval 0.1 to 1.22
|
0.47 Percentage of subjects
Interval 0.01 to 2.56
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 35-45
|
1.37 Percentage of subjects
Interval 1.03 to 1.78
|
0.54 Percentage of subjects
Interval 0.21 to 1.12
|
0.42 Percentage of subjects
Interval 0.05 to 1.51
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 35-46
|
1.36 Percentage of subjects
Interval 1.02 to 1.76
|
0.48 Percentage of subjects
Interval 0.17 to 1.07
|
0.40 Percentage of subjects
Interval 0.05 to 1.45
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 35-47
|
1.34 Percentage of subjects
Interval 1.0 to 1.74
|
0.46 Percentage of subjects
Interval 0.16 to 1.03
|
0.37 Percentage of subjects
Interval 0.05 to 1.34
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 35-48
|
1.32 Percentage of subjects
Interval 0.99 to 1.73
|
0.44 Percentage of subjects
Interval 0.15 to 1.0
|
0.37 Percentage of subjects
Interval 0.04 to 1.32
|
PRIMARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in electronic health record (EHR), using card-based ADR reporting system during the safety follow-up (FU) period (from vaccination up to 7 days post-vaccination).
Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The weekly incidence rates expressed as the percentage of subjects, of AEIs were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16387 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=2946 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=546 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 37
|
0.65 Percentage of subjects
Interval 0.01 to 4.33
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 44
|
0.27 Percentage of subjects
Interval 0.02 to 1.2
|
0.65 Percentage of subjects
Interval 0.01 to 3.77
|
0.00 Percentage of subjects
Interval 0.0 to 11.57
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 38
|
0.55 Percentage of subjects
Interval 0.07 to 1.92
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 39
|
0.36 Percentage of subjects
Interval 0.03 to 1.54
|
0.00 Percentage of subjects
Interval 0.0 to 3.85
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 40
|
0.39 Percentage of subjects
Interval 0.06 to 1.28
|
0.59 Percentage of subjects
Interval 0.01 to 3.61
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 41
|
0.24 Percentage of subjects
Interval 0.05 to 0.7
|
0.59 Percentage of subjects
Interval 0.07 to 2.12
|
0.00 Percentage of subjects
Interval 0.0 to 6.38
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 0.4
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 43
|
0.20 Percentage of subjects
Interval 0.0 to 1.37
|
0.00 Percentage of subjects
Interval 0.0 to 0.97
|
0.00 Percentage of subjects
Interval 0.0 to 15.44
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.00 Percentage of subjects
Interval 0.0 to 0.91
|
0.38 Percentage of subjects
Interval 0.01 to 2.12
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 46
|
0.29 Percentage of subjects
Interval 0.0 to 2.1
|
0.00 Percentage of subjects
Interval 0.0 to 1.39
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 1.42
|
0.00 Percentage of subjects
Interval 0.0 to 2.32
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
PRIMARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start, up to end of the week of interest and were registered in EHR, using card-based ADR reporting system during the safety FU period (from vaccination up to 7 days post-vaccination).
Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The cumulative incidence rates expressed as the percentage of subjects, of AEIs were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16387 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=2946 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=546 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 35-38
|
0.60 Percentage of subjects
Interval 0.03 to 2.83
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
0.00 Percentage of subjects
Interval 0.0 to 10.0
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 35-46
|
0.39 Percentage of subjects
Interval 0.03 to 1.55
|
0.26 Percentage of subjects
Interval 0.02 to 1.17
|
0.20 Percentage of subjects
Interval 0.01 to 1.12
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 35-39
|
0.49 Percentage of subjects
Interval 0.03 to 2.23
|
0.00 Percentage of subjects
Interval 0.0 to 3.45
|
0.00 Percentage of subjects
Interval 0.0 to 6.06
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 35-40
|
0.48 Percentage of subjects
Interval 0.03 to 2.05
|
0.45 Percentage of subjects
Interval 0.01 to 2.35
|
0.00 Percentage of subjects
Interval 0.0 to 4.02
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 35-41
|
0.45 Percentage of subjects
Interval 0.04 to 1.81
|
0.51 Percentage of subjects
Interval 0.04 to 2.05
|
0.00 Percentage of subjects
Interval 0.0 to 2.49
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 35-37
|
0.65 Percentage of subjects
Interval 0.01 to 4.33
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 35-42
|
0.42 Percentage of subjects
Interval 0.03 to 1.73
|
0.34 Percentage of subjects
Interval 0.04 to 1.26
|
0.00 Percentage of subjects
Interval 0.0 to 2.24
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 35-43
|
0.41 Percentage of subjects
Interval 0.03 to 1.67
|
0.26 Percentage of subjects
Interval 0.03 to 0.97
|
0.00 Percentage of subjects
Interval 0.0 to 1.97
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 35-44
|
0.40 Percentage of subjects
Interval 0.04 to 1.58
|
0.35 Percentage of subjects
Interval 0.03 to 1.43
|
0.00 Percentage of subjects
Interval 0.0 to 1.7
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 35-45
|
0.39 Percentage of subjects
Interval 0.04 to 1.54
|
0.29 Percentage of subjects
Interval 0.02 to 1.24
|
0.21 Percentage of subjects
Interval 0.01 to 1.16
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 35-47
|
0.38 Percentage of subjects
Interval 0.03 to 1.53
|
0.25 Percentage of subjects
Interval 0.01 to 1.11
|
0.19 Percentage of subjects
Interval 0.0 to 1.04
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 35-48
|
0.38 Percentage of subjects
Interval 0.03 to 1.51
|
0.24 Percentage of subjects
Interval 0.01 to 1.08
|
0.18 Percentage of subjects
Interval 0.0 to 1.02
|
PRIMARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in electronic health record (EHR), using card-based ADR reporting system during the safety follow-up (FU) period (from vaccination up to 7 days post-vaccination).
The weekly incidence rates expressed as the percentage of subjects, of AEIs were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16387 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=2946 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=546 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group
Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group
Week 38
|
0.29 Percentage of subjects
Interval 0.1 to 0.67
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group
Week 40
|
0.44 Percentage of subjects
Interval 0.2 to 0.83
|
0.00 Percentage of subjects
Interval 0.0 to 1.09
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group
Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 0.4
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group
Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.00 Percentage of subjects
Interval 0.0 to 0.91
|
0.00 Percentage of subjects
Interval 0.0 to 1.4
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group
Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group
Week 37
|
0.53 Percentage of subjects
Interval 0.23 to 1.04
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group
Week 39
|
0.19 Percentage of subjects
Interval 0.08 to 0.38
|
0.00 Percentage of subjects
Interval 0.0 to 3.85
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group
Week 41
|
0.12 Percentage of subjects
Interval 0.01 to 0.44
|
0.30 Percentage of subjects
Interval 0.01 to 1.64
|
0.00 Percentage of subjects
Interval 0.0 to 6.38
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group
Week 43
|
0.40 Percentage of subjects
Interval 0.03 to 1.69
|
0.00 Percentage of subjects
Interval 0.0 to 0.97
|
0.00 Percentage of subjects
Interval 0.0 to 15.44
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group
Week 44
|
0.40 Percentage of subjects
Interval 0.02 to 1.8
|
0.00 Percentage of subjects
Interval 0.0 to 0.79
|
0.00 Percentage of subjects
Interval 0.0 to 11.57
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group
Week 46
|
0.29 Percentage of subjects
Interval 0.0 to 2.08
|
0.00 Percentage of subjects
Interval 0.0 to 1.39
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group
Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 1.42
|
0.00 Percentage of subjects
Interval 0.0 to 2.32
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
PRIMARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start, up to end of the week of interest and were registered in EHR, using card-based ADR reporting system during the safety FU period (from vaccination up to 7 days post-vaccination).
The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16387 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=2946 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=546 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group
Week 35-38
|
0.40 Percentage of subjects
Interval 0.17 to 0.8
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
0.00 Percentage of subjects
Interval 0.0 to 10.0
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group
Week 35-40
|
0.33 Percentage of subjects
Interval 0.22 to 0.48
|
0.00 Percentage of subjects
Interval 0.0 to 0.83
|
0.00 Percentage of subjects
Interval 0.0 to 4.02
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group
Week 35-45
|
0.29 Percentage of subjects
Interval 0.2 to 0.4
|
0.04 Percentage of subjects
Interval 0.0 to 0.23
|
0.00 Percentage of subjects
Interval 0.0 to 0.77
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group
Week 35-48
|
0.28 Percentage of subjects
Interval 0.2 to 0.39
|
0.03 Percentage of subjects
Interval 0.0 to 0.19
|
0.00 Percentage of subjects
Interval 0.0 to 0.67
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group
Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group
Week 35-37
|
0.53 Percentage of subjects
Interval 0.23 to 1.04
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group
Week 35-39
|
0.31 Percentage of subjects
Interval 0.17 to 0.53
|
0.00 Percentage of subjects
Interval 0.0 to 3.45
|
0.00 Percentage of subjects
Interval 0.0 to 6.06
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group
Week 35-41
|
0.31 Percentage of subjects
Interval 0.2 to 0.44
|
0.13 Percentage of subjects
Interval 0.0 to 0.71
|
0.00 Percentage of subjects
Interval 0.0 to 2.49
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group
Week 35-42
|
0.29 Percentage of subjects
Interval 0.19 to 0.41
|
0.08 Percentage of subjects
Interval 0.0 to 0.47
|
0.00 Percentage of subjects
Interval 0.0 to 2.24
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group
Week 35-43
|
0.29 Percentage of subjects
Interval 0.2 to 0.41
|
0.06 Percentage of subjects
Interval 0.0 to 0.36
|
0.00 Percentage of subjects
Interval 0.0 to 1.97
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group
Week 35-44
|
0.30 Percentage of subjects
Interval 0.21 to 0.41
|
0.05 Percentage of subjects
Interval 0.0 to 0.28
|
0.00 Percentage of subjects
Interval 0.0 to 1.7
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group
Week 35-46
|
0.29 Percentage of subjects
Interval 0.2 to 0.4
|
0.04 Percentage of subjects
Interval 0.0 to 0.21
|
0.00 Percentage of subjects
Interval 0.0 to 0.74
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group
Week 35-47
|
0.28 Percentage of subjects
Interval 0.2 to 0.39
|
0.04 Percentage of subjects
Interval 0.0 to 0.2
|
0.00 Percentage of subjects
Interval 0.0 to 0.69
|
PRIMARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in electronic health record (EHR), using card-based ADR reporting system during the safety follow-up (FU) period (from vaccination up to 7 days post-vaccination).
Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16387 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=2946 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=546 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 41
|
1.99 Percentage of subjects
Interval 1.37 to 2.79
|
0.00 Percentage of subjects
Interval 0.0 to 1.09
|
0.00 Percentage of subjects
Interval 0.0 to 6.38
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 42
|
1.54 Percentage of subjects
Interval 0.59 to 3.23
|
0.25 Percentage of subjects
Interval 0.01 to 1.38
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 43
|
2.82 Percentage of subjects
Interval 1.31 to 5.26
|
0.00 Percentage of subjects
Interval 0.0 to 0.97
|
0.00 Percentage of subjects
Interval 0.0 to 15.44
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 37
|
3.65 Percentage of subjects
Interval 2.94 to 4.47
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
6.25 Percentage of subjects
Interval 0.16 to 30.23
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 38
|
2.82 Percentage of subjects
Interval 2.12 to 3.67
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
6.25 Percentage of subjects
Interval 0.01 to 45.43
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 39
|
2.55 Percentage of subjects
Interval 2.04 to 3.14
|
0.00 Percentage of subjects
Interval 0.0 to 3.85
|
4.17 Percentage of subjects
Interval 0.11 to 21.12
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 40
|
2.19 Percentage of subjects
Interval 1.6 to 2.92
|
1.19 Percentage of subjects
Interval 0.02 to 7.15
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 44
|
1.60 Percentage of subjects
Interval 0.39 to 4.27
|
1.08 Percentage of subjects
Interval 0.02 to 6.23
|
0.00 Percentage of subjects
Interval 0.0 to 11.57
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 45
|
1.32 Percentage of subjects
Interval 0.26 to 3.91
|
0.25 Percentage of subjects
Interval 0.01 to 1.38
|
0.38 Percentage of subjects
Interval 0.01 to 2.12
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 46
|
0.86 Percentage of subjects
Interval 0.17 to 2.52
|
0.38 Percentage of subjects
Interval 0.0 to 2.63
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 47
|
0.39 Percentage of subjects
Interval 0.0 to 2.82
|
0.00 Percentage of subjects
Interval 0.0 to 2.32
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
PRIMARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start, up to end of the week of interest and were registered in EHR, using card-based ADR reporting system during the safety FU period (from vaccination up to 7 days post-vaccination).
Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16387 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=2946 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=546 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 35-37
|
3.65 Percentage of subjects
Interval 2.94 to 4.47
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
5.26 Percentage of subjects
Interval 0.13 to 26.03
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 35-43
|
2.62 Percentage of subjects
Interval 2.12 to 3.19
|
0.32 Percentage of subjects
Interval 0.03 to 1.21
|
1.62 Percentage of subjects
Interval 0.34 to 4.67
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 35-44
|
2.57 Percentage of subjects
Interval 2.08 to 3.13
|
0.49 Percentage of subjects
Interval 0.04 to 2.04
|
1.40 Percentage of subjects
Interval 0.26 to 4.21
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 35-45
|
2.53 Percentage of subjects
Interval 2.05 to 3.1
|
0.45 Percentage of subjects
Interval 0.03 to 1.94
|
0.84 Percentage of subjects
Interval 0.14 to 2.67
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 35-46
|
2.50 Percentage of subjects
Interval 2.01 to 3.06
|
0.45 Percentage of subjects
Interval 0.03 to 1.99
|
0.81 Percentage of subjects
Interval 0.14 to 2.56
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 35-38
|
3.21 Percentage of subjects
Interval 2.56 to 3.98
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
5.71 Percentage of subjects
Interval 0.61 to 20.03
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 35-39
|
2.92 Percentage of subjects
Interval 2.35 to 3.58
|
0.00 Percentage of subjects
Interval 0.0 to 3.45
|
5.08 Percentage of subjects
Interval 1.06 to 14.15
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 35-40
|
2.79 Percentage of subjects
Interval 2.32 to 3.32
|
0.90 Percentage of subjects
Interval 0.03 to 4.68
|
3.33 Percentage of subjects
Interval 0.69 to 9.43
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 35-48
|
2.44 Percentage of subjects
Interval 1.96 to 3.0
|
0.41 Percentage of subjects
Interval 0.02 to 1.84
|
0.73 Percentage of subjects
Interval 0.13 to 2.24
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 35-41
|
2.69 Percentage of subjects
Interval 2.21 to 3.23
|
0.51 Percentage of subjects
Interval 0.04 to 2.05
|
2.05 Percentage of subjects
Interval 0.42 to 5.91
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 35-42
|
2.61 Percentage of subjects
Interval 2.12 to 3.18
|
0.42 Percentage of subjects
Interval 0.05 to 1.57
|
1.84 Percentage of subjects
Interval 0.38 to 5.28
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 35-47
|
2.46 Percentage of subjects
Interval 1.98 to 3.02
|
0.42 Percentage of subjects
Interval 0.02 to 1.9
|
0.75 Percentage of subjects
Interval 0.14 to 2.27
|
PRIMARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in electronic health record (EHR), using card-based ADR reporting system during the safety follow-up (FU) period (from vaccination up to 7 days post-vaccination).
Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16387 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=2946 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=546 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 41
|
0.18 Percentage of subjects
Interval 0.03 to 0.59
|
0.30 Percentage of subjects
Interval 0.01 to 1.64
|
1.79 Percentage of subjects
Interval 0.05 to 9.55
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 0.4
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 0.74
|
0.00 Percentage of subjects
Interval 0.0 to 0.97
|
0.00 Percentage of subjects
Interval 0.0 to 15.44
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 1.42
|
0.00 Percentage of subjects
Interval 0.0 to 2.32
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 44
|
0.13 Percentage of subjects
Interval 0.0 to 1.05
|
0.00 Percentage of subjects
Interval 0.0 to 0.79
|
0.00 Percentage of subjects
Interval 0.0 to 11.57
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 37
|
0.28 Percentage of subjects
Interval 0.11 to 0.58
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 38
|
0.26 Percentage of subjects
Interval 0.1 to 0.53
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 39
|
0.17 Percentage of subjects
Interval 0.04 to 0.44
|
0.00 Percentage of subjects
Interval 0.0 to 3.85
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 0.18
|
0.30 Percentage of subjects
Interval 0.0 to 1.82
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.00 Percentage of subjects
Interval 0.0 to 0.91
|
0.00 Percentage of subjects
Interval 0.0 to 1.4
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.00 Percentage of subjects
Interval 0.0 to 1.39
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
PRIMARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start, up to end of the week of interest and were registered in EHR, using card-based ADR reporting system during the safety FU period (from vaccination up to 7 days post-vaccination).
Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16387 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=2946 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=546 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 35-40
|
0.18 Percentage of subjects
Interval 0.09 to 0.34
|
0.23 Percentage of subjects
Interval 0.01 to 1.25
|
0.00 Percentage of subjects
Interval 0.0 to 4.02
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 35-37
|
0.28 Percentage of subjects
Interval 0.11 to 0.58
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 35-38
|
0.27 Percentage of subjects
Interval 0.15 to 0.45
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
0.00 Percentage of subjects
Interval 0.0 to 10.0
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 35-39
|
0.23 Percentage of subjects
Interval 0.12 to 0.39
|
0.00 Percentage of subjects
Interval 0.0 to 3.45
|
0.00 Percentage of subjects
Interval 0.0 to 6.06
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 35-41
|
0.18 Percentage of subjects
Interval 0.1 to 0.31
|
0.26 Percentage of subjects
Interval 0.02 to 1.03
|
0.68 Percentage of subjects
Interval 0.02 to 3.76
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 35-42
|
0.17 Percentage of subjects
Interval 0.09 to 0.29
|
0.17 Percentage of subjects
Interval 0.02 to 0.63
|
0.61 Percentage of subjects
Interval 0.02 to 3.37
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 35-43
|
0.17 Percentage of subjects
Interval 0.09 to 0.28
|
0.13 Percentage of subjects
Interval 0.01 to 0.48
|
0.54 Percentage of subjects
Interval 0.01 to 2.97
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 35-44
|
0.16 Percentage of subjects
Interval 0.09 to 0.28
|
0.10 Percentage of subjects
Interval 0.01 to 0.41
|
0.47 Percentage of subjects
Interval 0.01 to 2.56
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 35-45
|
0.16 Percentage of subjects
Interval 0.09 to 0.27
|
0.08 Percentage of subjects
Interval 0.01 to 0.35
|
0.21 Percentage of subjects
Interval 0.01 to 1.16
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 35-48
|
0.15 Percentage of subjects
Interval 0.08 to 0.26
|
0.07 Percentage of subjects
Interval 0.0 to 0.31
|
0.18 Percentage of subjects
Interval 0.0 to 1.02
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 35-46
|
0.16 Percentage of subjects
Interval 0.08 to 0.27
|
0.07 Percentage of subjects
Interval 0.0 to 0.33
|
0.20 Percentage of subjects
Interval 0.01 to 1.12
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group
Any, Week 35-47
|
0.15 Percentage of subjects
Interval 0.08 to 0.26
|
0.07 Percentage of subjects
Interval 0.0 to 0.32
|
0.19 Percentage of subjects
Interval 0.0 to 1.04
|
PRIMARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in electronic health record (EHR), using card-based ADR reporting system during the safety follow-up (FU) period (from vaccination up to 7 days post-vaccination).
The weekly incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card; * The numerator was the number of subjects from the denominator who reported any SAEs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine. Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16387 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=2946 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=546 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Weekly Incidence Rates of SAEs Reported Via ADR Card by Vaccine Group
Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of SAEs Reported Via ADR Card by Vaccine Group
Week 37
|
0.00 Percentage of subjects
Interval 0.0 to 0.15
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Incidence Rates of SAEs Reported Via ADR Card by Vaccine Group
Week 38
|
0.00 Percentage of subjects
Interval 0.0 to 0.14
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Weekly Incidence Rates of SAEs Reported Via ADR Card by Vaccine Group
Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 0.09
|
0.00 Percentage of subjects
Interval 0.0 to 3.85
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
|
Weekly Incidence Rates of SAEs Reported Via ADR Card by Vaccine Group
Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 0.18
|
0.00 Percentage of subjects
Interval 0.0 to 1.09
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Weekly Incidence Rates of SAEs Reported Via ADR Card by Vaccine Group
Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 0.74
|
0.00 Percentage of subjects
Interval 0.0 to 0.97
|
0.00 Percentage of subjects
Interval 0.0 to 15.44
|
|
Weekly Incidence Rates of SAEs Reported Via ADR Card by Vaccine Group
Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 0.49
|
0.00 Percentage of subjects
Interval 0.0 to 0.79
|
0.00 Percentage of subjects
Interval 0.0 to 11.57
|
|
Weekly Incidence Rates of SAEs Reported Via ADR Card by Vaccine Group
Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.00 Percentage of subjects
Interval 0.0 to 1.39
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Weekly Incidence Rates of SAEs Reported Via ADR Card by Vaccine Group
Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 1.42
|
0.00 Percentage of subjects
Interval 0.0 to 2.32
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
|
Weekly Incidence Rates of SAEs Reported Via ADR Card by Vaccine Group
Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of SAEs Reported Via ADR Card by Vaccine Group
Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 0.22
|
0.00 Percentage of subjects
Interval 0.0 to 1.09
|
0.00 Percentage of subjects
Interval 0.0 to 6.38
|
|
Weekly Incidence Rates of SAEs Reported Via ADR Card by Vaccine Group
Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 0.4
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
|
Weekly Incidence Rates of SAEs Reported Via ADR Card by Vaccine Group
Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.00 Percentage of subjects
Interval 0.0 to 0.91
|
0.00 Percentage of subjects
Interval 0.0 to 1.4
|
PRIMARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start, up to end of the week of interest and were registered in EHR, using card-based ADR reporting system during the safety FU period (from vaccination up to 7 days post-vaccination).
The cumulative incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card; * The numerator was the number of subjects from the denominator who reported any SAEs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine. Vaccination of the subjects happened between week 35 and week 48 of the year 2017.
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16387 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=2946 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=546 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card by Vaccine Group
Week 35-37
|
0.00 Percentage of subjects
Interval 0.0 to 0.15
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card by Vaccine Group
Week 35-41
|
0.00 Percentage of subjects
Interval 0.0 to 0.03
|
0.00 Percentage of subjects
Interval 0.0 to 0.47
|
0.00 Percentage of subjects
Interval 0.0 to 2.49
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card by Vaccine Group
Week 35-42
|
0.00 Percentage of subjects
Interval 0.0 to 0.03
|
0.00 Percentage of subjects
Interval 0.0 to 0.31
|
0.00 Percentage of subjects
Interval 0.0 to 2.24
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card by Vaccine Group
Week 35-43
|
0.00 Percentage of subjects
Interval 0.0 to 0.03
|
0.00 Percentage of subjects
Interval 0.0 to 0.24
|
0.00 Percentage of subjects
Interval 0.0 to 1.97
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card by Vaccine Group
Week 35-44
|
0.00 Percentage of subjects
Interval 0.0 to 0.02
|
0.00 Percentage of subjects
Interval 0.0 to 0.18
|
0.00 Percentage of subjects
Interval 0.0 to 1.7
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card by Vaccine Group
Week 35-46
|
0.00 Percentage of subjects
Interval 0.0 to 0.02
|
0.00 Percentage of subjects
Interval 0.0 to 0.14
|
0.00 Percentage of subjects
Interval 0.0 to 0.74
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card by Vaccine Group
Week 35-48
|
0.00 Percentage of subjects
Interval 0.0 to 0.02
|
0.00 Percentage of subjects
Interval 0.0 to 0.13
|
0.00 Percentage of subjects
Interval 0.0 to 0.67
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card by Vaccine Group
Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card by Vaccine Group
Week 35-38
|
0.00 Percentage of subjects
Interval 0.0 to 0.07
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
0.00 Percentage of subjects
Interval 0.0 to 10.0
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card by Vaccine Group
Week 35-39
|
0.00 Percentage of subjects
Interval 0.0 to 0.04
|
0.00 Percentage of subjects
Interval 0.0 to 3.45
|
0.00 Percentage of subjects
Interval 0.0 to 6.06
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card by Vaccine Group
Week 35-40
|
0.00 Percentage of subjects
Interval 0.0 to 0.03
|
0.00 Percentage of subjects
Interval 0.0 to 0.83
|
0.00 Percentage of subjects
Interval 0.0 to 4.02
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card by Vaccine Group
Week 35-45
|
0.00 Percentage of subjects
Interval 0.0 to 0.02
|
0.00 Percentage of subjects
Interval 0.0 to 0.15
|
0.00 Percentage of subjects
Interval 0.0 to 0.77
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card by Vaccine Group
Week 35-47
|
0.00 Percentage of subjects
Interval 0.0 to 0.02
|
0.00 Percentage of subjects
Interval 0.0 to 0.13
|
0.00 Percentage of subjects
Interval 0.0 to 0.69
|
PRIMARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in electronic health record (EHR), using card-based ADR reporting system during the safety follow-up (FU) period (from vaccination up to 7 days post-vaccination).
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16387 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=2946 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=546 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
1.63 Percentage of subjects
Interval 0.02 to 10.28
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.52 Percentage of subjects
Interval 0.0 to 3.94
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 2.55
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 44
|
—
|
1.97 Percentage of subjects
Interval 0.07 to 9.78
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 3.21
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 45
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.82
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 47
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 4.99
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 37
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
—
|
—
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
—
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 40
|
33.33 Percentage of subjects
Interval 0.0 to 100.0
|
14.29 Percentage of subjects
Interval 3.05 to 36.34
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 39
|
7.14 Percentage of subjects
Interval 0.02 to 44.9
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
11.11 Percentage of subjects
Interval 0.19 to 51.19
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
—
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 13.72
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
—
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
18-65 years, Week 37
|
9.87 Percentage of subjects
Interval 6.92 to 13.55
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
22.22 Percentage of subjects
Interval 2.81 to 60.01
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
18-65 years, Week 38
|
7.45 Percentage of subjects
Interval 4.89 to 10.79
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
18-65 years, Week 39
|
8.48 Percentage of subjects
Interval 7.08 to 10.06
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
18-65 years, Week 40
|
8.37 Percentage of subjects
Interval 4.12 to 14.76
|
6.78 Percentage of subjects
Interval 1.88 to 16.46
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
18-65 years, Week 41
|
4.88 Percentage of subjects
Interval 2.78 to 7.88
|
4.44 Percentage of subjects
Interval 1.22 to 10.99
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
18-65 years, Week 42
|
3.67 Percentage of subjects
Interval 1.25 to 8.2
|
0.00 Percentage of subjects
Interval 0.0 to 3.48
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
18-65 years, Week 44
|
3.83 Percentage of subjects
Interval 1.31 to 8.54
|
8.97 Percentage of subjects
Interval 0.36 to 37.68
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
18-65 years, Week 45
|
2.25 Percentage of subjects
Interval 0.6 to 5.75
|
1.82 Percentage of subjects
Interval 0.0 to 93.05
|
5.88 Percentage of subjects
Interval 0.72 to 19.68
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
18-65 years, Week 46
|
4.93 Percentage of subjects
Interval 1.73 to 10.77
|
8.00 Percentage of subjects
Interval 0.74 to 28.24
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
18-65 years, Week 47
|
2.74 Percentage of subjects
Interval 0.36 to 9.27
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
18-65 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 4.11
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 37
|
10.27 Percentage of subjects
Interval 8.88 to 11.79
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 38
|
7.90 Percentage of subjects
Interval 6.31 to 9.74
|
16.67 Percentage of subjects
Interval 0.0 to 91.51
|
20.00 Percentage of subjects
Interval 1.06 to 65.28
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 40
|
8.15 Percentage of subjects
Interval 5.16 to 12.1
|
2.44 Percentage of subjects
Interval 0.06 to 12.86
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 39
|
7.74 Percentage of subjects
Interval 6.52 to 9.12
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
5.88 Percentage of subjects
Interval 0.15 to 28.69
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 41
|
7.43 Percentage of subjects
Interval 5.38 to 9.96
|
6.33 Percentage of subjects
Interval 2.09 to 14.16
|
33.33 Percentage of subjects
Interval 0.0 to 99.94
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 42
|
3.85 Percentage of subjects
Interval 1.67 to 7.46
|
6.15 Percentage of subjects
Interval 1.7 to 15.01
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 43
|
4.74 Percentage of subjects
Interval 1.88 to 9.68
|
3.70 Percentage of subjects
Interval 0.0 to 98.52
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 44
|
4.88 Percentage of subjects
Interval 1.08 to 13.29
|
7.81 Percentage of subjects
Interval 0.0 to 63.88
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 45
|
5.41 Percentage of subjects
Interval 2.08 to 11.19
|
16.22 Percentage of subjects
Interval 0.0 to 99.95
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 46
|
3.51 Percentage of subjects
Interval 0.58 to 10.84
|
2.70 Percentage of subjects
Interval 0.0 to 99.94
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 3.42
|
3.70 Percentage of subjects
Interval 0.0 to 99.88
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 15.44
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
18-65 years, Week 43
|
4.59 Percentage of subjects
Interval 1.48 to 10.46
|
6.03 Percentage of subjects
Interval 2.46 to 12.04
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
3.38 Percentage of subjects
Interval 1.37 to 6.84
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 48
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 38
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
—
|
—
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 13.72
|
—
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
1.06 Percentage of subjects
Interval 0.02 to 5.93
|
—
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.99 Percentage of subjects
Interval 0.0 to 10.54
|
—
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 47
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
—
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 37
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
—
|
—
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 38
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
—
|
—
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
1.25 Percentage of subjects
Interval 0.03 to 6.77
|
1.46 Percentage of subjects
Interval 0.3 to 4.22
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
PRIMARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start, up to end of the week of interest and were registered in EHR, using card-based ADR reporting system during the safety FU period (from vaccination up to 7 days post-vaccination).
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16387 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=2946 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=546 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-47
|
2.13 Percentage of subjects
Interval 0.0 to 17.04
|
1.31 Percentage of subjects
Interval 0.05 to 6.49
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-39
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-40
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
2.59 Percentage of subjects
Interval 0.63 to 6.88
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-41
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
2.29 Percentage of subjects
Interval 0.33 to 7.54
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-42
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
1.71 Percentage of subjects
Interval 0.25 to 5.63
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-43
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
1.38 Percentage of subjects
Interval 0.15 to 5.09
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-44
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
1.51 Percentage of subjects
Interval 0.26 to 4.71
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-45
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
1.32 Percentage of subjects
Interval 0.2 to 4.3
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-46
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
1.19 Percentage of subjects
Interval 0.18 to 3.94
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-47
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
1.13 Percentage of subjects
Interval 0.16 to 3.75
|
0.00 Percentage of subjects
Interval 0.0 to 8.04
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-48
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
1.10 Percentage of subjects
Interval 0.16 to 3.67
|
0.00 Percentage of subjects
Interval 0.0 to 7.4
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-37
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
—
|
—
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-38
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
—
|
—
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-39
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
—
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-40
|
3.70 Percentage of subjects
Interval 0.0 to 39.49
|
7.32 Percentage of subjects
Interval 0.9 to 24.0
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-41
|
3.45 Percentage of subjects
Interval 0.0 to 35.58
|
4.29 Percentage of subjects
Interval 0.36 to 16.39
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-42
|
2.94 Percentage of subjects
Interval 0.0 to 26.56
|
3.19 Percentage of subjects
Interval 0.28 to 12.23
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-43
|
2.86 Percentage of subjects
Interval 0.0 to 25.94
|
2.52 Percentage of subjects
Interval 0.21 to 9.89
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-44
|
2.44 Percentage of subjects
Interval 0.0 to 20.29
|
1.88 Percentage of subjects
Interval 0.24 to 6.46
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-45
|
2.38 Percentage of subjects
Interval 0.0 to 19.99
|
1.59 Percentage of subjects
Interval 0.07 to 7.48
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-46
|
2.13 Percentage of subjects
Interval 0.0 to 17.04
|
1.37 Percentage of subjects
Interval 0.05 to 6.77
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-48
|
2.08 Percentage of subjects
Interval 0.0 to 16.23
|
1.25 Percentage of subjects
Interval 0.04 to 6.39
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-37
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
—
|
—
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-38
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
—
|
—
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-39
|
2.63 Percentage of subjects
Interval 0.01 to 18.97
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-40
|
2.22 Percentage of subjects
Interval 0.02 to 14.79
|
7.14 Percentage of subjects
Interval 0.04 to 41.49
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-41
|
1.82 Percentage of subjects
Interval 0.01 to 12.25
|
3.23 Percentage of subjects
Interval 0.01 to 24.14
|
0.00 Percentage of subjects
Interval 0.0 to 10.58
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-42
|
1.69 Percentage of subjects
Interval 0.02 to 10.77
|
2.08 Percentage of subjects
Interval 0.02 to 13.45
|
0.00 Percentage of subjects
Interval 0.0 to 10.58
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-43
|
1.64 Percentage of subjects
Interval 0.02 to 10.46
|
1.64 Percentage of subjects
Interval 0.01 to 11.31
|
0.00 Percentage of subjects
Interval 0.0 to 10.28
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-44
|
1.61 Percentage of subjects
Interval 0.02 to 10.31
|
1.16 Percentage of subjects
Interval 0.01 to 8.31
|
0.00 Percentage of subjects
Interval 0.0 to 9.03
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-45
|
1.43 Percentage of subjects
Interval 0.02 to 9.07
|
1.20 Percentage of subjects
Interval 0.15 to 4.28
|
1.23 Percentage of subjects
Interval 0.25 to 3.55
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-46
|
7.00 Percentage of subjects
Interval 5.66 to 8.54
|
4.84 Percentage of subjects
Interval 3.21 to 6.96
|
3.92 Percentage of subjects
Interval 1.08 to 9.74
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-46
|
1.32 Percentage of subjects
Interval 0.01 to 8.53
|
1.12 Percentage of subjects
Interval 0.14 to 4.0
|
1.22 Percentage of subjects
Interval 0.25 to 3.52
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-47
|
1.22 Percentage of subjects
Interval 0.01 to 8.11
|
1.09 Percentage of subjects
Interval 0.13 to 3.89
|
1.20 Percentage of subjects
Interval 0.25 to 3.45
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-48
|
1.16 Percentage of subjects
Interval 0.01 to 7.7
|
1.09 Percentage of subjects
Interval 0.13 to 3.87
|
1.20 Percentage of subjects
Interval 0.25 to 3.45
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-37
|
9.87 Percentage of subjects
Interval 6.92 to 13.55
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
22.22 Percentage of subjects
Interval 2.81 to 60.01
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-38
|
8.56 Percentage of subjects
Interval 6.27 to 11.34
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
13.33 Percentage of subjects
Interval 1.66 to 40.46
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-39
|
8.52 Percentage of subjects
Interval 7.4 to 9.75
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
10.00 Percentage of subjects
Interval 1.23 to 31.7
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-40
|
8.49 Percentage of subjects
Interval 7.19 to 9.94
|
6.15 Percentage of subjects
Interval 1.7 to 15.01
|
6.90 Percentage of subjects
Interval 0.85 to 22.77
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-41
|
7.97 Percentage of subjects
Interval 6.82 to 9.23
|
5.16 Percentage of subjects
Interval 2.25 to 9.92
|
5.13 Percentage of subjects
Interval 0.63 to 17.32
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-42
|
7.64 Percentage of subjects
Interval 6.47 to 8.95
|
3.09 Percentage of subjects
Interval 1.34 to 6.0
|
4.65 Percentage of subjects
Interval 0.57 to 15.81
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-43
|
7.51 Percentage of subjects
Interval 6.29 to 8.88
|
4.00 Percentage of subjects
Interval 2.26 to 6.51
|
3.57 Percentage of subjects
Interval 0.44 to 12.31
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-44
|
7.29 Percentage of subjects
Interval 6.02 to 8.73
|
4.86 Percentage of subjects
Interval 3.07 to 7.26
|
3.13 Percentage of subjects
Interval 0.38 to 10.84
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-45
|
7.09 Percentage of subjects
Interval 5.82 to 8.52
|
4.53 Percentage of subjects
Interval 2.89 to 6.72
|
4.08 Percentage of subjects
Interval 1.12 to 10.12
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-47
|
6.89 Percentage of subjects
Interval 5.57 to 8.42
|
4.53 Percentage of subjects
Interval 3.01 to 6.52
|
3.42 Percentage of subjects
Interval 0.94 to 8.52
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-48
|
6.79 Percentage of subjects
Interval 5.46 to 8.33
|
4.32 Percentage of subjects
Interval 2.87 to 6.22
|
3.31 Percentage of subjects
Interval 0.91 to 8.25
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-37
|
10.26 Percentage of subjects
Interval 8.87 to 11.78
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-38
|
9.04 Percentage of subjects
Interval 7.7 to 10.54
|
12.50 Percentage of subjects
Interval 0.1 to 60.63
|
10.00 Percentage of subjects
Interval 0.88 to 34.7
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-39
|
8.49 Percentage of subjects
Interval 7.3 to 9.8
|
9.09 Percentage of subjects
Interval 0.21 to 41.85
|
8.11 Percentage of subjects
Interval 1.7 to 21.91
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-40
|
8.43 Percentage of subjects
Interval 7.22 to 9.77
|
3.85 Percentage of subjects
Interval 0.47 to 13.21
|
6.12 Percentage of subjects
Interval 1.28 to 16.87
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-41
|
8.31 Percentage of subjects
Interval 7.08 to 9.68
|
5.34 Percentage of subjects
Interval 2.18 to 10.7
|
7.69 Percentage of subjects
Interval 2.14 to 18.54
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-42
|
8.04 Percentage of subjects
Interval 6.77 to 9.47
|
5.61 Percentage of subjects
Interval 2.83 to 9.82
|
7.02 Percentage of subjects
Interval 1.95 to 17.0
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-44
|
7.81 Percentage of subjects
Interval 6.57 to 9.21
|
5.57 Percentage of subjects
Interval 3.11 to 9.11
|
6.25 Percentage of subjects
Interval 1.73 to 15.24
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-46
|
7.71 Percentage of subjects
Interval 6.45 to 9.14
|
6.27 Percentage of subjects
Interval 4.13 to 9.05
|
4.44 Percentage of subjects
Interval 0.54 to 15.14
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-48
|
7.59 Percentage of subjects
Interval 6.31 to 9.05
|
5.82 Percentage of subjects
Interval 3.87 to 8.35
|
4.21 Percentage of subjects
Interval 0.49 to 14.59
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-43
|
7.95 Percentage of subjects
Interval 6.66 to 9.39
|
5.05 Percentage of subjects
Interval 2.56 to 8.85
|
6.67 Percentage of subjects
Interval 1.85 to 16.2
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-45
|
7.76 Percentage of subjects
Interval 6.52 to 9.16
|
6.61 Percentage of subjects
Interval 6.61 to 9.61
|
4.76 Percentage of subjects
Interval 0.69 to 15.23
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-47
|
7.63 Percentage of subjects
Interval 6.35 to 9.08
|
6.11 Percentage of subjects
Interval 4.06 to 8.76
|
4.30 Percentage of subjects
Interval 0.52 to 14.72
|
PRIMARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in electronic health record (EHR), using card-based ADR reporting system during the safety follow-up (FU) period (from vaccination up to 7 days post-vaccination).
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16387 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=2946 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=546 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 1.91
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 2.55
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 44
|
—
|
0.49 Percentage of subjects
Interval 0.01 to 2.71
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 45
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.82
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 3.21
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 47
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 4.99
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 48
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 37
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
—
|
—
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 38
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
—
|
—
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
—
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
4.76 Percentage of subjects
Interval 0.03 to 29.74
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 13.72
|
—
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 3.85
|
—
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 3.59
|
—
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 47
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
—
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 37
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
—
|
—
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 41
|
1.04 Percentage of subjects
Interval 0.02 to 1.39
|
0.00 Percentage of subjects
Interval 0.0 to 4.02
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 1.04
|
0.00 Percentage of subjects
Interval 0.0 to 3.48
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 43
|
0.46 Percentage of subjects
Interval 0.01 to 2.96
|
0.00 Percentage of subjects
Interval 0.0 to 3.13
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 47
|
0.68 Percentage of subjects
Interval 0.0 to 4.94
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 4.11
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 40
|
0.23 Percentage of subjects
Interval 0.05 to 0.67
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 41
|
0.40 Percentage of subjects
Interval 0.09 to 1.11
|
2.53 Percentage of subjects
Interval 0.31 to 8.85
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 0.67
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 1.65
|
0.00 Percentage of subjects
Interval 0.0 to 9.49
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 46
|
0.88 Percentage of subjects
Interval 0.01 to 6.2
|
0.00 Percentage of subjects
Interval 0.0 to 9.49
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 3.42
|
0.00 Percentage of subjects
Interval 0.0 to 12.77
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 15.44
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
1.45 Percentage of subjects
Interval 0.3 to 4.18
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 2.95
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 38
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
—
|
—
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
—
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 13.72
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 4.51
|
0.49 Percentage of subjects
Interval 0.01 to 2.69
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
—
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 37
|
0.56 Percentage of subjects
Interval 0.15 to 1.42
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 38
|
0.81 Percentage of subjects
Interval 0.13 to 2.66
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 39
|
0.57 Percentage of subjects
Interval 0.24 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 40
|
0.54 Percentage of subjects
Interval 0.05 to 2.16
|
0.00 Percentage of subjects
Interval 0.0 to 6.06
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 44
|
0.32 Percentage of subjects
Interval 0.01 to 1.77
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 1.65
|
0.00 Percentage of subjects
Interval 0.0 to 6.49
|
0.00 Percentage of subjects
Interval 0.0 to 10.28
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 46
|
0.45 Percentage of subjects
Interval 0.0 to 3.36
|
0.00 Percentage of subjects
Interval 0.0 to 7.11
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 37
|
0.40 Percentage of subjects
Interval 0.16 to 0.83
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 38
|
0.38 Percentage of subjects
Interval 0.15 to 0.78
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 39
|
0.41 Percentage of subjects
Interval 0.12 to 1.01
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 43
|
0.36 Percentage of subjects
Interval 0.0 to 2.44
|
0.00 Percentage of subjects
Interval 0.0 to 4.45
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 44
|
0.23 Percentage of subjects
Interval 0.01 to 1.29
|
1.56 Percentage of subjects
Interval 0.0 to 64.84
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
PRIMARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start, up to end of the week of interest and were registered in EHR, using card-based ADR reporting system during the safety FU period (from vaccination up to 7 days post-vaccination).
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16387 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=2946 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=546 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-39
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-40
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
1.11 Percentage of subjects
Interval 0.14 to 3.88
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-43
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.41 Percentage of subjects
Interval 0.01 to 2.18
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-45
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.38 Percentage of subjects
Interval 0.03 to 1.53
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-48
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.31 Percentage of subjects
Interval 0.02 to 1.31
|
0.00 Percentage of subjects
Interval 0.0 to 7.4
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-39
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
—
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-47
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
0.26 Percentage of subjects
Interval 0.0 to 2.22
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-44
|
0.51 Percentage of subjects
Interval 0.25 to 0.94
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.00 Percentage of subjects
Interval 0.0 to 5.6
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-46
|
0.49 Percentage of subjects
Interval 0.22 to 0.94
|
0.00 Percentage of subjects
Interval 0.0 to 0.66
|
0.00 Percentage of subjects
Interval 0.0 to 3.55
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-46
|
0.34 Percentage of subjects
Interval 0.21 to 0.54
|
0.72 Percentage of subjects
Interval 0.15 to 2.1
|
0.00 Percentage of subjects
Interval 0.0 to 4.02
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-41
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.76 Percentage of subjects
Interval 0.06 to 3.15
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-42
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.51 Percentage of subjects
Interval 0.02 to 2.44
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-44
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.43 Percentage of subjects
Interval 0.04 to 1.68
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-46
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.34 Percentage of subjects
Interval 0.03 to 1.41
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-47
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.32 Percentage of subjects
Interval 0.02 to 1.34
|
0.00 Percentage of subjects
Interval 0.0 to 8.04
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-37
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
—
|
—
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-38
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
—
|
—
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-40
|
0.00 Percentage of subjects
Interval 0.0 to 12.77
|
2.44 Percentage of subjects
Interval 0.03 to 14.54
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-41
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
1.43 Percentage of subjects
Interval 0.01 to 9.35
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-42
|
0.00 Percentage of subjects
Interval 0.0 to 10.28
|
1.06 Percentage of subjects
Interval 0.01 to 7.27
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-43
|
0.00 Percentage of subjects
Interval 0.0 to 10.0
|
0.84 Percentage of subjects
Interval 0.01 to 5.77
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-44
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
0.47 Percentage of subjects
Interval 0.0 to 3.56
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-45
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
0.32 Percentage of subjects
Interval 0.0 to 2.62
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-46
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
0.27 Percentage of subjects
Interval 0.0 to 2.31
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-48
|
0.00 Percentage of subjects
Interval 0.0 to 7.4
|
0.25 Percentage of subjects
Interval 0.0 to 2.15
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-37
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
—
|
—
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-38
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
—
|
—
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-39
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-40
|
0.00 Percentage of subjects
Interval 0.0 to 7.87
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-41
|
0.00 Percentage of subjects
Interval 0.0 to 6.49
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 10.58
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-42
|
0.00 Percentage of subjects
Interval 0.0 to 6.06
|
0.00 Percentage of subjects
Interval 0.0 to 7.4
|
0.00 Percentage of subjects
Interval 0.0 to 10.58
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-43
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
0.00 Percentage of subjects
Interval 0.0 to 10.28
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-44
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
0.00 Percentage of subjects
Interval 0.0 to 4.2
|
0.00 Percentage of subjects
Interval 0.0 to 9.03
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-45
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
0.00 Percentage of subjects
Interval 0.0 to 2.2
|
0.41 Percentage of subjects
Interval 0.01 to 2.26
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-46
|
0.00 Percentage of subjects
Interval 0.0 to 4.74
|
0.00 Percentage of subjects
Interval 0.0 to 2.05
|
0.41 Percentage of subjects
Interval 0.01 to 2.24
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-47
|
0.00 Percentage of subjects
Interval 0.0 to 4.4
|
0.00 Percentage of subjects
Interval 0.0 to 2.0
|
0.40 Percentage of subjects
Interval 0.01 to 2.2
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-48
|
0.00 Percentage of subjects
Interval 0.0 to 4.2
|
0.00 Percentage of subjects
Interval 0.0 to 1.98
|
0.40 Percentage of subjects
Interval 0.01 to 2.2
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-37
|
0.56 Percentage of subjects
Interval 0.15 to 1.42
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-38
|
0.70 Percentage of subjects
Interval 0.22 to 1.64
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-39
|
0.63 Percentage of subjects
Interval 0.26 to 1.29
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-40
|
0.62 Percentage of subjects
Interval 0.28 to 1.17
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-41
|
0.57 Percentage of subjects
Interval 0.29 to 1.02
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
0.00 Percentage of subjects
Interval 0.0 to 9.03
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-42
|
0.53 Percentage of subjects
Interval 0.26 to 0.97
|
0.00 Percentage of subjects
Interval 0.0 to 1.41
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-43
|
0.53 Percentage of subjects
Interval 0.25 to 0.97
|
0.00 Percentage of subjects
Interval 0.0 to 0.98
|
0.00 Percentage of subjects
Interval 0.0 to 6.38
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-45
|
0.49 Percentage of subjects
Interval 0.24 to 0.9
|
0.00 Percentage of subjects
Interval 0.0 to 0.72
|
0.00 Percentage of subjects
Interval 0.0 to 3.69
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-47
|
0.50 Percentage of subjects
Interval 0.24 to 0.91
|
0.00 Percentage of subjects
Interval 0.0 to 0.62
|
0.00 Percentage of subjects
Interval 0.0 to 3.1
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-48
|
0.49 Percentage of subjects
Interval 0.24 to 0.89
|
0.00 Percentage of subjects
Interval 0.0 to 0.59
|
0.00 Percentage of subjects
Interval 0.0 to 3.0
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-37
|
0.40 Percentage of subjects
Interval 0.16 to 0.83
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-38
|
0.39 Percentage of subjects
Interval 0.21 to 0.65
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-39
|
0.40 Percentage of subjects
Interval 0.22 to 0.66
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
0.00 Percentage of subjects
Interval 0.0 to 9.49
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-40
|
0.37 Percentage of subjects
Interval 0.22 to 0.58
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 7.25
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-41
|
0.37 Percentage of subjects
Interval 0.24 to 0.55
|
1.53 Percentage of subjects
Interval 0.19 to 5.41
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-42
|
0.35 Percentage of subjects
Interval 0.22 to 0.53
|
1.02 Percentage of subjects
Interval 0.12 to 3.64
|
0.00 Percentage of subjects
Interval 0.0 to 6.27
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-43
|
0.35 Percentage of subjects
Interval 0.22 to 0.54
|
0.72 Percentage of subjects
Interval 0.09 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 5.96
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-44
|
0.35 Percentage of subjects
Interval 0.21 to 0.53
|
0.88 Percentage of subjects
Interval 0.18 to 2.55
|
0.00 Percentage of subjects
Interval 0.0 to 5.6
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-45
|
0.34 Percentage of subjects
Interval 0.21 to 0.52
|
0.79 Percentage of subjects
Interval 0.16 to 2.3
|
0.00 Percentage of subjects
Interval 0.0 to 4.3
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-47
|
0.34 Percentage of subjects
Interval 0.2 to 0.54
|
0.68 Percentage of subjects
Interval 0.14 to 1.97
|
0.00 Percentage of subjects
Interval 0.0 to 3.89
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-48
|
0.34 Percentage of subjects
Interval 0.2 to 0.53
|
0.65 Percentage of subjects
Interval 0.13 to 1.88
|
0.00 Percentage of subjects
Interval 0.0 to 3.81
|
PRIMARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in electronic health record (EHR), using card-based ADR reporting system during the safety follow-up (FU) period (from vaccination up to 7 days post-vaccination).
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Local symptoms include local erythema. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16387 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=2946 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=546 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 1.77
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 2.95
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 38
|
3.03 Percentage of subjects
Interval 1.36 to 5.75
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 44
|
2.24 Percentage of subjects
Interval 0.76 to 5.02
|
1.28 Percentage of subjects
Interval 0.03 to 6.94
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 1.91
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 2.55
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 44
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.8
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 45
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.82
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 3.21
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 47
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 4.99
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 48
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 37
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
—
|
—
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 38
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
—
|
—
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
—
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 13.72
|
—
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 3.85
|
—
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 3.59
|
—
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 47
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
—
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 37
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
—
|
—
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 38
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
—
|
—
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
—
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 13.72
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 1.78
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
—
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 37
|
3.06 Percentage of subjects
Interval 1.93 to 4.6
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
11.11 Percentage of subjects
Interval 0.19 to 51.19
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 39
|
2.12 Percentage of subjects
Interval 1.26 to 3.33
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 40
|
3.10 Percentage of subjects
Interval 0.67 to 8.64
|
1.69 Percentage of subjects
Interval 0.04 to 9.09
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 41
|
1.26 Percentage of subjects
Interval 0.55 to 2.47
|
2.22 Percentage of subjects
Interval 0.27 to 7.8
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 42
|
0.85 Percentage of subjects
Interval 0.06 to 3.52
|
0.00 Percentage of subjects
Interval 0.0 to 3.48
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 43
|
0.46 Percentage of subjects
Interval 0.01 to 2.96
|
1.72 Percentage of subjects
Interval 0.11 to 7.43
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 1.65
|
0.00 Percentage of subjects
Interval 0.0 to 6.49
|
0.00 Percentage of subjects
Interval 0.0 to 10.28
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 46
|
2.24 Percentage of subjects
Interval 0.3 to 7.65
|
4.00 Percentage of subjects
Interval 0.49 to 13.71
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 47
|
2.05 Percentage of subjects
Interval 0.1 to 9.4
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 4.11
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 37
|
1.38 Percentage of subjects
Interval 0.31 to 3.85
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 38
|
0.97 Percentage of subjects
Interval 0.53 to 1.63
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 39
|
1.80 Percentage of subjects
Interval 1.19 to 2.6
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 40
|
1.31 Percentage of subjects
Interval 0.44 to 2.97
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 41
|
1.59 Percentage of subjects
Interval 0.91 to 2.56
|
1.27 Percentage of subjects
Interval 0.03 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 42
|
0.37 Percentage of subjects
Interval 0.0 to 2.82
|
3.08 Percentage of subjects
Interval 0.37 to 10.68
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 43
|
0.36 Percentage of subjects
Interval 0.0 to 2.55
|
1.23 Percentage of subjects
Interval 0.0 to 73.92
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 44
|
0.47 Percentage of subjects
Interval 0.02 to 2.39
|
3.13 Percentage of subjects
Interval 0.0 to 46.96
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 45
|
1.35 Percentage of subjects
Interval 0.09 to 5.79
|
5.41 Percentage of subjects
Interval 0.0 to 99.64
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
2.70 Percentage of subjects
Interval 0.0 to 99.94
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 3.42
|
0.00 Percentage of subjects
Interval 0.0 to 12.77
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 15.44
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
PRIMARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start, up to end of the week of interest and were registered in EHR, using card-based ADR reporting system during the safety FU period (from vaccination up to 7 days post-vaccination).
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Local symptoms include local erythema. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16387 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=2946 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=546 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-46
|
2.19 Percentage of subjects
Interval 1.41 to 3.25
|
1.43 Percentage of subjects
Interval 0.62 to 2.81
|
0.98 Percentage of subjects
Interval 0.02 to 5.69
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-39
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-40
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 1.36
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-41
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 0.93
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-42
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.00 Percentage of subjects
Interval 0.0 to 0.63
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-43
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 0.51
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-44
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 0.4
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-45
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 0.35
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-46
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.31
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-47
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.3
|
0.00 Percentage of subjects
Interval 0.0 to 8.04
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-48
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.29
|
0.00 Percentage of subjects
Interval 0.0 to 7.4
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-37
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
—
|
—
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-38
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
—
|
—
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-39
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
—
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-40
|
0.00 Percentage of subjects
Interval 0.0 to 12.77
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-41
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-42
|
0.00 Percentage of subjects
Interval 0.0 to 10.28
|
0.00 Percentage of subjects
Interval 0.0 to 3.85
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-43
|
0.00 Percentage of subjects
Interval 0.0 to 10.0
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-44
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
0.00 Percentage of subjects
Interval 0.0 to 1.72
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-45
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
0.00 Percentage of subjects
Interval 0.0 to 1.17
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-46
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
0.00 Percentage of subjects
Interval 0.0 to 1.0
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-47
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
0.00 Percentage of subjects
Interval 0.0 to 0.96
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-48
|
0.00 Percentage of subjects
Interval 0.0 to 7.4
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-37
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
—
|
—
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-38
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
—
|
—
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-39
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-40
|
0.00 Percentage of subjects
Interval 0.0 to 7.87
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-41
|
0.00 Percentage of subjects
Interval 0.0 to 6.49
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 10.58
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-42
|
0.00 Percentage of subjects
Interval 0.0 to 6.06
|
0.00 Percentage of subjects
Interval 0.0 to 7.4
|
0.00 Percentage of subjects
Interval 0.0 to 10.58
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-43
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
0.00 Percentage of subjects
Interval 0.0 to 10.28
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-44
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
0.00 Percentage of subjects
Interval 0.0 to 4.2
|
0.00 Percentage of subjects
Interval 0.0 to 9.03
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-45
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
0.00 Percentage of subjects
Interval 0.0 to 2.2
|
0.00 Percentage of subjects
Interval 0.0 to 1.5
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-46
|
0.00 Percentage of subjects
Interval 0.0 to 4.74
|
0.00 Percentage of subjects
Interval 0.0 to 2.05
|
0.00 Percentage of subjects
Interval 0.0 to 1.49
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-47
|
0.00 Percentage of subjects
Interval 0.0 to 4.4
|
0.00 Percentage of subjects
Interval 0.0 to 2.0
|
0.00 Percentage of subjects
Interval 0.0 to 1.46
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-48
|
0.00 Percentage of subjects
Interval 0.0 to 4.2
|
0.00 Percentage of subjects
Interval 0.0 to 1.98
|
0.00 Percentage of subjects
Interval 0.0 to 1.46
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-37
|
3.06 Percentage of subjects
Interval 1.93 to 4.6
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
11.11 Percentage of subjects
Interval 0.19 to 51.19
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-38
|
3.04 Percentage of subjects
Interval 1.83 to 4.73
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
6.67 Percentage of subjects
Interval 0.17 to 31.95
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-39
|
2.61 Percentage of subjects
Interval 1.61 to 3.97
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
5.00 Percentage of subjects
Interval 0.1 to 26.11
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-40
|
2.70 Percentage of subjects
Interval 1.52 to 4.42
|
1.54 Percentage of subjects
Interval 0.04 to 8.28
|
3.45 Percentage of subjects
Interval 0.05 to 19.42
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-41
|
2.49 Percentage of subjects
Interval 1.48 to 3.92
|
1.94 Percentage of subjects
Interval 0.4 to 5.55
|
2.56 Percentage of subjects
Interval 0.05 to 14.2
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-42
|
2.37 Percentage of subjects
Interval 1.44 to 3.67
|
1.16 Percentage of subjects
Interval 0.24 to 3.35
|
2.33 Percentage of subjects
Interval 0.06 to 12.41
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-43
|
2.29 Percentage of subjects
Interval 1.39 to 3.52
|
1.33 Percentage of subjects
Interval 0.43 to 3.08
|
1.79 Percentage of subjects
Interval 0.05 to 9.55
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-44
|
2.28 Percentage of subjects
Interval 1.44 to 3.43
|
1.32 Percentage of subjects
Interval 0.49 to 2.86
|
1.56 Percentage of subjects
Interval 0.04 to 8.4
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-45
|
2.19 Percentage of subjects
Interval 1.38 to 3.3
|
1.18 Percentage of subjects
Interval 0.43 to 2.55
|
1.02 Percentage of subjects
Interval 0.02 to 5.93
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-47
|
2.19 Percentage of subjects
Interval 1.43 to 3.2
|
1.34 Percentage of subjects
Interval 0.58 to 2.63
|
0.85 Percentage of subjects
Interval 0.02 to 4.96
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-48
|
2.16 Percentage of subjects
Interval 1.41 to 3.16
|
1.28 Percentage of subjects
Interval 0.55 to 2.51
|
0.83 Percentage of subjects
Interval 0.01 to 4.93
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-37
|
1.38 Percentage of subjects
Interval 0.31 to 3.85
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-38
|
1.17 Percentage of subjects
Interval 0.47 to 2.42
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-39
|
1.44 Percentage of subjects
Interval 0.82 to 2.34
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
0.00 Percentage of subjects
Interval 0.0 to 9.49
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-40
|
1.42 Percentage of subjects
Interval 0.87 to 2.16
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 7.25
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-41
|
1.44 Percentage of subjects
Interval 0.94 to 2.1
|
0.76 Percentage of subjects
Interval 0.02 to 4.18
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-42
|
1.37 Percentage of subjects
Interval 0.93 to 1.94
|
1.53 Percentage of subjects
Interval 0.32 to 4.41
|
0.00 Percentage of subjects
Interval 0.0 to 6.27
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-43
|
1.34 Percentage of subjects
Interval 0.92 to 1.89
|
1.44 Percentage of subjects
Interval 0.39 to 3.66
|
0.00 Percentage of subjects
Interval 0.0 to 5.96
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-44
|
1.30 Percentage of subjects
Interval 0.9 to 1.83
|
1.76 Percentage of subjects
Interval 0.65 to 3.79
|
0.00 Percentage of subjects
Interval 0.0 to 5.6
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-45
|
1.31 Percentage of subjects
Interval 0.9 to 1.83
|
2.12 Percentage of subjects
Interval 0.92 to 4.13
|
0.00 Percentage of subjects
Interval 0.0 to 4.3
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-46
|
1.29 Percentage of subjects
Interval 0.89 to 1.81
|
2.17 Percentage of subjects
Interval 1.0 to 4.08
|
0.00 Percentage of subjects
Interval 0.0 to 4.02
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-47
|
1.28 Percentage of subjects
Interval 0.88 to 1.79
|
2.04 Percentage of subjects
Interval 0.94 to 3.83
|
0.00 Percentage of subjects
Interval 0.0 to 3.89
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-48
|
1.27 Percentage of subjects
Interval 0.88 to 1.78
|
1.94 Percentage of subjects
Interval 0.89 to 3.65
|
0.00 Percentage of subjects
Interval 0.0 to 3.81
|
PRIMARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in electronic health record (EHR), using card-based ADR reporting system during the safety follow-up (FU) period (from vaccination up to 7 days post-vaccination).
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16387 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=2946 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=546 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 38
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
—
|
—
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 4.11
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 1.77
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 2.95
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 1.91
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 2.55
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 44
|
—
|
0.49 Percentage of subjects
Interval 0.01 to 2.71
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 45
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.82
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 3.21
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 47
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 4.99
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 48
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 37
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
—
|
—
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 38
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
—
|
—
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
—
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
9.52 Percentage of subjects
Interval 1.17 to 30.38
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 13.72
|
—
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 3.85
|
—
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.99 Percentage of subjects
Interval 0.0 to 10.54
|
—
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 47
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
—
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 37
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
—
|
—
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
—
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 13.72
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 4.51
|
0.49 Percentage of subjects
Interval 0.01 to 2.69
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 37
|
3.98 Percentage of subjects
Interval 3.11 to 5.01
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
—
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 37
|
3.76 Percentage of subjects
Interval 2.09 to 6.18
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
11.11 Percentage of subjects
Interval 0.03 to 62.14
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 38
|
3.26 Percentage of subjects
Interval 1.9 to 5.19
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 39
|
3.75 Percentage of subjects
Interval 2.61 to 5.18
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 40
|
2.56 Percentage of subjects
Interval 1.55 to 3.98
|
3.39 Percentage of subjects
Interval 0.41 to 11.71
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 41
|
1.42 Percentage of subjects
Interval 0.65 to 2.67
|
2.22 Percentage of subjects
Interval 0.27 to 7.8
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 42
|
2.54 Percentage of subjects
Interval 0.87 to 5.7
|
0.00 Percentage of subjects
Interval 0.0 to 3.48
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 43
|
0.46 Percentage of subjects
Interval 0.0 to 3.13
|
1.72 Percentage of subjects
Interval 0.11 to 7.43
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 44
|
1.60 Percentage of subjects
Interval 0.48 to 3.84
|
5.13 Percentage of subjects
Interval 0.23 to 22.68
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 45
|
0.90 Percentage of subjects
Interval 0.09 to 3.43
|
1.82 Percentage of subjects
Interval 0.0 to 93.05
|
0.00 Percentage of subjects
Interval 0.0 to 10.28
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 46
|
0.45 Percentage of subjects
Interval 0.0 to 3.36
|
4.00 Percentage of subjects
Interval 0.0 to 40.02
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 2.49
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 38
|
2.87 Percentage of subjects
Interval 2.06 to 3.88
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 39
|
2.54 Percentage of subjects
Interval 1.78 to 3.51
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
5.88 Percentage of subjects
Interval 0.15 to 28.69
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 40
|
2.38 Percentage of subjects
Interval 1.49 to 3.59
|
2.44 Percentage of subjects
Interval 0.06 to 12.86
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 41
|
1.98 Percentage of subjects
Interval 1.17 to 3.13
|
2.53 Percentage of subjects
Interval 0.31 to 8.85
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 42
|
0.92 Percentage of subjects
Interval 0.11 to 3.23
|
1.54 Percentage of subjects
Interval 0.04 to 8.28
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 43
|
2.92 Percentage of subjects
Interval 1.11 to 6.13
|
2.47 Percentage of subjects
Interval 0.0 to 93.58
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 44
|
1.63 Percentage of subjects
Interval 0.53 to 3.74
|
1.56 Percentage of subjects
Interval 0.0 to 64.84
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 45
|
1.35 Percentage of subjects
Interval 0.11 to 5.51
|
5.41 Percentage of subjects
Interval 0.03 to 33.24
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 46
|
0.88 Percentage of subjects
Interval 0.01 to 6.2
|
0.00 Percentage of subjects
Interval 0.0 to 9.49
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 3.42
|
0.00 Percentage of subjects
Interval 0.0 to 12.77
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 15.44
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
PRIMARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start, up to end of the week of interest and were registered in EHR, using card-based ADR reporting system during the safety FU period (from vaccination up to 7 days post-vaccination).
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16387 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=2946 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=546 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-41
|
2.81 Percentage of subjects
Interval 2.11 to 3.67
|
2.29 Percentage of subjects
Interval 0.47 to 6.55
|
1.92 Percentage of subjects
Interval 0.05 to 10.26
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-45
|
2.63 Percentage of subjects
Interval 1.92 to 3.52
|
2.38 Percentage of subjects
Interval 1.09 to 4.47
|
1.19 Percentage of subjects
Interval 0.02 to 7.24
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-39
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-40
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 1.36
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-41
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 0.93
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-42
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.00 Percentage of subjects
Interval 0.0 to 0.63
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-43
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 0.51
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-44
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.11 Percentage of subjects
Interval 0.0 to 0.78
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-45
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.09 Percentage of subjects
Interval 0.0 to 0.7
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-46
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.09 Percentage of subjects
Interval 0.0 to 0.62
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-47
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.08 Percentage of subjects
Interval 0.0 to 0.58
|
0.00 Percentage of subjects
Interval 0.0 to 8.04
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-48
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.08 Percentage of subjects
Interval 0.0 to 0.56
|
0.00 Percentage of subjects
Interval 0.0 to 7.4
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-37
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
—
|
—
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-38
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
—
|
—
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-39
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
—
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-40
|
0.00 Percentage of subjects
Interval 0.0 to 12.77
|
4.88 Percentage of subjects
Interval 0.6 to 16.53
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-41
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
2.86 Percentage of subjects
Interval 0.34 to 10.06
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-42
|
0.00 Percentage of subjects
Interval 0.0 to 10.28
|
2.13 Percentage of subjects
Interval 0.26 to 7.48
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-43
|
0.00 Percentage of subjects
Interval 0.0 to 10.0
|
1.68 Percentage of subjects
Interval 0.2 to 5.94
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-44
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
0.94 Percentage of subjects
Interval 0.07 to 3.94
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-45
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
0.96 Percentage of subjects
Interval 0.02 to 5.2
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-46
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
0.82 Percentage of subjects
Interval 0.02 to 4.69
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-47
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
0.79 Percentage of subjects
Interval 0.02 to 4.5
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-48
|
0.00 Percentage of subjects
Interval 0.0 to 7.4
|
0.75 Percentage of subjects
Interval 0.01 to 4.41
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-37
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
—
|
—
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-38
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
—
|
—
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-39
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-40
|
0.00 Percentage of subjects
Interval 0.0 to 7.87
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-41
|
0.00 Percentage of subjects
Interval 0.0 to 6.49
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 10.58
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-42
|
0.00 Percentage of subjects
Interval 0.0 to 6.06
|
0.00 Percentage of subjects
Interval 0.0 to 7.4
|
0.00 Percentage of subjects
Interval 0.0 to 10.58
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-43
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
0.00 Percentage of subjects
Interval 0.0 to 10.28
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-44
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
0.00 Percentage of subjects
Interval 0.0 to 4.2
|
0.00 Percentage of subjects
Interval 0.0 to 9.03
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-45
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
0.00 Percentage of subjects
Interval 0.0 to 2.2
|
0.41 Percentage of subjects
Interval 0.01 to 2.26
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-46
|
0.00 Percentage of subjects
Interval 0.0 to 4.74
|
0.00 Percentage of subjects
Interval 0.0 to 2.05
|
0.41 Percentage of subjects
Interval 0.01 to 2.24
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-47
|
0.00 Percentage of subjects
Interval 0.0 to 4.4
|
0.00 Percentage of subjects
Interval 0.0 to 2.0
|
0.40 Percentage of subjects
Interval 0.01 to 2.2
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-48
|
0.00 Percentage of subjects
Interval 0.0 to 4.2
|
0.00 Percentage of subjects
Interval 0.0 to 1.98
|
0.40 Percentage of subjects
Interval 0.01 to 2.2
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-37
|
3.76 Percentage of subjects
Interval 2.09 to 6.18
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
11.11 Percentage of subjects
Interval 0.03 to 62.14
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-38
|
3.49 Percentage of subjects
Interval 2.1 to 5.41
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
6.67 Percentage of subjects
Interval 0.04 to 38.91
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-39
|
3.61 Percentage of subjects
Interval 2.61 to 4.85
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
5.00 Percentage of subjects
Interval 0.03 to 30.57
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-40
|
3.40 Percentage of subjects
Interval 2.6 to 4.37
|
3.08 Percentage of subjects
Interval 0.37 to 10.68
|
3.45 Percentage of subjects
Interval 0.05 to 19.42
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-41
|
3.11 Percentage of subjects
Interval 2.3 to 4.11
|
2.58 Percentage of subjects
Interval 0.71 to 6.48
|
2.56 Percentage of subjects
Interval 0.06 to 13.56
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-42
|
3.07 Percentage of subjects
Interval 2.29 to 4.02
|
1.54 Percentage of subjects
Interval 0.42 to 3.91
|
2.33 Percentage of subjects
Interval 0.05 to 12.95
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-43
|
2.95 Percentage of subjects
Interval 2.17 to 3.92
|
1.60 Percentage of subjects
Interval 0.59 to 3.45
|
1.79 Percentage of subjects
Interval 0.03 to 10.14
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-44
|
2.87 Percentage of subjects
Interval 2.1 to 3.83
|
2.21 Percentage of subjects
Interval 1.06 to 4.02
|
1.56 Percentage of subjects
Interval 0.02 to 9.62
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-45
|
2.79 Percentage of subjects
Interval 2.05 to 3.71
|
2.17 Percentage of subjects
Interval 1.09 to 3.84
|
1.02 Percentage of subjects
Interval 0.03 to 5.55
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-46
|
2.70 Percentage of subjects
Interval 1.95 to 3.65
|
2.33 Percentage of subjects
Interval 1.25 to 3.95
|
0.98 Percentage of subjects
Interval 0.02 to 5.34
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-47
|
2.63 Percentage of subjects
Interval 1.89 to 3.57
|
2.18 Percentage of subjects
Interval 1.17 to 3.7
|
0.85 Percentage of subjects
Interval 0.02 to 4.67
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-48
|
2.60 Percentage of subjects
Interval 1.85 to 3.53
|
2.08 Percentage of subjects
Interval 1.11 to 3.53
|
0.83 Percentage of subjects
Interval 0.02 to 4.52
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-37
|
3.98 Percentage of subjects
Interval 3.11 to 5.01
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-38
|
3.40 Percentage of subjects
Interval 2.73 to 4.19
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-39
|
3.04 Percentage of subjects
Interval 2.29 to 3.95
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
2.70 Percentage of subjects
Interval 0.07 to 14.16
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-40
|
2.92 Percentage of subjects
Interval 2.19 to 3.83
|
1.92 Percentage of subjects
Interval 0.05 to 10.26
|
2.04 Percentage of subjects
Interval 0.05 to 10.85
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-42
|
2.70 Percentage of subjects
Interval 1.98 to 3.59
|
2.04 Percentage of subjects
Interval 0.56 to 5.14
|
1.75 Percentage of subjects
Interval 0.04 to 9.39
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-43
|
2.71 Percentage of subjects
Interval 1.98 to 3.61
|
2.17 Percentage of subjects
Interval 0.8 to 4.65
|
1.67 Percentage of subjects
Interval 0.04 to 8.94
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-44
|
2.66 Percentage of subjects
Interval 1.94 to 3.56
|
2.05 Percentage of subjects
Interval 0.83 to 4.18
|
1.56 Percentage of subjects
Interval 0.04 to 8.4
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-46
|
2.61 Percentage of subjects
Interval 1.89 to 3.51
|
2.17 Percentage of subjects
Interval 1.0 to 4.08
|
1.11 Percentage of subjects
Interval 0.01 to 7.09
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-47
|
2.58 Percentage of subjects
Interval 1.86 to 3.49
|
2.04 Percentage of subjects
Interval 0.91 to 3.89
|
1.08 Percentage of subjects
Interval 0.01 to 6.96
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-48
|
2.57 Percentage of subjects
Interval 1.85 to 3.47
|
1.94 Percentage of subjects
Interval 0.84 to 3.79
|
1.05 Percentage of subjects
Interval 0.01 to 6.88
|
PRIMARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in electronic health record (EHR), using card-based ADR reporting system during the safety follow-up (FU) period (from vaccination up to 7 days post-vaccination).
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16387 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=2946 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=546 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
1.06 Percentage of subjects
Interval 0.02 to 5.93
|
—
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 3.59
|
—
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 37
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
—
|
—
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
2.90 Percentage of subjects
Interval 1.07 to 6.2
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
1.63 Percentage of subjects
Interval 0.02 to 10.28
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.52 Percentage of subjects
Interval 0.0 to 3.94
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 2.55
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 44
|
—
|
1.97 Percentage of subjects
Interval 0.07 to 9.78
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 45
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.82
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 3.21
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 47
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 4.99
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 48
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 37
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
—
|
—
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 38
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
—
|
—
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
—
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 40
|
33.33 Percentage of subjects
Interval 0.0 to 100.0
|
9.52 Percentage of subjects
Interval 1.17 to 30.38
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 13.72
|
—
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 47
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
—
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 38
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
—
|
—
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 39
|
7.14 Percentage of subjects
Interval 0.02 to 44.9
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
11.11 Percentage of subjects
Interval 0.19 to 51.19
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
—
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 13.72
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 4.51
|
1.46 Percentage of subjects
Interval 0.3 to 4.22
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
—
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 37
|
5.98 Percentage of subjects
Interval 3.78 to 8.93
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 38
|
3.38 Percentage of subjects
Interval 2.06 to 5.2
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 39
|
4.66 Percentage of subjects
Interval 3.43 to 6.18
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 40
|
3.24 Percentage of subjects
Interval 2.01 to 4.91
|
0.00 Percentage of subjects
Interval 0.0 to 6.06
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 41
|
2.52 Percentage of subjects
Interval 1.45 to 4.06
|
2.22 Percentage of subjects
Interval 0.27 to 7.8
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 42
|
1.69 Percentage of subjects
Interval 0.61 to 3.69
|
0.00 Percentage of subjects
Interval 0.0 to 3.48
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 43
|
1.83 Percentage of subjects
Interval 0.3 to 5.81
|
5.17 Percentage of subjects
Interval 1.92 to 10.92
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 44
|
1.60 Percentage of subjects
Interval 0.52 to 3.69
|
1.28 Percentage of subjects
Interval 0.03 to 6.94
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 45
|
1.80 Percentage of subjects
Interval 0.46 to 4.69
|
1.82 Percentage of subjects
Interval 0.0 to 93.05
|
5.88 Percentage of subjects
Interval 0.72 to 19.68
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 46
|
1.35 Percentage of subjects
Interval 0.21 to 4.35
|
6.00 Percentage of subjects
Interval 0.0 to 54.61
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 47
|
2.74 Percentage of subjects
Interval 0.36 to 9.27
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 4.11
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 37
|
5.71 Percentage of subjects
Interval 4.66 to 6.91
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 38
|
4.17 Percentage of subjects
Interval 3.29 to 5.2
|
16.67 Percentage of subjects
Interval 0.0 to 91.51
|
10.00 Percentage of subjects
Interval 0.25 to 44.5
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 39
|
4.00 Percentage of subjects
Interval 2.98 to 5.25
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 40
|
5.30 Percentage of subjects
Interval 2.9 to 8.81
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 41
|
3.87 Percentage of subjects
Interval 2.34 to 5.97
|
3.80 Percentage of subjects
Interval 0.79 to 10.7
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 42
|
2.38 Percentage of subjects
Interval 0.86 to 5.17
|
1.54 Percentage of subjects
Interval 0.04 to 8.28
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 43
|
3.28 Percentage of subjects
Interval 1.32 to 6.67
|
1.23 Percentage of subjects
Interval 0.0 to 73.92
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 44
|
3.02 Percentage of subjects
Interval 0.48 to 9.57
|
6.25 Percentage of subjects
Interval 0.14 to 30.86
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 45
|
1.80 Percentage of subjects
Interval 0.29 to 5.74
|
8.11 Percentage of subjects
Interval 0.0 to 99.99
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 46
|
1.75 Percentage of subjects
Interval 0.12 to 7.34
|
0.00 Percentage of subjects
Interval 0.0 to 9.49
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 3.42
|
3.70 Percentage of subjects
Interval 0.0 to 99.88
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 15.44
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
PRIMARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start, up to end of the week of interest and were registered in EHR, using card-based ADR reporting system during the safety FU period (from vaccination up to 7 days post-vaccination).
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16387 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=2946 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=546 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-48
|
2.08 Percentage of subjects
Interval 0.0 to 16.23
|
0.75 Percentage of subjects
Interval 0.05 to 3.29
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-38
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
—
|
—
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-39
|
4.61 Percentage of subjects
Interval 3.81 to 5.53
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-47
|
3.49 Percentage of subjects
Interval 2.98 to 4.06
|
2.18 Percentage of subjects
Interval 1.17 to 3.7
|
1.71 Percentage of subjects
Interval 0.11 to 7.37
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-48
|
3.44 Percentage of subjects
Interval 2.93 to 4.0
|
2.08 Percentage of subjects
Interval 1.11 to 3.53
|
1.65 Percentage of subjects
Interval 0.12 to 6.86
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-37
|
5.71 Percentage of subjects
Interval 4.66 to 6.9
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-38
|
4.91 Percentage of subjects
Interval 4.23 to 5.67
|
12.50 Percentage of subjects
Interval 0.1 to 60.63
|
5.00 Percentage of subjects
Interval 0.13 to 24.87
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-47
|
4.21 Percentage of subjects
Interval 3.25 to 5.36
|
3.17 Percentage of subjects
Interval 1.74 to 5.26
|
1.08 Percentage of subjects
Interval 0.01 to 6.96
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-45
|
3.60 Percentage of subjects
Interval 3.03 to 4.23
|
1.97 Percentage of subjects
Interval 0.95 to 3.59
|
2.04 Percentage of subjects
Interval 0.14 to 8.5
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-46
|
3.51 Percentage of subjects
Interval 2.96 to 4.13
|
2.33 Percentage of subjects
Interval 1.25 to 3.95
|
1.96 Percentage of subjects
Interval 0.13 to 8.26
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-39
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-40
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
2.22 Percentage of subjects
Interval 0.58 to 5.73
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-41
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
2.04 Percentage of subjects
Interval 0.32 to 6.56
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-42
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
1.54 Percentage of subjects
Interval 0.25 to 4.89
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-43
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
1.24 Percentage of subjects
Interval 0.15 to 4.43
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-44
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
1.40 Percentage of subjects
Interval 0.25 to 4.31
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-45
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
1.23 Percentage of subjects
Interval 0.2 to 3.94
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-46
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
1.11 Percentage of subjects
Interval 0.17 to 3.6
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-47
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
1.05 Percentage of subjects
Interval 0.16 to 3.42
|
0.00 Percentage of subjects
Interval 0.0 to 8.04
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-48
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
1.02 Percentage of subjects
Interval 0.16 to 3.35
|
0.00 Percentage of subjects
Interval 0.0 to 7.4
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-37
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
—
|
—
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-38
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
—
|
—
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-39
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
—
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-40
|
3.70 Percentage of subjects
Interval 0.0 to 39.49
|
4.88 Percentage of subjects
Interval 0.6 to 16.53
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-41
|
3.45 Percentage of subjects
Interval 0.0 to 35.58
|
2.86 Percentage of subjects
Interval 0.34 to 10.06
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-42
|
2.94 Percentage of subjects
Interval 0.0 to 26.56
|
2.13 Percentage of subjects
Interval 0.26 to 7.48
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-43
|
2.86 Percentage of subjects
Interval 0.0 to 25.94
|
1.68 Percentage of subjects
Interval 0.2 to 5.94
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-44
|
2.44 Percentage of subjects
Interval 0.0 to 20.29
|
1.41 Percentage of subjects
Interval 0.26 to 4.26
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-45
|
2.38 Percentage of subjects
Interval 0.0 to 19.99
|
0.96 Percentage of subjects
Interval 0.08 to 3.79
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-46
|
2.13 Percentage of subjects
Interval 0.0 to 17.04
|
0.82 Percentage of subjects
Interval 0.06 to 3.47
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-47
|
2.13 Percentage of subjects
Interval 0.0 to 17.04
|
0.79 Percentage of subjects
Interval 0.06 to 3.32
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-37
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
—
|
—
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-39
|
2.63 Percentage of subjects
Interval 0.01 to 18.97
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-40
|
2.22 Percentage of subjects
Interval 0.02 to 14.79
|
7.14 Percentage of subjects
Interval 0.04 to 41.49
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-41
|
1.82 Percentage of subjects
Interval 0.01 to 12.25
|
3.23 Percentage of subjects
Interval 0.01 to 24.14
|
0.00 Percentage of subjects
Interval 0.0 to 10.58
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-42
|
1.69 Percentage of subjects
Interval 0.02 to 10.77
|
2.08 Percentage of subjects
Interval 0.02 to 13.45
|
0.00 Percentage of subjects
Interval 0.0 to 10.58
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-43
|
1.64 Percentage of subjects
Interval 0.02 to 10.46
|
1.64 Percentage of subjects
Interval 0.01 to 11.31
|
0.00 Percentage of subjects
Interval 0.0 to 10.28
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-44
|
1.61 Percentage of subjects
Interval 0.02 to 10.31
|
1.16 Percentage of subjects
Interval 0.01 to 8.31
|
0.00 Percentage of subjects
Interval 0.0 to 9.03
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-45
|
1.43 Percentage of subjects
Interval 0.02 to 9.07
|
0.60 Percentage of subjects
Interval 0.0 to 5.27
|
1.23 Percentage of subjects
Interval 0.25 to 3.55
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-46
|
1.32 Percentage of subjects
Interval 0.01 to 8.53
|
0.56 Percentage of subjects
Interval 0.0 to 4.82
|
1.22 Percentage of subjects
Interval 0.25 to 3.52
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-47
|
1.22 Percentage of subjects
Interval 0.01 to 8.11
|
0.55 Percentage of subjects
Interval 0.0 to 4.69
|
1.20 Percentage of subjects
Interval 0.25 to 3.45
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-48
|
1.16 Percentage of subjects
Interval 0.01 to 7.7
|
0.54 Percentage of subjects
Interval 0.0 to 4.66
|
1.20 Percentage of subjects
Interval 0.25 to 3.45
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-37
|
5.98 Percentage of subjects
Interval 3.78 to 8.93
|
0.0 Percentage of subjects
Interval 0.0 to 84.19
|
0.0 Percentage of subjects
Interval 0.0 to 33.63
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-38
|
4.56 Percentage of subjects
Interval 3.03 to 6.56
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-40
|
4.34 Percentage of subjects
Interval 3.7 to 5.06
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-41
|
4.07 Percentage of subjects
Interval 3.51 to 4.7
|
1.29 Percentage of subjects
Interval 0.16 to 4.58
|
0.00 Percentage of subjects
Interval 0.0 to 9.03
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-42
|
3.90 Percentage of subjects
Interval 3.28 to 4.59
|
0.77 Percentage of subjects
Interval 0.09 to 2.76
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-43
|
3.80 Percentage of subjects
Interval 3.19 to 4.5
|
2.13 Percentage of subjects
Interval 0.93 to 4.16
|
0.00 Percentage of subjects
Interval 0.0 to 6.38
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-44
|
3.67 Percentage of subjects
Interval 3.08 to 4.34
|
1.99 Percentage of subjects
Interval 0.91 to 3.74
|
0.00 Percentage of subjects
Interval 0.0 to 5.6
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-39
|
4.52 Percentage of subjects
Interval 3.8 to 5.34
|
9.09 Percentage of subjects
Interval 0.21 to 41.85
|
2.70 Percentage of subjects
Interval 0.07 to 14.16
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-40
|
4.66 Percentage of subjects
Interval 3.75 to 5.71
|
1.92 Percentage of subjects
Interval 0.05 to 10.26
|
2.04 Percentage of subjects
Interval 0.05 to 10.85
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-41
|
4.56 Percentage of subjects
Interval 3.64 to 5.65
|
3.05 Percentage of subjects
Interval 0.84 to 7.63
|
1.92 Percentage of subjects
Interval 0.05 to 10.26
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-42
|
4.43 Percentage of subjects
Interval 3.48 to 5.56
|
2.55 Percentage of subjects
Interval 0.83 to 5.85
|
1.75 Percentage of subjects
Interval 0.04 to 9.39
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-43
|
4.40 Percentage of subjects
Interval 3.43 to 5.55
|
2.17 Percentage of subjects
Interval 0.8 to 4.65
|
1.67 Percentage of subjects
Interval 0.04 to 8.94
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-44
|
4.34 Percentage of subjects
Interval 3.4 to 5.45
|
2.93 Percentage of subjects
Interval 1.42 to 5.33
|
1.56 Percentage of subjects
Interval 0.04 to 8.4
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-45
|
4.28 Percentage of subjects
Interval 3.34 to 5.4
|
3.44 Percentage of subjects
Interval 1.84 to 5.81
|
1.19 Percentage of subjects
Interval 0.02 to 7.24
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-46
|
4.26 Percentage of subjects
Interval 3.3 to 5.39
|
3.13 Percentage of subjects
Interval 1.68 to 5.3
|
1.11 Percentage of subjects
Interval 0.01 to 7.09
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-48
|
4.19 Percentage of subjects
Interval 3.23 to 5.34
|
3.02 Percentage of subjects
Interval 1.66 to 5.01
|
1.05 Percentage of subjects
Interval 0.01 to 6.88
|
PRIMARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in electronic health record (EHR), using card-based ADR reporting system during the safety follow-up (FU) period (from vaccination up to 7 days post-vaccination).
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhoea, nausea and vomiting. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16387 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=2946 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=546 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 47
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 4.99
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 37
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
—
|
—
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 38
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
—
|
—
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.97 Percentage of subjects
Interval 0.12 to 3.45
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
—
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 2.49
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 4.11
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 38
|
1.68 Percentage of subjects
Interval 1.1 to 2.44
|
16.67 Percentage of subjects
Interval 0.0 to 91.51
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 45
|
2.70 Percentage of subjects
Interval 0.54 to 7.83
|
2.70 Percentage of subjects
Interval 0.0 to 93.12
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 41
|
1.29 Percentage of subjects
Interval 0.59 to 2.43
|
2.53 Percentage of subjects
Interval 0.31 to 8.85
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 43
|
0.73 Percentage of subjects
Interval 0.06 to 2.9
|
0.00 Percentage of subjects
Interval 0.0 to 4.45
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 44
|
0.47 Percentage of subjects
Interval 0.06 to 1.67
|
1.56 Percentage of subjects
Interval 0.0 to 64.84
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 3.21
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 37
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
—
|
—
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 38
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
—
|
—
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
—
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 48
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 45
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.82
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 13.72
|
—
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
—
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 3.85
|
—
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.99 Percentage of subjects
Interval 0.0 to 10.54
|
—
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 47
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 2.95
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 1.91
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 2.55
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 44
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.8
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 13.72
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 37
|
2.08 Percentage of subjects
Interval 0.98 to 3.85
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 39
|
1.12 Percentage of subjects
Interval 0.73 to 1.66
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 40
|
1.23 Percentage of subjects
Interval 0.52 to 2.45
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 42
|
0.55 Percentage of subjects
Interval 0.09 to 1.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 46
|
2.63 Percentage of subjects
Interval 0.2 to 10.66
|
0.00 Percentage of subjects
Interval 0.0 to 9.49
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 3.42
|
0.00 Percentage of subjects
Interval 0.0 to 12.77
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 15.44
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
1.25 Percentage of subjects
Interval 0.03 to 6.77
|
0.49 Percentage of subjects
Interval 0.01 to 2.69
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
—
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 37
|
1.95 Percentage of subjects
Interval 0.56 to 4.8
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
11.11 Percentage of subjects
Interval 0.03 to 62.14
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 38
|
1.63 Percentage of subjects
Interval 0.59 to 3.56
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 39
|
1.77 Percentage of subjects
Interval 0.7 to 3.63
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 40
|
1.62 Percentage of subjects
Interval 0.46 to 4.04
|
3.39 Percentage of subjects
Interval 0.41 to 11.71
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 41
|
0.94 Percentage of subjects
Interval 0.35 to 2.05
|
0.00 Percentage of subjects
Interval 0.0 to 4.02
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 42
|
0.85 Percentage of subjects
Interval 0.12 to 2.86
|
0.00 Percentage of subjects
Interval 0.0 to 3.48
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 1.68
|
0.00 Percentage of subjects
Interval 0.0 to 3.13
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 44
|
0.32 Percentage of subjects
Interval 0.0 to 2.44
|
1.28 Percentage of subjects
Interval 0.03 to 6.94
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 1.65
|
1.82 Percentage of subjects
Interval 0.0 to 93.05
|
0.00 Percentage of subjects
Interval 0.0 to 10.28
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 1.64
|
0.00 Percentage of subjects
Interval 0.0 to 7.11
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
PRIMARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start, up to end of the week of interest and were registered in EHR, using card-based ADR reporting system during the safety FU period (from vaccination up to 7 days post-vaccination).
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhea, nausea, and vomiting. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16387 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=2946 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=546 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-44
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.22 Percentage of subjects
Interval 0.0 to 1.24
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-47
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.16 Percentage of subjects
Interval 0.0 to 0.99
|
0.00 Percentage of subjects
Interval 0.0 to 8.04
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-46
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
0.27 Percentage of subjects
Interval 0.0 to 2.31
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-45
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
0.60 Percentage of subjects
Interval 0.02 to 3.31
|
0.41 Percentage of subjects
Interval 0.01 to 2.26
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-47
|
0.00 Percentage of subjects
Interval 0.0 to 4.4
|
0.55 Percentage of subjects
Interval 0.01 to 3.01
|
0.40 Percentage of subjects
Interval 0.01 to 2.2
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-37
|
1.95 Percentage of subjects
Interval 0.56 to 4.8
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
11.11 Percentage of subjects
Interval 0.03 to 62.14
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-39
|
1.77 Percentage of subjects
Interval 0.84 to 3.26
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
5.00 Percentage of subjects
Interval 0.03 to 30.57
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-40
|
1.74 Percentage of subjects
Interval 0.99 to 2.82
|
3.08 Percentage of subjects
Interval 0.37 to 10.68
|
3.45 Percentage of subjects
Interval 0.05 to 19.42
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-43
|
1.50 Percentage of subjects
Interval 0.87 to 2.4
|
0.53 Percentage of subjects
Interval 0.06 to 1.91
|
1.79 Percentage of subjects
Interval 0.03 to 10.14
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-46
|
1.32 Percentage of subjects
Interval 0.73 to 2.17
|
0.72 Percentage of subjects
Interval 0.2 to 1.83
|
0.98 Percentage of subjects
Interval 0.02 to 5.34
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-47
|
1.28 Percentage of subjects
Interval 0.71 to 2.12
|
0.67 Percentage of subjects
Interval 0.18 to 1.71
|
0.85 Percentage of subjects
Interval 0.02 to 4.67
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-39
|
1.55 Percentage of subjects
Interval 1.15 to 2.04
|
9.09 Percentage of subjects
Interval 0.21 to 41.85
|
0.00 Percentage of subjects
Interval 0.0 to 9.49
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-42
|
1.42 Percentage of subjects
Interval 1.07 to 1.83
|
1.53 Percentage of subjects
Interval 0.32 to 4.41
|
0.00 Percentage of subjects
Interval 0.0 to 6.27
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-45
|
1.38 Percentage of subjects
Interval 1.09 to 1.73
|
1.32 Percentage of subjects
Interval 0.43 to 3.06
|
0.00 Percentage of subjects
Interval 0.0 to 4.3
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-39
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-40
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.74 Percentage of subjects
Interval 0.09 to 2.65
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-41
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.51 Percentage of subjects
Interval 0.04 to 2.11
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-42
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.34 Percentage of subjects
Interval 0.02 to 1.63
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-43
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.28 Percentage of subjects
Interval 0.01 to 1.46
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-45
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.19 Percentage of subjects
Interval 0.0 to 1.12
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-46
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.17 Percentage of subjects
Interval 0.0 to 1.04
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-48
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.16 Percentage of subjects
Interval 0.0 to 0.97
|
0.00 Percentage of subjects
Interval 0.0 to 7.4
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-37
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
—
|
—
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-38
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
—
|
—
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-39
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
—
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-40
|
0.00 Percentage of subjects
Interval 0.0 to 12.77
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-41
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-42
|
0.00 Percentage of subjects
Interval 0.0 to 10.28
|
0.00 Percentage of subjects
Interval 0.0 to 3.85
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-43
|
0.00 Percentage of subjects
Interval 0.0 to 10.0
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-44
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
0.00 Percentage of subjects
Interval 0.0 to 1.72
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-45
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
0.32 Percentage of subjects
Interval 0.0 to 2.62
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-47
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
0.26 Percentage of subjects
Interval 0.0 to 2.22
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-48
|
0.00 Percentage of subjects
Interval 0.0 to 7.4
|
0.25 Percentage of subjects
Interval 0.0 to 2.15
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-37
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
—
|
—
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-38
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
—
|
—
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-39
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-40
|
0.00 Percentage of subjects
Interval 0.0 to 7.87
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-41
|
0.00 Percentage of subjects
Interval 0.0 to 6.49
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 10.58
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-42
|
0.00 Percentage of subjects
Interval 0.0 to 6.06
|
0.00 Percentage of subjects
Interval 0.0 to 7.4
|
0.00 Percentage of subjects
Interval 0.0 to 10.58
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-43
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
0.00 Percentage of subjects
Interval 0.0 to 10.28
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-44
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
0.00 Percentage of subjects
Interval 0.0 to 4.2
|
0.00 Percentage of subjects
Interval 0.0 to 9.03
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-46
|
0.00 Percentage of subjects
Interval 0.0 to 4.74
|
0.56 Percentage of subjects
Interval 0.01 to 3.09
|
0.41 Percentage of subjects
Interval 0.01 to 2.24
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-48
|
0.00 Percentage of subjects
Interval 0.0 to 4.2
|
0.54 Percentage of subjects
Interval 0.01 to 2.99
|
0.40 Percentage of subjects
Interval 0.01 to 2.2
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-38
|
1.77 Percentage of subjects
Interval 0.6 to 4.01
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
6.67 Percentage of subjects
Interval 0.04 to 38.91
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-41
|
1.63 Percentage of subjects
Interval 0.95 to 2.58
|
1.29 Percentage of subjects
Interval 0.16 to 4.58
|
2.56 Percentage of subjects
Interval 0.06 to 13.56
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-42
|
1.57 Percentage of subjects
Interval 0.93 to 2.47
|
0.77 Percentage of subjects
Interval 0.09 to 2.76
|
2.33 Percentage of subjects
Interval 0.05 to 12.95
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-44
|
1.43 Percentage of subjects
Interval 0.81 to 2.32
|
0.66 Percentage of subjects
Interval 0.14 to 1.92
|
1.56 Percentage of subjects
Interval 0.02 to 9.62
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-45
|
1.37 Percentage of subjects
Interval 0.77 to 2.24
|
0.79 Percentage of subjects
Interval 0.21 to 2.0
|
1.02 Percentage of subjects
Interval 0.03 to 5.55
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-48
|
1.26 Percentage of subjects
Interval 0.7 to 2.09
|
0.64 Percentage of subjects
Interval 0.17 to 1.63
|
0.83 Percentage of subjects
Interval 0.02 to 4.52
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-37
|
2.07 Percentage of subjects
Interval 0.98 to 3.84
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-38
|
1.87 Percentage of subjects
Interval 1.45 to 2.37
|
12.50 Percentage of subjects
Interval 0.1 to 60.63
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-40
|
1.50 Percentage of subjects
Interval 1.11 to 1.97
|
1.92 Percentage of subjects
Interval 0.05 to 10.26
|
0.00 Percentage of subjects
Interval 0.0 to 7.25
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-41
|
1.47 Percentage of subjects
Interval 1.1 to 1.93
|
2.29 Percentage of subjects
Interval 0.47 to 6.55
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-43
|
1.40 Percentage of subjects
Interval 1.06 to 1.81
|
1.08 Percentage of subjects
Interval 0.22 to 3.13
|
0.00 Percentage of subjects
Interval 0.0 to 5.96
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-44
|
1.35 Percentage of subjects
Interval 1.04 to 1.73
|
1.17 Percentage of subjects
Interval 0.32 to 2.98
|
0.00 Percentage of subjects
Interval 0.0 to 5.6
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-46
|
1.40 Percentage of subjects
Interval 1.09 to 1.77
|
1.20 Percentage of subjects
Interval 0.39 to 2.79
|
0.00 Percentage of subjects
Interval 0.0 to 4.02
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-47
|
1.38 Percentage of subjects
Interval 1.08 to 1.75
|
1.13 Percentage of subjects
Interval 0.37 to 2.62
|
0.00 Percentage of subjects
Interval 0.0 to 3.89
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-48
|
1.38 Percentage of subjects
Interval 1.07 to 1.74
|
1.08 Percentage of subjects
Interval 0.35 to 2.5
|
0.00 Percentage of subjects
Interval 0.0 to 3.81
|
PRIMARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in electronic health record (EHR), using card-based ADR reporting system during the safety follow-up (FU) period (from vaccination up to 7 days post-vaccination).
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial oedema and hypersensitivity reactions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16387 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=2946 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=546 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 1.77
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 44
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.8
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 45
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.82
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 3.21
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 13.72
|
—
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 3.85
|
—
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 47
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 38
|
0.70 Percentage of subjects
Interval 0.06 to 2.79
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 1.68
|
0.00 Percentage of subjects
Interval 0.0 to 3.13
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 4.11
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 0.67
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.00 Percentage of subjects
Interval 0.0 to 9.49
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 15.44
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 2.95
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 1.91
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 2.55
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 47
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 4.99
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 48
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 37
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
—
|
—
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 38
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
—
|
—
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
—
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 3.59
|
—
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
—
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 37
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
—
|
—
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 38
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
—
|
—
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
—
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 13.72
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 1.78
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
—
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 37
|
0.56 Percentage of subjects
Interval 0.01 to 3.49
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 39
|
0.71 Percentage of subjects
Interval 0.05 to 3.0
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 40
|
0.27 Percentage of subjects
Interval 0.03 to 0.97
|
3.39 Percentage of subjects
Interval 0.41 to 11.71
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 41
|
0.31 Percentage of subjects
Interval 0.01 to 1.85
|
1.11 Percentage of subjects
Interval 0.03 to 6.04
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 1.04
|
0.00 Percentage of subjects
Interval 0.0 to 3.48
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 1.17
|
3.85 Percentage of subjects
Interval 0.18 to 17.3
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 1.65
|
0.00 Percentage of subjects
Interval 0.0 to 6.49
|
2.94 Percentage of subjects
Interval 0.07 to 15.33
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 46
|
0.45 Percentage of subjects
Interval 0.0 to 3.36
|
0.00 Percentage of subjects
Interval 0.0 to 7.11
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 2.49
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 37
|
0.69 Percentage of subjects
Interval 0.01 to 4.78
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 38
|
0.49 Percentage of subjects
Interval 0.08 to 1.58
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 39
|
0.19 Percentage of subjects
Interval 0.02 to 0.74
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 40
|
0.46 Percentage of subjects
Interval 0.03 to 2.06
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 41
|
0.20 Percentage of subjects
Interval 0.01 to 0.94
|
1.27 Percentage of subjects
Interval 0.03 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 43
|
0.36 Percentage of subjects
Interval 0.0 to 2.55
|
0.00 Percentage of subjects
Interval 0.0 to 4.45
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 44
|
0.47 Percentage of subjects
Interval 0.02 to 2.39
|
0.00 Percentage of subjects
Interval 0.0 to 5.6
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 1.65
|
0.00 Percentage of subjects
Interval 0.0 to 9.49
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 3.42
|
0.00 Percentage of subjects
Interval 0.0 to 12.77
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
PRIMARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start, up to end of the week of interest and were registered in EHR, using card-based ADR reporting system during the safety FU period (from vaccination up to 7 days post-vaccination).
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16387 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=2946 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=546 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-43
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 0.51
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-44
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 0.4
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-45
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 0.35
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-47
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.3
|
0.00 Percentage of subjects
Interval 0.0 to 8.04
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-41
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-42
|
0.00 Percentage of subjects
Interval 0.0 to 10.28
|
0.00 Percentage of subjects
Interval 0.0 to 3.85
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-45
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
0.00 Percentage of subjects
Interval 0.0 to 1.17
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-46
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
0.00 Percentage of subjects
Interval 0.0 to 1.0
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-48
|
0.00 Percentage of subjects
Interval 0.0 to 4.2
|
0.00 Percentage of subjects
Interval 0.0 to 1.98
|
0.00 Percentage of subjects
Interval 0.0 to 1.46
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-39
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35- 40
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 1.36
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-41
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 0.93
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-42
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.00 Percentage of subjects
Interval 0.0 to 0.63
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-46
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.31
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-48
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.29
|
0.00 Percentage of subjects
Interval 0.0 to 7.4
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-37
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
—
|
—
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-38
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
—
|
—
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-39
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
—
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-40
|
0.00 Percentage of subjects
Interval 0.0 to 12.77
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-43
|
0.00 Percentage of subjects
Interval 0.0 to 10.0
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-44
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
0.00 Percentage of subjects
Interval 0.0 to 1.72
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-47
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
0.00 Percentage of subjects
Interval 0.0 to 0.96
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-48
|
0.00 Percentage of subjects
Interval 0.0 to 7.4
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-37
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
—
|
—
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-38
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
—
|
—
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-39
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-40
|
0.00 Percentage of subjects
Interval 0.0 to 7.87
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-41
|
0.00 Percentage of subjects
Interval 0.0 to 6.49
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 10.58
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-42
|
0.00 Percentage of subjects
Interval 0.0 to 6.06
|
0.00 Percentage of subjects
Interval 0.0 to 7.4
|
0.00 Percentage of subjects
Interval 0.0 to 10.58
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-43
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
0.00 Percentage of subjects
Interval 0.0 to 10.28
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-44
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
0.00 Percentage of subjects
Interval 0.0 to 4.2
|
0.00 Percentage of subjects
Interval 0.0 to 9.03
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-45
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
0.00 Percentage of subjects
Interval 0.0 to 2.2
|
0.00 Percentage of subjects
Interval 0.0 to 1.5
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-46
|
0.00 Percentage of subjects
Interval 0.0 to 4.74
|
0.00 Percentage of subjects
Interval 0.0 to 2.05
|
0.00 Percentage of subjects
Interval 0.0 to 1.49
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-47
|
0.00 Percentage of subjects
Interval 0.0 to 4.4
|
0.00 Percentage of subjects
Interval 0.0 to 2.0
|
0.00 Percentage of subjects
Interval 0.0 to 1.46
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-37
|
0.56 Percentage of subjects
Interval 0.01 to 3.49
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-38
|
0.63 Percentage of subjects
Interval 0.03 to 2.94
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-39
|
0.67 Percentage of subjects
Interval 0.04 to 2.9
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-40
|
0.59 Percentage of subjects
Interval 0.05 to 2.39
|
3.08 Percentage of subjects
Interval 0.37 to 10.68
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-41
|
0.55 Percentage of subjects
Interval 0.06 to 2.08
|
1.94 Percentage of subjects
Interval 0.4 to 5.55
|
0.00 Percentage of subjects
Interval 0.0 to 9.03
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-42
|
0.51 Percentage of subjects
Interval 0.05 to 1.97
|
1.16 Percentage of subjects
Interval 0.24 to 3.35
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-43
|
0.49 Percentage of subjects
Interval 0.05 to 1.91
|
0.80 Percentage of subjects
Interval 0.17 to 2.32
|
0.00 Percentage of subjects
Interval 0.0 to 6.38
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-44
|
0.46 Percentage of subjects
Interval 0.04 to 1.82
|
1.32 Percentage of subjects
Interval 0.49 to 2.86
|
0.00 Percentage of subjects
Interval 0.0 to 5.6
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-45
|
0.44 Percentage of subjects
Interval 0.04 to 1.76
|
1.18 Percentage of subjects
Interval 0.43 to 2.55
|
1.02 Percentage of subjects
Interval 0.03 to 5.55
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-46
|
0.44 Percentage of subjects
Interval 0.04 to 1.8
|
1.08 Percentage of subjects
Interval 0.4 to 2.33
|
0.98 Percentage of subjects
Interval 0.02 to 5.34
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-47
|
0.43 Percentage of subjects
Interval 0.03 to 1.76
|
1.01 Percentage of subjects
Interval 0.37 to 2.18
|
0.85 Percentage of subjects
Interval 0.02 to 4.67
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-48
|
0.42 Percentage of subjects
Interval 0.03 to 1.73
|
0.96 Percentage of subjects
Interval 0.35 to 2.08
|
0.83 Percentage of subjects
Interval 0.02 to 4.52
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-37
|
0.69 Percentage of subjects
Interval 0.01 to 4.78
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-38
|
0.59 Percentage of subjects
Interval 0.03 to 2.82
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-39
|
0.42 Percentage of subjects
Interval 0.02 to 1.91
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
0.00 Percentage of subjects
Interval 0.0 to 9.49
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-40
|
0.42 Percentage of subjects
Interval 0.02 to 1.92
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 7.25
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-41
|
0.40 Percentage of subjects
Interval 0.03 to 1.71
|
0.76 Percentage of subjects
Interval 0.02 to 4.18
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-42
|
0.37 Percentage of subjects
Interval 0.02 to 1.63
|
0.51 Percentage of subjects
Interval 0.01 to 2.81
|
0.00 Percentage of subjects
Interval 0.0 to 6.27
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-43
|
0.37 Percentage of subjects
Interval 0.03 to 1.57
|
0.36 Percentage of subjects
Interval 0.01 to 1.99
|
0.00 Percentage of subjects
Interval 0.0 to 5.96
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-44
|
0.38 Percentage of subjects
Interval 0.03 to 1.49
|
0.29 Percentage of subjects
Interval 0.01 to 1.62
|
0.00 Percentage of subjects
Interval 0.0 to 5.6
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-45
|
0.37 Percentage of subjects
Interval 0.03 to 1.46
|
0.26 Percentage of subjects
Interval 0.01 to 1.47
|
0.00 Percentage of subjects
Interval 0.0 to 4.3
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-46
|
0.36 Percentage of subjects
Interval 0.03 to 1.45
|
0.24 Percentage of subjects
Interval 0.01 to 1.34
|
0.00 Percentage of subjects
Interval 0.0 to 4.02
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-47
|
0.36 Percentage of subjects
Interval 0.03 to 1.43
|
0.23 Percentage of subjects
Interval 0.01 to 1.25
|
0.00 Percentage of subjects
Interval 0.0 to 3.89
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-48
|
0.36 Percentage of subjects
Interval 0.03 to 1.43
|
0.22 Percentage of subjects
Interval 0.01 to 1.19
|
0.00 Percentage of subjects
Interval 0.0 to 3.81
|
PRIMARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in electronic health record (EHR), using card-based ADR reporting system during the safety follow-up (FU) period (from vaccination up to 7 days post-vaccination).
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16387 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=2946 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=546 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 38
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
—
|
—
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
—
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 3.59
|
—
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
—
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 38
|
0.47 Percentage of subjects
Interval 0.07 to 1.58
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 43
|
0.92 Percentage of subjects
Interval 0.08 to 3.71
|
0.00 Percentage of subjects
Interval 0.0 to 3.13
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 44
|
0.64 Percentage of subjects
Interval 0.06 to 2.51
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 37
|
0.63 Percentage of subjects
Interval 0.28 to 1.22
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 39
|
0.11 Percentage of subjects
Interval 0.02 to 0.36
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 0.67
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 1.34
|
0.00 Percentage of subjects
Interval 0.0 to 4.45
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 44
|
0.23 Percentage of subjects
Interval 0.01 to 1.29
|
0.00 Percentage of subjects
Interval 0.0 to 5.6
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.00 Percentage of subjects
Interval 0.0 to 9.49
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 3.42
|
0.00 Percentage of subjects
Interval 0.0 to 12.77
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 1.77
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 2.95
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 1.91
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 2.55
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 44
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.8
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 45
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.82
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 3.21
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 47
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 4.99
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 48
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 37
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
—
|
—
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 13.72
|
—
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 3.85
|
—
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 47
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
—
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 37
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
—
|
—
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 38
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
—
|
—
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
—
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 13.72
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 1.78
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 37
|
0.28 Percentage of subjects
Interval 0.0 to 1.8
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 39
|
0.35 Percentage of subjects
Interval 0.11 to 0.82
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 40
|
0.54 Percentage of subjects
Interval 0.15 to 1.38
|
0.00 Percentage of subjects
Interval 0.0 to 6.06
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 0.58
|
0.00 Percentage of subjects
Interval 0.0 to 4.02
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 1.04
|
0.00 Percentage of subjects
Interval 0.0 to 3.48
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 1.65
|
0.00 Percentage of subjects
Interval 0.0 to 6.49
|
0.00 Percentage of subjects
Interval 0.0 to 10.28
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 46
|
0.45 Percentage of subjects
Interval 0.0 to 3.27
|
0.00 Percentage of subjects
Interval 0.0 to 7.11
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 2.49
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 4.11
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 38
|
0.22 Percentage of subjects
Interval 0.04 to 0.68
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 40
|
0.38 Percentage of subjects
Interval 0.12 to 0.89
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 41
|
0.20 Percentage of subjects
Interval 0.02 to 0.71
|
1.27 Percentage of subjects
Interval 0.03 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 1.65
|
0.00 Percentage of subjects
Interval 0.0 to 9.49
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 15.44
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
PRIMARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start, up to end of the week of interest and were registered in EHR, using card-based ADR reporting system during the safety FU period (from vaccination up to 7 days post-vaccination).
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16387 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=2946 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=546 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-39
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-47
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.3
|
0.00 Percentage of subjects
Interval 0.0 to 8.04
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-40
|
0.00 Percentage of subjects
Interval 0.0 to 12.77
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-41
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-44
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
0.00 Percentage of subjects
Interval 0.0 to 1.72
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-45
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
0.00 Percentage of subjects
Interval 0.0 to 1.17
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-46
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
0.00 Percentage of subjects
Interval 0.0 to 1.0
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-42
|
0.00 Percentage of subjects
Interval 0.0 to 6.06
|
0.00 Percentage of subjects
Interval 0.0 to 7.4
|
0.00 Percentage of subjects
Interval 0.0 to 10.58
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-39
|
0.37 Percentage of subjects
Interval 0.18 to 0.66
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-46
|
0.35 Percentage of subjects
Interval 0.21 to 0.54
|
0.00 Percentage of subjects
Interval 0.0 to 0.66
|
0.00 Percentage of subjects
Interval 0.0 to 3.55
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-40
|
0.30 Percentage of subjects
Interval 0.16 to 0.54
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 7.25
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-40
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 1.36
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-41
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 0.93
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-42
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.00 Percentage of subjects
Interval 0.0 to 0.63
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-43
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 0.51
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-44
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 0.4
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-45
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 0.35
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-46
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.31
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-48
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.29
|
0.00 Percentage of subjects
Interval 0.0 to 7.4
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-37
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
—
|
—
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-38
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
—
|
—
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-39
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
—
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-42
|
0.00 Percentage of subjects
Interval 0.0 to 10.28
|
0.00 Percentage of subjects
Interval 0.0 to 3.85
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-43
|
0.00 Percentage of subjects
Interval 0.0 to 10.0
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-47
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
0.00 Percentage of subjects
Interval 0.0 to 0.96
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-48
|
0.00 Percentage of subjects
Interval 0.0 to 7.4
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-37
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
—
|
—
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-38
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
—
|
—
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-39
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-40
|
0.00 Percentage of subjects
Interval 0.0 to 7.87
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-41
|
0.00 Percentage of subjects
Interval 0.0 to 6.49
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 10.58
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-43
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
0.00 Percentage of subjects
Interval 0.0 to 10.28
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-44
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
0.00 Percentage of subjects
Interval 0.0 to 4.2
|
0.00 Percentage of subjects
Interval 0.0 to 9.03
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-45
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
0.00 Percentage of subjects
Interval 0.0 to 2.2
|
0.00 Percentage of subjects
Interval 0.0 to 1.5
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-46
|
0.00 Percentage of subjects
Interval 0.0 to 4.74
|
0.00 Percentage of subjects
Interval 0.0 to 2.05
|
0.00 Percentage of subjects
Interval 0.0 to 1.49
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-47
|
0.00 Percentage of subjects
Interval 0.0 to 4.4
|
0.00 Percentage of subjects
Interval 0.0 to 2.0
|
0.00 Percentage of subjects
Interval 0.0 to 1.46
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-48
|
0.00 Percentage of subjects
Interval 0.0 to 4.2
|
0.00 Percentage of subjects
Interval 0.0 to 1.98
|
0.00 Percentage of subjects
Interval 0.0 to 1.46
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-37
|
0.28 Percentage of subjects
Interval 0.0 to 1.8
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-38
|
0.38 Percentage of subjects
Interval 0.12 to 0.89
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-40
|
0.40 Percentage of subjects
Interval 0.22 to 0.67
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-41
|
0.34 Percentage of subjects
Interval 0.19 to 0.57
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
0.00 Percentage of subjects
Interval 0.0 to 9.03
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-42
|
0.32 Percentage of subjects
Interval 0.18 to 0.52
|
0.00 Percentage of subjects
Interval 0.0 to 1.41
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-43
|
0.34 Percentage of subjects
Interval 0.2 to 0.55
|
0.00 Percentage of subjects
Interval 0.0 to 0.98
|
0.00 Percentage of subjects
Interval 0.0 to 6.38
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-44
|
0.36 Percentage of subjects
Interval 0.22 to 0.57
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.00 Percentage of subjects
Interval 0.0 to 5.6
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-45
|
0.35 Percentage of subjects
Interval 0.21 to 0.55
|
0.00 Percentage of subjects
Interval 0.0 to 0.72
|
0.00 Percentage of subjects
Interval 0.0 to 3.69
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-47
|
0.34 Percentage of subjects
Interval 0.21 to 0.53
|
0.00 Percentage of subjects
Interval 0.0 to 0.62
|
0.00 Percentage of subjects
Interval 0.0 to 3.1
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-48
|
0.34 Percentage of subjects
Interval 0.21 to 0.52
|
0.00 Percentage of subjects
Interval 0.0 to 0.59
|
0.00 Percentage of subjects
Interval 0.0 to 3.0
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-37
|
0.63 Percentage of subjects
Interval 0.28 to 1.22
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-38
|
0.42 Percentage of subjects
Interval 0.18 to 0.82
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-39
|
0.29 Percentage of subjects
Interval 0.13 to 0.56
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
0.00 Percentage of subjects
Interval 0.0 to 9.49
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-41
|
0.29 Percentage of subjects
Interval 0.15 to 0.5
|
0.76 Percentage of subjects
Interval 0.02 to 4.18
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-42
|
0.27 Percentage of subjects
Interval 0.15 to 0.47
|
0.51 Percentage of subjects
Interval 0.01 to 2.81
|
0.00 Percentage of subjects
Interval 0.0 to 6.27
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-43
|
0.27 Percentage of subjects
Interval 0.14 to 0.45
|
0.36 Percentage of subjects
Interval 0.01 to 1.99
|
0.00 Percentage of subjects
Interval 0.0 to 5.96
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-44
|
0.26 Percentage of subjects
Interval 0.15 to 0.43
|
0.29 Percentage of subjects
Interval 0.01 to 1.62
|
0.00 Percentage of subjects
Interval 0.0 to 5.6
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-45
|
0.26 Percentage of subjects
Interval 0.15 to 0.42
|
0.26 Percentage of subjects
Interval 0.01 to 1.47
|
0.00 Percentage of subjects
Interval 0.0 to 4.3
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-46
|
0.26 Percentage of subjects
Interval 0.14 to 0.42
|
0.24 Percentage of subjects
Interval 0.01 to 1.34
|
0.00 Percentage of subjects
Interval 0.0 to 4.02
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-47
|
0.25 Percentage of subjects
Interval 0.14 to 0.42
|
0.23 Percentage of subjects
Interval 0.01 to 1.25
|
0.00 Percentage of subjects
Interval 0.0 to 3.89
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-48
|
0.25 Percentage of subjects
Interval 0.14 to 0.41
|
0.22 Percentage of subjects
Interval 0.01 to 1.19
|
0.00 Percentage of subjects
Interval 0.0 to 3.81
|
PRIMARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in electronic health record (EHR), using card-based ADR reporting system during the safety follow-up (FU) period (from vaccination up to 7 days post-vaccination).
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16387 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=2946 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=546 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 47
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 4.99
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 38
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
—
|
—
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
—
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 4.11
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 38
|
2.81 Percentage of subjects
Interval 2.04 to 3.78
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
10.00 Percentage of subjects
Interval 0.0 to 75.66
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 45
|
1.80 Percentage of subjects
Interval 0.09 to 8.23
|
2.70 Percentage of subjects
Interval 0.0 to 99.67
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 1.77
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 2.95
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 1.91
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 2.55
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 44
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.8
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 45
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.82
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 3.21
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 48
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 37
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
—
|
—
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 38
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
—
|
—
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
—
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 13.72
|
—
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 3.85
|
—
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 3.59
|
—
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 47
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
—
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 37
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
—
|
—
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 13.72
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 4.51
|
0.49 Percentage of subjects
Interval 0.01 to 2.69
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
—
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 37
|
4.59 Percentage of subjects
Interval 3.1 to 6.51
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
11.11 Percentage of subjects
Interval 0.19 to 51.19
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 38
|
2.91 Percentage of subjects
Interval 1.89 to 4.27
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 39
|
2.76 Percentage of subjects
Interval 1.88 to 3.89
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 40
|
2.56 Percentage of subjects
Interval 1.55 to 3.98
|
5.08 Percentage of subjects
Interval 1.06 to 14.15
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 41
|
1.57 Percentage of subjects
Interval 0.76 to 2.88
|
0.00 Percentage of subjects
Interval 0.0 to 4.02
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 42
|
1.69 Percentage of subjects
Interval 0.36 to 4.79
|
0.00 Percentage of subjects
Interval 0.0 to 3.48
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 43
|
3.67 Percentage of subjects
Interval 1.6 to 7.1
|
0.00 Percentage of subjects
Interval 0.0 to 3.13
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 44
|
1.28 Percentage of subjects
Interval 0.25 to 3.78
|
3.85 Percentage of subjects
Interval 0.18 to 17.3
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 45
|
0.90 Percentage of subjects
Interval 0.09 to 3.43
|
0.00 Percentage of subjects
Interval 0.0 to 6.49
|
0.00 Percentage of subjects
Interval 0.0 to 10.28
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 46
|
1.35 Percentage of subjects
Interval 0.24 to 4.12
|
2.00 Percentage of subjects
Interval 0.0 to 21.99
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 47
|
0.68 Percentage of subjects
Interval 0.0 to 4.94
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 37
|
3.29 Percentage of subjects
Interval 2.5 to 4.24
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 39
|
2.47 Percentage of subjects
Interval 1.82 to 3.27
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
5.88 Percentage of subjects
Interval 0.15 to 28.69
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 40
|
2.00 Percentage of subjects
Interval 0.99 to 3.58
|
2.44 Percentage of subjects
Interval 0.06 to 12.86
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 41
|
2.28 Percentage of subjects
Interval 1.18 to 3.95
|
0.00 Percentage of subjects
Interval 0.0 to 4.56
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 42
|
1.47 Percentage of subjects
Interval 0.49 to 3.33
|
1.54 Percentage of subjects
Interval 0.04 to 8.28
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 43
|
2.19 Percentage of subjects
Interval 0.81 to 4.71
|
0.00 Percentage of subjects
Interval 0.0 to 4.45
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 44
|
1.86 Percentage of subjects
Interval 0.16 to 7.37
|
3.13 Percentage of subjects
Interval 0.0 to 88.31
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.00 Percentage of subjects
Interval 0.0 to 9.49
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 3.42
|
0.00 Percentage of subjects
Interval 0.0 to 12.77
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 15.44
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
PRIMARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start, up to end of the week of interest and were registered in EHR, using card-based ADR reporting system during the safety FU period (from vaccination up to 7 days post-vaccination).
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16387 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=2946 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=546 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-44
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
0.00 Percentage of subjects
Interval 0.0 to 1.72
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-45
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
0.00 Percentage of subjects
Interval 0.0 to 1.17
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-39
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-40
|
0.00 Percentage of subjects
Interval 0.0 to 7.87
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-41
|
0.00 Percentage of subjects
Interval 0.0 to 6.49
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 10.58
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-42
|
0.00 Percentage of subjects
Interval 0.0 to 6.06
|
0.00 Percentage of subjects
Interval 0.0 to 7.4
|
0.00 Percentage of subjects
Interval 0.0 to 10.58
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-44
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
0.00 Percentage of subjects
Interval 0.0 to 4.2
|
0.00 Percentage of subjects
Interval 0.0 to 9.03
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-45
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
0.00 Percentage of subjects
Interval 0.0 to 2.2
|
0.41 Percentage of subjects
Interval 0.01 to 2.26
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-46
|
0.00 Percentage of subjects
Interval 0.0 to 4.74
|
0.00 Percentage of subjects
Interval 0.0 to 2.05
|
0.41 Percentage of subjects
Interval 0.01 to 2.24
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-39
|
3.24 Percentage of subjects
Interval 2.55 to 4.06
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
5.00 Percentage of subjects
Interval 0.1 to 26.11
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-40
|
3.11 Percentage of subjects
Interval 2.57 to 3.71
|
4.62 Percentage of subjects
Interval 0.96 to 12.9
|
3.45 Percentage of subjects
Interval 0.05 to 19.42
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-37
|
3.29 Percentage of subjects
Interval 2.5 to 4.24
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-39
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
—
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-37
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
—
|
—
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-38
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
—
|
—
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-40
|
0.00 Percentage of subjects
Interval 0.0 to 12.77
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-41
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-42
|
0.00 Percentage of subjects
Interval 0.0 to 10.28
|
0.00 Percentage of subjects
Interval 0.0 to 3.85
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-43
|
0.00 Percentage of subjects
Interval 0.0 to 10.0
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-46
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
0.00 Percentage of subjects
Interval 0.0 to 1.0
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-47
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
0.00 Percentage of subjects
Interval 0.0 to 0.96
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-48
|
0.00 Percentage of subjects
Interval 0.0 to 7.4
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-37
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
—
|
—
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-38
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
—
|
—
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-43
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
0.00 Percentage of subjects
Interval 0.0 to 10.28
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-47
|
0.00 Percentage of subjects
Interval 0.0 to 4.4
|
0.00 Percentage of subjects
Interval 0.0 to 2.0
|
0.40 Percentage of subjects
Interval 0.01 to 2.2
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-48
|
0.00 Percentage of subjects
Interval 0.0 to 4.2
|
0.00 Percentage of subjects
Interval 0.0 to 1.98
|
0.40 Percentage of subjects
Interval 0.01 to 2.2
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-37
|
4.59 Percentage of subjects
Interval 3.1 to 6.51
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
11.11 Percentage of subjects
Interval 0.19 to 51.19
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-38
|
3.68 Percentage of subjects
Interval 2.63 to 4.99
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
6.67 Percentage of subjects
Interval 0.17 to 31.95
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-41
|
2.88 Percentage of subjects
Interval 2.39 to 3.45
|
1.94 Percentage of subjects
Interval 0.4 to 5.55
|
2.56 Percentage of subjects
Interval 0.05 to 14.2
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-42
|
2.79 Percentage of subjects
Interval 2.24 to 3.45
|
1.16 Percentage of subjects
Interval 0.24 to 3.35
|
2.33 Percentage of subjects
Interval 0.06 to 12.41
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-43
|
2.83 Percentage of subjects
Interval 2.28 to 3.48
|
0.80 Percentage of subjects
Interval 0.17 to 2.32
|
1.79 Percentage of subjects
Interval 0.05 to 9.55
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-44
|
2.74 Percentage of subjects
Interval 2.15 to 3.45
|
1.32 Percentage of subjects
Interval 0.49 to 2.86
|
1.56 Percentage of subjects
Interval 0.04 to 8.4
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-45
|
2.67 Percentage of subjects
Interval 2.11 to 3.33
|
1.18 Percentage of subjects
Interval 0.43 to 2.55
|
1.02 Percentage of subjects
Interval 0.02 to 5.93
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-46
|
2.61 Percentage of subjects
Interval 2.07 to 3.26
|
1.25 Percentage of subjects
Interval 0.51 to 2.57
|
0.98 Percentage of subjects
Interval 0.02 to 5.69
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-47
|
2.57 Percentage of subjects
Interval 2.04 to 3.19
|
1.17 Percentage of subjects
Interval 0.45 to 2.47
|
0.85 Percentage of subjects
Interval 0.02 to 4.96
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-48
|
2.53 Percentage of subjects
Interval 2.0 to 3.14
|
1.12 Percentage of subjects
Interval 0.41 to 2.41
|
0.83 Percentage of subjects
Interval 0.01 to 4.93
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-38
|
3.04 Percentage of subjects
Interval 2.48 to 3.7
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
5.00 Percentage of subjects
Interval 0.01 to 35.33
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-39
|
2.80 Percentage of subjects
Interval 2.21 to 3.5
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
5.41 Percentage of subjects
Interval 0.66 to 18.19
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-40
|
2.66 Percentage of subjects
Interval 2.14 to 3.27
|
1.92 Percentage of subjects
Interval 0.05 to 10.26
|
4.08 Percentage of subjects
Interval 0.5 to 13.98
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-41
|
2.61 Percentage of subjects
Interval 2.09 to 3.23
|
0.76 Percentage of subjects
Interval 0.02 to 4.18
|
3.85 Percentage of subjects
Interval 0.47 to 13.21
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-42
|
2.55 Percentage of subjects
Interval 2.02 to 3.16
|
1.02 Percentage of subjects
Interval 0.12 to 3.64
|
3.51 Percentage of subjects
Interval 0.43 to 12.11
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-43
|
2.54 Percentage of subjects
Interval 2.01 to 3.16
|
0.72 Percentage of subjects
Interval 0.09 to 2.58
|
3.33 Percentage of subjects
Interval 0.41 to 11.53
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-44
|
2.51 Percentage of subjects
Interval 2.04 to 3.05
|
1.17 Percentage of subjects
Interval 0.32 to 2.98
|
3.13 Percentage of subjects
Interval 0.35 to 11.09
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-45
|
2.49 Percentage of subjects
Interval 2.01 to 3.05
|
1.32 Percentage of subjects
Interval 0.43 to 3.06
|
2.38 Percentage of subjects
Interval 0.15 to 10.17
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-46
|
2.46 Percentage of subjects
Interval 1.98 to 3.02
|
1.20 Percentage of subjects
Interval 0.3 to 3.22
|
2.22 Percentage of subjects
Interval 0.12 to 9.92
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-47
|
2.44 Percentage of subjects
Interval 1.96 to 3.0
|
1.13 Percentage of subjects
Interval 0.24 to 3.21
|
2.15 Percentage of subjects
Interval 0.11 to 9.7
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-48
|
2.42 Percentage of subjects
Interval 1.94 to 2.99
|
1.08 Percentage of subjects
Interval 0.22 to 3.13
|
2.11 Percentage of subjects
Interval 0.11 to 9.58
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-39
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-40
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 1.36
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-41
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 0.93
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-42
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.00 Percentage of subjects
Interval 0.0 to 0.63
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-43
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 0.51
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-44
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 0.4
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-45
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 0.35
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-46
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.31
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-47
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.3
|
0.00 Percentage of subjects
Interval 0.0 to 8.04
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-48
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.29
|
0.00 Percentage of subjects
Interval 0.0 to 7.4
|
PRIMARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in electronic health record (EHR), using card-based ADR reporting system during the safety follow-up (FU) period (from vaccination up to 7 days post-vaccination).
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16387 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=2946 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=546 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 3.21
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 37
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
—
|
—
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
—
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 3.59
|
—
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 47
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 37
|
0.28 Percentage of subjects
Interval 0.03 to 1.0
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 39
|
0.14 Percentage of subjects
Interval 0.0 to 0.86
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 1.04
|
0.00 Percentage of subjects
Interval 0.0 to 3.48
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 1.68
|
0.00 Percentage of subjects
Interval 0.0 to 3.13
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 0.67
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 1.77
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 2.95
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 1.91
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 2.55
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 44
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.8
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 45
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.82
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 47
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 4.99
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 48
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 38
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
—
|
—
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 13.72
|
—
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 3.85
|
—
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
—
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 37
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
—
|
—
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 38
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
—
|
—
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
—
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 13.72
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 1.78
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
—
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 38
|
0.35 Percentage of subjects
Interval 0.04 to 1.25
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 0.5
|
1.69 Percentage of subjects
Interval 0.04 to 9.09
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 41
|
0.16 Percentage of subjects
Interval 0.0 to 0.93
|
1.11 Percentage of subjects
Interval 0.03 to 6.04
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 1.17
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 1.65
|
0.00 Percentage of subjects
Interval 0.0 to 6.49
|
0.00 Percentage of subjects
Interval 0.0 to 10.28
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 1.64
|
0.00 Percentage of subjects
Interval 0.0 to 7.11
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 2.49
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 4.11
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 37
|
0.29 Percentage of subjects
Interval 0.09 to 0.67
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 38
|
0.22 Percentage of subjects
Interval 0.05 to 0.59
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 39
|
0.19 Percentage of subjects
Interval 0.06 to 0.44
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 0.28
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 41
|
0.20 Percentage of subjects
Interval 0.0 to 1.21
|
0.00 Percentage of subjects
Interval 0.0 to 4.56
|
33.33 Percentage of subjects
Interval 0.0 to 99.94
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 1.34
|
0.00 Percentage of subjects
Interval 0.0 to 4.45
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 44
|
0.23 Percentage of subjects
Interval 0.0 to 1.9
|
0.00 Percentage of subjects
Interval 0.0 to 5.6
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 1.65
|
0.00 Percentage of subjects
Interval 0.0 to 9.49
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.00 Percentage of subjects
Interval 0.0 to 9.49
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 3.42
|
0.00 Percentage of subjects
Interval 0.0 to 12.77
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 15.44
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
PRIMARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start, up to end of the week of interest and were registered in EHR, using card-based ADR reporting system during the safety FU period (from vaccination up to 7 days post-vaccination).
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16387 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=2946 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=546 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-41
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 0.93
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-43
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 0.51
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-40
|
0.00 Percentage of subjects
Interval 0.0 to 12.77
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-41
|
0.00 Percentage of subjects
Interval 0.0 to 6.49
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 10.58
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-47
|
0.00 Percentage of subjects
Interval 0.0 to 4.4
|
0.00 Percentage of subjects
Interval 0.0 to 2.0
|
0.00 Percentage of subjects
Interval 0.0 to 1.46
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-40
|
0.19 Percentage of subjects
Interval 0.05 to 0.51
|
1.54 Percentage of subjects
Interval 0.04 to 8.28
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-41
|
0.18 Percentage of subjects
Interval 0.05 to 0.45
|
1.29 Percentage of subjects
Interval 0.16 to 4.58
|
0.00 Percentage of subjects
Interval 0.0 to 9.03
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-42
|
0.17 Percentage of subjects
Interval 0.05 to 0.43
|
0.77 Percentage of subjects
Interval 0.09 to 2.76
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-45
|
0.15 Percentage of subjects
Interval 0.04 to 0.38
|
0.39 Percentage of subjects
Interval 0.05 to 1.41
|
0.00 Percentage of subjects
Interval 0.0 to 3.69
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-37
|
0.29 Percentage of subjects
Interval 0.09 to 0.67
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-41
|
0.19 Percentage of subjects
Interval 0.1 to 0.31
|
0.00 Percentage of subjects
Interval 0.0 to 2.78
|
1.92 Percentage of subjects
Interval 0.0 to 15.59
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-42
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.00 Percentage of subjects
Interval 0.0 to 0.63
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-39
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-40
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 1.36
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-44
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 0.4
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-45
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 0.35
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-46
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.31
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-47
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.3
|
0.00 Percentage of subjects
Interval 0.0 to 8.04
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-48
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.29
|
0.00 Percentage of subjects
Interval 0.0 to 7.4
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-37
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
—
|
—
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-38
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
—
|
—
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-39
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
—
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-41
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-42
|
0.00 Percentage of subjects
Interval 0.0 to 10.28
|
0.00 Percentage of subjects
Interval 0.0 to 3.85
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-43
|
0.00 Percentage of subjects
Interval 0.0 to 10.0
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-44
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
0.00 Percentage of subjects
Interval 0.0 to 1.72
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-45
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
0.00 Percentage of subjects
Interval 0.0 to 1.17
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-46
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
0.00 Percentage of subjects
Interval 0.0 to 1.0
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-47
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
0.00 Percentage of subjects
Interval 0.0 to 0.96
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-48
|
0.00 Percentage of subjects
Interval 0.0 to 7.4
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-37
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
—
|
—
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-38
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
—
|
—
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-39
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-40
|
0.00 Percentage of subjects
Interval 0.0 to 7.87
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-42
|
0.00 Percentage of subjects
Interval 0.0 to 6.06
|
0.00 Percentage of subjects
Interval 0.0 to 7.4
|
0.00 Percentage of subjects
Interval 0.0 to 10.58
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-43
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
0.00 Percentage of subjects
Interval 0.0 to 10.28
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-44
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
0.00 Percentage of subjects
Interval 0.0 to 4.2
|
0.00 Percentage of subjects
Interval 0.0 to 9.03
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-45
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
0.00 Percentage of subjects
Interval 0.0 to 2.2
|
0.00 Percentage of subjects
Interval 0.0 to 1.5
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-46
|
0.00 Percentage of subjects
Interval 0.0 to 4.74
|
0.00 Percentage of subjects
Interval 0.0 to 2.05
|
0.00 Percentage of subjects
Interval 0.0 to 1.49
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-48
|
0.00 Percentage of subjects
Interval 0.0 to 4.2
|
0.00 Percentage of subjects
Interval 0.0 to 1.98
|
0.00 Percentage of subjects
Interval 0.0 to 1.46
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-37
|
0.28 Percentage of subjects
Interval 0.03 to 1.0
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-38
|
0.32 Percentage of subjects
Interval 0.07 to 0.89
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-39
|
0.23 Percentage of subjects
Interval 0.07 to 0.57
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-43
|
0.16 Percentage of subjects
Interval 0.04 to 0.41
|
0.53 Percentage of subjects
Interval 0.06 to 1.91
|
0.00 Percentage of subjects
Interval 0.0 to 6.38
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-44
|
0.15 Percentage of subjects
Interval 0.04 to 0.39
|
0.44 Percentage of subjects
Interval 0.05 to 1.59
|
0.00 Percentage of subjects
Interval 0.0 to 5.6
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-46
|
0.14 Percentage of subjects
Interval 0.04 to 0.36
|
0.36 Percentage of subjects
Interval 0.04 to 1.29
|
0.00 Percentage of subjects
Interval 0.0 to 3.55
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-47
|
0.14 Percentage of subjects
Interval 0.04 to 0.36
|
0.34 Percentage of subjects
Interval 0.04 to 1.21
|
0.00 Percentage of subjects
Interval 0.0 to 3.1
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-48
|
0.13 Percentage of subjects
Interval 0.04 to 0.35
|
0.32 Percentage of subjects
Interval 0.04 to 1.15
|
0.00 Percentage of subjects
Interval 0.0 to 3.0
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-38
|
0.25 Percentage of subjects
Interval 0.11 to 0.48
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-39
|
0.22 Percentage of subjects
Interval 0.12 to 0.39
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
0.00 Percentage of subjects
Interval 0.0 to 9.49
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-40
|
0.19 Percentage of subjects
Interval 0.09 to 0.33
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 7.25
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-42
|
0.18 Percentage of subjects
Interval 0.09 to 0.3
|
0.00 Percentage of subjects
Interval 0.0 to 1.86
|
1.75 Percentage of subjects
Interval 0.0 to 13.94
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-43
|
0.17 Percentage of subjects
Interval 0.09 to 0.29
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
1.67 Percentage of subjects
Interval 0.0 to 13.08
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-44
|
0.17 Percentage of subjects
Interval 0.09 to 0.29
|
0.00 Percentage of subjects
Interval 0.0 to 1.08
|
1.56 Percentage of subjects
Interval 0.01 to 11.81
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-45
|
0.17 Percentage of subjects
Interval 0.09 to 0.29
|
0.00 Percentage of subjects
Interval 0.0 to 0.97
|
1.19 Percentage of subjects
Interval 0.0 to 9.68
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-46
|
0.17 Percentage of subjects
Interval 0.09 to 0.29
|
0.00 Percentage of subjects
Interval 0.0 to 0.88
|
1.11 Percentage of subjects
Interval 0.0 to 9.22
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-47
|
0.17 Percentage of subjects
Interval 0.09 to 0.28
|
0.00 Percentage of subjects
Interval 0.0 to 0.83
|
1.08 Percentage of subjects
Interval 0.0 to 8.81
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-48
|
0.16 Percentage of subjects
Interval 0.09 to 0.28
|
0.00 Percentage of subjects
Interval 0.0 to 0.79
|
1.05 Percentage of subjects
Interval 0.0 to 8.66
|
PRIMARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in electronic health record (EHR), using card-based ADR reporting system during the safety follow-up (FU) period (from vaccination up to 7 days post-vaccination).
SAE data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. The weekly incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any SAEs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16387 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=2946 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=546 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Weekly Incidence Rates of Serious Adverse Events (SAEs) Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
|
Weekly Incidence Rates of Serious Adverse Events (SAEs) Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Serious Adverse Events (SAEs) Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 1.64
|
0.00 Percentage of subjects
Interval 0.0 to 7.11
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Serious Adverse Events (SAEs) Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 0.14
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
|
Weekly Incidence Rates of Serious Adverse Events (SAEs) Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Serious Adverse Events (SAEs) Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 1.77
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Serious Adverse Events (SAEs) Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 2.95
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Serious Adverse Events (SAEs) Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 1.91
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Serious Adverse Events (SAEs) Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 2.55
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Serious Adverse Events (SAEs) Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 44
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.8
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
|
Weekly Incidence Rates of Serious Adverse Events (SAEs) Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 45
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.82
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Serious Adverse Events (SAEs) Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 3.21
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Serious Adverse Events (SAEs) Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 47
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 4.99
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
|
Weekly Incidence Rates of Serious Adverse Events (SAEs) Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 48
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Serious Adverse Events (SAEs) Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 37
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
—
|
—
|
|
Weekly Incidence Rates of Serious Adverse Events (SAEs) Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 38
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
—
|
—
|
|
Weekly Incidence Rates of Serious Adverse Events (SAEs) Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
—
|
|
Weekly Incidence Rates of Serious Adverse Events (SAEs) Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
—
|
|
Weekly Incidence Rates of Serious Adverse Events (SAEs) Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Serious Adverse Events (SAEs) Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Serious Adverse Events (SAEs) Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 13.72
|
—
|
|
Weekly Incidence Rates of Serious Adverse Events (SAEs) Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 3.85
|
—
|
|
Weekly Incidence Rates of Serious Adverse Events (SAEs) Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 3.59
|
—
|
|
Weekly Incidence Rates of Serious Adverse Events (SAEs) Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Serious Adverse Events (SAEs) Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 47
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of Serious Adverse Events (SAEs) Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
—
|
|
Weekly Incidence Rates of Serious Adverse Events (SAEs) Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 37
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
—
|
—
|
|
Weekly Incidence Rates of Serious Adverse Events (SAEs) Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 38
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
—
|
—
|
|
Weekly Incidence Rates of Serious Adverse Events (SAEs) Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Serious Adverse Events (SAEs) Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Serious Adverse Events (SAEs) Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Weekly Incidence Rates of Serious Adverse Events (SAEs) Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Serious Adverse Events (SAEs) Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 13.72
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Serious Adverse Events (SAEs) Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 1.78
|
|
Weekly Incidence Rates of Serious Adverse Events (SAEs) Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Serious Adverse Events (SAEs) Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
—
|
|
Weekly Incidence Rates of Serious Adverse Events (SAEs) Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 37
|
0.00 Percentage of subjects
Interval 0.0 to 0.51
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
|
Weekly Incidence Rates of Serious Adverse Events (SAEs) Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 38
|
0.00 Percentage of subjects
Interval 0.0 to 0.43
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
|
Weekly Incidence Rates of Serious Adverse Events (SAEs) Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 0.26
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Serious Adverse Events (SAEs) Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 0.5
|
0.00 Percentage of subjects
Interval 0.0 to 6.06
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
|
Weekly Incidence Rates of Serious Adverse Events (SAEs) Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 0.58
|
0.00 Percentage of subjects
Interval 0.0 to 4.02
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of Serious Adverse Events (SAEs) Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 1.04
|
0.00 Percentage of subjects
Interval 0.0 to 3.48
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Serious Adverse Events (SAEs) Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 1.68
|
0.00 Percentage of subjects
Interval 0.0 to 3.13
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Serious Adverse Events (SAEs) Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 1.17
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
|
Weekly Incidence Rates of Serious Adverse Events (SAEs) Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 1.65
|
0.00 Percentage of subjects
Interval 0.0 to 6.49
|
0.00 Percentage of subjects
Interval 0.0 to 10.28
|
|
Weekly Incidence Rates of Serious Adverse Events (SAEs) Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 2.49
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
|
Weekly Incidence Rates of Serious Adverse Events (SAEs) Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 4.11
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Serious Adverse Events (SAEs) Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of Serious Adverse Events (SAEs) Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 37
|
0.00 Percentage of subjects
Interval 0.0 to 0.21
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
|
Weekly Incidence Rates of Serious Adverse Events (SAEs) Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 38
|
0.00 Percentage of subjects
Interval 0.0 to 0.2
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of Serious Adverse Events (SAEs) Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 0.28
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
|
Weekly Incidence Rates of Serious Adverse Events (SAEs) Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 0.36
|
0.00 Percentage of subjects
Interval 0.0 to 4.56
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of Serious Adverse Events (SAEs) Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 0.67
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Serious Adverse Events (SAEs) Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 1.34
|
0.00 Percentage of subjects
Interval 0.0 to 4.45
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of Serious Adverse Events (SAEs) Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 0.85
|
0.00 Percentage of subjects
Interval 0.0 to 5.6
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Serious Adverse Events (SAEs) Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 1.65
|
0.00 Percentage of subjects
Interval 0.0 to 9.49
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
|
Weekly Incidence Rates of Serious Adverse Events (SAEs) Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.00 Percentage of subjects
Interval 0.0 to 9.49
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
|
Weekly Incidence Rates of Serious Adverse Events (SAEs) Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 3.42
|
0.00 Percentage of subjects
Interval 0.0 to 12.77
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of Serious Adverse Events (SAEs) Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 15.44
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
PRIMARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start, up to end of the week of interest and were registered in EHR, using card-based ADR reporting system during the safety FU period (from vaccination up to 7 days post-vaccination).
SAE data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. The cumulative incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any SAEs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16387 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=2946 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=546 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-45
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 0.35
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-46
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
0.00 Percentage of subjects
Interval 0.0 to 1.0
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-37
|
0.00 Percentage of subjects
Interval 0.0 to 0.51
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-38
|
0.00 Percentage of subjects
Interval 0.0 to 0.23
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-39
|
0.00 Percentage of subjects
Interval 0.0 to 0.12
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-40
|
0.00 Percentage of subjects
Interval 0.0 to 0.1
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-41
|
0.00 Percentage of subjects
Interval 0.0 to 0.08
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
0.00 Percentage of subjects
Interval 0.0 to 9.03
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-44
|
0.00 Percentage of subjects
Interval 0.0 to 0.07
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.00 Percentage of subjects
Interval 0.0 to 5.6
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-45
|
0.00 Percentage of subjects
Interval 0.0 to 0.07
|
0.00 Percentage of subjects
Interval 0.0 to 0.72
|
0.00 Percentage of subjects
Interval 0.0 to 3.69
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-46
|
0.00 Percentage of subjects
Interval 0.0 to 0.06
|
0.00 Percentage of subjects
Interval 0.0 to 0.66
|
0.00 Percentage of subjects
Interval 0.0 to 3.55
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-47
|
0.00 Percentage of subjects
Interval 0.0 to 0.06
|
0.00 Percentage of subjects
Interval 0.0 to 0.62
|
0.00 Percentage of subjects
Interval 0.0 to 3.1
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-48
|
0.00 Percentage of subjects
Interval 0.0 to 0.06
|
0.00 Percentage of subjects
Interval 0.0 to 0.59
|
0.00 Percentage of subjects
Interval 0.0 to 3.0
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-37
|
0.00 Percentage of subjects
Interval 0.0 to 0.21
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-38
|
0.00 Percentage of subjects
Interval 0.0 to 0.1
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-39
|
0.00 Percentage of subjects
Interval 0.0 to 0.06
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
0.00 Percentage of subjects
Interval 0.0 to 9.49
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-40
|
0.00 Percentage of subjects
Interval 0.0 to 0.05
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 7.25
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-43
|
0.00 Percentage of subjects
Interval 0.0 to 0.04
|
0.00 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 5.96
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-44
|
0.00 Percentage of subjects
Interval 0.0 to 0.04
|
0.00 Percentage of subjects
Interval 0.0 to 1.08
|
0.00 Percentage of subjects
Interval 0.0 to 5.6
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-47
|
0.00 Percentage of subjects
Interval 0.0 to 0.04
|
0.00 Percentage of subjects
Interval 0.0 to 0.83
|
0.00 Percentage of subjects
Interval 0.0 to 3.89
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-48
|
0.00 Percentage of subjects
Interval 0.0 to 0.04
|
0.00 Percentage of subjects
Interval 0.0 to 0.79
|
0.00 Percentage of subjects
Interval 0.0 to 3.81
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-39
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-40
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 1.36
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-41
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 0.93
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-42
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.00 Percentage of subjects
Interval 0.0 to 0.63
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-43
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 0.51
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-44
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 0.4
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-46
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.31
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-47
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.3
|
0.00 Percentage of subjects
Interval 0.0 to 8.04
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine and Age Group
6 months to 5 years, Week 35-48
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.29
|
0.00 Percentage of subjects
Interval 0.0 to 7.4
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-37
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
—
|
—
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-38
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
—
|
—
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-39
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
—
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-40
|
0.00 Percentage of subjects
Interval 0.0 to 12.77
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-41
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-42
|
0.00 Percentage of subjects
Interval 0.0 to 10.28
|
0.00 Percentage of subjects
Interval 0.0 to 3.85
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-43
|
0.00 Percentage of subjects
Interval 0.0 to 10.0
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-44
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
0.00 Percentage of subjects
Interval 0.0 to 1.72
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-45
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
0.00 Percentage of subjects
Interval 0.0 to 1.17
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-47
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
0.00 Percentage of subjects
Interval 0.0 to 0.96
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine and Age Group
6 - 12 years, Week 35-48
|
0.00 Percentage of subjects
Interval 0.0 to 7.4
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-37
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
—
|
—
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-38
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
—
|
—
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-39
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-40
|
0.00 Percentage of subjects
Interval 0.0 to 7.87
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-41
|
0.00 Percentage of subjects
Interval 0.0 to 6.49
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 10.58
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-42
|
0.00 Percentage of subjects
Interval 0.0 to 6.06
|
0.00 Percentage of subjects
Interval 0.0 to 7.4
|
0.00 Percentage of subjects
Interval 0.0 to 10.58
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-43
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
0.00 Percentage of subjects
Interval 0.0 to 10.28
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-44
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
0.00 Percentage of subjects
Interval 0.0 to 4.2
|
0.00 Percentage of subjects
Interval 0.0 to 9.03
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-45
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
0.00 Percentage of subjects
Interval 0.0 to 2.2
|
0.00 Percentage of subjects
Interval 0.0 to 1.5
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-46
|
0.00 Percentage of subjects
Interval 0.0 to 4.74
|
0.00 Percentage of subjects
Interval 0.0 to 2.05
|
0.00 Percentage of subjects
Interval 0.0 to 1.49
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-47
|
0.00 Percentage of subjects
Interval 0.0 to 4.4
|
0.00 Percentage of subjects
Interval 0.0 to 2.0
|
0.00 Percentage of subjects
Interval 0.0 to 1.46
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine and Age Group
13 - 17 years, Week 35-48
|
0.00 Percentage of subjects
Interval 0.0 to 4.2
|
0.00 Percentage of subjects
Interval 0.0 to 1.98
|
0.00 Percentage of subjects
Interval 0.0 to 1.46
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-42
|
0.00 Percentage of subjects
Interval 0.0 to 0.08
|
0.00 Percentage of subjects
Interval 0.0 to 1.41
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine and Age Group
18 - 65 years, Week 35-43
|
0.00 Percentage of subjects
Interval 0.0 to 0.07
|
0.00 Percentage of subjects
Interval 0.0 to 0.98
|
0.00 Percentage of subjects
Interval 0.0 to 6.38
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-41
|
0.00 Percentage of subjects
Interval 0.0 to 0.04
|
0.00 Percentage of subjects
Interval 0.0 to 2.78
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-42
|
0.00 Percentage of subjects
Interval 0.0 to 0.04
|
0.00 Percentage of subjects
Interval 0.0 to 1.86
|
0.00 Percentage of subjects
Interval 0.0 to 6.27
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-45
|
0.00 Percentage of subjects
Interval 0.0 to 0.04
|
0.00 Percentage of subjects
Interval 0.0 to 0.97
|
0.00 Percentage of subjects
Interval 0.0 to 4.3
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine and Age Group
>65 years, Week 35-46
|
0.00 Percentage of subjects
Interval 0.0 to 0.04
|
0.00 Percentage of subjects
Interval 0.0 to 0.88
|
0.00 Percentage of subjects
Interval 0.0 to 4.02
|
PRIMARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in electronic health record (EHR), using card-based ADR reporting system during the safety follow-up (FU) period (from vaccination up to 7 days post-vaccination).
The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16387 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=2946 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=546 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group and United Kingdom Chief Medical Officer (UK CMO)-Specified Risk Status
At risk, Week 46
|
2.60 Percentage of subjects
Interval 0.72 to 6.52
|
0.87 Percentage of subjects
Interval 0.0 to 6.67
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group and United Kingdom Chief Medical Officer (UK CMO)-Specified Risk Status
At risk, Week 38
|
7.56 Percentage of subjects
Interval 5.85 to 9.58
|
14.29 Percentage of subjects
Interval 0.0 to 90.97
|
15.38 Percentage of subjects
Interval 1.47 to 48.44
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group and United Kingdom Chief Medical Officer (UK CMO)-Specified Risk Status
At risk, Week 39
|
7.79 Percentage of subjects
Interval 6.95 to 8.69
|
0.00 Percentage of subjects
Interval 0.0 to 4.06
|
4.17 Percentage of subjects
Interval 0.11 to 21.12
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group and United Kingdom Chief Medical Officer (UK CMO)-Specified Risk Status
At risk, Week 40
|
8.14 Percentage of subjects
Interval 4.89 to 12.57
|
5.14 Percentage of subjects
Interval 2.97 to 8.22
|
0.00 Percentage of subjects
Interval 0.0 to 12.77
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group and United Kingdom Chief Medical Officer (UK CMO)-Specified Risk Status
At risk, Week 41
|
6.43 Percentage of subjects
Interval 4.46 to 8.92
|
3.67 Percentage of subjects
Interval 1.08 to 8.82
|
2.78 Percentage of subjects
Interval 0.07 to 14.53
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group and United Kingdom Chief Medical Officer (UK CMO)-Specified Risk Status
At risk, Week 42
|
4.13 Percentage of subjects
Interval 1.91 to 7.68
|
1.42 Percentage of subjects
Interval 0.35 to 3.82
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group and United Kingdom Chief Medical Officer (UK CMO)-Specified Risk Status
At risk, Week 43
|
4.72 Percentage of subjects
Interval 2.0 to 9.26
|
2.15 Percentage of subjects
Interval 0.66 to 5.09
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group and United Kingdom Chief Medical Officer (UK CMO)-Specified Risk Status
At risk, Week 44
|
4.41 Percentage of subjects
Interval 1.31 to 10.49
|
2.92 Percentage of subjects
Interval 0.61 to 8.3
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group and United Kingdom Chief Medical Officer (UK CMO)-Specified Risk Status
At risk, Week 47
|
1.42 Percentage of subjects
Interval 0.26 to 4.32
|
0.73 Percentage of subjects
Interval 0.02 to 4.06
|
0.00 Percentage of subjects
Interval 0.0 to 10.58
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group and United Kingdom Chief Medical Officer (UK CMO)-Specified Risk Status
At risk, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.00 Percentage of subjects
Interval 0.0 to 4.3
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group and United Kingdom Chief Medical Officer (UK CMO)-Specified Risk Status
Not at risk, Week 37
|
12.78 Percentage of subjects
Interval 7.63 to 19.67
|
—
|
50.00 Percentage of subjects
Interval 0.0 to 100.0
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group and United Kingdom Chief Medical Officer (UK CMO)-Specified Risk Status
Not at risk, Week 38
|
9.70 Percentage of subjects
Interval 5.4 to 15.75
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group and United Kingdom Chief Medical Officer (UK CMO)-Specified Risk Status
At risk, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group and United Kingdom Chief Medical Officer (UK CMO)-Specified Risk Status
At risk, Week 37
|
9.94 Percentage of subjects
Interval 8.24 to 11.87
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group and United Kingdom Chief Medical Officer (UK CMO)-Specified Risk Status
At risk, Week 45
|
3.69 Percentage of subjects
Interval 1.48 to 7.5
|
2.32 Percentage of subjects
Interval 0.05 to 12.57
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group and United Kingdom Chief Medical Officer (UK CMO)-Specified Risk Status
Not at risk, Week 39
|
10.00 Percentage of subjects
Interval 6.17 to 15.1
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
—
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group and United Kingdom Chief Medical Officer (UK CMO)-Specified Risk Status
Not at risk, Week 40
|
9.14 Percentage of subjects
Interval 4.45 to 16.21
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group and United Kingdom Chief Medical Officer (UK CMO)-Specified Risk Status
Not at risk, Week 41
|
6.10 Percentage of subjects
Interval 1.66 to 15.01
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group and United Kingdom Chief Medical Officer (UK CMO)-Specified Risk Status
Not at risk, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 4.15
|
0.00 Percentage of subjects
Interval 0.0 to 7.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group and United Kingdom Chief Medical Officer (UK CMO)-Specified Risk Status
Not at risk, Week 43
|
3.92 Percentage of subjects
Interval 0.34 to 14.93
|
5.77 Percentage of subjects
Interval 0.44 to 22.18
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group and United Kingdom Chief Medical Officer (UK CMO)-Specified Risk Status
Not at risk, Week 44
|
4.35 Percentage of subjects
Interval 0.91 to 12.18
|
9.43 Percentage of subjects
Interval 2.0 to 25.09
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group and United Kingdom Chief Medical Officer (UK CMO)-Specified Risk Status
Not at risk, Week 45
|
4.05 Percentage of subjects
Interval 0.64 to 12.73
|
2.00 Percentage of subjects
Interval 0.1 to 9.21
|
2.29 Percentage of subjects
Interval 0.75 to 5.27
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group and United Kingdom Chief Medical Officer (UK CMO)-Specified Risk Status
Not at risk, Week 46
|
9.88 Percentage of subjects
Interval 2.59 to 24.02
|
8.57 Percentage of subjects
Interval 1.8 to 23.06
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group and United Kingdom Chief Medical Officer (UK CMO)-Specified Risk Status
Not at risk, Week 47
|
2.17 Percentage of subjects
Interval 0.01 to 16.04
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
|
Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group and United Kingdom Chief Medical Officer (UK CMO)-Specified Risk Status
Not at risk, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
PRIMARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start, up to end of the week of interest and were registered in EHR, using card-based ADR reporting system during the safety FU period (from vaccination up to 7 days post-vaccination).
The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16387 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=2946 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=546 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-38
|
8.70 Percentage of subjects
Interval 7.07 to 10.56
|
9.09 Percentage of subjects
Interval 0.08 to 47.67
|
7.14 Percentage of subjects
Interval 0.68 to 25.29
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-37
|
9.94 Percentage of subjects
Interval 8.23 to 11.87
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-39
|
8.30 Percentage of subjects
Interval 7.13 to 9.59
|
1.00 Percentage of subjects
Interval 0.03 to 5.45
|
5.77 Percentage of subjects
Interval 1.21 to 15.95
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-40
|
8.27 Percentage of subjects
Interval 7.09 to 9.57
|
4.14 Percentage of subjects
Interval 2.39 to 6.61
|
3.80 Percentage of subjects
Interval 0.7 to 11.27
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-41
|
8.04 Percentage of subjects
Interval 6.86 to 9.36
|
3.94 Percentage of subjects
Interval 2.11 to 6.65
|
3.48 Percentage of subjects
Interval 0.88 to 9.02
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-42
|
7.79 Percentage of subjects
Interval 6.57 to 9.16
|
3.11 Percentage of subjects
Interval 1.57 to 5.47
|
3.08 Percentage of subjects
Interval 0.7 to 8.37
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-43
|
7.69 Percentage of subjects
Interval 6.44 to 9.09
|
2.88 Percentage of subjects
Interval 1.38 to 5.25
|
2.78 Percentage of subjects
Interval 0.61 to 7.71
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-44
|
7.53 Percentage of subjects
Interval 6.28 to 8.94
|
2.89 Percentage of subjects
Interval 1.24 to 5.66
|
2.31 Percentage of subjects
Interval 0.45 to 6.76
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-45
|
7.43 Percentage of subjects
Interval 6.19 to 8.83
|
2.81 Percentage of subjects
Interval 1.19 to 5.54
|
1.85 Percentage of subjects
Interval 0.31 to 5.77
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-46
|
7.34 Percentage of subjects
Interval 6.07 to 8.78
|
2.62 Percentage of subjects
Interval 0.98 to 5.58
|
1.75 Percentage of subjects
Interval 0.28 to 5.54
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-47
|
7.26 Percentage of subjects
Interval 5.97 to 8.72
|
2.51 Percentage of subjects
Interval 0.91 to 5.45
|
1.53 Percentage of subjects
Interval 0.27 to 4.71
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-48
|
7.20 Percentage of subjects
Interval 5.91 to 8.67
|
2.43 Percentage of subjects
Interval 0.88 to 5.28
|
1.48 Percentage of subjects
Interval 0.25 to 4.61
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-37
|
12.78 Percentage of subjects
Interval 7.63 to 19.67
|
—
|
50.00 Percentage of subjects
Interval 0.0 to 100.0
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-38
|
11.07 Percentage of subjects
Interval 7.75 to 15.2
|
—
|
28.57 Percentage of subjects
Interval 3.67 to 70.96
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-39
|
10.50 Percentage of subjects
Interval 7.61 to 14.02
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
28.57 Percentage of subjects
Interval 3.67 to 70.96
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-40
|
10.21 Percentage of subjects
Interval 7.67 to 13.25
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
18.18 Percentage of subjects
Interval 1.26 to 58.58
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-41
|
9.52 Percentage of subjects
Interval 7.05 to 12.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.21
|
6.45 Percentage of subjects
Interval 0.79 to 21.42
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-42
|
8.74 Percentage of subjects
Interval 6.6 to 11.3
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
6.06 Percentage of subjects
Interval 0.74 to 20.23
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-43
|
8.52 Percentage of subjects
Interval 6.46 to 10.98
|
1.75 Percentage of subjects
Interval 0.36 to 5.04
|
4.88 Percentage of subjects
Interval 0.6 to 16.53
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-44
|
8.28 Percentage of subjects
Interval 6.26 to 10.68
|
3.57 Percentage of subjects
Interval 1.55 to 6.92
|
4.76 Percentage of subjects
Interval 0.58 to 16.16
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-45
|
8.03 Percentage of subjects
Interval 6.11 to 10.32
|
3.09 Percentage of subjects
Interval 1.49 to 5.6
|
2.69 Percentage of subjects
Interval 1.09 to 5.47
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-46
|
8.14 Percentage of subjects
Interval 6.25 to 10.38
|
3.62 Percentage of subjects
Interval 1.94 to 6.11
|
2.63 Percentage of subjects
Interval 1.06 to 5.35
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-47
|
7.94 Percentage of subjects
Interval 6.1 to 10.13
|
3.43 Percentage of subjects
Interval 1.84 to 5.79
|
2.55 Percentage of subjects
Interval 1.03 to 5.19
|
|
Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-48
|
7.77 Percentage of subjects
Interval 5.9 to 9.99
|
3.29 Percentage of subjects
Interval 1.76 to 5.56
|
2.55 Percentage of subjects
Interval 1.03 to 5.17
|
PRIMARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in electronic health record (EHR), using card-based ADR reporting system during the safety follow-up (FU) period (from vaccination up to 7 days post-vaccination).
Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16387 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=2946 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=546 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 43
|
0.45 Percentage of subjects
Interval 0.05 to 1.63
|
0.00 Percentage of subjects
Interval 0.0 to 1.13
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 37
|
0.39 Percentage of subjects
Interval 0.17 to 0.76
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 38
|
0.43 Percentage of subjects
Interval 0.13 to 1.05
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 39
|
0.48 Percentage of subjects
Interval 0.21 to 0.91
|
0.00 Percentage of subjects
Interval 0.0 to 4.06
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 40
|
0.27 Percentage of subjects
Interval 0.09 to 0.62
|
1.29 Percentage of subjects
Interval 0.12 to 4.97
|
0.00 Percentage of subjects
Interval 0.0 to 12.77
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 41
|
0.40 Percentage of subjects
Interval 0.15 to 0.87
|
0.67 Percentage of subjects
Interval 0.08 to 2.39
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 0.45
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 44
|
0.29 Percentage of subjects
Interval 0.02 to 1.34
|
0.49 Percentage of subjects
Interval 0.06 to 1.75
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 0.97
|
0.00 Percentage of subjects
Interval 0.0 to 1.21
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 46
|
0.37 Percentage of subjects
Interval 0.0 to 2.71
|
0.00 Percentage of subjects
Interval 0.0 to 1.6
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 47
|
0.47 Percentage of subjects
Interval 0.0 to 3.37
|
0.00 Percentage of subjects
Interval 0.0 to 2.66
|
0.00 Percentage of subjects
Interval 0.0 to 10.58
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.00 Percentage of subjects
Interval 0.0 to 4.3
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 37
|
1.50 Percentage of subjects
Interval 0.18 to 5.33
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 38
|
1.82 Percentage of subjects
Interval 0.3 to 5.77
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 39
|
0.29 Percentage of subjects
Interval 0.01 to 1.63
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
—
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 40
|
1.14 Percentage of subjects
Interval 0.02 to 6.55
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 2.22
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 4.15
|
0.00 Percentage of subjects
Interval 0.0 to 7.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 6.98
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 5.21
|
0.00 Percentage of subjects
Interval 0.0 to 6.72
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.46 Percentage of subjects
Interval 0.01 to 2.53
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 46
|
1.23 Percentage of subjects
Interval 0.0 to 9.48
|
0.00 Percentage of subjects
Interval 0.0 to 10.0
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 7.71
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
PRIMARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start, up to end of the week of interest and were registered in EHR, using card-based ADR reporting system during the safety FU period (from vaccination up to 7 days post-vaccination).
Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16387 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=2946 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=546 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-37
|
0.39 Percentage of subjects
Interval 0.17 to 0.76
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-38
|
0.41 Percentage of subjects
Interval 0.24 to 0.65
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
0.00 Percentage of subjects
Interval 0.0 to 12.34
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-39
|
0.44 Percentage of subjects
Interval 0.24 to 0.74
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-40
|
0.41 Percentage of subjects
Interval 0.24 to 0.66
|
0.97 Percentage of subjects
Interval 0.04 to 4.78
|
0.00 Percentage of subjects
Interval 0.0 to 4.56
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-41
|
0.41 Percentage of subjects
Interval 0.26 to 0.61
|
0.84 Percentage of subjects
Interval 0.19 to 2.34
|
0.00 Percentage of subjects
Interval 0.0 to 3.16
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-42
|
0.38 Percentage of subjects
Interval 0.24 to 0.58
|
0.56 Percentage of subjects
Interval 0.1 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-43
|
0.38 Percentage of subjects
Interval 0.24 to 0.58
|
0.43 Percentage of subjects
Interval 0.06 to 1.5
|
0.00 Percentage of subjects
Interval 0.0 to 2.53
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-44
|
0.38 Percentage of subjects
Interval 0.24 to 0.57
|
0.44 Percentage of subjects
Interval 0.11 to 1.2
|
0.00 Percentage of subjects
Interval 0.0 to 2.11
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-45
|
0.37 Percentage of subjects
Interval 0.23 to 0.56
|
0.38 Percentage of subjects
Interval 0.08 to 1.09
|
0.00 Percentage of subjects
Interval 0.0 to 1.69
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-46
|
0.37 Percentage of subjects
Interval 0.23 to 0.56
|
0.34 Percentage of subjects
Interval 0.07 to 1.01
|
0.00 Percentage of subjects
Interval 0.0 to 1.6
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-47
|
0.37 Percentage of subjects
Interval 0.23 to 0.56
|
0.32 Percentage of subjects
Interval 0.06 to 0.96
|
0.00 Percentage of subjects
Interval 0.0 to 1.4
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-48
|
0.37 Percentage of subjects
Interval 0.23 to 0.55
|
0.31 Percentage of subjects
Interval 0.06 to 0.94
|
0.00 Percentage of subjects
Interval 0.0 to 1.35
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-37
|
1.50 Percentage of subjects
Interval 0.18 to 5.33
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-38
|
1.68 Percentage of subjects
Interval 0.36 to 4.74
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-39
|
0.94 Percentage of subjects
Interval 0.2 to 2.69
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-40
|
0.98 Percentage of subjects
Interval 0.24 to 2.64
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-41
|
0.82 Percentage of subjects
Interval 0.19 to 2.27
|
0.00 Percentage of subjects
Interval 0.0 to 5.21
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-42
|
0.75 Percentage of subjects
Interval 0.16 to 2.14
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
0.00 Percentage of subjects
Interval 0.0 to 10.58
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-43
|
0.72 Percentage of subjects
Interval 0.15 to 2.08
|
0.00 Percentage of subjects
Interval 0.0 to 2.13
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-44
|
0.68 Percentage of subjects
Interval 0.13 to 2.01
|
0.00 Percentage of subjects
Interval 0.0 to 1.63
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-45
|
0.64 Percentage of subjects
Interval 0.12 to 1.91
|
0.00 Percentage of subjects
Interval 0.0 to 1.13
|
0.38 Percentage of subjects
Interval 0.01 to 2.12
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-46
|
0.67 Percentage of subjects
Interval 0.11 to 2.18
|
0.00 Percentage of subjects
Interval 0.0 to 1.02
|
0.38 Percentage of subjects
Interval 0.01 to 2.08
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-47
|
0.65 Percentage of subjects
Interval 0.1 to 2.1
|
0.00 Percentage of subjects
Interval 0.0 to 0.97
|
0.36 Percentage of subjects
Interval 0.01 to 2.02
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-48
|
0.64 Percentage of subjects
Interval 0.1 to 2.06
|
0.00 Percentage of subjects
Interval 0.0 to 0.93
|
0.36 Percentage of subjects
Interval 0.01 to 2.01
|
PRIMARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in electronic health record (EHR), using card-based ADR reporting system during the safety follow-up (FU) period (from vaccination up to 7 days post-vaccination).
Local symptoms include local erythema. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16387 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=2946 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=546 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 45
|
0.79 Percentage of subjects
Interval 0.07 to 3.18
|
0.66 Percentage of subjects
Interval 0.0 to 4.57
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 37
|
1.67 Percentage of subjects
Interval 0.58 to 3.73
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 38
|
1.33 Percentage of subjects
Interval 0.65 to 2.4
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 39
|
1.77 Percentage of subjects
Interval 1.24 to 2.46
|
0.00 Percentage of subjects
Interval 0.0 to 4.06
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 40
|
1.70 Percentage of subjects
Interval 0.72 to 3.39
|
0.32 Percentage of subjects
Interval 0.0 to 2.12
|
0.00 Percentage of subjects
Interval 0.0 to 12.77
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 41
|
1.54 Percentage of subjects
Interval 0.98 to 2.3
|
1.00 Percentage of subjects
Interval 0.14 to 3.4
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 42
|
0.61 Percentage of subjects
Interval 0.1 to 1.96
|
0.57 Percentage of subjects
Interval 0.07 to 2.07
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 43
|
0.45 Percentage of subjects
Interval 0.05 to 1.67
|
0.61 Percentage of subjects
Interval 0.04 to 2.66
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 44
|
0.88 Percentage of subjects
Interval 0.13 to 2.95
|
0.49 Percentage of subjects
Interval 0.06 to 1.75
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 46
|
0.74 Percentage of subjects
Interval 0.09 to 2.7
|
0.44 Percentage of subjects
Interval 0.0 to 3.38
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 47
|
0.94 Percentage of subjects
Interval 0.05 to 4.24
|
0.00 Percentage of subjects
Interval 0.0 to 2.66
|
0.00 Percentage of subjects
Interval 0.0 to 10.58
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.00 Percentage of subjects
Interval 0.0 to 4.3
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 37
|
5.26 Percentage of subjects
Interval 1.54 to 12.59
|
—
|
25.00 Percentage of subjects
Interval 0.0 to 100.0
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 38
|
6.06 Percentage of subjects
Interval 2.82 to 11.16
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 39
|
3.24 Percentage of subjects
Interval 1.06 to 7.38
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
—
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 40
|
4.57 Percentage of subjects
Interval 1.62 to 9.92
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 41
|
0.61 Percentage of subjects
Interval 0.0 to 4.32
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 4.15
|
0.00 Percentage of subjects
Interval 0.0 to 7.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 6.98
|
1.92 Percentage of subjects
Interval 0.05 to 10.26
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 44
|
4.35 Percentage of subjects
Interval 0.91 to 12.18
|
1.89 Percentage of subjects
Interval 0.05 to 10.07
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 1.68
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 46
|
3.70 Percentage of subjects
Interval 0.08 to 40.0
|
5.71 Percentage of subjects
Interval 0.7 to 19.16
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 47
|
2.17 Percentage of subjects
Interval 0.01 to 16.04
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
|
Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
PRIMARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start, up to end of the week of interest and were registered in EHR, using card-based ADR reporting system during the safety FU period (from vaccination up to 7 days post-vaccination).
Local symptoms include local erythema. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16387 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=2946 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=546 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-40
|
1.63 Percentage of subjects
Interval 1.05 to 2.41
|
0.24 Percentage of subjects
Interval 0.01 to 1.35
|
0.00 Percentage of subjects
Interval 0.0 to 4.56
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-41
|
1.62 Percentage of subjects
Interval 1.1 to 2.29
|
0.56 Percentage of subjects
Interval 0.04 to 2.4
|
0.00 Percentage of subjects
Interval 0.0 to 3.16
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-42
|
1.55 Percentage of subjects
Interval 1.1 to 2.13
|
0.56 Percentage of subjects
Interval 0.05 to 2.26
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-43
|
1.52 Percentage of subjects
Interval 1.08 to 2.07
|
0.58 Percentage of subjects
Interval 0.05 to 2.32
|
0.00 Percentage of subjects
Interval 0.0 to 2.53
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-37
|
1.67 Percentage of subjects
Interval 0.58 to 3.72
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-38
|
1.49 Percentage of subjects
Interval 0.78 to 2.57
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
0.00 Percentage of subjects
Interval 0.0 to 12.34
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-39
|
1.61 Percentage of subjects
Interval 1.02 to 2.42
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-44
|
1.49 Percentage of subjects
Interval 1.07 to 2.01
|
0.56 Percentage of subjects
Interval 0.07 to 1.99
|
0.00 Percentage of subjects
Interval 0.0 to 2.11
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-45
|
1.47 Percentage of subjects
Interval 1.06 to 1.98
|
0.57 Percentage of subjects
Interval 0.11 to 1.73
|
0.00 Percentage of subjects
Interval 0.0 to 1.69
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-46
|
1.45 Percentage of subjects
Interval 1.05 to 1.96
|
0.56 Percentage of subjects
Interval 0.09 to 1.81
|
0.00 Percentage of subjects
Interval 0.0 to 1.6
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-47
|
1.45 Percentage of subjects
Interval 1.05 to 1.95
|
0.53 Percentage of subjects
Interval 0.08 to 1.72
|
0.00 Percentage of subjects
Interval 0.0 to 1.4
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-48
|
1.44 Percentage of subjects
Interval 1.04 to 1.93
|
0.51 Percentage of subjects
Interval 0.08 to 1.66
|
0.00 Percentage of subjects
Interval 0.0 to 1.35
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-37
|
5.26 Percentage of subjects
Interval 1.54 to 12.59
|
—
|
25.00 Percentage of subjects
Interval 0.0 to 100.0
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-38
|
5.70 Percentage of subjects
Interval 2.72 to 10.36
|
—
|
14.29 Percentage of subjects
Interval 0.04 to 71.51
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-39
|
4.39 Percentage of subjects
Interval 1.96 to 8.34
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
14.29 Percentage of subjects
Interval 0.04 to 71.51
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-40
|
4.43 Percentage of subjects
Interval 2.31 to 7.59
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
9.09 Percentage of subjects
Interval 0.0 to 65.53
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-41
|
3.79 Percentage of subjects
Interval 2.04 to 6.37
|
0.00 Percentage of subjects
Interval 0.0 to 5.21
|
3.23 Percentage of subjects
Interval 0.0 to 33.66
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-42
|
3.48 Percentage of subjects
Interval 1.94 to 5.72
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
3.03 Percentage of subjects
Interval 0.0 to 26.51
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-43
|
3.32 Percentage of subjects
Interval 1.89 to 5.37
|
0.58 Percentage of subjects
Interval 0.01 to 3.22
|
2.44 Percentage of subjects
Interval 0.01 to 17.96
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-44
|
3.38 Percentage of subjects
Interval 2.04 to 5.24
|
0.89 Percentage of subjects
Interval 0.11 to 3.19
|
2.38 Percentage of subjects
Interval 0.01 to 17.83
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-45
|
3.18 Percentage of subjects
Interval 1.93 to 4.92
|
0.62 Percentage of subjects
Interval 0.07 to 2.21
|
0.38 Percentage of subjects
Interval 0.0 to 5.26
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-46
|
3.21 Percentage of subjects
Interval 2.16 to 4.59
|
1.11 Percentage of subjects
Interval 0.3 to 2.83
|
0.38 Percentage of subjects
Interval 0.0 to 4.72
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-47
|
3.18 Percentage of subjects
Interval 2.14 to 4.52
|
1.06 Percentage of subjects
Interval 0.29 to 2.68
|
0.36 Percentage of subjects
Interval 0.0 to 4.34
|
|
Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-48
|
3.11 Percentage of subjects
Interval 2.09 to 4.44
|
1.01 Percentage of subjects
Interval 0.28 to 2.57
|
0.36 Percentage of subjects
Interval 0.0 to 4.33
|
PRIMARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in electronic health record (EHR), using card-based ADR reporting system during the safety follow-up (FU) period (from vaccination up to 7 days post-vaccination).
General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability and malaise. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16387 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=2946 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=546 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 6.98
|
1.92 Percentage of subjects
Interval 0.05 to 10.26
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 37
|
3.86 Percentage of subjects
Interval 3.11 to 4.72
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 38
|
2.96 Percentage of subjects
Interval 2.02 to 4.19
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 39
|
2.78 Percentage of subjects
Interval 2.18 to 3.49
|
0.00 Percentage of subjects
Interval 0.0 to 4.06
|
4.17 Percentage of subjects
Interval 0.11 to 21.12
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 40
|
2.39 Percentage of subjects
Interval 1.75 to 3.19
|
1.61 Percentage of subjects
Interval 0.31 to 4.76
|
0.00 Percentage of subjects
Interval 0.0 to 12.77
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 41
|
1.74 Percentage of subjects
Interval 0.95 to 2.92
|
1.33 Percentage of subjects
Interval 0.18 to 4.53
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 42
|
1.70 Percentage of subjects
Interval 0.59 to 3.8
|
0.28 Percentage of subjects
Interval 0.01 to 1.58
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 43
|
2.02 Percentage of subjects
Interval 0.63 to 4.79
|
0.92 Percentage of subjects
Interval 0.06 to 3.98
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 44
|
1.76 Percentage of subjects
Interval 0.74 to 3.52
|
0.97 Percentage of subjects
Interval 0.09 to 3.76
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 45
|
1.06 Percentage of subjects
Interval 0.19 to 3.22
|
0.99 Percentage of subjects
Interval 0.06 to 4.45
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 46
|
0.37 Percentage of subjects
Interval 0.0 to 2.71
|
0.44 Percentage of subjects
Interval 0.0 to 3.38
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 1.72
|
0.00 Percentage of subjects
Interval 0.0 to 2.66
|
0.00 Percentage of subjects
Interval 0.0 to 10.58
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.00 Percentage of subjects
Interval 0.0 to 4.3
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 37
|
4.51 Percentage of subjects
Interval 1.67 to 9.56
|
—
|
25.00 Percentage of subjects
Interval 0.0 to 99.42
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 38
|
3.03 Percentage of subjects
Interval 0.99 to 6.93
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 39
|
4.71 Percentage of subjects
Interval 1.62 to 10.38
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
—
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 40
|
2.86 Percentage of subjects
Interval 0.76 to 7.27
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 41
|
1.83 Percentage of subjects
Interval 0.23 to 6.42
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 4.15
|
0.00 Percentage of subjects
Interval 0.0 to 7.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 5.21
|
3.77 Percentage of subjects
Interval 0.17 to 17.08
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 45
|
1.35 Percentage of subjects
Interval 0.01 to 9.52
|
1.00 Percentage of subjects
Interval 0.0 to 15.27
|
0.46 Percentage of subjects
Interval 0.01 to 2.53
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 46
|
1.23 Percentage of subjects
Interval 0.0 to 9.48
|
2.86 Percentage of subjects
Interval 0.07 to 14.92
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 7.71
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
|
Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
PRIMARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start, up to end of the week of interest and were registered in EHR, using card-based ADR reporting system during the safety FU period (from vaccination up to 7 days post-vaccination).
General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16387 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=2946 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=546 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-37
|
3.86 Percentage of subjects
Interval 3.11 to 4.72
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-38
|
3.39 Percentage of subjects
Interval 2.57 to 4.38
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
0.00 Percentage of subjects
Interval 0.0 to 12.34
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-39
|
3.12 Percentage of subjects
Interval 2.36 to 4.04
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
1.92 Percentage of subjects
Interval 0.05 to 10.26
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-40
|
2.99 Percentage of subjects
Interval 2.29 to 3.84
|
1.22 Percentage of subjects
Interval 0.37 to 2.91
|
1.27 Percentage of subjects
Interval 0.03 to 6.85
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-41
|
2.84 Percentage of subjects
Interval 2.15 to 3.67
|
1.27 Percentage of subjects
Interval 0.33 to 3.3
|
0.87 Percentage of subjects
Interval 0.01 to 5.18
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-42
|
2.77 Percentage of subjects
Interval 2.07 to 3.61
|
0.94 Percentage of subjects
Interval 0.25 to 2.41
|
0.77 Percentage of subjects
Interval 0.01 to 4.74
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-43
|
2.74 Percentage of subjects
Interval 2.04 to 3.61
|
0.94 Percentage of subjects
Interval 0.2 to 2.67
|
0.69 Percentage of subjects
Interval 0.01 to 4.39
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-44
|
2.69 Percentage of subjects
Interval 1.98 to 3.57
|
0.94 Percentage of subjects
Interval 0.18 to 2.86
|
0.58 Percentage of subjects
Interval 0.0 to 3.95
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-45
|
2.65 Percentage of subjects
Interval 1.95 to 3.51
|
0.95 Percentage of subjects
Interval 0.2 to 2.71
|
0.46 Percentage of subjects
Interval 0.0 to 3.33
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-46
|
2.61 Percentage of subjects
Interval 1.91 to 3.48
|
0.90 Percentage of subjects
Interval 0.16 to 2.77
|
0.44 Percentage of subjects
Interval 0.0 to 3.19
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-47
|
2.57 Percentage of subjects
Interval 1.87 to 3.44
|
0.85 Percentage of subjects
Interval 0.15 to 2.63
|
0.38 Percentage of subjects
Interval 0.0 to 2.86
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-48
|
2.55 Percentage of subjects
Interval 1.86 to 3.42
|
0.82 Percentage of subjects
Interval 0.15 to 2.54
|
0.37 Percentage of subjects
Interval 0.0 to 2.79
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-37
|
4.51 Percentage of subjects
Interval 1.67 to 9.56
|
—
|
25.00 Percentage of subjects
Interval 0.0 to 99.42
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-38
|
3.69 Percentage of subjects
Interval 1.86 to 6.51
|
—
|
14.29 Percentage of subjects
Interval 0.35 to 58.19
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-39
|
4.23 Percentage of subjects
Interval 2.22 to 7.23
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
14.29 Percentage of subjects
Interval 0.35 to 58.19
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-40
|
3.94 Percentage of subjects
Interval 2.3 to 6.24
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
9.09 Percentage of subjects
Interval 0.05 to 50.77
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-41
|
3.58 Percentage of subjects
Interval 1.95 to 5.98
|
0.00 Percentage of subjects
Interval 0.0 to 5.21
|
3.23 Percentage of subjects
Interval 0.08 to 16.7
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-42
|
3.29 Percentage of subjects
Interval 1.78 to 5.51
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
3.03 Percentage of subjects
Interval 0.08 to 15.76
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-43
|
3.14 Percentage of subjects
Interval 1.71 to 5.26
|
0.58 Percentage of subjects
Interval 0.01 to 3.22
|
2.44 Percentage of subjects
Interval 0.06 to 12.86
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-44
|
2.96 Percentage of subjects
Interval 1.57 to 5.02
|
1.34 Percentage of subjects
Interval 0.28 to 3.86
|
2.38 Percentage of subjects
Interval 0.06 to 12.57
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-45
|
2.86 Percentage of subjects
Interval 1.59 to 4.72
|
1.23 Percentage of subjects
Interval 0.34 to 3.13
|
0.77 Percentage of subjects
Interval 0.09 to 2.75
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-46
|
2.76 Percentage of subjects
Interval 1.49 to 4.66
|
1.39 Percentage of subjects
Interval 0.45 to 3.22
|
0.75 Percentage of subjects
Interval 0.09 to 2.69
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-47
|
2.67 Percentage of subjects
Interval 1.43 to 4.54
|
1.32 Percentage of subjects
Interval 0.43 to 3.05
|
0.73 Percentage of subjects
Interval 0.09 to 2.61
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-48
|
2.61 Percentage of subjects
Interval 1.39 to 4.45
|
1.27 Percentage of subjects
Interval 0.41 to 2.93
|
0.73 Percentage of subjects
Interval 0.09 to 2.6
|
PRIMARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in electronic health record (EHR), using card-based ADR reporting system during the safety follow-up (FU) period (from vaccination up to 7 days post-vaccination).
Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16387 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=2946 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=546 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 37
|
5.62 Percentage of subjects
Interval 4.72 to 6.63
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 38
|
3.86 Percentage of subjects
Interval 2.98 to 4.91
|
14.29 Percentage of subjects
Interval 0.0 to 90.97
|
7.69 Percentage of subjects
Interval 0.19 to 36.03
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 39
|
4.03 Percentage of subjects
Interval 3.26 to 4.91
|
0.00 Percentage of subjects
Interval 0.0 to 4.06
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 40
|
4.68 Percentage of subjects
Interval 2.7 to 7.49
|
2.89 Percentage of subjects
Interval 0.64 to 8.0
|
0.00 Percentage of subjects
Interval 0.0 to 12.77
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 41
|
3.35 Percentage of subjects
Interval 2.14 to 4.97
|
2.33 Percentage of subjects
Interval 0.79 to 5.27
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 42
|
2.31 Percentage of subjects
Interval 1.05 to 4.37
|
0.57 Percentage of subjects
Interval 0.07 to 2.04
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 43
|
2.92 Percentage of subjects
Interval 0.97 to 6.65
|
1.53 Percentage of subjects
Interval 0.5 to 3.54
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 44
|
2.50 Percentage of subjects
Interval 0.55 to 6.92
|
1.95 Percentage of subjects
Interval 0.53 to 4.9
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 45
|
1.32 Percentage of subjects
Interval 0.35 to 3.4
|
1.32 Percentage of subjects
Interval 0.01 to 9.0
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 46
|
0.74 Percentage of subjects
Interval 0.05 to 3.22
|
0.44 Percentage of subjects
Interval 0.0 to 3.38
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 47
|
1.42 Percentage of subjects
Interval 0.26 to 4.32
|
0.73 Percentage of subjects
Interval 0.02 to 4.06
|
0.00 Percentage of subjects
Interval 0.0 to 10.58
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.00 Percentage of subjects
Interval 0.0 to 4.3
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 37
|
8.27 Percentage of subjects
Interval 4.2 to 14.32
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 38
|
4.24 Percentage of subjects
Interval 1.72 to 8.55
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 39
|
6.47 Percentage of subjects
Interval 2.73 to 12.64
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
—
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 40
|
3.43 Percentage of subjects
Interval 1.27 to 7.31
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 41
|
3.05 Percentage of subjects
Interval 1.0 to 6.97
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 4.15
|
0.00 Percentage of subjects
Interval 0.0 to 7.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 6.98
|
3.85 Percentage of subjects
Interval 0.3 to 15.08
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 44
|
1.45 Percentage of subjects
Interval 0.01 to 10.55
|
3.77 Percentage of subjects
Interval 0.46 to 12.98
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 45
|
4.05 Percentage of subjects
Interval 0.64 to 12.73
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
2.29 Percentage of subjects
Interval 0.75 to 5.27
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 46
|
3.70 Percentage of subjects
Interval 0.77 to 10.44
|
5.71 Percentage of subjects
Interval 0.7 to 19.16
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 47
|
2.17 Percentage of subjects
Interval 0.01 to 16.04
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
PRIMARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start, up to end of the week of interest and were registered in EHR, using card-based ADR reporting system during the safety FU period (from vaccination up to 7 days post-vaccination).
Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16387 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=2946 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=546 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-37
|
5.61 Percentage of subjects
Interval 4.71 to 6.62
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-38
|
4.69 Percentage of subjects
Interval 3.96 to 5.53
|
9.09 Percentage of subjects
Interval 0.08 to 47.67
|
3.57 Percentage of subjects
Interval 0.08 to 18.86
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-39
|
4.40 Percentage of subjects
Interval 3.75 to 5.13
|
1.00 Percentage of subjects
Interval 0.03 to 5.45
|
1.92 Percentage of subjects
Interval 0.05 to 10.26
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-40
|
4.45 Percentage of subjects
Interval 3.71 to 5.3
|
2.43 Percentage of subjects
Interval 0.53 to 6.77
|
1.27 Percentage of subjects
Interval 0.03 to 6.85
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-41
|
4.32 Percentage of subjects
Interval 3.56 to 5.18
|
2.39 Percentage of subjects
Interval 0.94 to 4.93
|
0.87 Percentage of subjects
Interval 0.01 to 5.18
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-42
|
4.19 Percentage of subjects
Interval 3.41 to 5.09
|
1.79 Percentage of subjects
Interval 0.69 to 3.74
|
0.77 Percentage of subjects
Interval 0.01 to 4.74
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-43
|
4.15 Percentage of subjects
Interval 3.34 to 5.08
|
1.73 Percentage of subjects
Interval 0.81 to 3.22
|
0.69 Percentage of subjects
Interval 0.01 to 4.39
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-44
|
4.07 Percentage of subjects
Interval 3.27 to 4.99
|
1.78 Percentage of subjects
Interval 0.91 to 3.13
|
0.58 Percentage of subjects
Interval 0.0 to 3.95
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-45
|
3.99 Percentage of subjects
Interval 3.2 to 4.92
|
1.71 Percentage of subjects
Interval 0.79 to 3.23
|
0.46 Percentage of subjects
Interval 0.0 to 3.33
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-46
|
3.93 Percentage of subjects
Interval 3.12 to 4.89
|
1.59 Percentage of subjects
Interval 0.71 to 3.05
|
0.44 Percentage of subjects
Interval 0.0 to 3.19
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-47
|
3.90 Percentage of subjects
Interval 3.09 to 4.85
|
1.54 Percentage of subjects
Interval 0.69 to 2.96
|
0.38 Percentage of subjects
Interval 0.0 to 2.86
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-48
|
3.87 Percentage of subjects
Interval 3.06 to 4.82
|
1.49 Percentage of subjects
Interval 0.66 to 2.87
|
0.37 Percentage of subjects
Interval 0.0 to 2.79
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-37
|
8.27 Percentage of subjects
Interval 4.2 to 14.32
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-38
|
6.04 Percentage of subjects
Interval 3.59 to 9.43
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-39
|
6.27 Percentage of subjects
Interval 3.96 to 9.35
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-40
|
5.66 Percentage of subjects
Interval 3.7 to 8.24
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-41
|
5.22 Percentage of subjects
Interval 3.64 to 7.22
|
0.00 Percentage of subjects
Interval 0.0 to 5.21
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-42
|
4.79 Percentage of subjects
Interval 3.37 to 6.59
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
0.00 Percentage of subjects
Interval 0.0 to 10.58
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-43
|
4.57 Percentage of subjects
Interval 3.25 to 6.23
|
1.17 Percentage of subjects
Interval 0.14 to 4.16
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-44
|
4.39 Percentage of subjects
Interval 3.15 to 5.94
|
1.79 Percentage of subjects
Interval 0.49 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-45
|
4.37 Percentage of subjects
Interval 3.26 to 5.72
|
1.23 Percentage of subjects
Interval 0.34 to 3.13
|
1.92 Percentage of subjects
Interval 0.63 to 4.43
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-46
|
4.33 Percentage of subjects
Interval 3.31 to 5.56
|
1.67 Percentage of subjects
Interval 0.62 to 3.6
|
1.88 Percentage of subjects
Interval 0.61 to 4.33
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-47
|
4.26 Percentage of subjects
Interval 3.26 to 5.46
|
1.58 Percentage of subjects
Interval 0.58 to 3.41
|
1.82 Percentage of subjects
Interval 0.6 to 4.21
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-48
|
4.17 Percentage of subjects
Interval 3.19 to 5.34
|
1.52 Percentage of subjects
Interval 0.56 to 3.28
|
1.82 Percentage of subjects
Interval 0.59 to 4.19
|
PRIMARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in electronic health record (EHR), using card-based ADR reporting system during the safety follow-up (FU) period (from vaccination up to 7 days post-vaccination).
Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhea, nausea, and vomiting. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16387 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=2946 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=546 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 42
|
0.73 Percentage of subjects
Interval 0.21 to 1.82
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
2.00 Percentage of subjects
Interval 0.1 to 9.21
|
0.46 Percentage of subjects
Interval 0.01 to 2.53
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 4.45
|
0.00 Percentage of subjects
Interval 0.0 to 10.0
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 7.71
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 37
|
2.01 Percentage of subjects
Interval 1.33 to 2.93
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 38
|
1.64 Percentage of subjects
Interval 0.89 to 2.75
|
14.29 Percentage of subjects
Interval 0.0 to 90.97
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 39
|
1.27 Percentage of subjects
Interval 0.8 to 1.92
|
0.00 Percentage of subjects
Interval 0.0 to 4.06
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 40
|
1.44 Percentage of subjects
Interval 0.87 to 2.23
|
1.29 Percentage of subjects
Interval 0.35 to 3.26
|
0.00 Percentage of subjects
Interval 0.0 to 12.77
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 41
|
1.14 Percentage of subjects
Interval 0.58 to 2.01
|
0.67 Percentage of subjects
Interval 0.08 to 2.39
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 43
|
0.45 Percentage of subjects
Interval 0.04 to 1.77
|
0.00 Percentage of subjects
Interval 0.0 to 1.13
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 44
|
0.44 Percentage of subjects
Interval 0.09 to 1.28
|
0.24 Percentage of subjects
Interval 0.0 to 1.5
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 45
|
1.58 Percentage of subjects
Interval 0.27 to 4.95
|
0.66 Percentage of subjects
Interval 0.0 to 4.57
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 46
|
1.12 Percentage of subjects
Interval 0.07 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 1.6
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 1.72
|
0.00 Percentage of subjects
Interval 0.0 to 2.66
|
0.00 Percentage of subjects
Interval 0.0 to 10.58
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.00 Percentage of subjects
Interval 0.0 to 4.3
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 37
|
2.26 Percentage of subjects
Interval 0.23 to 8.42
|
—
|
25.00 Percentage of subjects
Interval 0.0 to 99.42
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 38
|
1.82 Percentage of subjects
Interval 0.21 to 6.56
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 39
|
2.06 Percentage of subjects
Interval 0.68 to 4.71
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
—
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 40
|
0.57 Percentage of subjects
Interval 0.01 to 3.31
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 41
|
1.22 Percentage of subjects
Interval 0.03 to 6.81
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 4.15
|
0.00 Percentage of subjects
Interval 0.0 to 7.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 6.98
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 5.21
|
1.89 Percentage of subjects
Interval 0.05 to 10.07
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
PRIMARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start, up to end of the week of interest and were registered in EHR, using card-based ADR reporting system during the safety FU period (from vaccination up to 7 days post-vaccination).
Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhea, nausea, and vomiting. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16387 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=2946 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=546 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-37
|
2.01 Percentage of subjects
Interval 1.33 to 2.93
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-38
|
1.82 Percentage of subjects
Interval 1.39 to 2.33
|
9.09 Percentage of subjects
Interval 0.08 to 47.67
|
0.00 Percentage of subjects
Interval 0.0 to 12.34
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-39
|
1.58 Percentage of subjects
Interval 1.12 to 2.15
|
1.00 Percentage of subjects
Interval 0.03 to 5.45
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-40
|
1.55 Percentage of subjects
Interval 1.17 to 2.02
|
1.22 Percentage of subjects
Interval 0.4 to 2.82
|
0.00 Percentage of subjects
Interval 0.0 to 4.56
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-41
|
1.50 Percentage of subjects
Interval 1.12 to 1.96
|
0.98 Percentage of subjects
Interval 0.35 to 2.17
|
0.00 Percentage of subjects
Interval 0.0 to 3.16
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-42
|
1.45 Percentage of subjects
Interval 1.09 to 1.9
|
0.66 Percentage of subjects
Interval 0.23 to 1.46
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-43
|
1.42 Percentage of subjects
Interval 1.06 to 1.86
|
0.50 Percentage of subjects
Interval 0.16 to 1.2
|
0.00 Percentage of subjects
Interval 0.0 to 2.53
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-44
|
1.37 Percentage of subjects
Interval 1.02 to 1.8
|
0.44 Percentage of subjects
Interval 0.1 to 1.25
|
0.00 Percentage of subjects
Interval 0.0 to 2.11
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-45
|
1.38 Percentage of subjects
Interval 1.05 to 1.77
|
0.48 Percentage of subjects
Interval 0.17 to 1.06
|
0.00 Percentage of subjects
Interval 0.0 to 1.69
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-46
|
1.37 Percentage of subjects
Interval 1.05 to 1.77
|
0.43 Percentage of subjects
Interval 0.13 to 1.02
|
0.00 Percentage of subjects
Interval 0.0 to 1.6
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-47
|
1.35 Percentage of subjects
Interval 1.03 to 1.75
|
0.41 Percentage of subjects
Interval 0.12 to 0.97
|
0.00 Percentage of subjects
Interval 0.0 to 1.4
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-48
|
1.34 Percentage of subjects
Interval 1.02 to 1.73
|
0.39 Percentage of subjects
Interval 0.12 to 0.94
|
0.00 Percentage of subjects
Interval 0.0 to 1.35
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-37
|
2.26 Percentage of subjects
Interval 0.23 to 8.42
|
—
|
25.00 Percentage of subjects
Interval 0.0 to 99.42
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-38
|
2.01 Percentage of subjects
Interval 0.38 to 6.01
|
—
|
14.29 Percentage of subjects
Interval 0.35 to 58.19
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-39
|
2.04 Percentage of subjects
Interval 0.66 to 4.71
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
14.29 Percentage of subjects
Interval 0.35 to 58.19
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-40
|
1.72 Percentage of subjects
Interval 0.58 to 3.91
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
9.09 Percentage of subjects
Interval 0.05 to 50.77
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-41
|
1.64 Percentage of subjects
Interval 0.64 to 3.41
|
0.00 Percentage of subjects
Interval 0.0 to 5.21
|
3.23 Percentage of subjects
Interval 0.08 to 16.7
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-42
|
1.50 Percentage of subjects
Interval 0.57 to 3.19
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
3.03 Percentage of subjects
Interval 0.08 to 15.76
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-43
|
1.43 Percentage of subjects
Interval 0.54 to 3.05
|
0.00 Percentage of subjects
Interval 0.0 to 2.13
|
2.44 Percentage of subjects
Interval 0.06 to 12.86
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-44
|
1.35 Percentage of subjects
Interval 0.49 to 2.96
|
0.45 Percentage of subjects
Interval 0.01 to 2.46
|
2.38 Percentage of subjects
Interval 0.06 to 12.57
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-45
|
1.27 Percentage of subjects
Interval 0.45 to 2.8
|
0.93 Percentage of subjects
Interval 0.19 to 2.68
|
0.77 Percentage of subjects
Interval 0.09 to 2.75
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-46
|
1.19 Percentage of subjects
Interval 0.41 to 2.69
|
0.84 Percentage of subjects
Interval 0.17 to 2.42
|
0.75 Percentage of subjects
Interval 0.09 to 2.69
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-47
|
1.16 Percentage of subjects
Interval 0.39 to 2.61
|
0.79 Percentage of subjects
Interval 0.16 to 2.3
|
0.73 Percentage of subjects
Interval 0.09 to 2.61
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-48
|
1.13 Percentage of subjects
Interval 0.39 to 2.55
|
0.76 Percentage of subjects
Interval 0.16 to 2.2
|
0.73 Percentage of subjects
Interval 0.09 to 2.6
|
PRIMARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in electronic health record (EHR), using card-based ADR reporting system during the safety follow-up (FU) period (from vaccination up to 7 days post-vaccination).
Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16387 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=2946 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=546 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 37
|
0.64 Percentage of subjects
Interval 0.01 to 4.3
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 38
|
0.51 Percentage of subjects
Interval 0.05 to 1.93
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 39
|
0.29 Percentage of subjects
Interval 0.02 to 1.34
|
0.00 Percentage of subjects
Interval 0.0 to 4.06
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 40
|
0.43 Percentage of subjects
Interval 0.06 to 1.4
|
0.64 Percentage of subjects
Interval 0.01 to 4.22
|
0.00 Percentage of subjects
Interval 0.0 to 12.77
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 41
|
0.20 Percentage of subjects
Interval 0.04 to 0.6
|
0.67 Percentage of subjects
Interval 0.08 to 2.39
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 0.45
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 43
|
0.22 Percentage of subjects
Interval 0.0 to 1.52
|
0.00 Percentage of subjects
Interval 0.0 to 1.13
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 44
|
0.29 Percentage of subjects
Interval 0.02 to 1.34
|
0.24 Percentage of subjects
Interval 0.0 to 1.5
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 0.97
|
0.00 Percentage of subjects
Interval 0.0 to 1.21
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 46
|
0.37 Percentage of subjects
Interval 0.0 to 2.68
|
0.00 Percentage of subjects
Interval 0.0 to 1.6
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 1.72
|
0.00 Percentage of subjects
Interval 0.0 to 2.66
|
0.00 Percentage of subjects
Interval 0.0 to 10.58
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.00 Percentage of subjects
Interval 0.0 to 4.3
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 37
|
0.75 Percentage of subjects
Interval 0.01 to 5.16
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 38
|
1.21 Percentage of subjects
Interval 0.15 to 4.31
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 39
|
1.18 Percentage of subjects
Interval 0.17 to 3.93
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
—
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 2.09
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 41
|
0.61 Percentage of subjects
Interval 0.01 to 3.69
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 4.15
|
0.00 Percentage of subjects
Interval 0.0 to 7.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 6.98
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 5.21
|
3.77 Percentage of subjects
Interval 0.17 to 17.08
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.46 Percentage of subjects
Interval 0.01 to 2.53
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 4.45
|
0.00 Percentage of subjects
Interval 0.0 to 10.0
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 7.71
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
PRIMARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start, up to end of the week of interest and were registered in EHR, using card-based ADR reporting system during the safety FU period (from vaccination up to 7 days post-vaccination).
Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16387 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=2946 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=546 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-37
|
0.75 Percentage of subjects
Interval 0.01 to 5.16
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-42
|
0.75 Percentage of subjects
Interval 0.12 to 2.39
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
0.00 Percentage of subjects
Interval 0.0 to 10.58
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-46
|
0.60 Percentage of subjects
Interval 0.09 to 2.01
|
0.56 Percentage of subjects
Interval 0.07 to 2.0
|
0.38 Percentage of subjects
Interval 0.01 to 2.08
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-37
|
0.64 Percentage of subjects
Interval 0.01 to 4.3
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-38
|
0.57 Percentage of subjects
Interval 0.02 to 2.84
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
0.00 Percentage of subjects
Interval 0.0 to 12.34
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-39
|
0.45 Percentage of subjects
Interval 0.02 to 2.15
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-40
|
0.45 Percentage of subjects
Interval 0.03 to 1.99
|
0.49 Percentage of subjects
Interval 0.01 to 2.67
|
0.00 Percentage of subjects
Interval 0.0 to 4.56
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-41
|
0.42 Percentage of subjects
Interval 0.03 to 1.77
|
0.56 Percentage of subjects
Interval 0.04 to 2.4
|
0.00 Percentage of subjects
Interval 0.0 to 3.16
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-42
|
0.39 Percentage of subjects
Interval 0.03 to 1.68
|
0.38 Percentage of subjects
Interval 0.03 to 1.51
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-43
|
0.38 Percentage of subjects
Interval 0.03 to 1.63
|
0.29 Percentage of subjects
Interval 0.02 to 1.16
|
0.00 Percentage of subjects
Interval 0.0 to 2.53
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-44
|
0.38 Percentage of subjects
Interval 0.03 to 1.54
|
0.28 Percentage of subjects
Interval 0.02 to 1.22
|
0.00 Percentage of subjects
Interval 0.0 to 2.11
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-45
|
0.37 Percentage of subjects
Interval 0.03 to 1.5
|
0.24 Percentage of subjects
Interval 0.01 to 1.12
|
0.00 Percentage of subjects
Interval 0.0 to 1.69
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-46
|
0.37 Percentage of subjects
Interval 0.03 to 1.52
|
0.21 Percentage of subjects
Interval 0.01 to 1.06
|
0.00 Percentage of subjects
Interval 0.0 to 1.6
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-47
|
0.36 Percentage of subjects
Interval 0.03 to 1.5
|
0.20 Percentage of subjects
Interval 0.01 to 1.01
|
0.00 Percentage of subjects
Interval 0.0 to 1.4
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-48
|
0.36 Percentage of subjects
Interval 0.03 to 1.49
|
0.20 Percentage of subjects
Interval 0.01 to 0.97
|
0.00 Percentage of subjects
Interval 0.0 to 1.35
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-38
|
1.01 Percentage of subjects
Interval 0.18 to 3.13
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-39
|
1.10 Percentage of subjects
Interval 0.21 to 3.29
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-40
|
0.86 Percentage of subjects
Interval 0.12 to 2.89
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-41
|
0.82 Percentage of subjects
Interval 0.15 to 2.52
|
0.00 Percentage of subjects
Interval 0.0 to 5.21
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-43
|
0.72 Percentage of subjects
Interval 0.11 to 2.31
|
0.00 Percentage of subjects
Interval 0.0 to 2.13
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-44
|
0.68 Percentage of subjects
Interval 0.1 to 2.23
|
0.89 Percentage of subjects
Interval 0.11 to 3.19
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-45
|
0.64 Percentage of subjects
Interval 0.09 to 2.11
|
0.62 Percentage of subjects
Interval 0.07 to 2.21
|
0.38 Percentage of subjects
Interval 0.01 to 2.12
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-47
|
0.58 Percentage of subjects
Interval 0.08 to 1.94
|
0.53 Percentage of subjects
Interval 0.06 to 1.89
|
0.36 Percentage of subjects
Interval 0.01 to 2.02
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-48
|
0.56 Percentage of subjects
Interval 0.08 to 1.89
|
0.51 Percentage of subjects
Interval 0.06 to 1.82
|
0.36 Percentage of subjects
Interval 0.01 to 2.01
|
PRIMARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in electronic health record (EHR), using card-based ADR reporting system during the safety follow-up (FU) period (from vaccination up to 7 days post-vaccination).
The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16387 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=2946 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=546 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 37
|
0.51 Percentage of subjects
Interval 0.23 to 1.0
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 38
|
0.23 Percentage of subjects
Interval 0.08 to 0.53
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 39
|
0.16 Percentage of subjects
Interval 0.06 to 0.35
|
0.00 Percentage of subjects
Interval 0.0 to 4.06
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 40
|
0.48 Percentage of subjects
Interval 0.22 to 0.91
|
0.00 Percentage of subjects
Interval 0.0 to 1.18
|
0.00 Percentage of subjects
Interval 0.0 to 12.77
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 41
|
0.13 Percentage of subjects
Interval 0.02 to 0.48
|
0.33 Percentage of subjects
Interval 0.01 to 1.84
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 0.45
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 43
|
0.45 Percentage of subjects
Interval 0.03 to 1.87
|
0.00 Percentage of subjects
Interval 0.0 to 1.13
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 44
|
0.44 Percentage of subjects
Interval 0.03 to 2.0
|
0.00 Percentage of subjects
Interval 0.0 to 0.89
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 0.97
|
0.00 Percentage of subjects
Interval 0.0 to 1.21
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 1.36
|
0.00 Percentage of subjects
Interval 0.0 to 1.6
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 1.72
|
0.00 Percentage of subjects
Interval 0.0 to 2.66
|
0.00 Percentage of subjects
Interval 0.0 to 10.58
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.00 Percentage of subjects
Interval 0.0 to 4.3
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 37
|
0.75 Percentage of subjects
Interval 0.01 to 4.87
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 38
|
1.21 Percentage of subjects
Interval 0.1 to 4.88
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 39
|
0.59 Percentage of subjects
Interval 0.05 to 2.42
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
—
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 2.09
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 2.22
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 4.15
|
0.00 Percentage of subjects
Interval 0.0 to 7.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 6.98
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 5.21
|
0.00 Percentage of subjects
Interval 0.0 to 6.72
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 1.68
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 46
|
1.23 Percentage of subjects
Interval 0.01 to 8.69
|
0.00 Percentage of subjects
Interval 0.0 to 10.0
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 7.71
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
|
Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
PRIMARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start, up to end of the week of interest and were registered in EHR, using card-based ADR reporting system during the safety FU period (from vaccination up to 7 days post-vaccination).
The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16387 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=2946 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=546 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-37
|
0.51 Percentage of subjects
Interval 0.23 to 1.0
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-38
|
0.37 Percentage of subjects
Interval 0.16 to 0.72
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
0.00 Percentage of subjects
Interval 0.0 to 12.34
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-39
|
0.28 Percentage of subjects
Interval 0.15 to 0.47
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-40
|
0.31 Percentage of subjects
Interval 0.21 to 0.46
|
0.00 Percentage of subjects
Interval 0.0 to 0.89
|
0.00 Percentage of subjects
Interval 0.0 to 4.56
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-41
|
0.29 Percentage of subjects
Interval 0.19 to 0.42
|
0.14 Percentage of subjects
Interval 0.0 to 0.78
|
0.00 Percentage of subjects
Interval 0.0 to 3.16
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-42
|
0.27 Percentage of subjects
Interval 0.18 to 0.39
|
0.09 Percentage of subjects
Interval 0.0 to 0.52
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-43
|
0.28 Percentage of subjects
Interval 0.19 to 0.4
|
0.07 Percentage of subjects
Interval 0.0 to 0.4
|
0.00 Percentage of subjects
Interval 0.0 to 2.53
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-44
|
0.29 Percentage of subjects
Interval 0.19 to 0.41
|
0.06 Percentage of subjects
Interval 0.0 to 0.31
|
0.00 Percentage of subjects
Interval 0.0 to 2.11
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-45
|
0.28 Percentage of subjects
Interval 0.19 to 0.4
|
0.05 Percentage of subjects
Interval 0.0 to 0.26
|
0.00 Percentage of subjects
Interval 0.0 to 1.69
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-46
|
0.27 Percentage of subjects
Interval 0.18 to 0.39
|
0.04 Percentage of subjects
Interval 0.0 to 0.24
|
0.00 Percentage of subjects
Interval 0.0 to 1.6
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-47
|
0.27 Percentage of subjects
Interval 0.18 to 0.38
|
0.04 Percentage of subjects
Interval 0.0 to 0.23
|
0.00 Percentage of subjects
Interval 0.0 to 1.4
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-48
|
0.27 Percentage of subjects
Interval 0.18 to 0.38
|
0.04 Percentage of subjects
Interval 0.0 to 0.22
|
0.00 Percentage of subjects
Interval 0.0 to 1.35
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-37
|
0.75 Percentage of subjects
Interval 0.01 to 4.87
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-38
|
1.01 Percentage of subjects
Interval 0.21 to 2.91
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-39
|
0.78 Percentage of subjects
Interval 0.21 to 2.02
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-40
|
0.62 Percentage of subjects
Interval 0.18 to 1.53
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-41
|
0.51 Percentage of subjects
Interval 0.15 to 1.26
|
0.00 Percentage of subjects
Interval 0.0 to 5.21
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-42
|
0.47 Percentage of subjects
Interval 0.14 to 1.14
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
0.00 Percentage of subjects
Interval 0.0 to 10.58
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-43
|
0.45 Percentage of subjects
Interval 0.14 to 1.07
|
0.00 Percentage of subjects
Interval 0.0 to 2.13
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-44
|
0.42 Percentage of subjects
Interval 0.13 to 1.02
|
0.00 Percentage of subjects
Interval 0.0 to 1.63
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-45
|
0.40 Percentage of subjects
Interval 0.12 to 0.96
|
0.00 Percentage of subjects
Interval 0.0 to 1.13
|
0.00 Percentage of subjects
Interval 0.0 to 1.41
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-46
|
0.45 Percentage of subjects
Interval 0.16 to 0.97
|
0.00 Percentage of subjects
Interval 0.0 to 1.02
|
0.00 Percentage of subjects
Interval 0.0 to 1.38
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-47
|
0.43 Percentage of subjects
Interval 0.16 to 0.94
|
0.00 Percentage of subjects
Interval 0.0 to 0.97
|
0.00 Percentage of subjects
Interval 0.0 to 1.34
|
|
Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-48
|
0.42 Percentage of subjects
Interval 0.16 to 0.92
|
0.00 Percentage of subjects
Interval 0.0 to 0.93
|
0.00 Percentage of subjects
Interval 0.0 to 1.33
|
PRIMARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in electronic health record (EHR), using card-based ADR reporting system during the safety follow-up (FU) period (from vaccination up to 7 days post-vaccination).
Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16387 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=2946 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=546 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 37
|
3.51 Percentage of subjects
Interval 2.79 to 4.37
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 38
|
2.81 Percentage of subjects
Interval 2.03 to 3.78
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
7.69 Percentage of subjects
Interval 0.0 to 57.26
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 39
|
2.41 Percentage of subjects
Interval 1.9 to 3.02
|
0.00 Percentage of subjects
Interval 0.0 to 4.06
|
4.17 Percentage of subjects
Interval 0.11 to 21.12
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 40
|
2.02 Percentage of subjects
Interval 1.37 to 2.88
|
1.29 Percentage of subjects
Interval 0.01 to 8.32
|
0.00 Percentage of subjects
Interval 0.0 to 12.77
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 41
|
1.94 Percentage of subjects
Interval 1.2 to 2.96
|
0.00 Percentage of subjects
Interval 0.0 to 1.22
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 42
|
1.70 Percentage of subjects
Interval 0.66 to 3.56
|
0.28 Percentage of subjects
Interval 0.01 to 1.58
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 43
|
2.70 Percentage of subjects
Interval 1.36 to 4.75
|
0.00 Percentage of subjects
Interval 0.0 to 1.13
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 44
|
1.76 Percentage of subjects
Interval 0.42 to 4.74
|
0.97 Percentage of subjects
Interval 0.01 to 5.9
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 45
|
1.32 Percentage of subjects
Interval 0.17 to 4.62
|
0.33 Percentage of subjects
Interval 0.0 to 2.45
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 46
|
0.37 Percentage of subjects
Interval 0.01 to 2.19
|
0.00 Percentage of subjects
Interval 0.0 to 1.6
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 47
|
0.47 Percentage of subjects
Interval 0.0 to 3.37
|
0.00 Percentage of subjects
Interval 0.0 to 2.66
|
0.00 Percentage of subjects
Interval 0.0 to 10.58
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.00 Percentage of subjects
Interval 0.0 to 4.3
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 37
|
6.02 Percentage of subjects
Interval 2.38 to 12.21
|
—
|
25.00 Percentage of subjects
Interval 0.0 to 100.0
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 38
|
3.03 Percentage of subjects
Interval 0.99 to 6.93
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 39
|
4.12 Percentage of subjects
Interval 1.4 to 9.18
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
—
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 40
|
4.00 Percentage of subjects
Interval 1.42 to 8.69
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 41
|
4.00 Percentage of subjects
Interval 1.42 to 8.69
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 4.15
|
0.00 Percentage of subjects
Interval 0.0 to 7.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 43
|
3.92 Percentage of subjects
Interval 0.34 to 14.93
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 5.21
|
1.89 Percentage of subjects
Interval 1.89 to 10.07
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 45
|
1.35 Percentage of subjects
Interval 0.01 to 9.52
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.46 Percentage of subjects
Interval 0.01 to 2.53
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 46
|
2.47 Percentage of subjects
Interval 0.07 to 12.65
|
2.86 Percentage of subjects
Interval 0.07 to 14.92
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 7.71
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
PRIMARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start, up to end of the week of interest and were registered in EHR, using card-based ADR reporting system during the safety FU period (from vaccination up to 7 days post-vaccination).
Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16387 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=2946 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=546 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-45
|
2.47 Percentage of subjects
Interval 1.97 to 3.06
|
0.48 Percentage of subjects
Interval 0.02 to 2.24
|
0.93 Percentage of subjects
Interval 0.05 to 4.23
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-46
|
2.43 Percentage of subjects
Interval 1.93 to 3.01
|
0.43 Percentage of subjects
Interval 0.02 to 2.12
|
0.87 Percentage of subjects
Interval 0.04 to 4.08
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-37
|
3.51 Percentage of subjects
Interval 2.78 to 4.37
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-38
|
3.14 Percentage of subjects
Interval 2.41 to 4.03
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
3.57 Percentage of subjects
Interval 0.01 to 24.71
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-39
|
2.82 Percentage of subjects
Interval 2.2 to 3.57
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
3.85 Percentage of subjects
Interval 0.47 to 13.21
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-40
|
2.68 Percentage of subjects
Interval 2.19 to 3.25
|
0.97 Percentage of subjects
Interval 0.02 to 5.3
|
2.53 Percentage of subjects
Interval 0.31 to 8.85
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-41
|
2.59 Percentage of subjects
Interval 2.08 to 3.18
|
0.56 Percentage of subjects
Interval 0.04 to 2.4
|
1.74 Percentage of subjects
Interval 0.17 to 6.55
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-42
|
2.53 Percentage of subjects
Interval 2.01 to 3.15
|
0.47 Percentage of subjects
Interval 0.04 to 1.88
|
1.54 Percentage of subjects
Interval 0.15 to 5.92
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-43
|
2.54 Percentage of subjects
Interval 2.02 to 3.14
|
0.36 Percentage of subjects
Interval 0.03 to 1.45
|
1.39 Percentage of subjects
Interval 0.12 to 5.49
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-44
|
2.50 Percentage of subjects
Interval 2.0 to 3.09
|
0.50 Percentage of subjects
Interval 0.03 to 2.19
|
1.16 Percentage of subjects
Interval 0.08 to 4.94
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-47
|
2.40 Percentage of subjects
Interval 1.91 to 2.98
|
0.41 Percentage of subjects
Interval 0.02 to 2.01
|
0.76 Percentage of subjects
Interval 0.05 to 3.4
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-48
|
2.38 Percentage of subjects
Interval 1.89 to 2.96
|
0.39 Percentage of subjects
Interval 0.02 to 1.94
|
0.74 Percentage of subjects
Interval 0.04 to 3.35
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-37
|
6.02 Percentage of subjects
Interval 2.38 to 12.21
|
—
|
25.00 Percentage of subjects
Interval 0.0 to 100.0
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-38
|
4.36 Percentage of subjects
Interval 2.34 to 7.34
|
—
|
14.29 Percentage of subjects
Interval 0.04 to 71.51
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-39
|
4.23 Percentage of subjects
Interval 2.26 to 7.15
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
14.29 Percentage of subjects
Interval 0.04 to 71.51
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-40
|
4.18 Percentage of subjects
Interval 2.41 to 6.71
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
9.09 Percentage of subjects
Interval 0.0 to 65.53
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-41
|
3.89 Percentage of subjects
Interval 2.35 to 6.02
|
0.00 Percentage of subjects
Interval 0.0 to 5.21
|
3.23 Percentage of subjects
Interval 0.0 to 33.66
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-42
|
3.57 Percentage of subjects
Interval 2.21 to 5.44
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
3.03 Percentage of subjects
Interval 0.0 to 26.51
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-43
|
3.59 Percentage of subjects
Interval 2.28 to 5.36
|
0.00 Percentage of subjects
Interval 0.0 to 2.13
|
2.44 Percentage of subjects
Interval 0.01 to 17.96
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-44
|
3.38 Percentage of subjects
Interval 2.18 to 4.99
|
0.45 Percentage of subjects
Interval 0.01 to 2.46
|
2.38 Percentage of subjects
Interval 0.01 to 17.83
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-45
|
3.26 Percentage of subjects
Interval 2.14 to 4.75
|
0.31 Percentage of subjects
Interval 0.01 to 1.71
|
0.77 Percentage of subjects
Interval 0.04 to 3.45
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-46
|
3.21 Percentage of subjects
Interval 2.19 to 4.53
|
0.56 Percentage of subjects
Interval 0.07 to 2.0
|
0.75 Percentage of subjects
Interval 0.06 to 3.14
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-47
|
3.10 Percentage of subjects
Interval 2.08 to 4.45
|
0.53 Percentage of subjects
Interval 0.06 to 1.89
|
0.73 Percentage of subjects
Interval 0.06 to 2.93
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-48
|
3.04 Percentage of subjects
Interval 2.01 to 4.38
|
0.51 Percentage of subjects
Interval 0.06 to 1.82
|
0.73 Percentage of subjects
Interval 0.06 to 2.92
|
PRIMARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in electronic health record (EHR), using card-based ADR reporting system during the safety follow-up (FU) period (from vaccination up to 7 days post-vaccination).
Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16387 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=2946 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=546 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 37
|
0.21 Percentage of subjects
Interval 0.07 to 0.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 38
|
0.23 Percentage of subjects
Interval 0.08 to 0.51
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 39
|
0.19 Percentage of subjects
Interval 0.05 to 0.5
|
0.00 Percentage of subjects
Interval 0.0 to 4.06
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 0.2
|
0.32 Percentage of subjects
Interval 0.0 to 2.12
|
0.00 Percentage of subjects
Interval 0.0 to 12.77
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 41
|
0.20 Percentage of subjects
Interval 0.03 to 0.66
|
0.33 Percentage of subjects
Interval 0.01 to 1.84
|
2.78 Percentage of subjects
Interval 0.07 to 14.53
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 0.45
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 0.83
|
0.00 Percentage of subjects
Interval 0.0 to 1.13
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 44
|
0.15 Percentage of subjects
Interval 0.0 to 1.16
|
0.00 Percentage of subjects
Interval 0.0 to 0.89
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 0.97
|
0.00 Percentage of subjects
Interval 0.0 to 1.21
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 1.36
|
0.00 Percentage of subjects
Interval 0.0 to 1.6
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 1.72
|
0.00 Percentage of subjects
Interval 0.0 to 2.66
|
0.00 Percentage of subjects
Interval 0.0 to 10.58
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.00 Percentage of subjects
Interval 0.0 to 4.3
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 37
|
1.50 Percentage of subjects
Interval 0.18 to 5.33
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 38
|
0.61 Percentage of subjects
Interval 0.01 to 4.01
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 1.08
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
—
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 2.09
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 2.22
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 4.15
|
0.00 Percentage of subjects
Interval 0.0 to 7.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 6.98
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 5.21
|
0.00 Percentage of subjects
Interval 0.0 to 6.72
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 1.68
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 4.45
|
0.00 Percentage of subjects
Interval 0.0 to 10.0
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 7.71
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
|
Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
PRIMARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start, up to end of the week of interest and were registered in EHR, using card-based ADR reporting system during the safety FU period (from vaccination up to 7 days post-vaccination).
Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16387 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=2946 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=546 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-47
|
0.22 Percentage of subjects
Interval 0.02 to 0.88
|
0.00 Percentage of subjects
Interval 0.0 to 0.97
|
0.00 Percentage of subjects
Interval 0.0 to 1.34
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-37
|
0.21 Percentage of subjects
Interval 0.07 to 0.5
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-38
|
0.22 Percentage of subjects
Interval 0.11 to 0.4
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
0.00 Percentage of subjects
Interval 0.0 to 12.34
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-39
|
0.21 Percentage of subjects
Interval 0.09 to 0.4
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-40
|
0.17 Percentage of subjects
Interval 0.07 to 0.34
|
0.24 Percentage of subjects
Interval 0.01 to 1.35
|
0.00 Percentage of subjects
Interval 0.0 to 4.56
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-41
|
0.17 Percentage of subjects
Interval 0.09 to 0.31
|
0.28 Percentage of subjects
Interval 0.02 to 1.2
|
0.87 Percentage of subjects
Interval 0.02 to 5.09
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-42
|
0.16 Percentage of subjects
Interval 0.08 to 0.3
|
0.19 Percentage of subjects
Interval 0.02 to 0.76
|
0.77 Percentage of subjects
Interval 0.01 to 4.61
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-43
|
0.16 Percentage of subjects
Interval 0.08 to 0.29
|
0.14 Percentage of subjects
Interval 0.01 to 0.58
|
0.69 Percentage of subjects
Interval 0.01 to 4.07
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-44
|
0.16 Percentage of subjects
Interval 0.08 to 0.29
|
0.11 Percentage of subjects
Interval 0.01 to 0.49
|
0.58 Percentage of subjects
Interval 0.01 to 3.18
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-45
|
0.15 Percentage of subjects
Interval 0.07 to 0.28
|
0.10 Percentage of subjects
Interval 0.0 to 0.45
|
0.46 Percentage of subjects
Interval 0.01 to 2.55
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-46
|
0.15 Percentage of subjects
Interval 0.07 to 0.27
|
0.09 Percentage of subjects
Interval 0.0 to 0.42
|
0.44 Percentage of subjects
Interval 0.01 to 2.41
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-47
|
0.15 Percentage of subjects
Interval 0.07 to 0.27
|
0.08 Percentage of subjects
Interval 0.0 to 0.4
|
0.38 Percentage of subjects
Interval 0.01 to 2.11
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-48
|
0.15 Percentage of subjects
Interval 0.07 to 0.27
|
0.08 Percentage of subjects
Interval 0.0 to 0.39
|
0.37 Percentage of subjects
Interval 0.01 to 2.04
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-37
|
1.50 Percentage of subjects
Interval 0.18 to 5.33
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-38
|
1.01 Percentage of subjects
Interval 0.13 to 3.49
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-39
|
0.47 Percentage of subjects
Interval 0.04 to 1.84
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-40
|
0.37 Percentage of subjects
Interval 0.03 to 1.49
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-41
|
0.31 Percentage of subjects
Interval 0.02 to 1.26
|
0.00 Percentage of subjects
Interval 0.0 to 5.21
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-42
|
0.28 Percentage of subjects
Interval 0.02 to 1.15
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
0.00 Percentage of subjects
Interval 0.0 to 10.58
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-43
|
0.27 Percentage of subjects
Interval 0.02 to 1.08
|
0.00 Percentage of subjects
Interval 0.0 to 2.13
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-44
|
0.25 Percentage of subjects
Interval 0.02 to 1.03
|
0.00 Percentage of subjects
Interval 0.0 to 1.63
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-45
|
0.24 Percentage of subjects
Interval 0.02 to 0.97
|
0.00 Percentage of subjects
Interval 0.0 to 1.13
|
0.00 Percentage of subjects
Interval 0.0 to 1.41
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-46
|
0.22 Percentage of subjects
Interval 0.02 to 0.9
|
0.00 Percentage of subjects
Interval 0.0 to 1.02
|
0.00 Percentage of subjects
Interval 0.0 to 1.38
|
|
Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-48
|
0.21 Percentage of subjects
Interval 0.02 to 0.86
|
0.00 Percentage of subjects
Interval 0.0 to 0.93
|
0.00 Percentage of subjects
Interval 0.0 to 1.33
|
PRIMARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in electronic health record (EHR), using card-based ADR reporting system during the safety follow-up (FU) period (from vaccination up to 7 days post-vaccination).
The weekly incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any SAEs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16387 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=2946 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=546 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Weekly Incidence Rates of SAEs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 0.83
|
0.00 Percentage of subjects
Interval 0.0 to 1.13
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
|
Weekly Incidence Rates of SAEs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 0.54
|
0.00 Percentage of subjects
Interval 0.0 to 0.89
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
|
Weekly Incidence Rates of SAEs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 0.97
|
0.00 Percentage of subjects
Interval 0.0 to 1.21
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Incidence Rates of SAEs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 1.36
|
0.00 Percentage of subjects
Interval 0.0 to 1.6
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
|
Weekly Incidence Rates of SAEs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 1.72
|
0.00 Percentage of subjects
Interval 0.0 to 2.66
|
0.00 Percentage of subjects
Interval 0.0 to 10.58
|
|
Weekly Incidence Rates of SAEs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.00 Percentage of subjects
Interval 0.0 to 4.3
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
|
Weekly Incidence Rates of SAEs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 37
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of SAEs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 38
|
0.00 Percentage of subjects
Interval 0.0 to 2.21
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of SAEs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 1.08
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
—
|
|
Weekly Incidence Rates of SAEs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 2.09
|
0.00 Percentage of subjects
Interval 0.0 to 13.23
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of SAEs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 2.22
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
|
Weekly Incidence Rates of SAEs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 4.15
|
0.00 Percentage of subjects
Interval 0.0 to 7.11
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of SAEs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 6.98
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
|
Weekly Incidence Rates of SAEs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 5.21
|
0.00 Percentage of subjects
Interval 0.0 to 6.72
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of SAEs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 1.68
|
|
Weekly Incidence Rates of SAEs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 4.45
|
0.00 Percentage of subjects
Interval 0.0 to 10.0
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
|
Weekly Incidence Rates of SAEs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 7.71
|
0.00 Percentage of subjects
Interval 0.0 to 16.84
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
|
Weekly Incidence Rates of SAEs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of SAEs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Weekly Incidence Rates of SAEs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 37
|
0.00 Percentage of subjects
Interval 0.0 to 0.16
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
|
Weekly Incidence Rates of SAEs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 38
|
0.00 Percentage of subjects
Interval 0.0 to 0.14
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
|
Weekly Incidence Rates of SAEs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 0.1
|
0.00 Percentage of subjects
Interval 0.0 to 4.06
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
|
Weekly Incidence Rates of SAEs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 0.2
|
0.00 Percentage of subjects
Interval 0.0 to 1.18
|
0.00 Percentage of subjects
Interval 0.0 to 12.77
|
|
Weekly Incidence Rates of SAEs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 0.25
|
0.00 Percentage of subjects
Interval 0.0 to 1.22
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
|
Weekly Incidence Rates of SAEs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 0.45
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
PRIMARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start, up to end of the week of interest and were registered in EHR, using card-based ADR reporting system during the safety FU period (from vaccination up to 7 days post-vaccination).
The cumulative incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any SAEs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16387 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=2946 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=546 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-48
|
0.00 Percentage of subjects
Interval 0.0 to 0.26
|
0.00 Percentage of subjects
Interval 0.0 to 0.93
|
0.00 Percentage of subjects
Interval 0.0 to 1.33
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-37
|
0.00 Percentage of subjects
Interval 0.0 to 0.16
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-38
|
0.00 Percentage of subjects
Interval 0.0 to 0.08
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
0.00 Percentage of subjects
Interval 0.0 to 12.34
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-39
|
0.00 Percentage of subjects
Interval 0.0 to 0.04
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-40
|
0.00 Percentage of subjects
Interval 0.0 to 0.03
|
0.00 Percentage of subjects
Interval 0.0 to 0.89
|
0.00 Percentage of subjects
Interval 0.0 to 4.56
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-41
|
0.00 Percentage of subjects
Interval 0.0 to 0.03
|
0.00 Percentage of subjects
Interval 0.0 to 0.52
|
0.00 Percentage of subjects
Interval 0.0 to 3.16
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-42
|
0.00 Percentage of subjects
Interval 0.0 to 0.03
|
0.00 Percentage of subjects
Interval 0.0 to 0.35
|
0.00 Percentage of subjects
Interval 0.0 to 2.8
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-43
|
0.00 Percentage of subjects
Interval 0.0 to 0.03
|
0.00 Percentage of subjects
Interval 0.0 to 0.27
|
0.00 Percentage of subjects
Interval 0.0 to 2.53
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-44
|
0.00 Percentage of subjects
Interval 0.0 to 0.03
|
0.00 Percentage of subjects
Interval 0.0 to 0.2
|
0.00 Percentage of subjects
Interval 0.0 to 2.11
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-45
|
0.00 Percentage of subjects
Interval 0.0 to 0.03
|
0.00 Percentage of subjects
Interval 0.0 to 0.18
|
0.00 Percentage of subjects
Interval 0.0 to 1.69
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-46
|
0.00 Percentage of subjects
Interval 0.0 to 0.03
|
0.00 Percentage of subjects
Interval 0.0 to 0.16
|
0.00 Percentage of subjects
Interval 0.0 to 1.6
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-47
|
0.00 Percentage of subjects
Interval 0.0 to 0.02
|
0.00 Percentage of subjects
Interval 0.0 to 0.15
|
0.00 Percentage of subjects
Interval 0.0 to 1.4
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-48
|
0.00 Percentage of subjects
Interval 0.0 to 0.02
|
0.00 Percentage of subjects
Interval 0.0 to 0.14
|
0.00 Percentage of subjects
Interval 0.0 to 1.35
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-37
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-38
|
0.00 Percentage of subjects
Interval 0.0 to 1.23
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-39
|
0.00 Percentage of subjects
Interval 0.0 to 0.58
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-40
|
0.00 Percentage of subjects
Interval 0.0 to 0.45
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 28.49
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-41
|
0.00 Percentage of subjects
Interval 0.0 to 0.38
|
0.00 Percentage of subjects
Interval 0.0 to 5.21
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-42
|
0.00 Percentage of subjects
Interval 0.0 to 0.35
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
0.00 Percentage of subjects
Interval 0.0 to 10.58
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-43
|
0.00 Percentage of subjects
Interval 0.0 to 0.33
|
0.00 Percentage of subjects
Interval 0.0 to 2.13
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-44
|
0.00 Percentage of subjects
Interval 0.0 to 0.31
|
0.00 Percentage of subjects
Interval 0.0 to 1.63
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-45
|
0.00 Percentage of subjects
Interval 0.0 to 0.29
|
0.00 Percentage of subjects
Interval 0.0 to 1.13
|
0.00 Percentage of subjects
Interval 0.0 to 1.41
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-46
|
0.00 Percentage of subjects
Interval 0.0 to 0.28
|
0.00 Percentage of subjects
Interval 0.0 to 1.02
|
0.00 Percentage of subjects
Interval 0.0 to 1.38
|
|
Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-47
|
0.00 Percentage of subjects
Interval 0.0 to 0.27
|
0.00 Percentage of subjects
Interval 0.0 to 0.97
|
0.00 Percentage of subjects
Interval 0.0 to 1.34
|
SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in EHR (combining routine data collection and card-based ADR reporting system) during the safety follow-up period (from vaccination up to 7 days post-vaccination).
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from General Practitioners (GPs). The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16433 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=3310 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=4196 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Weekly Incidence Rates of Any AEIs Recorded in Electronic Health Record (EHR), by Vaccine Group
Week 35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Any AEIs Recorded in Electronic Health Record (EHR), by Vaccine Group
Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
1.64 Percentage of subjects
Interval 0.0 to 15.62
|
|
Weekly Incidence Rates of Any AEIs Recorded in Electronic Health Record (EHR), by Vaccine Group
Week 37
|
11.63 Percentage of subjects
Interval 9.72 to 13.77
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
1.28 Percentage of subjects
Interval 0.4 to 3.0
|
|
Weekly Incidence Rates of Any AEIs Recorded in Electronic Health Record (EHR), by Vaccine Group
Week 38
|
10.01 Percentage of subjects
Interval 7.49 to 13.03
|
10.00 Percentage of subjects
Interval 0.0 to 74.36
|
1.48 Percentage of subjects
Interval 0.64 to 2.89
|
|
Weekly Incidence Rates of Any AEIs Recorded in Electronic Health Record (EHR), by Vaccine Group
Week 39
|
10.03 Percentage of subjects
Interval 8.81 to 11.36
|
1.89 Percentage of subjects
Interval 0.23 to 6.65
|
2.26 Percentage of subjects
Interval 0.9 to 4.64
|
|
Weekly Incidence Rates of Any AEIs Recorded in Electronic Health Record (EHR), by Vaccine Group
Week 40
|
9.97 Percentage of subjects
Interval 6.19 to 14.98
|
7.31 Percentage of subjects
Interval 4.79 to 10.6
|
1.54 Percentage of subjects
Interval 0.46 to 3.74
|
|
Weekly Incidence Rates of Any AEIs Recorded in Electronic Health Record (EHR), by Vaccine Group
Week 41
|
8.58 Percentage of subjects
Interval 6.13 to 11.61
|
5.54 Percentage of subjects
Interval 2.93 to 9.41
|
0.50 Percentage of subjects
Interval 0.06 to 1.86
|
|
Weekly Incidence Rates of Any AEIs Recorded in Electronic Health Record (EHR), by Vaccine Group
Week 42
|
5.26 Percentage of subjects
Interval 2.93 to 8.62
|
2.18 Percentage of subjects
Interval 1.0 to 4.11
|
1.66 Percentage of subjects
Interval 0.21 to 5.75
|
|
Weekly Incidence Rates of Any AEIs Recorded in Electronic Health Record (EHR), by Vaccine Group
Week 43
|
6.01 Percentage of subjects
Interval 2.73 to 11.23
|
4.45 Percentage of subjects
Interval 2.19 to 7.95
|
1.83 Percentage of subjects
Interval 0.38 to 5.25
|
|
Weekly Incidence Rates of Any AEIs Recorded in Electronic Health Record (EHR), by Vaccine Group
Week 44
|
6.00 Percentage of subjects
Interval 2.35 to 12.24
|
5.94 Percentage of subjects
Interval 1.76 to 14.05
|
0.36 Percentage of subjects
Interval 0.04 to 1.28
|
|
Weekly Incidence Rates of Any AEIs Recorded in Electronic Health Record (EHR), by Vaccine Group
Week 45
|
6.59 Percentage of subjects
Interval 3.97 to 10.2
|
3.23 Percentage of subjects
Interval 0.38 to 11.32
|
4.00 Percentage of subjects
Interval 2.04 to 6.98
|
|
Weekly Incidence Rates of Any AEIs Recorded in Electronic Health Record (EHR), by Vaccine Group
Week 46
|
7.43 Percentage of subjects
Interval 3.88 to 12.65
|
1.56 Percentage of subjects
Interval 0.13 to 6.27
|
3.09 Percentage of subjects
Interval 0.24 to 12.26
|
|
Weekly Incidence Rates of Any AEIs Recorded in Electronic Health Record (EHR), by Vaccine Group
Week 47
|
4.26 Percentage of subjects
Interval 1.74 to 8.55
|
3.16 Percentage of subjects
Interval 1.04 to 7.23
|
1.51 Percentage of subjects
Interval 0.16 to 5.6
|
|
Weekly Incidence Rates of Any AEIs Recorded in Electronic Health Record (EHR), by Vaccine Group
Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
5.00 Percentage of subjects
Interval 1.06 to 13.81
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in EHR (combining routine data collection and card-based ADR reporting system) during the safety follow-up period (from vaccination up to 7 days post-vaccination).
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16433 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=3310 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=4196 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group
Week 35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group
Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group
Week 37
|
0.45 Percentage of subjects
Interval 0.2 to 0.85
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 0.78
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group
Week 38
|
0.54 Percentage of subjects
Interval 0.19 to 1.23
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.68
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group
Week 39
|
0.51 Percentage of subjects
Interval 0.21 to 1.04
|
0.00 Percentage of subjects
Interval 0.0 to 3.42
|
0.21 Percentage of subjects
Interval 0.0 to 1.5
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group
Week 40
|
0.44 Percentage of subjects
Interval 0.11 to 1.19
|
1.46 Percentage of subjects
Interval 0.41 to 3.63
|
0.00 Percentage of subjects
Interval 0.0 to 0.63
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group
Week 41
|
0.36 Percentage of subjects
Interval 0.13 to 0.78
|
0.58 Percentage of subjects
Interval 0.07 to 2.09
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group
Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 0.4
|
0.00 Percentage of subjects
Interval 0.0 to 0.89
|
0.00 Percentage of subjects
Interval 0.0 to 1.52
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group
Week 43
|
0.40 Percentage of subjects
Interval 0.05 to 1.46
|
0.00 Percentage of subjects
Interval 0.0 to 0.96
|
0.00 Percentage of subjects
Interval 0.0 to 2.22
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group
Week 44
|
0.27 Percentage of subjects
Interval 0.02 to 1.2
|
0.42 Percentage of subjects
Interval 0.05 to 1.53
|
0.00 Percentage of subjects
Interval 0.0 to 0.66
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group
Week 45
|
0.22 Percentage of subjects
Interval 0.0 to 1.6
|
0.00 Percentage of subjects
Interval 0.0 to 0.91
|
0.29 Percentage of subjects
Interval 0.01 to 1.58
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group
Week 46
|
0.57 Percentage of subjects
Interval 0.03 to 2.58
|
0.17 Percentage of subjects
Interval 0.0 to 1.71
|
0.00 Percentage of subjects
Interval 0.0 to 3.73
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group
Week 47
|
0.39 Percentage of subjects
Interval 0.0 to 2.82
|
0.63 Percentage of subjects
Interval 0.01 to 4.02
|
0.00 Percentage of subjects
Interval 0.0 to 1.84
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group
Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in EHR (combining routine data collection and card-based ADR reporting system) during the safety follow-up period (from vaccination up to 7 days post-vaccination).
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Local symptoms include local erythema. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16433 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=3310 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=4196 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group
Week 35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group
Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group
Week 37
|
1.91 Percentage of subjects
Interval 0.82 to 3.74
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.21 Percentage of subjects
Interval 0.01 to 1.18
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group
Week 38
|
1.63 Percentage of subjects
Interval 0.89 to 2.75
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.68
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group
Week 39
|
1.94 Percentage of subjects
Interval 1.31 to 2.77
|
0.00 Percentage of subjects
Interval 0.0 to 3.42
|
0.00 Percentage of subjects
Interval 0.0 to 0.76
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group
Week 40
|
1.94 Percentage of subjects
Interval 0.77 to 4.02
|
0.29 Percentage of subjects
Interval 0.0 to 1.78
|
0.00 Percentage of subjects
Interval 0.0 to 0.63
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group
Week 41
|
1.44 Percentage of subjects
Interval 0.93 to 2.14
|
0.87 Percentage of subjects
Interval 0.16 to 2.69
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group
Week 42
|
0.55 Percentage of subjects
Interval 0.09 to 1.78
|
0.49 Percentage of subjects
Interval 0.06 to 1.74
|
0.00 Percentage of subjects
Interval 0.0 to 1.52
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group
Week 43
|
0.40 Percentage of subjects
Interval 0.04 to 1.49
|
0.79 Percentage of subjects
Interval 0.06 to 3.25
|
0.00 Percentage of subjects
Interval 0.0 to 2.22
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group
Week 44
|
1.20 Percentage of subjects
Interval 0.25 to 3.43
|
0.64 Percentage of subjects
Interval 0.08 to 2.26
|
0.00 Percentage of subjects
Interval 0.0 to 0.66
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group
Week 45
|
0.88 Percentage of subjects
Interval 0.15 to 2.76
|
0.50 Percentage of subjects
Interval 0.0 to 3.52
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group
Week 46
|
1.43 Percentage of subjects
Interval 0.2 to 4.82
|
0.52 Percentage of subjects
Interval 0.01 to 3.35
|
0.00 Percentage of subjects
Interval 0.0 to 3.73
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group
Week 47
|
1.16 Percentage of subjects
Interval 0.06 to 5.45
|
0.00 Percentage of subjects
Interval 0.0 to 2.31
|
0.00 Percentage of subjects
Interval 0.0 to 1.84
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group
Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in EHR (combining routine data collection and card-based ADR reporting system) during the safety follow-up period (from vaccination up to 7 days post-vaccination).
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16433 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=3310 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=4196 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Any, Week 39
|
3.30 Percentage of subjects
Interval 2.61 to 4.12
|
0.94 Percentage of subjects
Interval 0.02 to 5.14
|
0.41 Percentage of subjects
Interval 0.05 to 1.48
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Irritability, Week 41
|
0.12 Percentage of subjects
Interval 0.01 to 0.43
|
0.00 Percentage of subjects
Interval 0.0 to 1.07
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Malaise, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 0.49
|
0.00 Percentage of subjects
Interval 0.0 to 0.78
|
0.00 Percentage of subjects
Interval 0.0 to 0.66
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Any, Week 35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Any, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Any, Week 37
|
4.01 Percentage of subjects
Interval 3.23 to 4.92
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.21 Percentage of subjects
Interval 0.0 to 1.8
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Any, Week 38
|
3.19 Percentage of subjects
Interval 2.35 to 4.23
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.68
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Any, Week 40
|
2.72 Percentage of subjects
Interval 2.06 to 3.52
|
2.34 Percentage of subjects
Interval 0.64 to 5.88
|
0.00 Percentage of subjects
Interval 0.0 to 0.63
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Any, Week 41
|
1.98 Percentage of subjects
Interval 1.37 to 2.77
|
1.17 Percentage of subjects
Interval 0.21 to 3.57
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Any, Week 42
|
1.64 Percentage of subjects
Interval 0.58 to 3.64
|
0.49 Percentage of subjects
Interval 0.06 to 1.74
|
0.00 Percentage of subjects
Interval 0.0 to 1.52
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Any, Week 43
|
2.00 Percentage of subjects
Interval 0.73 to 4.36
|
1.05 Percentage of subjects
Interval 0.08 to 4.32
|
0.00 Percentage of subjects
Interval 0.0 to 2.22
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Any, Week 44
|
1.87 Percentage of subjects
Interval 0.74 to 3.85
|
1.70 Percentage of subjects
Interval 0.2 to 6.03
|
0.00 Percentage of subjects
Interval 0.0 to 0.66
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Any, Week 45
|
1.54 Percentage of subjects
Interval 0.33 to 4.38
|
1.49 Percentage of subjects
Interval 0.27 to 4.57
|
1.43 Percentage of subjects
Interval 0.47 to 3.3
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Any, Week 46
|
1.14 Percentage of subjects
Interval 0.31 to 2.91
|
0.35 Percentage of subjects
Interval 0.0 to 3.2
|
0.00 Percentage of subjects
Interval 0.0 to 3.73
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Any, Week 47
|
0.39 Percentage of subjects
Interval 0.01 to 2.41
|
0.00 Percentage of subjects
Interval 0.0 to 2.31
|
0.00 Percentage of subjects
Interval 0.0 to 1.84
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Any, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Drowsiness, Week 35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Drowsiness, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Drowsiness, Week 37
|
1.05 Percentage of subjects
Interval 0.62 to 1.68
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 0.78
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Drowsiness, Week 38
|
0.80 Percentage of subjects
Interval 0.29 to 1.75
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.68
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Drowsiness, Week 39
|
0.63 Percentage of subjects
Interval 0.32 to 1.12
|
0.00 Percentage of subjects
Interval 0.0 to 3.42
|
0.00 Percentage of subjects
Interval 0.0 to 0.76
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Drowsiness, Week 40
|
0.68 Percentage of subjects
Interval 0.37 to 1.14
|
0.29 Percentage of subjects
Interval 0.01 to 1.62
|
0.00 Percentage of subjects
Interval 0.0 to 0.63
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Drowsiness, Week 41
|
0.54 Percentage of subjects
Interval 0.25 to 1.02
|
0.58 Percentage of subjects
Interval 0.07 to 2.09
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Drowsiness, Week 42
|
0.33 Percentage of subjects
Interval 0.02 to 1.52
|
0.00 Percentage of subjects
Interval 0.0 to 0.89
|
0.00 Percentage of subjects
Interval 0.0 to 1.52
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Drowsiness, Week 43
|
0.80 Percentage of subjects
Interval 0.01 to 5.27
|
0.26 Percentage of subjects
Interval 0.01 to 1.45
|
0.00 Percentage of subjects
Interval 0.0 to 2.22
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Drowsiness, Week 44
|
0.27 Percentage of subjects
Interval 0.02 to 1.18
|
0.42 Percentage of subjects
Interval 0.01 to 2.49
|
0.00 Percentage of subjects
Interval 0.0 to 0.66
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Drowsiness, Week 45
|
0.22 Percentage of subjects
Interval 0.0 to 1.58
|
0.00 Percentage of subjects
Interval 0.0 to 0.91
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Drowsiness, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.17 Percentage of subjects
Interval 0.0 to 1.61
|
0.00 Percentage of subjects
Interval 0.0 to 3.73
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Drowsiness, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 1.42
|
0.00 Percentage of subjects
Interval 0.0 to 2.31
|
0.00 Percentage of subjects
Interval 0.0 to 1.84
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Drowsiness, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Fatigue, Week 35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Fatigue, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Fatigue, Week 37
|
2.19 Percentage of subjects
Interval 1.65 to 2.85
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.21 Percentage of subjects
Interval 0.0 to 1.8
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Fatigue, Week 38
|
1.89 Percentage of subjects
Interval 1.33 to 2.59
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.68
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Fatigue, Week 39
|
1.80 Percentage of subjects
Interval 1.4 to 2.27
|
0.00 Percentage of subjects
Interval 0.0 to 3.42
|
0.21 Percentage of subjects
Interval 0.0 to 1.29
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Fatigue, Week 40
|
1.17 Percentage of subjects
Interval 0.6 to 2.03
|
0.58 Percentage of subjects
Interval 0.01 to 3.53
|
0.00 Percentage of subjects
Interval 0.0 to 0.63
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Fatigue, Week 41
|
1.20 Percentage of subjects
Interval 0.73 to 1.85
|
0.29 Percentage of subjects
Interval 0.01 to 1.61
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Fatigue, Week 42
|
0.77 Percentage of subjects
Interval 0.08 to 2.91
|
0.00 Percentage of subjects
Interval 0.0 to 0.89
|
0.00 Percentage of subjects
Interval 0.0 to 1.52
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Fatigue, Week 43
|
0.80 Percentage of subjects
Interval 0.14 to 2.52
|
0.52 Percentage of subjects
Interval 0.04 to 2.17
|
0.00 Percentage of subjects
Interval 0.0 to 2.22
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Fatigue, Week 44
|
0.67 Percentage of subjects
Interval 0.22 to 1.55
|
0.64 Percentage of subjects
Interval 0.1 to 2.06
|
0.00 Percentage of subjects
Interval 0.0 to 0.66
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Fatigue, Week 45
|
1.10 Percentage of subjects
Interval 0.19 to 3.42
|
0.50 Percentage of subjects
Interval 0.02 to 2.38
|
0.29 Percentage of subjects
Interval 0.01 to 1.58
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Fatigue,Week 46
|
1.14 Percentage of subjects
Interval 0.31 to 2.91
|
0.00 Percentage of subjects
Interval 0.0 to 0.64
|
0.00 Percentage of subjects
Interval 0.0 to 3.73
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Fatigue,Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 1.42
|
0.00 Percentage of subjects
Interval 0.0 to 2.31
|
0.00 Percentage of subjects
Interval 0.0 to 1.84
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Fatigue,Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Headache, Week 35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Headache, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Headache, Week 37
|
2.27 Percentage of subjects
Interval 1.61 to 3.11
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 0.78
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Headache, Week 38
|
1.92 Percentage of subjects
Interval 1.11 to 3.08
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.68
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Headache, Week 39
|
1.92 Percentage of subjects
Interval 1.29 to 2.73
|
0.94 Percentage of subjects
Interval 0.02 to 5.14
|
0.21 Percentage of subjects
Interval 0.0 to 1.15
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Headache, Week 40
|
1.60 Percentage of subjects
Interval 1.02 to 2.4
|
1.46 Percentage of subjects
Interval 0.07 to 6.71
|
0.00 Percentage of subjects
Interval 0.0 to 0.63
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Headache, Week 41
|
0.96 Percentage of subjects
Interval 0.55 to 1.55
|
0.87 Percentage of subjects
Interval 0.16 to 2.69
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Headache, Week 42
|
0.88 Percentage of subjects
Interval 0.22 to 2.35
|
0.24 Percentage of subjects
Interval 0.01 to 1.34
|
0.00 Percentage of subjects
Interval 0.0 to 1.52
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Headache, Week 43
|
1.40 Percentage of subjects
Interval 0.43 to 3.37
|
0.79 Percentage of subjects
Interval 0.06 to 3.25
|
0.00 Percentage of subjects
Interval 0.0 to 2.22
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Headache, Week 44
|
1.47 Percentage of subjects
Interval 0.61 to 2.94
|
1.06 Percentage of subjects
Interval 0.26 to 2.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.66
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Headache, Week 45
|
1.32 Percentage of subjects
Interval 0.17 to 4.59
|
0.99 Percentage of subjects
Interval 0.16 to 3.22
|
1.43 Percentage of subjects
Interval 0.47 to 3.3
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Headache, Week 46
|
0.29 Percentage of subjects
Interval 0.0 to 2.15
|
0.17 Percentage of subjects
Interval 0.0 to 1.61
|
0.00 Percentage of subjects
Interval 0.0 to 3.73
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Headache, Week 47
|
0.39 Percentage of subjects
Interval 0.01 to 2.41
|
0.00 Percentage of subjects
Interval 0.0 to 2.31
|
0.00 Percentage of subjects
Interval 0.0 to 1.84
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Headache, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Irritability, Week 35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Irritability, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Irritability, Week 37
|
0.41 Percentage of subjects
Interval 0.19 to 0.74
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 0.78
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Irritability, Week 38
|
0.25 Percentage of subjects
Interval 0.09 to 0.55
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.68
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Irritability, Week 39
|
0.36 Percentage of subjects
Interval 0.11 to 0.88
|
0.00 Percentage of subjects
Interval 0.0 to 3.42
|
0.00 Percentage of subjects
Interval 0.0 to 0.76
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Irritability, Week 40
|
0.15 Percentage of subjects
Interval 0.03 to 0.43
|
0.00 Percentage of subjects
Interval 0.0 to 1.07
|
0.00 Percentage of subjects
Interval 0.0 to 0.63
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Irritability, Week 42
|
0.11 Percentage of subjects
Interval 0.0 to 0.79
|
0.24 Percentage of subjects
Interval 0.01 to 1.34
|
0.00 Percentage of subjects
Interval 0.0 to 1.52
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Irritability, Week 43
|
0.20 Percentage of subjects
Interval 0.0 to 1.33
|
0.26 Percentage of subjects
Interval 0.01 to 1.45
|
0.00 Percentage of subjects
Interval 0.0 to 2.22
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Irritability, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 0.49
|
0.42 Percentage of subjects
Interval 0.01 to 2.49
|
0.00 Percentage of subjects
Interval 0.0 to 0.66
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Irritability, Week 45
|
0.44 Percentage of subjects
Interval 0.0 to 3.14
|
0.00 Percentage of subjects
Interval 0.0 to 0.91
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Irritability, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.00 Percentage of subjects
Interval 0.0 to 0.64
|
0.00 Percentage of subjects
Interval 0.0 to 3.73
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Irritability, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 1.42
|
0.00 Percentage of subjects
Interval 0.0 to 2.31
|
0.00 Percentage of subjects
Interval 0.0 to 1.84
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Irritability, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Malaise, Week 35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Malaise, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Malaise, Week 37
|
0.04 Percentage of subjects
Interval 0.0 to 0.25
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 0.78
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Malaise, Week 38
|
0.00 Percentage of subjects
Interval 0.0 to 0.13
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.68
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Malaise, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 0.09
|
0.00 Percentage of subjects
Interval 0.0 to 3.42
|
0.00 Percentage of subjects
Interval 0.0 to 0.76
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Malaise, Week 40
|
0.05 Percentage of subjects
Interval 0.0 to 0.28
|
0.29 Percentage of subjects
Interval 0.01 to 1.62
|
0.00 Percentage of subjects
Interval 0.0 to 0.63
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Malaise, Week 41
|
0.06 Percentage of subjects
Interval 0.0 to 0.37
|
0.00 Percentage of subjects
Interval 0.0 to 1.07
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Malaise, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 0.4
|
0.24 Percentage of subjects
Interval 0.01 to 1.34
|
0.00 Percentage of subjects
Interval 0.0 to 1.52
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Malaise, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 0.74
|
0.00 Percentage of subjects
Interval 0.0 to 0.96
|
0.00 Percentage of subjects
Interval 0.0 to 2.22
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Malaise, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.25 Percentage of subjects
Interval 0.0 to 1.77
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Malaise, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.00 Percentage of subjects
Interval 0.0 to 0.64
|
0.00 Percentage of subjects
Interval 0.0 to 3.73
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Malaise, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 1.42
|
0.00 Percentage of subjects
Interval 0.0 to 2.31
|
0.00 Percentage of subjects
Interval 0.0 to 1.84
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Malaise, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in EHR (combining routine data collection and card-based ADR reporting system) during the safety follow-up period (from vaccination up to 7 days post-vaccination).
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16433 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=3310 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=4196 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Conjunctivitis, Week 43
|
0.20 Percentage of subjects
Interval 0.0 to 1.33
|
0.26 Percentage of subjects
Interval 0.01 to 1.45
|
0.00 Percentage of subjects
Interval 0.0 to 2.22
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Hoarseness, Week 35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Rhinorrhoea, Week 40
|
2.43 Percentage of subjects
Interval 1.31 to 4.1
|
1.17 Percentage of subjects
Interval 0.22 to 3.53
|
0.00 Percentage of subjects
Interval 0.0 to 0.63
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Rhinorrhoea, Week 41
|
1.92 Percentage of subjects
Interval 1.19 to 2.92
|
1.75 Percentage of subjects
Interval 0.64 to 3.79
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Rhinorrhoea, Week 43
|
2.00 Percentage of subjects
Interval 0.48 to 5.36
|
1.57 Percentage of subjects
Interval 0.58 to 3.39
|
0.00 Percentage of subjects
Interval 0.0 to 2.22
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
1.64 Percentage of subjects
Interval 0.0 to 15.62
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 37
|
6.45 Percentage of subjects
Interval 5.26 to 7.8
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.64 Percentage of subjects
Interval 0.07 to 2.39
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 38
|
4.86 Percentage of subjects
Interval 3.59 to 6.42
|
10.00 Percentage of subjects
Interval 0.0 to 74.36
|
0.55 Percentage of subjects
Interval 0.03 to 2.54
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 39
|
4.98 Percentage of subjects
Interval 4.33 to 5.69
|
0.94 Percentage of subjects
Interval 0.02 to 5.14
|
1.23 Percentage of subjects
Interval 0.34 to 3.12
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 40
|
5.30 Percentage of subjects
Interval 3.29 to 8.02
|
4.09 Percentage of subjects
Interval 2.26 to 6.77
|
1.03 Percentage of subjects
Interval 0.37 to 2.23
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 41
|
4.68 Percentage of subjects
Interval 3.48 to 6.15
|
3.79 Percentage of subjects
Interval 2.03 to 6.39
|
0.25 Percentage of subjects
Interval 0.0 to 1.66
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 42
|
2.52 Percentage of subjects
Interval 1.4 to 4.15
|
0.73 Percentage of subjects
Interval 0.15 to 2.13
|
1.66 Percentage of subjects
Interval 0.21 to 5.75
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 43
|
2.81 Percentage of subjects
Interval 0.88 to 6.58
|
2.88 Percentage of subjects
Interval 1.17 to 5.84
|
0.00 Percentage of subjects
Interval 0.0 to 2.22
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 44
|
3.07 Percentage of subjects
Interval 1.08 to 6.74
|
3.61 Percentage of subjects
Interval 1.41 to 7.45
|
0.36 Percentage of subjects
Interval 0.04 to 1.28
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 45
|
2.20 Percentage of subjects
Interval 0.63 to 5.41
|
1.24 Percentage of subjects
Interval 0.05 to 6.01
|
2.29 Percentage of subjects
Interval 0.99 to 4.45
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 46
|
2.86 Percentage of subjects
Interval 1.09 to 6.01
|
0.69 Percentage of subjects
Interval 0.02 to 3.73
|
0.00 Percentage of subjects
Interval 0.0 to 3.73
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 47
|
2.71 Percentage of subjects
Interval 0.51 to 8.06
|
1.27 Percentage of subjects
Interval 0.15 to 4.5
|
1.51 Percentage of subjects
Interval 0.16 to 5.6
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
2.00 Percentage of subjects
Interval 0.24 to 7.04
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Conjunctivitis, Week 35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Conjunctivitis, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Conjunctivitis, Week 37
|
0.24 Percentage of subjects
Interval 0.09 to 0.53
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 0.78
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Conjunctivitis, Week 38
|
0.51 Percentage of subjects
Interval 0.18 to 1.14
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.68
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Conjunctivitis, Week 39
|
0.32 Percentage of subjects
Interval 0.17 to 0.55
|
0.00 Percentage of subjects
Interval 0.0 to 3.42
|
0.21 Percentage of subjects
Interval 0.0 to 1.56
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Conjunctivitis, Week 40
|
0.34 Percentage of subjects
Interval 0.14 to 0.7
|
0.00 Percentage of subjects
Interval 0.0 to 1.07
|
0.00 Percentage of subjects
Interval 0.0 to 0.63
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Conjunctivitis, Week 41
|
0.42 Percentage of subjects
Interval 0.09 to 1.19
|
0.00 Percentage of subjects
Interval 0.0 to 1.07
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Conjunctivitis, Week 42
|
0.11 Percentage of subjects
Interval 0.0 to 0.79
|
0.24 Percentage of subjects
Interval 0.01 to 1.34
|
0.41 Percentage of subjects
Interval 0.0 to 3.24
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Conjunctivitis, Week 44
|
0.53 Percentage of subjects
Interval 0.11 to 1.53
|
0.21 Percentage of subjects
Interval 0.0 to 1.46
|
0.18 Percentage of subjects
Interval 0.0 to 0.99
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Conjunctivitis, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.00 Percentage of subjects
Interval 0.0 to 0.91
|
0.57 Percentage of subjects
Interval 0.07 to 2.05
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Conjunctivitis, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.00 Percentage of subjects
Interval 0.0 to 0.64
|
0.00 Percentage of subjects
Interval 0.0 to 3.73
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Conjunctivitis, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 1.42
|
0.00 Percentage of subjects
Interval 0.0 to 2.31
|
0.00 Percentage of subjects
Interval 0.0 to 1.84
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Conjunctivitis, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Coryza, Week 35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Coryza, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Coryza, Week 37
|
1.38 Percentage of subjects
Interval 0.75 to 2.32
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 0.78
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Coryza, Week 38
|
0.94 Percentage of subjects
Interval 0.5 to 1.62
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.18 Percentage of subjects
Interval 0.0 to 1.36
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Coryza, Week 39
|
1.24 Percentage of subjects
Interval 0.85 to 1.75
|
0.00 Percentage of subjects
Interval 0.0 to 3.42
|
0.00 Percentage of subjects
Interval 0.0 to 0.76
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Coryza, Week 40
|
1.02 Percentage of subjects
Interval 0.63 to 1.56
|
1.46 Percentage of subjects
Interval 0.48 to 3.38
|
0.00 Percentage of subjects
Interval 0.0 to 0.63
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Coryza, Week 41
|
1.26 Percentage of subjects
Interval 0.7 to 2.1
|
0.29 Percentage of subjects
Interval 0.01 to 1.61
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Coryza, Week 42
|
0.44 Percentage of subjects
Interval 0.12 to 1.12
|
0.00 Percentage of subjects
Interval 0.0 to 0.89
|
0.00 Percentage of subjects
Interval 0.0 to 1.52
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Coryza, Week 43
|
0.60 Percentage of subjects
Interval 0.04 to 2.61
|
0.79 Percentage of subjects
Interval 0.16 to 2.31
|
0.00 Percentage of subjects
Interval 0.0 to 2.22
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Coryza, Week 44
|
0.67 Percentage of subjects
Interval 0.11 to 2.15
|
0.42 Percentage of subjects
Interval 0.05 to 1.53
|
0.00 Percentage of subjects
Interval 0.0 to 0.66
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Coryza, Week 45
|
0.44 Percentage of subjects
Interval 0.0 to 3.14
|
0.25 Percentage of subjects
Interval 0.0 to 1.77
|
0.29 Percentage of subjects
Interval 0.01 to 1.58
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Coryza, Week 46
|
0.86 Percentage of subjects
Interval 0.14 to 2.76
|
0.00 Percentage of subjects
Interval 0.0 to 0.64
|
0.00 Percentage of subjects
Interval 0.0 to 3.73
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Coryza, Week 47
|
0.78 Percentage of subjects
Interval 0.08 to 2.99
|
0.00 Percentage of subjects
Interval 0.0 to 2.31
|
0.00 Percentage of subjects
Interval 0.0 to 1.84
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Coryza, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Cough, Week 35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Cough, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
1.64 Percentage of subjects
Interval 0.0 to 15.62
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Cough, Week 37
|
2.31 Percentage of subjects
Interval 1.64 to 3.16
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.64 Percentage of subjects
Interval 0.07 to 2.39
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Cough, Week 38
|
1.96 Percentage of subjects
Interval 1.36 to 2.72
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.18 Percentage of subjects
Interval 0.0 to 1.36
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Cough, Week 39
|
2.31 Percentage of subjects
Interval 1.87 to 2.81
|
0.94 Percentage of subjects
Interval 0.02 to 5.14
|
1.03 Percentage of subjects
Interval 0.19 to 3.09
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Cough, Week 40
|
1.65 Percentage of subjects
Interval 0.74 to 3.18
|
2.63 Percentage of subjects
Interval 1.13 to 5.16
|
0.85 Percentage of subjects
Interval 0.22 to 2.25
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Cough, Week 41
|
2.04 Percentage of subjects
Interval 1.17 to 3.29
|
2.04 Percentage of subjects
Interval 0.82 to 4.16
|
0.25 Percentage of subjects
Interval 0.0 to 1.66
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Cough, Week 42
|
1.10 Percentage of subjects
Interval 0.53 to 2.01
|
0.24 Percentage of subjects
Interval 0.0 to 2.15
|
0.41 Percentage of subjects
Interval 0.0 to 3.45
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Cough, Week 43
|
1.20 Percentage of subjects
Interval 0.26 to 3.4
|
1.83 Percentage of subjects
Interval 0.74 to 3.74
|
0.00 Percentage of subjects
Interval 0.0 to 2.22
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Cough, Week 44
|
1.33 Percentage of subjects
Interval 0.59 to 2.58
|
2.12 Percentage of subjects
Interval 0.63 to 5.12
|
0.00 Percentage of subjects
Interval 0.0 to 0.66
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Cough, Week 45
|
1.32 Percentage of subjects
Interval 0.24 to 4.0
|
0.99 Percentage of subjects
Interval 0.06 to 4.42
|
0.86 Percentage of subjects
Interval 0.18 to 2.48
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Cough, Week 46
|
2.29 Percentage of subjects
Interval 0.91 to 4.69
|
0.35 Percentage of subjects
Interval 0.0 to 3.2
|
0.00 Percentage of subjects
Interval 0.0 to 3.73
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Cough, Week 47
|
1.55 Percentage of subjects
Interval 0.15 to 5.98
|
0.00 Percentage of subjects
Interval 0.0 to 2.31
|
1.01 Percentage of subjects
Interval 0.05 to 4.78
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Cough, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
2.00 Percentage of subjects
Interval 0.24 to 7.04
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Epistaxis, Week 35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Epistaxis, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Epistaxis, Week 37
|
0.08 Percentage of subjects
Interval 0.0 to 0.48
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 0.78
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Epistaxis, Week 38
|
0.04 Percentage of subjects
Interval 0.0 to 0.27
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.68
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Epistaxis, Week 39
|
0.12 Percentage of subjects
Interval 0.02 to 0.39
|
0.00 Percentage of subjects
Interval 0.0 to 3.42
|
0.00 Percentage of subjects
Interval 0.0 to 0.76
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Epistaxis, Week 40
|
0.15 Percentage of subjects
Interval 0.02 to 0.5
|
0.00 Percentage of subjects
Interval 0.0 to 1.07
|
0.00 Percentage of subjects
Interval 0.0 to 0.63
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Epistaxis, Week 41
|
0.06 Percentage of subjects
Interval 0.0 to 0.37
|
0.00 Percentage of subjects
Interval 0.0 to 1.07
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Epistaxis, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 0.4
|
0.00 Percentage of subjects
Interval 0.0 to 0.89
|
0.00 Percentage of subjects
Interval 0.0 to 1.52
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Epistaxis, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 0.74
|
0.00 Percentage of subjects
Interval 0.0 to 0.96
|
0.00 Percentage of subjects
Interval 0.0 to 2.22
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Epistaxis, Week 44
|
0.27 Percentage of subjects
Interval 0.03 to 0.96
|
0.00 Percentage of subjects
Interval 0.0 to 0.78
|
0.00 Percentage of subjects
Interval 0.0 to 0.66
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Epistaxis, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.00 Percentage of subjects
Interval 0.0 to 0.91
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Epistaxis, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.00 Percentage of subjects
Interval 0.0 to 0.64
|
0.00 Percentage of subjects
Interval 0.0 to 3.73
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Epistaxis, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 1.42
|
0.00 Percentage of subjects
Interval 0.0 to 2.31
|
0.00 Percentage of subjects
Interval 0.0 to 1.84
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Epistaxis, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Hoarseness, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Hoarseness, Week 37
|
1.09 Percentage of subjects
Interval 0.72 to 1.59
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 0.78
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Hoarseness, Week 38
|
0.83 Percentage of subjects
Interval 0.46 to 1.4
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.68
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Hoarseness, Week 39
|
0.53 Percentage of subjects
Interval 0.34 to 0.81
|
0.00 Percentage of subjects
Interval 0.0 to 3.42
|
0.00 Percentage of subjects
Interval 0.0 to 0.76
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Hoarseness, Week 40
|
0.49 Percentage of subjects
Interval 0.23 to 0.89
|
0.29 Percentage of subjects
Interval 0.01 to 1.62
|
0.00 Percentage of subjects
Interval 0.0 to 0.63
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Hoarseness, Week 41
|
0.54 Percentage of subjects
Interval 0.12 to 1.53
|
0.58 Percentage of subjects
Interval 0.07 to 2.09
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Hoarseness, Week 42
|
0.22 Percentage of subjects
Interval 0.02 to 0.86
|
0.00 Percentage of subjects
Interval 0.0 to 0.89
|
0.00 Percentage of subjects
Interval 0.0 to 1.52
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Hoarseness, Week 43
|
0.80 Percentage of subjects
Interval 0.15 to 2.43
|
0.26 Percentage of subjects
Interval 0.01 to 1.45
|
0.00 Percentage of subjects
Interval 0.0 to 2.22
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Hoarseness, Week 44
|
0.27 Percentage of subjects
Interval 0.02 to 1.2
|
0.21 Percentage of subjects
Interval 0.0 to 1.25
|
0.00 Percentage of subjects
Interval 0.0 to 0.66
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Hoarseness, Week 45
|
0.66 Percentage of subjects
Interval 0.0 to 4.69
|
0.00 Percentage of subjects
Interval 0.0 to 0.91
|
0.29 Percentage of subjects
Interval 0.01 to 1.58
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Hoarseness, Week 46
|
0.29 Percentage of subjects
Interval 0.0 to 1.91
|
0.00 Percentage of subjects
Interval 0.0 to 0.64
|
0.00 Percentage of subjects
Interval 0.0 to 3.73
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Hoarseness, Week 47
|
0.39 Percentage of subjects
Interval 0.0 to 2.82
|
0.00 Percentage of subjects
Interval 0.0 to 2.31
|
0.00 Percentage of subjects
Interval 0.0 to 1.84
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Hoarseness, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Nasal congestion, Week 35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Nasal congestion, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Nasal congestion, Week 37
|
1.34 Percentage of subjects
Interval 0.92 to 1.87
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 0.78
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Nasal congestion, Week 38
|
0.91 Percentage of subjects
Interval 0.51 to 1.49
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.18 Percentage of subjects
Interval 0.0 to 1.36
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Nasal congestion, Week 39
|
0.95 Percentage of subjects
Interval 0.62 to 1.39
|
0.00 Percentage of subjects
Interval 0.0 to 3.42
|
0.00 Percentage of subjects
Interval 0.0 to 0.76
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Nasal congestion, Week 40
|
0.88 Percentage of subjects
Interval 0.37 to 1.74
|
0.58 Percentage of subjects
Interval 0.04 to 2.49
|
0.00 Percentage of subjects
Interval 0.0 to 0.63
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Nasal congestion, Week 41
|
0.48 Percentage of subjects
Interval 0.21 to 0.94
|
0.87 Percentage of subjects
Interval 0.16 to 2.69
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Nasal congestion, Week 42
|
0.44 Percentage of subjects
Interval 0.02 to 2.19
|
0.00 Percentage of subjects
Interval 0.0 to 0.89
|
0.41 Percentage of subjects
Interval 0.0 to 3.2
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Nasal congestion, Week 43
|
0.20 Percentage of subjects
Interval 0.0 to 1.37
|
0.79 Percentage of subjects
Interval 0.16 to 2.28
|
0.00 Percentage of subjects
Interval 0.0 to 2.22
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Nasal congestion, Week 44
|
0.27 Percentage of subjects
Interval 0.03 to 0.96
|
0.21 Percentage of subjects
Interval 0.0 to 1.46
|
0.00 Percentage of subjects
Interval 0.0 to 0.66
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Nasal congestion, Week 45
|
0.88 Percentage of subjects
Interval 0.14 to 2.81
|
0.25 Percentage of subjects
Interval 0.0 to 1.77
|
0.29 Percentage of subjects
Interval 0.01 to 1.58
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Nasal congestion, Week 46
|
0.86 Percentage of subjects
Interval 0.12 to 2.94
|
0.00 Percentage of subjects
Interval 0.0 to 0.64
|
0.00 Percentage of subjects
Interval 0.0 to 3.73
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Nasal congestion, Week 47
|
0.78 Percentage of subjects
Interval 0.05 to 3.4
|
0.00 Percentage of subjects
Interval 0.0 to 2.31
|
0.00 Percentage of subjects
Interval 0.0 to 1.84
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Nasal congestion, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Oropharyngeal pain, Week 35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Oropharyngeal pain, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Oropharyngeal pain, Week 37
|
2.27 Percentage of subjects
Interval 1.64 to 3.06
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 0.78
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Oropharyngeal pain, Week 38
|
1.38 Percentage of subjects
Interval 0.79 to 2.22
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.18 Percentage of subjects
Interval 0.0 to 1.28
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Oropharyngeal pain, Week 39
|
1.58 Percentage of subjects
Interval 1.22 to 2.01
|
0.00 Percentage of subjects
Interval 0.0 to 3.42
|
0.00 Percentage of subjects
Interval 0.0 to 0.76
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Oropharyngeal pain, Week 40
|
1.02 Percentage of subjects
Interval 0.48 to 1.91
|
0.29 Percentage of subjects
Interval 0.0 to 1.78
|
0.17 Percentage of subjects
Interval 0.0 to 1.48
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Oropharyngeal pain, Week 41
|
1.20 Percentage of subjects
Interval 0.54 to 2.29
|
0.87 Percentage of subjects
Interval 0.16 to 2.69
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Oropharyngeal pain, Week 42
|
0.44 Percentage of subjects
Interval 0.07 to 1.43
|
0.24 Percentage of subjects
Interval 0.0 to 2.05
|
0.41 Percentage of subjects
Interval 0.0 to 3.14
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Oropharyngeal pain, Week 43
|
0.60 Percentage of subjects
Interval 0.05 to 2.44
|
0.52 Percentage of subjects
Interval 0.04 to 2.17
|
0.00 Percentage of subjects
Interval 0.0 to 2.22
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Oropharyngeal pain, Week 44
|
0.93 Percentage of subjects
Interval 0.22 to 2.56
|
0.64 Percentage of subjects
Interval 0.01 to 3.72
|
0.18 Percentage of subjects
Interval 0.0 to 0.99
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Oropharyngeal pain, Week 45
|
0.88 Percentage of subjects
Interval 0.03 to 4.37
|
0.50 Percentage of subjects
Interval 0.0 to 3.52
|
0.57 Percentage of subjects
Interval 0.07 to 2.05
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Oropharyngeal pain, Week 46
|
0.29 Percentage of subjects
Interval 0.0 to 1.91
|
0.00 Percentage of subjects
Interval 0.0 to 0.64
|
0.00 Percentage of subjects
Interval 0.0 to 3.73
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Oropharyngeal pain, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 1.42
|
0.00 Percentage of subjects
Interval 0.0 to 2.31
|
0.50 Percentage of subjects
Interval 0.0 to 3.77
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Rhinorrhoea, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Rhinorrhoea, Week 37
|
3.28 Percentage of subjects
Interval 2.18 to 4.74
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 0.78
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Rhinorrhoea, Week 38
|
2.43 Percentage of subjects
Interval 1.71 to 3.35
|
10.00 Percentage of subjects
Interval 0.0 to 74.36
|
0.00 Percentage of subjects
Interval 0.0 to 0.68
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Rhinorrhoea, Week 39
|
2.26 Percentage of subjects
Interval 1.68 to 2.97
|
0.00 Percentage of subjects
Interval 0.0 to 3.42
|
0.00 Percentage of subjects
Interval 0.0 to 0.76
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Rhinorrhoea, Week 42
|
0.99 Percentage of subjects
Interval 0.33 to 2.27
|
0.49 Percentage of subjects
Interval 0.06 to 1.74
|
0.00 Percentage of subjects
Interval 0.0 to 1.52
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Rhinorrhoea, Week 44
|
1.47 Percentage of subjects
Interval 0.37 to 3.86
|
1.06 Percentage of subjects
Interval 0.25 to 2.89
|
0.00 Percentage of subjects
Interval 0.0 to 0.66
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Rhinorrhoea, Week 45
|
1.32 Percentage of subjects
Interval 0.38 to 3.24
|
0.50 Percentage of subjects
Interval 0.0 to 3.52
|
0.86 Percentage of subjects
Interval 0.18 to 2.48
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Rhinorrhoea, Week 46
|
1.14 Percentage of subjects
Interval 0.27 to 3.12
|
0.17 Percentage of subjects
Interval 0.0 to 1.61
|
0.00 Percentage of subjects
Interval 0.0 to 3.73
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Rhinorrhoea, Week 47
|
1.16 Percentage of subjects
Interval 0.06 to 5.45
|
0.63 Percentage of subjects
Interval 0.02 to 3.48
|
0.00 Percentage of subjects
Interval 0.0 to 1.84
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Rhinorrhoea, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Wheezing, Week 35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Wheezing, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Wheezing, Week 37
|
0.93 Percentage of subjects
Interval 0.59 to 1.4
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 0.78
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Wheezing, Week 38
|
0.58 Percentage of subjects
Interval 0.29 to 1.02
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.68
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Wheezing, Week 39
|
0.41 Percentage of subjects
Interval 0.24 to 0.67
|
0.00 Percentage of subjects
Interval 0.0 to 3.42
|
0.00 Percentage of subjects
Interval 0.0 to 0.76
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Wheezing, Week 40
|
0.63 Percentage of subjects
Interval 0.25 to 1.33
|
0.29 Percentage of subjects
Interval 0.01 to 1.62
|
0.00 Percentage of subjects
Interval 0.0 to 0.63
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Wheezing, Week 41
|
0.30 Percentage of subjects
Interval 0.08 to 0.78
|
0.58 Percentage of subjects
Interval 0.07 to 2.09
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Wheezing, Week 42
|
0.22 Percentage of subjects
Interval 0.01 to 1.06
|
0.00 Percentage of subjects
Interval 0.0 to 0.89
|
0.00 Percentage of subjects
Interval 0.0 to 1.52
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Wheezing, Week 43
|
0.20 Percentage of subjects
Interval 0.0 to 1.46
|
0.52 Percentage of subjects
Interval 0.04 to 2.17
|
0.00 Percentage of subjects
Interval 0.0 to 2.22
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Wheezing, Week 44
|
0.27 Percentage of subjects
Interval 0.03 to 0.96
|
1.06 Percentage of subjects
Interval 0.2 to 3.19
|
0.00 Percentage of subjects
Interval 0.0 to 0.66
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Wheezing, Week 45
|
0.22 Percentage of subjects
Interval 0.0 to 1.58
|
0.00 Percentage of subjects
Interval 0.0 to 0.91
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Wheezing, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.35 Percentage of subjects
Interval 0.04 to 1.25
|
0.00 Percentage of subjects
Interval 0.0 to 3.73
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Wheezing, Week 47
|
0.39 Percentage of subjects
Interval 0.01 to 2.44
|
0.63 Percentage of subjects
Interval 0.01 to 3.88
|
0.00 Percentage of subjects
Interval 0.0 to 1.84
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Wheezing, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Oropharyngeal pain, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Rhinorrhoea, Week 35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in EHR (combining routine data collection and card-based ADR reporting system) during the safety follow-up period (from vaccination up to 7 days post-vaccination).
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhoea, nausea, and vomiting. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16433 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=3310 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=4196 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 37
|
2.11 Percentage of subjects
Interval 1.3 to 3.22
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.21 Percentage of subjects
Interval 0.0 to 1.8
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 38
|
1.81 Percentage of subjects
Interval 1.08 to 2.84
|
10.00 Percentage of subjects
Interval 0.0 to 74.36
|
0.00 Percentage of subjects
Interval 0.0 to 0.68
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 39
|
1.51 Percentage of subjects
Interval 0.99 to 2.19
|
0.00 Percentage of subjects
Interval 0.0 to 3.42
|
0.00 Percentage of subjects
Interval 0.0 to 0.76
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 40
|
1.46 Percentage of subjects
Interval 0.88 to 2.27
|
1.17 Percentage of subjects
Interval 0.32 to 2.97
|
0.00 Percentage of subjects
Interval 0.0 to 0.63
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 41
|
1.26 Percentage of subjects
Interval 0.63 to 2.24
|
0.58 Percentage of subjects
Interval 0.07 to 2.09
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 42
|
1.10 Percentage of subjects
Interval 0.46 to 2.18
|
0.00 Percentage of subjects
Interval 0.0 to 0.89
|
0.00 Percentage of subjects
Interval 0.0 to 1.52
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 43
|
0.80 Percentage of subjects
Interval 0.22 to 2.04
|
0.00 Percentage of subjects
Interval 0.0 to 0.96
|
0.61 Percentage of subjects
Interval 0.0 to 4.42
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 44
|
0.67 Percentage of subjects
Interval 0.22 to 1.55
|
0.42 Percentage of subjects
Interval 0.01 to 2.49
|
0.00 Percentage of subjects
Interval 0.0 to 0.66
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 45
|
1.98 Percentage of subjects
Interval 0.63 to 4.6
|
0.99 Percentage of subjects
Interval 0.15 to 3.23
|
0.86 Percentage of subjects
Interval 0.18 to 2.48
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 46
|
1.43 Percentage of subjects
Interval 0.18 to 5.01
|
0.17 Percentage of subjects
Interval 0.0 to 1.48
|
1.03 Percentage of subjects
Interval 0.01 to 6.91
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 1.42
|
0.00 Percentage of subjects
Interval 0.0 to 2.31
|
0.00 Percentage of subjects
Interval 0.0 to 1.84
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Decreased appetite, Week 35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Decreased appetite, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Decreased appetite, Week 37
|
0.73 Percentage of subjects
Interval 0.43 to 1.15
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 0.78
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Decreased appetite, Week 38
|
0.47 Percentage of subjects
Interval 0.25 to 0.81
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.68
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Decreased appetite, Week 39
|
0.46 Percentage of subjects
Interval 0.19 to 0.94
|
0.00 Percentage of subjects
Interval 0.0 to 3.42
|
0.00 Percentage of subjects
Interval 0.0 to 0.76
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Decreased appetite, Week 40
|
0.34 Percentage of subjects
Interval 0.12 to 0.75
|
1.17 Percentage of subjects
Interval 0.32 to 2.97
|
0.00 Percentage of subjects
Interval 0.0 to 0.63
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Decreased appetite, Week 41
|
0.48 Percentage of subjects
Interval 0.13 to 1.23
|
0.29 Percentage of subjects
Interval 0.01 to 1.61
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Decreased appetite, Week 42
|
0.22 Percentage of subjects
Interval 0.01 to 0.95
|
0.00 Percentage of subjects
Interval 0.0 to 0.89
|
0.00 Percentage of subjects
Interval 0.0 to 1.52
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Decreased appetite, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 0.74
|
0.00 Percentage of subjects
Interval 0.0 to 0.96
|
0.00 Percentage of subjects
Interval 0.0 to 2.22
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Decreased appetite, Week 44
|
0.13 Percentage of subjects
Interval 0.0 to 1.01
|
0.00 Percentage of subjects
Interval 0.0 to 0.78
|
0.00 Percentage of subjects
Interval 0.0 to 0.66
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Decreased appetite, Week 45
|
0.66 Percentage of subjects
Interval 0.09 to 2.22
|
0.25 Percentage of subjects
Interval 0.0 to 1.77
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Decreased appetite, Week 46
|
0.57 Percentage of subjects
Interval 0.04 to 2.38
|
0.00 Percentage of subjects
Interval 0.0 to 0.64
|
0.00 Percentage of subjects
Interval 0.0 to 3.73
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Decreased appetite, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 1.42
|
0.00 Percentage of subjects
Interval 0.0 to 2.31
|
0.00 Percentage of subjects
Interval 0.0 to 1.84
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Decreased appetite, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Diarrhoea, Week 35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Diarrhoea, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Diarrhoea, Week 37
|
0.97 Percentage of subjects
Interval 0.58 to 1.54
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.21 Percentage of subjects
Interval 0.0 to 1.8
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Diarrhoea, Week 38
|
0.76 Percentage of subjects
Interval 0.46 to 1.18
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.68
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Diarrhoea, Week 39
|
0.68 Percentage of subjects
Interval 0.45 to 0.98
|
0.00 Percentage of subjects
Interval 0.0 to 3.42
|
0.00 Percentage of subjects
Interval 0.0 to 0.76
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Diarrhoea, Week 40
|
0.68 Percentage of subjects
Interval 0.25 to 1.47
|
0.00 Percentage of subjects
Interval 0.0 to 1.07
|
0.00 Percentage of subjects
Interval 0.0 to 0.63
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Diarrhoea, Week 41
|
0.66 Percentage of subjects
Interval 0.28 to 1.3
|
0.00 Percentage of subjects
Interval 0.0 to 1.07
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Diarrhoea, Week 42
|
0.44 Percentage of subjects
Interval 0.12 to 1.12
|
0.00 Percentage of subjects
Interval 0.0 to 0.89
|
0.00 Percentage of subjects
Interval 0.0 to 1.52
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Diarrhoea, Week 43
|
0.40 Percentage of subjects
Interval 0.04 to 1.55
|
0.00 Percentage of subjects
Interval 0.0 to 0.96
|
0.61 Percentage of subjects
Interval 0.0 to 4.42
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Diarrhoea, Week 44
|
0.27 Percentage of subjects
Interval 0.01 to 1.27
|
0.21 Percentage of subjects
Interval 0.0 to 1.25
|
0.00 Percentage of subjects
Interval 0.0 to 0.66
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Diarrhoea, Week 45
|
0.66 Percentage of subjects
Interval 0.05 to 2.7
|
0.25 Percentage of subjects
Interval 0.01 to 1.37
|
0.29 Percentage of subjects
Interval 0.01 to 1.58
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Diarrhoea, Week 46
|
0.86 Percentage of subjects
Interval 0.07 to 3.46
|
0.00 Percentage of subjects
Interval 0.0 to 0.64
|
1.03 Percentage of subjects
Interval 0.01 to 6.91
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Diarrhoea, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 1.42
|
0.00 Percentage of subjects
Interval 0.0 to 2.31
|
0.00 Percentage of subjects
Interval 0.0 to 1.84
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Diarrhoea, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Nausea, Week 35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Nausea, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Nausea, Week 37
|
0.97 Percentage of subjects
Interval 0.49 to 1.72
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 0.78
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Nausea, Week 38
|
1.05 Percentage of subjects
Interval 0.43 to 2.14
|
10 Percentage of subjects
Interval 0.0 to 74.36
|
0.00 Percentage of subjects
Interval 0.0 to 0.68
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Nausea, Week 39
|
0.78 Percentage of subjects
Interval 0.35 to 1.5
|
0.00 Percentage of subjects
Interval 0.0 to 3.42
|
0.00 Percentage of subjects
Interval 0.0 to 0.76
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Nausea, Week 40
|
0.53 Percentage of subjects
Interval 0.23 to 1.05
|
0.00 Percentage of subjects
Interval 0.0 to 1.07
|
0.00 Percentage of subjects
Interval 0.0 to 0.63
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Nausea, Week 41
|
0.54 Percentage of subjects
Interval 0.25 to 1.02
|
0.00 Percentage of subjects
Interval 0.0 to 1.07
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Nausea, Week 42
|
0.33 Percentage of subjects
Interval 0.02 to 1.47
|
0.00 Percentage of subjects
Interval 0.0 to 0.89
|
0.00 Percentage of subjects
Interval 0.0 to 1.52
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Nausea, Week 43
|
0.40 Percentage of subjects
Interval 0.04 to 1.61
|
0.00 Percentage of subjects
Interval 0.0 to 0.96
|
0.00 Percentage of subjects
Interval 0.0 to 2.22
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Nausea, Week 44
|
0.53 Percentage of subjects
Interval 0.15 to 1.36
|
0.21 Percentage of subjects
Interval 0.0 to 1.25
|
0.00 Percentage of subjects
Interval 0.0 to 0.66
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Nausea, Week 45
|
0.88 Percentage of subjects
Interval 0.12 to 3.05
|
0.50 Percentage of subjects
Interval 0.02 to 2.38
|
0.29 Percentage of subjects
Interval 0.01 to 1.58
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Nausea, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.00 Percentage of subjects
Interval 0.0 to 0.64
|
0.00 Percentage of subjects
Interval 0.0 to 3.73
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Nausea, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 1.42
|
0.00 Percentage of subjects
Interval 0.0 to 2.31
|
0.00 Percentage of subjects
Interval 0.0 to 1.84
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Nausea, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Vomiting, Week 35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Vomiting, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Vomiting, Week 37
|
0.12 Percentage of subjects
Interval 0.02 to 0.38
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 0.78
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Vomiting, Week 38
|
0.22 Percentage of subjects
Interval 0.08 to 0.48
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.68
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Vomiting, Week 39
|
0.19 Percentage of subjects
Interval 0.08 to 0.38
|
0.00 Percentage of subjects
Interval 0.0 to 3.42
|
0.00 Percentage of subjects
Interval 0.0 to 0.76
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Vomiting, Week 40
|
0.05 Percentage of subjects
Interval 0.0 to 0.28
|
0.00 Percentage of subjects
Interval 0.0 to 1.07
|
0.00 Percentage of subjects
Interval 0.0 to 0.63
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Vomiting, Week 41
|
0.30 Percentage of subjects
Interval 0.05 to 0.92
|
0.29 Percentage of subjects
Interval 0.01 to 1.61
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Vomiting, Week 42
|
0.33 Percentage of subjects
Interval 0.03 to 1.37
|
0.00 Percentage of subjects
Interval 0.0 to 0.89
|
0.00 Percentage of subjects
Interval 0.0 to 1.52
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Vomiting, Week 43
|
0.20 Percentage of subjects
Interval 0.0 to 1.32
|
0.00 Percentage of subjects
Interval 0.0 to 0.96
|
0.00 Percentage of subjects
Interval 0.0 to 2.22
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Vomiting, Week 44
|
0.13 Percentage of subjects
Interval 0.0 to 1.05
|
0.00 Percentage of subjects
Interval 0.0 to 0.78
|
0.00 Percentage of subjects
Interval 0.0 to 0.66
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Vomiting, Week 45
|
0.44 Percentage of subjects
Interval 0.01 to 2.73
|
0.00 Percentage of subjects
Interval 0.0 to 0.91
|
0.57 Percentage of subjects
Interval 0.07 to 2.05
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Vomiting, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.17 Percentage of subjects
Interval 0.0 to 1.48
|
0.00 Percentage of subjects
Interval 0.0 to 3.73
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Vomiting, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 1.42
|
0.00 Percentage of subjects
Interval 0.0 to 2.31
|
0.00 Percentage of subjects
Interval 0.0 to 1.84
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Vomiting, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in EHR (combining routine data collection and card-based ADR reporting system) during the safety follow-up period (from vaccination up to 7 days post-vaccination).
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16433 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=3310 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=4196 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 0.4
|
0.24 Percentage of subjects
Interval 0.0 to 1.97
|
0.00 Percentage of subjects
Interval 0.0 to 1.52
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Facial oedema, Week 37
|
0.04 Percentage of subjects
Interval 0.0 to 0.27
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 0.78
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Facial oedema, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 0.74
|
0.00 Percentage of subjects
Interval 0.0 to 0.96
|
0.00 Percentage of subjects
Interval 0.0 to 2.22
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Facial oedema, Week 45
|
0.22 Percentage of subjects
Interval 0.0 to 1.58
|
0.00 Percentage of subjects
Interval 0.0 to 0.91
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Hypersensitivity reactions, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 0.4
|
0.24 Percentage of subjects
Interval 0.0 to 1.97
|
0.00 Percentage of subjects
Interval 0.0 to 1.52
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 37
|
0.69 Percentage of subjects
Interval 0.01 to 4.09
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 0.78
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 38
|
0.58 Percentage of subjects
Interval 0.07 to 2.1
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.18 Percentage of subjects
Interval 0.0 to 1.06
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 39
|
0.41 Percentage of subjects
Interval 0.04 to 1.65
|
0.00 Percentage of subjects
Interval 0.0 to 3.42
|
0.00 Percentage of subjects
Interval 0.0 to 0.76
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 40
|
0.44 Percentage of subjects
Interval 0.05 to 1.59
|
0.58 Percentage of subjects
Interval 0.01 to 3.53
|
0.00 Percentage of subjects
Interval 0.0 to 0.63
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 41
|
0.24 Percentage of subjects
Interval 0.05 to 0.69
|
0.87 Percentage of subjects
Interval 0.16 to 2.69
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 43
|
0.20 Percentage of subjects
Interval 0.0 to 1.37
|
0.00 Percentage of subjects
Interval 0.0 to 0.96
|
0.00 Percentage of subjects
Interval 0.0 to 2.22
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 44
|
0.27 Percentage of subjects
Interval 0.02 to 1.2
|
0.64 Percentage of subjects
Interval 0.01 to 3.72
|
0.00 Percentage of subjects
Interval 0.0 to 0.66
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 45
|
0.22 Percentage of subjects
Interval 0.0 to 1.58
|
0.00 Percentage of subjects
Interval 0.0 to 0.91
|
0.29 Percentage of subjects
Interval 0.01 to 1.58
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 46
|
0.29 Percentage of subjects
Interval 0.0 to 2.1
|
0.00 Percentage of subjects
Interval 0.0 to 0.64
|
0.00 Percentage of subjects
Interval 0.0 to 3.73
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 1.42
|
0.00 Percentage of subjects
Interval 0.0 to 2.31
|
0.00 Percentage of subjects
Interval 0.0 to 1.84
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Anaphylactic reactions, Week 35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Anaphylactic reactions, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Anaphylactic reactions, Week 37
|
0.61 Percentage of subjects
Interval 0.01 to 4.06
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 0.78
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Anaphylactic reactions, Week 38
|
0.44 Percentage of subjects
Interval 0.01 to 2.53
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.68
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Anaphylactic reactions, Week 39
|
0.29 Percentage of subjects
Interval 0.01 to 1.48
|
0.00 Percentage of subjects
Interval 0.0 to 3.42
|
0.00 Percentage of subjects
Interval 0.0 to 0.76
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Anaphylactic reactions, Week 40
|
0.19 Percentage of subjects
Interval 0.0 to 1.58
|
0.58 Percentage of subjects
Interval 0.01 to 3.53
|
0.00 Percentage of subjects
Interval 0.0 to 0.63
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Facial oedema, Week 38
|
0.07 Percentage of subjects
Interval 0.01 to 0.26
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.68
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Anaphylactic reactions, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 0.22
|
0.58 Percentage of subjects
Interval 0.07 to 2.09
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Anaphylactic reactions, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 0.4
|
0.00 Percentage of subjects
Interval 0.0 to 0.89
|
0.00 Percentage of subjects
Interval 0.0 to 1.52
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Facial oedema, Week 39
|
0.05 Percentage of subjects
Interval 0.0 to 0.2
|
0.00 Percentage of subjects
Interval 0.0 to 3.42
|
0.00 Percentage of subjects
Interval 0.0 to 0.76
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Anaphylactic reactions, Week 43
|
0.20 Percentage of subjects
Interval 0.0 to 1.37
|
0.00 Percentage of subjects
Interval 0.0 to 0.96
|
0.00 Percentage of subjects
Interval 0.0 to 2.22
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Anaphylactic reactions, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 0.49
|
0.64 Percentage of subjects
Interval 0.01 to 3.72
|
0.00 Percentage of subjects
Interval 0.0 to 0.66
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Anaphylactic reactions, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.00 Percentage of subjects
Interval 0.0 to 0.91
|
0.29 Percentage of subjects
Interval 0.01 to 1.58
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Anaphylactic reactions, Week 46
|
0.29 Percentage of subjects
Interval 0.0 to 2.1
|
0.00 Percentage of subjects
Interval 0.0 to 0.64
|
0.00 Percentage of subjects
Interval 0.0 to 3.73
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Anaphylactic reactions, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 1.42
|
0.00 Percentage of subjects
Interval 0.0 to 2.31
|
0.00 Percentage of subjects
Interval 0.0 to 1.84
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Facial oedema, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 0.18
|
0.00 Percentage of subjects
Interval 0.0 to 1.07
|
0.00 Percentage of subjects
Interval 0.0 to 0.63
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Facial oedema, Week 41
|
0.06 Percentage of subjects
Interval 0.0 to 0.45
|
0.00 Percentage of subjects
Interval 0.0 to 1.07
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Facial oedema, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 0.4
|
0.00 Percentage of subjects
Interval 0.0 to 0.89
|
0.00 Percentage of subjects
Interval 0.0 to 1.52
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Facial oedema, Week 44
|
0.13 Percentage of subjects
Interval 0.0 to 0.74
|
0.00 Percentage of subjects
Interval 0.0 to 0.78
|
0.00 Percentage of subjects
Interval 0.0 to 0.66
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Anaphylactic reactions, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Facial oedema, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.00 Percentage of subjects
Interval 0.0 to 0.64
|
0.00 Percentage of subjects
Interval 0.0 to 3.73
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Facial oedema, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 1.42
|
0.00 Percentage of subjects
Interval 0.0 to 2.31
|
0.00 Percentage of subjects
Interval 0.0 to 1.84
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Facial oedema, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Facial oedema, Week 35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Facial oedema, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Hypersensitivity reactions, Week 35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Hypersensitivity reactions, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Hypersensitivity reactions, Week 37
|
0.08 Percentage of subjects
Interval 0.01 to 0.29
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 0.78
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Hypersensitivity reactions, Week 38
|
0.11 Percentage of subjects
Interval 0.02 to 0.36
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.18 Percentage of subjects
Interval 0.0 to 1.06
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Hypersensitivity reactions, Week 39
|
0.07 Percentage of subjects
Interval 0.02 to 0.21
|
0.00 Percentage of subjects
Interval 0.0 to 3.42
|
0.00 Percentage of subjects
Interval 0.0 to 0.76
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Hypersensitivity reactions, Week 40
|
0.24 Percentage of subjects
Interval 0.08 to 0.57
|
0.00 Percentage of subjects
Interval 0.0 to 1.07
|
0.00 Percentage of subjects
Interval 0.0 to 0.63
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Hypersensitivity reactions, Week 41
|
0.24 Percentage of subjects
Interval 0.05 to 0.69
|
0.29 Percentage of subjects
Interval 0.01 to 1.61
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Hypersensitivity reactions, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 0.74
|
0.00 Percentage of subjects
Interval 0.0 to 0.96
|
0.00 Percentage of subjects
Interval 0.0 to 2.22
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Hypersensitivity reactions, Week 44
|
0.13 Percentage of subjects
Interval 0.0 to 0.74
|
0.00 Percentage of subjects
Interval 0.0 to 0.78
|
0.00 Percentage of subjects
Interval 0.0 to 0.66
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Hypersensitivity reactions, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.00 Percentage of subjects
Interval 0.0 to 0.91
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Hypersensitivity reactions, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.00 Percentage of subjects
Interval 0.0 to 0.64
|
0.00 Percentage of subjects
Interval 0.0 to 3.73
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Hypersensitivity reactions, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 1.42
|
0.00 Percentage of subjects
Interval 0.0 to 2.31
|
0.00 Percentage of subjects
Interval 0.0 to 1.84
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Hypersensitivity reactions, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in EHR (combining routine data collection and card-based ADR reporting system) during the safety follow-up period (from vaccination up to 7 days post-vaccination).
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16433 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=3310 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=4196 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 39
|
0.36 Percentage of subjects
Interval 0.2 to 0.6
|
0.00 Percentage of subjects
Interval 0.0 to 3.42
|
0.00 Percentage of subjects
Interval 0.0 to 0.76
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 40
|
0.58 Percentage of subjects
Interval 0.3 to 1.02
|
0.29 Percentage of subjects
Interval 0.01 to 1.62
|
0.17 Percentage of subjects
Interval 0.0 to 0.95
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 41
|
0.12 Percentage of subjects
Interval 0.01 to 0.43
|
0.58 Percentage of subjects
Interval 0.07 to 2.09
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 42
|
0.11 Percentage of subjects
Interval 0.0 to 0.8
|
0.00 Percentage of subjects
Interval 0.0 to 0.89
|
0.00 Percentage of subjects
Interval 0.0 to 1.52
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 43
|
0.60 Percentage of subjects
Interval 0.11 to 1.87
|
0.52 Percentage of subjects
Interval 0.06 to 1.88
|
0.00 Percentage of subjects
Interval 0.0 to 2.22
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 44
|
0.53 Percentage of subjects
Interval 0.11 to 1.53
|
0.21 Percentage of subjects
Interval 0.0 to 1.27
|
0.00 Percentage of subjects
Interval 0.0 to 0.66
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 45
|
0.22 Percentage of subjects
Interval 0.0 to 1.53
|
0.00 Percentage of subjects
Interval 0.0 to 0.91
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 46
|
0.57 Percentage of subjects
Interval 0.05 to 2.3
|
0.17 Percentage of subjects
Interval 0.0 to 1.59
|
0.00 Percentage of subjects
Interval 0.0 to 3.73
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 1.42
|
0.63 Percentage of subjects
Interval 0.02 to 3.48
|
0.00 Percentage of subjects
Interval 0.0 to 1.84
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 37
|
0.77 Percentage of subjects
Interval 0.46 to 1.2
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 0.78
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
1.00 Percentage of subjects
Interval 0.01 to 6.22
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 38
|
0.54 Percentage of subjects
Interval 0.24 to 1.06
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.37 Percentage of subjects
Interval 0.04 to 1.4
|
SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in EHR (combining routine data collection and card-based ADR reporting system) during the safety follow-up period (from vaccination up to 7 days post-vaccination).
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16433 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=3310 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=4196 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Arthropathy, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.00 Percentage of subjects
Interval 0.0 to 0.64
|
0.00 Percentage of subjects
Interval 0.0 to 3.73
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Muscle aches / myalgia, Week 37
|
3.77 Percentage of subjects
Interval 2.67 to 5.16
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.43 Percentage of subjects
Interval 0.05 to 1.53
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Muscle aches / myalgia, Week 38
|
3.08 Percentage of subjects
Interval 2.31 to 4.03
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.18 Percentage of subjects
Interval 0.0 to 1.14
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 42
|
1.97 Percentage of subjects
Interval 0.86 to 3.84
|
0.49 Percentage of subjects
Interval 0.06 to 1.74
|
0.00 Percentage of subjects
Interval 0.0 to 1.52
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 37
|
4.26 Percentage of subjects
Interval 3.33 to 5.34
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.43 Percentage of subjects
Interval 0.05 to 1.53
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 38
|
3.37 Percentage of subjects
Interval 2.47 to 4.5
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.37 Percentage of subjects
Interval 0.04 to 1.33
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 39
|
3.33 Percentage of subjects
Interval 2.78 to 3.95
|
0.00 Percentage of subjects
Interval 0.0 to 3.42
|
0.82 Percentage of subjects
Interval 0.22 to 2.09
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 40
|
2.63 Percentage of subjects
Interval 1.91 to 3.52
|
1.17 Percentage of subjects
Interval 0.02 to 6.99
|
0.51 Percentage of subjects
Interval 0.06 to 1.86
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 41
|
2.52 Percentage of subjects
Interval 1.82 to 3.39
|
0.00 Percentage of subjects
Interval 0.0 to 1.07
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 43
|
3.21 Percentage of subjects
Interval 1.38 to 6.25
|
0.26 Percentage of subjects
Interval 0.0 to 1.67
|
1.22 Percentage of subjects
Interval 0.15 to 4.34
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 44
|
1.87 Percentage of subjects
Interval 0.67 to 4.07
|
1.27 Percentage of subjects
Interval 0.02 to 7.37
|
0.00 Percentage of subjects
Interval 0.0 to 0.66
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 45
|
2.64 Percentage of subjects
Interval 1.12 to 5.21
|
0.50 Percentage of subjects
Interval 0.06 to 1.78
|
0.29 Percentage of subjects
Interval 0.01 to 1.58
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 46
|
1.43 Percentage of subjects
Interval 0.47 to 3.3
|
0.17 Percentage of subjects
Interval 0.0 to 1.61
|
2.06 Percentage of subjects
Interval 0.24 to 7.4
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 47
|
1.94 Percentage of subjects
Interval 0.49 to 5.06
|
0.00 Percentage of subjects
Interval 0.0 to 2.31
|
0.00 Percentage of subjects
Interval 0.0 to 1.84
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Arthropathy, Week 39
|
0.90 Percentage of subjects
Interval 0.55 to 1.38
|
0.00 Percentage of subjects
Interval 0.0 to 3.42
|
0.00 Percentage of subjects
Interval 0.0 to 0.76
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
2.00 Percentage of subjects
Interval 0.24 to 7.04
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Arthropathy, Week 40
|
0.78 Percentage of subjects
Interval 0.24 to 1.86
|
0.88 Percentage of subjects
Interval 0.01 to 5.27
|
0.00 Percentage of subjects
Interval 0.0 to 0.63
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Arthropathy, Week 35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Arthropathy, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Arthropathy, Week 41
|
0.60 Percentage of subjects
Interval 0.28 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 1.07
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Arthropathy, Week 42
|
0.33 Percentage of subjects
Interval 0.06 to 0.99
|
0.24 Percentage of subjects
Interval 0.01 to 1.34
|
0.00 Percentage of subjects
Interval 0.0 to 1.52
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Arthropathy, Week 37
|
1.42 Percentage of subjects
Interval 0.99 to 1.97
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 0.78
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Arthropathy, Week 43
|
1.00 Percentage of subjects
Interval 0.26 to 2.61
|
0.00 Percentage of subjects
Interval 0.0 to 0.96
|
0.00 Percentage of subjects
Interval 0.0 to 2.22
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Arthropathy, Week 38
|
1.05 Percentage of subjects
Interval 0.62 to 1.67
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.18 Percentage of subjects
Interval 0.0 to 1.06
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Arthropathy, Week 44
|
0.67 Percentage of subjects
Interval 0.12 to 2.05
|
0.64 Percentage of subjects
Interval 0.01 to 3.72
|
0.00 Percentage of subjects
Interval 0.0 to 0.66
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Arthropathy, Week 45
|
0.66 Percentage of subjects
Interval 0.04 to 2.96
|
0.00 Percentage of subjects
Interval 0.0 to 0.91
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Arthropathy, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 1.42
|
0.00 Percentage of subjects
Interval 0.0 to 2.31
|
0.00 Percentage of subjects
Interval 0.0 to 1.84
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Arthropathy, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Muscle aches / myalgia, Week 35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Muscle aches / myalgia, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Muscle aches / myalgia, Week 39
|
2.96 Percentage of subjects
Interval 2.47 to 3.53
|
0.00 Percentage of subjects
Interval 0.0 to 3.42
|
0.82 Percentage of subjects
Interval 0.22 to 2.09
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Muscle aches / myalgia, Week 40
|
2.43 Percentage of subjects
Interval 1.74 to 3.29
|
1.17 Percentage of subjects
Interval 0.02 to 6.99
|
0.51 Percentage of subjects
Interval 0.06 to 1.86
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Muscle aches / myalgia, Week 41
|
2.34 Percentage of subjects
Interval 1.64 to 3.23
|
0.00 Percentage of subjects
Interval 0.0 to 1.07
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Muscle aches / myalgia, Week 42
|
1.86 Percentage of subjects
Interval 0.75 to 3.8
|
0.49 Percentage of subjects
Interval 0.06 to 1.74
|
0.00 Percentage of subjects
Interval 0.0 to 1.52
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Muscle aches / myalgia, Week 43
|
3.01 Percentage of subjects
Interval 1.18 to 6.2
|
0.26 Percentage of subjects
Interval 0.0 to 1.67
|
1.22 Percentage of subjects
Interval 0.15 to 4.34
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Muscle aches / myalgia, Week 44
|
1.60 Percentage of subjects
Interval 0.66 to 3.22
|
1.27 Percentage of subjects
Interval 0.02 to 7.37
|
0.00 Percentage of subjects
Interval 0.0 to 0.66
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Muscle aches / myalgia, Week 45
|
2.42 Percentage of subjects
Interval 1.04 to 4.74
|
0.50 Percentage of subjects
Interval 0.06 to 1.78
|
0.29 Percentage of subjects
Interval 0.01 to 1.58
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Muscle aches / myalgia, Week 46
|
1.43 Percentage of subjects
Interval 0.47 to 3.3
|
0.17 Percentage of subjects
Interval 0.0 to 1.61
|
2.06 Percentage of subjects
Interval 0.24 to 7.4
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Muscle aches / myalgia, Week 47
|
1.94 Percentage of subjects
Interval 0.49 to 5.06
|
0.00 Percentage of subjects
Interval 0.0 to 2.31
|
0.00 Percentage of subjects
Interval 0.0 to 1.84
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Muscle aches / myalgia, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
2.00 Percentage of subjects
Interval 0.24 to 7.04
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in EHR (combining routine data collection and card-based ADR reporting system) during the safety follow-up period (from vaccination up to 7 days post-vaccination).
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16433 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=3310 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=4196 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 37
|
0.28 Percentage of subjects
Interval 0.11 to 0.58
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 0.78
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Bell's palsy, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Bell's palsy, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 0.74
|
0.00 Percentage of subjects
Interval 0.0 to 0.96
|
0.00 Percentage of subjects
Interval 0.0 to 2.22
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Bell's palsy, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.00 Percentage of subjects
Interval 0.0 to 0.64
|
0.00 Percentage of subjects
Interval 0.0 to 3.73
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Guillain-Barre Syndrome, Week 35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Guillain-Barre Syndrome, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Guillain-Barre Syndrome, Week 37
|
0.00 Percentage of subjects
Interval 0.0 to 0.15
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 0.78
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Guillain-Barre Syndrome, Week 38
|
0.00 Percentage of subjects
Interval 0.0 to 0.13
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.68
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Guillain-Barre Syndrome, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 0.09
|
0.00 Percentage of subjects
Interval 0.0 to 3.42
|
0.00 Percentage of subjects
Interval 0.0 to 0.76
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Guillain-Barre Syndrome, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 0.18
|
0.00 Percentage of subjects
Interval 0.0 to 1.07
|
0.00 Percentage of subjects
Interval 0.0 to 0.63
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Guillain-Barre Syndrome, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 0.22
|
0.00 Percentage of subjects
Interval 0.0 to 1.07
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Guillain-Barre Syndrome, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 0.4
|
0.00 Percentage of subjects
Interval 0.0 to 0.89
|
0.00 Percentage of subjects
Interval 0.0 to 1.52
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Guillain-Barre Syndrome, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 0.74
|
0.00 Percentage of subjects
Interval 0.0 to 0.96
|
0.00 Percentage of subjects
Interval 0.0 to 2.22
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Guillain-Barre Syndrome, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 0.49
|
0.00 Percentage of subjects
Interval 0.0 to 0.78
|
0.00 Percentage of subjects
Interval 0.0 to 0.66
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Guillain-Barre Syndrome, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.00 Percentage of subjects
Interval 0.0 to 0.91
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Guillain-Barre Syndrome, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.00 Percentage of subjects
Interval 0.0 to 0.64
|
0.00 Percentage of subjects
Interval 0.0 to 3.73
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Guillain-Barre Syndrome, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 1.42
|
0.00 Percentage of subjects
Interval 0.0 to 2.31
|
0.00 Percentage of subjects
Interval 0.0 to 1.84
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Guillain-Barre Syndrome, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Peripheral tremor, Week 35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Peripheral tremor, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Peripheral tremor, Week 37
|
0.24 Percentage of subjects
Interval 0.09 to 0.53
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 0.78
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Peripheral tremor, Week 44
|
0.13 Percentage of subjects
Interval 0.0 to 1.05
|
0.00 Percentage of subjects
Interval 0.0 to 0.78
|
0.00 Percentage of subjects
Interval 0.0 to 0.66
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Peripheral tremor, Week 38
|
0.29 Percentage of subjects
Interval 0.13 to 0.57
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.68
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Peripheral tremor, Week 39
|
0.19 Percentage of subjects
Interval 0.04 to 0.56
|
0.00 Percentage of subjects
Interval 0.0 to 3.42
|
0.00 Percentage of subjects
Interval 0.0 to 0.76
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Peripheral tremor, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 0.18
|
0.29 Percentage of subjects
Interval 0.0 to 1.78
|
0.00 Percentage of subjects
Interval 0.0 to 0.63
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Peripheral tremor, Week 41
|
0.18 Percentage of subjects
Interval 0.03 to 0.59
|
0.29 Percentage of subjects
Interval 0.01 to 1.61
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Peripheral tremor, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 0.4
|
0.00 Percentage of subjects
Interval 0.0 to 0.89
|
0.00 Percentage of subjects
Interval 0.0 to 1.52
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Peripheral tremor, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 0.74
|
0.00 Percentage of subjects
Interval 0.0 to 0.96
|
0.00 Percentage of subjects
Interval 0.0 to 2.22
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Peripheral tremor, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.00 Percentage of subjects
Interval 0.0 to 0.91
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Peripheral tremor, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.00 Percentage of subjects
Interval 0.0 to 0.64
|
0.00 Percentage of subjects
Interval 0.0 to 3.73
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Peripheral tremor, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 1.42
|
0.00 Percentage of subjects
Interval 0.0 to 2.31
|
0.00 Percentage of subjects
Interval 0.0 to 1.84
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Peripheral tremor, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Seizure/Febrile convulsions, Week 35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Seizure/Febrile convulsions, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Seizure/Febrile convulsions, Week 37
|
0.04 Percentage of subjects
Interval 0.0 to 0.25
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 0.78
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Seizure/Febrile convulsions, Week 38
|
0.00 Percentage of subjects
Interval 0.0 to 0.13
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.68
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Seizure/Febrile convulsions, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 0.09
|
0.00 Percentage of subjects
Interval 0.0 to 3.42
|
0.00 Percentage of subjects
Interval 0.0 to 0.76
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Seizure/Febrile convulsions, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 0.18
|
0.00 Percentage of subjects
Interval 0.0 to 1.07
|
0.00 Percentage of subjects
Interval 0.0 to 0.63
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Seizure/Febrile convulsions, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 0.22
|
0.00 Percentage of subjects
Interval 0.0 to 1.07
|
0.25 Percentage of subjects
Interval 0.0 to 1.69
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Seizure/Febrile convulsions, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 0.4
|
0.00 Percentage of subjects
Interval 0.0 to 0.89
|
0.00 Percentage of subjects
Interval 0.0 to 1.52
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Seizure/Febrile convulsions, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 0.74
|
0.00 Percentage of subjects
Interval 0.0 to 0.96
|
0.00 Percentage of subjects
Interval 0.0 to 2.22
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Seizure/Febrile convulsions, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 0.49
|
0.00 Percentage of subjects
Interval 0.0 to 0.78
|
0.00 Percentage of subjects
Interval 0.0 to 0.66
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Seizure/Febrile convulsions, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.00 Percentage of subjects
Interval 0.0 to 0.91
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Seizure/Febrile convulsions, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.00 Percentage of subjects
Interval 0.0 to 0.64
|
0.00 Percentage of subjects
Interval 0.0 to 3.73
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Seizure/Febrile convulsions, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 1.42
|
0.63 Percentage of subjects
Interval 0.01 to 4.02
|
0.00 Percentage of subjects
Interval 0.0 to 1.84
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Seizure/Febrile convulsions, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 38
|
0.29 Percentage of subjects
Interval 0.13 to 0.57
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.68
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 39
|
0.22 Percentage of subjects
Interval 0.06 to 0.57
|
0.00 Percentage of subjects
Interval 0.0 to 3.42
|
0.00 Percentage of subjects
Interval 0.0 to 0.76
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 0.18
|
0.29 Percentage of subjects
Interval 0.0 to 1.78
|
0.00 Percentage of subjects
Interval 0.0 to 0.63
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 41
|
0.18 Percentage of subjects
Interval 0.03 to 0.59
|
0.29 Percentage of subjects
Interval 0.01 to 1.61
|
0.25 Percentage of subjects
Interval 0.0 to 1.69
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 0.4
|
0.00 Percentage of subjects
Interval 0.0 to 0.89
|
0.00 Percentage of subjects
Interval 0.0 to 1.52
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 0.74
|
0.00 Percentage of subjects
Interval 0.0 to 0.96
|
0.00 Percentage of subjects
Interval 0.0 to 2.22
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 44
|
0.13 Percentage of subjects
Interval 0.0 to 1.05
|
0.00 Percentage of subjects
Interval 0.0 to 0.78
|
0.00 Percentage of subjects
Interval 0.0 to 0.66
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.00 Percentage of subjects
Interval 0.0 to 0.91
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.00 Percentage of subjects
Interval 0.0 to 0.64
|
0.00 Percentage of subjects
Interval 0.0 to 3.73
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 1.42
|
0.63 Percentage of subjects
Interval 0.01 to 4.02
|
0.00 Percentage of subjects
Interval 0.0 to 1.84
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Bell's palsy, Week 35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Bell's palsy, Week 37
|
0.00 Percentage of subjects
Interval 0.0 to 0.15
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 0.78
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Bell's palsy, Week 38
|
0.00 Percentage of subjects
Interval 0.0 to 0.13
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.68
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Bell's palsy, Week 39
|
0.02 Percentage of subjects
Interval 0.0 to 0.18
|
0.00 Percentage of subjects
Interval 0.0 to 3.42
|
0.00 Percentage of subjects
Interval 0.0 to 0.76
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Bell's palsy, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 0.18
|
0.00 Percentage of subjects
Interval 0.0 to 1.07
|
0.00 Percentage of subjects
Interval 0.0 to 0.63
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Bell's palsy, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 0.22
|
0.00 Percentage of subjects
Interval 0.0 to 1.07
|
0.00 Percentage of subjects
Interval 0.0 to 0.92
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Bell's palsy, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 0.4
|
0.00 Percentage of subjects
Interval 0.0 to 0.89
|
0.00 Percentage of subjects
Interval 0.0 to 1.52
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Bell's palsy, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 0.49
|
0.00 Percentage of subjects
Interval 0.0 to 0.78
|
0.00 Percentage of subjects
Interval 0.0 to 0.66
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Bell's palsy, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.00 Percentage of subjects
Interval 0.0 to 0.91
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Bell's palsy, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 1.42
|
0.00 Percentage of subjects
Interval 0.0 to 2.31
|
0.00 Percentage of subjects
Interval 0.0 to 1.84
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Bell's palsy, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 2.51
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in EHR (combining routine data collection and card-based ADR reporting system) during the safety follow-up period (from vaccination up to 7 days post-vaccination).
SAEs reported here are derived from 2 sources of data - ADR cards and SAE routinely collected from GPs. The weekly incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any SAEs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16433 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=3310 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=4196 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine Group
At Week 35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine Group
At Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine Group
At Week 37
|
0.12 Percentage of subjects
Interval 0.02 to 0.37
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.21 Percentage of subjects
Interval 0.0 to 1.71
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine Group
At Week 38
|
0.18 Percentage of subjects
Interval 0.04 to 0.52
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.37 Percentage of subjects
Interval 0.04 to 1.33
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine Group
At Week 39
|
0.07 Percentage of subjects
Interval 0.01 to 0.22
|
0.00 Percentage of subjects
Interval 0.0 to 3.42
|
0.00 Percentage of subjects
Interval 0.0 to 0.76
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine Group
At Week 40
|
0.19 Percentage of subjects
Interval 0.04 to 0.6
|
0.00 Percentage of subjects
Interval 0.0 to 1.07
|
0.17 Percentage of subjects
Interval 0.0 to 1.29
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine Group
At Week 41
|
0.12 Percentage of subjects
Interval 0.01 to 0.55
|
0.00 Percentage of subjects
Interval 0.0 to 1.07
|
0.50 Percentage of subjects
Interval 0.04 to 2.05
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine Group
At Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 0.4
|
0.24 Percentage of subjects
Interval 0.01 to 1.34
|
0.00 Percentage of subjects
Interval 0.0 to 1.52
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine Group
At Week 43
|
0.40 Percentage of subjects
Interval 0.01 to 2.45
|
0.00 Percentage of subjects
Interval 0.0 to 0.96
|
0.00 Percentage of subjects
Interval 0.0 to 2.22
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine Group
At Week 44
|
0.27 Percentage of subjects
Interval 0.0 to 1.9
|
0.21 Percentage of subjects
Interval 0.0 to 1.46
|
0.36 Percentage of subjects
Interval 0.0 to 2.77
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine Group
At Week 45
|
0.22 Percentage of subjects
Interval 0.0 to 1.6
|
0.25 Percentage of subjects
Interval 0.0 to 1.77
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine Group
At Week 46
|
0.57 Percentage of subjects
Interval 0.07 to 2.05
|
0.00 Percentage of subjects
Interval 0.0 to 0.64
|
1.03 Percentage of subjects
Interval 0.01 to 6.91
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine Group
At Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 1.42
|
0.00 Percentage of subjects
Interval 0.0 to 2.31
|
0.50 Percentage of subjects
Interval 0.0 to 4.16
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine Group
At Week 48
|
0.69 Percentage of subjects
Interval 0.01 to 4.21
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start up to end of the week of interest and were registered in EHR (routine data collection \& card-based ADR reporting) during FU period (from vaccination up to 7 days post-vaccination)
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16433 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=3310 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=4196 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group
Week 35-35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group
Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
1.61 Percentage of subjects
Interval 0.0 to 14.32
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group
Week 35-37
|
11.63 Percentage of subjects
Interval 9.72 to 13.76
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
1.32 Percentage of subjects
Interval 0.47 to 2.9
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group
Week 35-38
|
10.78 Percentage of subjects
Interval 8.92 to 12.86
|
6.25 Percentage of subjects
Interval 0.12 to 31.55
|
1.40 Percentage of subjects
Interval 0.78 to 2.3
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group
Week 35-39
|
10.45 Percentage of subjects
Interval 8.95 to 12.11
|
2.46 Percentage of subjects
Interval 0.33 to 8.32
|
1.67 Percentage of subjects
Interval 0.92 to 2.78
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group
Week 35-40
|
10.36 Percentage of subjects
Interval 8.58 to 12.37
|
6.03 Percentage of subjects
Interval 3.98 to 8.72
|
1.63 Percentage of subjects
Interval 0.82 to 2.89
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group
Week 35-41
|
10.13 Percentage of subjects
Interval 8.31 to 12.21
|
5.82 Percentage of subjects
Interval 3.69 to 8.68
|
1.46 Percentage of subjects
Interval 0.72 to 2.61
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group
Week 35-42
|
9.82 Percentage of subjects
Interval 7.97 to 11.93
|
4.59 Percentage of subjects
Interval 2.92 to 6.85
|
1.47 Percentage of subjects
Interval 0.74 to 2.61
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group
Week 35-43
|
9.69 Percentage of subjects
Interval 7.84 to 11.79
|
4.56 Percentage of subjects
Interval 2.86 to 6.86
|
1.49 Percentage of subjects
Interval 0.74 to 2.67
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group
Week 35-44
|
9.50 Percentage of subjects
Interval 7.65 to 11.63
|
4.87 Percentage of subjects
Interval 2.74 to 7.93
|
1.31 Percentage of subjects
Interval 0.69 to 2.24
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group
Week 35-45
|
9.42 Percentage of subjects
Interval 7.6 to 11.5
|
4.61 Percentage of subjects
Interval 2.45 to 7.8
|
1.56 Percentage of subjects
Interval 0.85 to 2.6
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group
Week 35-46
|
9.38 Percentage of subjects
Interval 7.54 to 11.48
|
4.03 Percentage of subjects
Interval 1.72 to 7.88
|
1.59 Percentage of subjects
Interval 0.92 to 2.56
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group
Week 35-47
|
9.30 Percentage of subjects
Interval 7.46 to 11.41
|
3.99 Percentage of subjects
Interval 1.72 to 7.76
|
1.59 Percentage of subjects
Interval 0.9 to 2.59
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group
Week 35-48
|
9.21 Percentage of subjects
Interval 7.37 to 11.34
|
4.02 Percentage of subjects
Interval 1.73 to 7.82
|
1.57 Percentage of subjects
Interval 0.89 to 2.56
|
SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start up to end of the week of interest and were registered in EHR (routine data collection \& card-based ADR reporting) during FU period (from vaccination up to 7 days post-vaccination)
"subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16433 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=3310 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=4196 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group
Week 35-35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group
Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group
Week 35-37
|
0.45 Percentage of subjects
Interval 0.2 to 0.85
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 0.69
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group
Week 35-38
|
0.50 Percentage of subjects
Interval 0.29 to 0.8
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 0.34
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group
Week 35-39
|
0.50 Percentage of subjects
Interval 0.26 to 0.87
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
0.06 Percentage of subjects
Interval 0.0 to 0.46
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group
Week 35-40
|
0.49 Percentage of subjects
Interval 0.29 to 0.79
|
1.08 Percentage of subjects
Interval 0.17 to 3.52
|
0.05 Percentage of subjects
Interval 0.0 to 0.34
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group
Week 35-41
|
0.47 Percentage of subjects
Interval 0.29 to 0.73
|
0.87 Percentage of subjects
Interval 0.27 to 2.05
|
0.04 Percentage of subjects
Interval 0.0 to 0.29
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group
Week 35-42
|
0.44 Percentage of subjects
Interval 0.26 to 0.7
|
0.57 Percentage of subjects
Interval 0.14 to 1.52
|
0.04 Percentage of subjects
Interval 0.0 to 0.26
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group
Week 35-43
|
0.44 Percentage of subjects
Interval 0.26 to 0.69
|
0.44 Percentage of subjects
Interval 0.09 to 1.27
|
0.03 Percentage of subjects
Interval 0.0 to 0.25
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group
Week 35-44
|
0.43 Percentage of subjects
Interval 0.26 to 0.68
|
0.43 Percentage of subjects
Interval 0.13 to 1.06
|
0.03 Percentage of subjects
Interval 0.0 to 0.21
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group
Week 35-45
|
0.43 Percentage of subjects
Interval 0.25 to 0.67
|
0.36 Percentage of subjects
Interval 0.1 to 0.94
|
0.05 Percentage of subjects
Interval 0.01 to 0.19
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group
Week 35-46
|
0.43 Percentage of subjects
Interval 0.25 to 0.69
|
0.33 Percentage of subjects
Interval 0.09 to 0.84
|
0.05 Percentage of subjects
Interval 0.01 to 0.18
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group
Week 35-47
|
0.43 Percentage of subjects
Interval 0.25 to 0.68
|
0.34 Percentage of subjects
Interval 0.12 to 0.77
|
0.05 Percentage of subjects
Interval 0.01 to 0.18
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group
Week 35-48
|
0.43 Percentage of subjects
Interval 0.25 to 0.67
|
0.33 Percentage of subjects
Interval 0.11 to 0.75
|
0.05 Percentage of subjects
Interval 0.01 to 0.18
|
SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start up to end of the week of interest and were registered in EHR (routine data collection \& card-based ADR reporting) during FU period (from vaccination up to 7 days post-vaccination)
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Local symptoms include local erythema. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16433 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=3310 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=4196 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group
Week 35-35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group
Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group
Week 35-37
|
1.90 Percentage of subjects
Interval 0.82 to 3.74
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.19 Percentage of subjects
Interval 0.0 to 1.04
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group
Week 35-38
|
1.76 Percentage of subjects
Interval 1.04 to 2.79
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.09 Percentage of subjects
Interval 0.0 to 0.53
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group
Week 35-39
|
1.84 Percentage of subjects
Interval 1.2 to 2.69
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
0.06 Percentage of subjects
Interval 0.0 to 0.38
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group
Week 35-40
|
1.86 Percentage of subjects
Interval 1.23 to 2.7
|
0.22 Percentage of subjects
Interval 0.01 to 1.19
|
0.05 Percentage of subjects
Interval 0.0 to 0.3
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group
Week 35-41
|
1.81 Percentage of subjects
Interval 1.24 to 2.53
|
0.50 Percentage of subjects
Interval 0.05 to 1.94
|
0.04 Percentage of subjects
Interval 0.0 to 0.25
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group
Week 35-42
|
1.72 Percentage of subjects
Interval 1.23 to 2.35
|
0.49 Percentage of subjects
Interval 0.06 to 1.81
|
0.04 Percentage of subjects
Interval 0.0 to 0.24
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group
Week 35-43
|
1.68 Percentage of subjects
Interval 1.2 to 2.27
|
0.56 Percentage of subjects
Interval 0.06 to 2.09
|
0.03 Percentage of subjects
Interval 0.0 to 0.22
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group
Week 35-44
|
1.66 Percentage of subjects
Interval 1.21 to 2.21
|
0.58 Percentage of subjects
Interval 0.08 to 1.99
|
0.03 Percentage of subjects
Interval 0.0 to 0.19
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group
Week 35-45
|
1.63 Percentage of subjects
Interval 1.2 to 2.17
|
0.57 Percentage of subjects
Interval 0.12 to 1.61
|
0.03 Percentage of subjects
Interval 0.0 to 0.18
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group
Week 35-46
|
1.63 Percentage of subjects
Interval 1.21 to 2.14
|
0.56 Percentage of subjects
Interval 0.09 to 1.76
|
0.03 Percentage of subjects
Interval 0.0 to 0.18
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group
Week 35-47
|
1.62 Percentage of subjects
Interval 1.21 to 2.13
|
0.53 Percentage of subjects
Interval 0.09 to 1.68
|
0.02 Percentage of subjects
Interval 0.0 to 0.17
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group
Week 35-48
|
1.61 Percentage of subjects
Interval 1.2 to 2.11
|
0.51 Percentage of subjects
Interval 0.09 to 1.63
|
0.02 Percentage of subjects
Interval 0.0 to 0.17
|
SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start up to end of the week of interest and were registered in EHR (routine data collection \& card-based ADR reporting) during FU period (from vaccination up to 7 days post-vaccination)
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16433 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=3310 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=4196 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Malaise, Week 35-47
|
0.02 Percentage of subjects
Interval 0.0 to 0.05
|
0.09 Percentage of subjects
Interval 0.02 to 0.27
|
0.00 Percentage of subjects
Interval 0.0 to 0.09
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Any, Week 35-35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Any, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Any, Week 35-37
|
4.01 Percentage of subjects
Interval 3.23 to 4.92
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.19 Percentage of subjects
Interval 0.0 to 1.6
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Any, Week 35-38
|
3.58 Percentage of subjects
Interval 2.78 to 4.53
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.09 Percentage of subjects
Interval 0.0 to 0.77
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Any, Week 35-39
|
3.46 Percentage of subjects
Interval 2.7 to 4.35
|
0.82 Percentage of subjects
Interval 0.02 to 4.48
|
0.19 Percentage of subjects
Interval 0.04 to 0.57
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Any, Week 35-40
|
3.33 Percentage of subjects
Interval 2.63 to 4.15
|
1.94 Percentage of subjects
Interval 0.67 to 4.31
|
0.14 Percentage of subjects
Interval 0.03 to 0.41
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Any, Week 35-41
|
3.15 Percentage of subjects
Interval 2.48 to 3.95
|
1.61 Percentage of subjects
Interval 0.55 to 3.63
|
0.12 Percentage of subjects
Interval 0.02 to 0.34
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Any, Week 35-42
|
3.06 Percentage of subjects
Interval 2.37 to 3.88
|
1.23 Percentage of subjects
Interval 0.41 to 2.83
|
0.11 Percentage of subjects
Interval 0.02 to 0.31
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Any, Week 35-43
|
3.02 Percentage of subjects
Interval 2.32 to 3.85
|
1.19 Percentage of subjects
Interval 0.31 to 3.08
|
0.10 Percentage of subjects
Interval 0.02 to 0.3
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Any, Week 35-44
|
2.96 Percentage of subjects
Interval 2.26 to 3.81
|
1.30 Percentage of subjects
Interval 0.3 to 3.57
|
0.09 Percentage of subjects
Interval 0.02 to 0.25
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Any, Week 35-45
|
2.92 Percentage of subjects
Interval 2.23 to 3.75
|
1.33 Percentage of subjects
Interval 0.4 to 3.21
|
0.21 Percentage of subjects
Interval 0.02 to 0.75
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Any, Week 35-46
|
2.88 Percentage of subjects
Interval 2.18 to 3.73
|
1.15 Percentage of subjects
Interval 0.24 to 3.32
|
0.20 Percentage of subjects
Interval 0.02 to 0.73
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Any, Week 35-47
|
2.84 Percentage of subjects
Interval 2.15 to 3.68
|
1.09 Percentage of subjects
Interval 0.22 to 3.17
|
0.19 Percentage of subjects
Interval 0.02 to 0.7
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Any, Week 35-48
|
2.82 Percentage of subjects
Interval 2.13 to 3.66
|
1.06 Percentage of subjects
Interval 0.22 to 3.07
|
0.19 Percentage of subjects
Interval 0.02 to 0.7
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Drowsiness, Week 35-35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Drowsiness, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Drowsiness, Week 35-37
|
1.05 Percentage of subjects
Interval 0.62 to 1.68
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 0.69
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Drowsiness, Week 35-38
|
0.92 Percentage of subjects
Interval 0.48 to 1.59
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 0.34
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Drowsiness, Week 35-39
|
0.79 Percentage of subjects
Interval 0.42 to 1.36
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
0.00 Percentage of subjects
Interval 0.0 to 0.24
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Drowsiness, Week 35-40
|
0.77 Percentage of subjects
Interval 0.43 to 1.28
|
0.22 Percentage of subjects
Interval 0.01 to 1.19
|
0.00 Percentage of subjects
Interval 0.0 to 0.17
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Drowsiness, Week 35-41
|
0.74 Percentage of subjects
Interval 0.41 to 1.23
|
0.37 Percentage of subjects
Interval 0.08 to 1.08
|
0.00 Percentage of subjects
Interval 0.0 to 0.15
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Drowsiness, Week 35-42
|
0.72 Percentage of subjects
Interval 0.38 to 1.21
|
0.25 Percentage of subjects
Interval 0.05 to 0.72
|
0.00 Percentage of subjects
Interval 0.0 to 0.13
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Drowsiness, Week 35-43
|
0.72 Percentage of subjects
Interval 0.37 to 1.26
|
0.25 Percentage of subjects
Interval 0.07 to 0.64
|
0.00 Percentage of subjects
Interval 0.0 to 0.13
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Drowsiness, Week 35-44
|
0.70 Percentage of subjects
Interval 0.35 to 1.24
|
0.29 Percentage of subjects
Interval 0.06 to 0.86
|
0.00 Percentage of subjects
Interval 0.0 to 0.11
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Drowsiness, Week 35-45
|
0.68 Percentage of subjects
Interval 0.34 to 1.21
|
0.24 Percentage of subjects
Interval 0.04 to 0.76
|
0.00 Percentage of subjects
Interval 0.0 to 0.1
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Drowsiness, Week 35-46
|
0.67 Percentage of subjects
Interval 0.34 to 1.19
|
0.23 Percentage of subjects
Interval 0.03 to 0.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.09
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Drowsiness, Week 35-47
|
0.66 Percentage of subjects
Interval 0.33 to 1.17
|
0.22 Percentage of subjects
Interval 0.02 to 0.82
|
0.00 Percentage of subjects
Interval 0.0 to 0.09
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Drowsiness, Week 35-48
|
0.65 Percentage of subjects
Interval 0.33 to 1.16
|
0.21 Percentage of subjects
Interval 0.02 to 0.79
|
0.00 Percentage of subjects
Interval 0.0 to 0.09
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Fatigue, Week 35-35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Fatigue, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Fatigue, Week 35-37
|
2.19 Percentage of subjects
Interval 1.65 to 2.85
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.19 Percentage of subjects
Interval 0.0 to 1.6
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Fatigue, Week 35-38
|
2.03 Percentage of subjects
Interval 1.57 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.09 Percentage of subjects
Interval 0.0 to 0.77
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Fatigue, Week 35-39
|
1.93 Percentage of subjects
Interval 1.5 to 2.44
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
0.13 Percentage of subjects
Interval 0.01 to 0.5
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Fatigue, Week 35-40
|
1.79 Percentage of subjects
Interval 1.4 to 2.26
|
0.43 Percentage of subjects
Interval 0.02 to 2.14
|
0.09 Percentage of subjects
Interval 0.01 to 0.38
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Fatigue, Week 35-41
|
1.71 Percentage of subjects
Interval 1.33 to 2.17
|
0.37 Percentage of subjects
Interval 0.04 to 1.45
|
0.08 Percentage of subjects
Interval 0.01 to 0.31
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Fatigue, Week 35-42
|
1.65 Percentage of subjects
Interval 1.26 to 2.13
|
0.25 Percentage of subjects
Interval 0.03 to 0.91
|
0.07 Percentage of subjects
Interval 0.01 to 0.28
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Fatigue, Week 35-43
|
1.62 Percentage of subjects
Interval 1.24 to 2.09
|
0.31 Percentage of subjects
Interval 0.03 to 0.31
|
0.07 Percentage of subjects
Interval 0.01 to 0.27
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Fatigue, Week 35-44
|
1.58 Percentage of subjects
Interval 1.2 to 2.04
|
0.39 Percentage of subjects
Interval 0.03 to 1.26
|
0.06 Percentage of subjects
Interval 0.01 to 0.21
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Fatigue, Week 35-45
|
1.56 Percentage of subjects
Interval 1.2 to 2.0
|
0.40 Percentage of subjects
Interval 0.13 to 0.93
|
0.08 Percentage of subjects
Interval 0.01 to 0.26
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Fatigue, Week 35-46
|
1.55 Percentage of subjects
Interval 1.18 to 2.01
|
0.33 Percentage of subjects
Interval 0.08 to 0.88
|
0.08 Percentage of subjects
Interval 0.01 to 0.26
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Fatigue, Week 35-47
|
1.53 Percentage of subjects
Interval 1.16 to 1.98
|
0.31 Percentage of subjects
Interval 0.08 to 0.84
|
0.07 Percentage of subjects
Interval 0.01 to 0.25
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Fatigue, Week 35-48
|
1.52 Percentage of subjects
Interval 1.14 to 1.97
|
0.30 Percentage of subjects
Interval 0.07 to 0.81
|
0.07 Percentage of subjects
Interval 0.01 to 0.24
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Headache, Week 35-35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Headache, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Headache, Week 35-37
|
2.27 Percentage of subjects
Interval 1.61 to 3.11
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 0.69
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Headache, Week 35-38
|
2.09 Percentage of subjects
Interval 1.36 to 3.06
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 0.34
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Headache, Week 35-39
|
2.01 Percentage of subjects
Interval 1.34 to 2.89
|
0.82 Percentage of subjects
Interval 0.02 to 4.48
|
0.06 Percentage of subjects
Interval 0.0 to 0.46
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Headache, Week 35-40
|
1.94 Percentage of subjects
Interval 1.34 to 2.71
|
1.29 Percentage of subjects
Interval 0.12 to 4.96
|
0.05 Percentage of subjects
Interval 0.0 to 0.28
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Headache, Week 35-41
|
1.81 Percentage of subjects
Interval 1.25 to 2.54
|
1.12 Percentage of subjects
Interval 0.18 to 3.56
|
0.04 Percentage of subjects
Interval 0.0 to 0.25
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Headache, Week 35-42
|
1.75 Percentage of subjects
Interval 1.2 to 2.46
|
0.82 Percentage of subjects
Interval 0.15 to 2.48
|
0.04 Percentage of subjects
Interval 0.0 to 0.23
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Headache, Week 35-43
|
1.74 Percentage of subjects
Interval 1.19 to 2.45
|
0.81 Percentage of subjects
Interval 0.14 to 2.56
|
0.03 Percentage of subjects
Interval 0.0 to 0.21
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Headache, Week 35-44
|
1.73 Percentage of subjects
Interval 1.19 to 2.42
|
0.87 Percentage of subjects
Interval 0.18 to 2.52
|
0.03 Percentage of subjects
Interval 0.0 to 0.19
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Headache, Week 35-45
|
1.72 Percentage of subjects
Interval 1.19 to 2.39
|
0.89 Percentage of subjects
Interval 0.21 to 2.41
|
0.16 Percentage of subjects
Interval 0.01 to 0.68
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Headache, Week 35-46
|
1.68 Percentage of subjects
Interval 1.16 to 2.36
|
0.75 Percentage of subjects
Interval 0.13 to 2.4
|
0.15 Percentage of subjects
Interval 0.01 to 0.66
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Headache, Week 35-47
|
1.66 Percentage of subjects
Interval 1.15 to 2.33
|
0.72 Percentage of subjects
Interval 0.12 to 2.29
|
0.14 Percentage of subjects
Interval 0.01 to 0.64
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Headache, Week 35-48
|
1.65 Percentage of subjects
Interval 1.14 to 2.31
|
0.69 Percentage of subjects
Interval 0.12 to 2.21
|
0.14 Percentage of subjects
Interval 0.01 to 0.63
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Irritability, Week 35-35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Irritability, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Irritability, Week 35-37
|
0.41 Percentage of subjects
Interval 0.19 to 0.74
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 0.69
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Irritability, Week 35-38
|
0.33 Percentage of subjects
Interval 0.15 to 0.61
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 0.34
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Irritability, Week 35-39
|
0.34 Percentage of subjects
Interval 0.16 to 0.63
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
0.00 Percentage of subjects
Interval 0.0 to 0.24
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Irritability, Week 35-40
|
0.31 Percentage of subjects
Interval 0.16 to 0.53
|
0.00 Percentage of subjects
Interval 0.0 to 0.79
|
0.00 Percentage of subjects
Interval 0.0 to 0.17
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Irritability, Week 35-41
|
0.28 Percentage of subjects
Interval 0.14 to 0.5
|
0.00 Percentage of subjects
Interval 0.0 to 0.46
|
0.00 Percentage of subjects
Interval 0.0 to 0.15
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Irritability, Week 35-42
|
0.27 Percentage of subjects
Interval 0.13 to 0.5
|
0.08 Percentage of subjects
Interval 0.0 to 0.46
|
0.00 Percentage of subjects
Interval 0.0 to 0.13
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Irritability, Week 35-43
|
0.27 Percentage of subjects
Interval 0.13 to 0.5
|
0.12 Percentage of subjects
Interval 0.01 to 0.47
|
0.00 Percentage of subjects
Interval 0.0 to 0.13
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Irritability, Week 35-44
|
0.26 Percentage of subjects
Interval 0.12 to 0.48
|
0.19 Percentage of subjects
Interval 0.02 to 0.79
|
0.00 Percentage of subjects
Interval 0.0 to 0.11
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Irritability, Week 35-45
|
0.26 Percentage of subjects
Interval 0.13 to 0.47
|
0.16 Percentage of subjects
Interval 0.01 to 0.69
|
0.00 Percentage of subjects
Interval 0.0 to 0.1
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Irritability, Week 35-46
|
0.26 Percentage of subjects
Interval 0.13 to 0.46
|
0.13 Percentage of subjects
Interval 0.01 to 0.63
|
0.00 Percentage of subjects
Interval 0.0 to 0.09
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Irritability, Week 35-47
|
0.25 Percentage of subjects
Interval 0.13 to 0.45
|
0.12 Percentage of subjects
Interval 0.01 to 0.6
|
0.00 Percentage of subjects
Interval 0.0 to 0.09
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Irritability, Week 35-48
|
0.25 Percentage of subjects
Interval 0.12 to 0.45
|
0.12 Percentage of subjects
Interval 0.01 to 0.58
|
0.00 Percentage of subjects
Interval 0.0 to 0.09
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Malaise, Week 35-35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Malaise, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Malaise, Week 35-37
|
0.04 Percentage of subjects
Interval 0.0 to 0.25
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 0.69
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Malaise, Week 35-38
|
0.02 Percentage of subjects
Interval 0.0 to 0.11
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 0.34
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Malaise, Week 35-39
|
0.01 Percentage of subjects
Interval 0.0 to 0.07
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
0.00 Percentage of subjects
Interval 0.0 to 0.24
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Malaise, Week 35-40
|
0.02 Percentage of subjects
Interval 0.0 to 0.07
|
0.22 Percentage of subjects
Interval 0.01 to 1.19
|
0.00 Percentage of subjects
Interval 0.0 to 0.17
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Malaise, Week 35-41
|
0.02 Percentage of subjects
Interval 0.0 to 0.07
|
0.12 Percentage of subjects
Interval 0.0 to 0.81
|
0.00 Percentage of subjects
Interval 0.0 to 0.15
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Malaise, Week 35-42
|
0.02 Percentage of subjects
Interval 0.0 to 0.06
|
0.16 Percentage of subjects
Interval 0.02 to 0.59
|
0.00 Percentage of subjects
Interval 0.0 to 0.13
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Malaise, Week 35-43
|
0.02 Percentage of subjects
Interval 0.0 to 0.06
|
0.12 Percentage of subjects
Interval 0.02 to 0.45
|
0.00 Percentage of subjects
Interval 0.0 to 0.13
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Malaise, Week 35-44
|
0.02 Percentage of subjects
Interval 0.0 to 0.06
|
0.10 Percentage of subjects
Interval 0.01 to 0.35
|
0.00 Percentage of subjects
Interval 0.0 to 0.11
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Malaise, Week 35-45
|
0.02 Percentage of subjects
Interval 0.0 to 0.06
|
0.12 Percentage of subjects
Interval 0.03 to 0.35
|
0.00 Percentage of subjects
Interval 0.0 to 0.1
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Malaise, Week 35-46
|
0.02 Percentage of subjects
Interval 0.0 to 0.05
|
0.10 Percentage of subjects
Interval 0.02 to 0.29
|
0.00 Percentage of subjects
Interval 0.0 to 0.09
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group
Malaise, Week 35-48
|
0.02 Percentage of subjects
Interval 0.0 to 0.05
|
0.09 Percentage of subjects
Interval 0.02 to 0.26
|
0.00 Percentage of subjects
Interval 0.0 to 0.09
|
SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start up to end of the week of interest and were registered in EHR (routine data collection \& card-based ADR reporting) during FU period (from vaccination up to 7 days post-vaccination)
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16433 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=3310 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=4196 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
1.61 Percentage of subjects
Interval 0.0 to 14.32
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-37
|
6.44 Percentage of subjects
Interval 5.26 to 7.8
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.75 Percentage of subjects
Interval 0.1 to 2.64
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-38
|
5.61 Percentage of subjects
Interval 4.75 to 6.57
|
6.25 Percentage of subjects
Interval 0.12 to 31.55
|
0.65 Percentage of subjects
Interval 0.12 to 1.96
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-39
|
5.33 Percentage of subjects
Interval 4.65 to 6.08
|
1.64 Percentage of subjects
Interval 0.2 to 5.8
|
0.83 Percentage of subjects
Interval 0.21 to 2.21
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-40
|
5.33 Percentage of subjects
Interval 4.5 to 6.26
|
3.45 Percentage of subjects
Interval 1.92 to 5.68
|
0.89 Percentage of subjects
Interval 0.25 to 2.22
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-41
|
5.24 Percentage of subjects
Interval 4.42 to 6.17
|
3.59 Percentage of subjects
Interval 2.39 to 5.17
|
0.79 Percentage of subjects
Interval 0.24 to 1.89
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-42
|
5.07 Percentage of subjects
Interval 4.22 to 6.02
|
2.63 Percentage of subjects
Interval 1.7 to 3.86
|
0.86 Percentage of subjects
Interval 0.3 to 1.93
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-43
|
4.99 Percentage of subjects
Interval 4.13 to 5.96
|
2.69 Percentage of subjects
Interval 1.78 to 3.87
|
0.81 Percentage of subjects
Interval 0.29 to 1.8
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-44
|
4.89 Percentage of subjects
Interval 4.03 to 5.88
|
2.90 Percentage of subjects
Interval 1.86 to 4.29
|
0.74 Percentage of subjects
Interval 0.3 to 1.53
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-45
|
4.82 Percentage of subjects
Interval 3.95 to 5.81
|
2.63 Percentage of subjects
Interval 1.49 to 4.26
|
0.88 Percentage of subjects
Interval 0.41 to 1.66
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-46
|
4.77 Percentage of subjects
Interval 3.88 to 5.79
|
2.26 Percentage of subjects
Interval 1.08 to 4.15
|
0.86 Percentage of subjects
Interval 0.4 to 1.62
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-47
|
4.74 Percentage of subjects
Interval 3.85 to 5.76
|
2.21 Percentage of subjects
Interval 1.08 to 4.0
|
0.89 Percentage of subjects
Interval 0.42 to 1.66
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-48
|
4.70 Percentage of subjects
Interval 3.81 to 5.73
|
2.21 Percentage of subjects
Interval 1.07 to 4.0
|
0.88 Percentage of subjects
Interval 0.41 to 1.64
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Conjunctivitis, Week 35-35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Conjunctivitis, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Conjunctivitis, Week 35-37
|
0.24 Percentage of subjects
Interval 0.09 to 0.53
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 0.69
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Conjunctivitis, Week 35-38
|
0.38 Percentage of subjects
Interval 0.16 to 0.77
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 0.34
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Conjunctivitis, Week 35-39
|
0.35 Percentage of subjects
Interval 0.21 to 0.56
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
0.06 Percentage of subjects
Interval 0.0 to 0.52
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Conjunctivitis, Week 35-40
|
0.35 Percentage of subjects
Interval 0.21 to 0.54
|
0.00 Percentage of subjects
Interval 0.0 to 0.79
|
0.05 Percentage of subjects
Interval 0.0 to 0.38
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Conjunctivitis, Week 35-41
|
0.36 Percentage of subjects
Interval 0.24 to 0.52
|
0.00 Percentage of subjects
Interval 0.0 to 0.46
|
0.04 Percentage of subjects
Interval 0.0 to 0.31
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Conjunctivitis, Week 35-42
|
0.34 Percentage of subjects
Interval 0.22 to 0.51
|
0.08 Percentage of subjects
Interval 0.0 to 0.46
|
0.07 Percentage of subjects
Interval 0.0 to 0.36
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Conjunctivitis, Week 35-43
|
0.34 Percentage of subjects
Interval 0.21 to 0.52
|
0.12 Percentage of subjects
Interval 0.01 to 0.47
|
0.07 Percentage of subjects
Interval 0.0 to 0.34
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Conjunctivitis, Week 35-44
|
0.35 Percentage of subjects
Interval 0.22 to 0.52
|
0.14 Percentage of subjects
Interval 0.03 to 0.42
|
0.09 Percentage of subjects
Interval 0.01 to 0.37
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Conjunctivitis, Week 35-45
|
0.34 Percentage of subjects
Interval 0.21 to 0.51
|
0.12 Percentage of subjects
Interval 0.03 to 0.35
|
0.13 Percentage of subjects
Interval 0.01 to 0.57
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Conjunctivitis, Week 35-46
|
0.33 Percentage of subjects
Interval 0.21 to 0.5
|
0.10 Percentage of subjects
Interval 0.02 to 0.29
|
0.13 Percentage of subjects
Interval 0.01 to 0.56
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Conjunctivitis, Week 35-47
|
0.33 Percentage of subjects
Interval 0.2 to 0.5
|
0.09 Percentage of subjects
Interval 0.02 to 0.27
|
0.12 Percentage of subjects
Interval 0.01 to 0.54
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Conjunctivitis, Week 35-48
|
0.32 Percentage of subjects
Interval 0.2 to 0.49
|
0.09 Percentage of subjects
Interval 0.02 to 0.26
|
0.12 Percentage of subjects
Interval 0.01 to 0.53
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Coryza, Week 35-35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Coryza, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Coryza, Week 35-37
|
1.38 Percentage of subjects
Interval 0.75 to 2.32
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 0.69
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Coryza, Week 35-38
|
1.15 Percentage of subjects
Interval 0.82 to 1.56
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.09 Percentage of subjects
Interval 0.0 to 0.74
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Coryza, Week 35-39
|
1.19 Percentage of subjects
Interval 0.91 to 1.53
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
0.06 Percentage of subjects
Interval 0.0 to 0.46
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Coryza, Week 35-40
|
1.16 Percentage of subjects
Interval 0.88 to 1.5
|
1.08 Percentage of subjects
Interval 0.34 to 2.54
|
0.05 Percentage of subjects
Interval 0.0 to 0.28
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Coryza, Week 35-41
|
1.17 Percentage of subjects
Interval 0.91 to 1.49
|
0.74 Percentage of subjects
Interval 0.27 to 1.61
|
0.04 Percentage of subjects
Interval 0.0 to 0.25
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Coryza, Week 35-42
|
1.12 Percentage of subjects
Interval 0.87 to 1.42
|
0.49 Percentage of subjects
Interval 0.15 to 1.19
|
0.04 Percentage of subjects
Interval 0.0 to 0.23
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Coryza, Week 35-43
|
1.11 Percentage of subjects
Interval 0.85 to 1.42
|
0.56 Percentage of subjects
Interval 0.2 to 1.25
|
0.03 Percentage of subjects
Interval 0.0 to 0.21
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Coryza, Week 35-44
|
1.08 Percentage of subjects
Interval 0.83 to 1.4
|
0.53 Percentage of subjects
Interval 0.25 to 0.99
|
0.03 Percentage of subjects
Interval 0.0 to 0.19
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Coryza, Week 35-45
|
1.07 Percentage of subjects
Interval 0.8 to 1.39
|
0.48 Percentage of subjects
Interval 0.2 to 1.0
|
0.05 Percentage of subjects
Interval 0.01 to 0.19
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Coryza, Week 35-46
|
1.06 Percentage of subjects
Interval 0.8 to 1.38
|
0.39 Percentage of subjects
Interval 0.14 to 0.87
|
0.05 Percentage of subjects
Interval 0.01 to 0.18
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Coryza, Week 35-47
|
1.06 Percentage of subjects
Interval 0.81 to 1.36
|
0.37 Percentage of subjects
Interval 0.13 to 0.83
|
0.05 Percentage of subjects
Interval 0.01 to 0.17
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Coryza, Week 35-48
|
1.05 Percentage of subjects
Interval 0.8 to 1.35
|
0.36 Percentage of subjects
Interval 0.13 to 0.8
|
0.05 Percentage of subjects
Interval 0.01 to 0.17
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Cough, Week 35-35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Cough, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
1.61 Percentage of subjects
Interval 0.0 to 14.32
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Cough, Week 35-37
|
2.31 Percentage of subjects
Interval 1.64 to 3.15
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.75 Percentage of subjects
Interval 0.1 to 2.64
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Cough, Week 35-38
|
2.12 Percentage of subjects
Interval 1.61 to 2.76
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.47 Percentage of subjects
Interval 0.1 to 1.32
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Cough, Week 35-39
|
2.21 Percentage of subjects
Interval 1.88 to 2.57
|
0.82 Percentage of subjects
Interval 0.02 to 4.48
|
0.64 Percentage of subjects
Interval 0.16 to 1.71
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Cough, Week 35-40
|
2.11 Percentage of subjects
Interval 1.71 to 2.57
|
2.16 Percentage of subjects
Interval 0.85 to 4.44
|
0.70 Percentage of subjects
Interval 0.17 to 1.89
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Cough, Week 35-41
|
2.10 Percentage of subjects
Interval 1.73 to 2.52
|
2.11 Percentage of subjects
Interval 1.18 to 3.45
|
0.63 Percentage of subjects
Interval 0.17 to 1.63
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Cough, Week 35-42
|
2.03 Percentage of subjects
Interval 1.66 to 2.46
|
1.48 Percentage of subjects
Interval 0.73 to 2.65
|
0.61 Percentage of subjects
Interval 0.18 to 1.49
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Cough, Week 35-43
|
2.00 Percentage of subjects
Interval 1.62 to 2.45
|
1.56 Percentage of subjects
Interval 0.97 to 2.37
|
0.58 Percentage of subjects
Interval 0.18 to 1.39
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Cough, Week 35-44
|
1.97 Percentage of subjects
Interval 1.59 to 2.41
|
1.69 Percentage of subjects
Interval 1.0 to 2.67
|
0.48 Percentage of subjects
Interval 0.13 to 1.23
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Cough, Week 35-45
|
1.95 Percentage of subjects
Interval 1.57 to 2.39
|
1.58 Percentage of subjects
Interval 0.84 to 2.67
|
0.52 Percentage of subjects
Interval 0.19 to 1.13
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Cough, Week 35-46
|
1.96 Percentage of subjects
Interval 1.58 to 2.4
|
1.34 Percentage of subjects
Interval 0.63 to 2.5
|
0.51 Percentage of subjects
Interval 0.18 to 1.11
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Cough, Week 35-47
|
1.95 Percentage of subjects
Interval 1.56 to 2.41
|
1.28 Percentage of subjects
Interval 0.6 to 2.36
|
0.53 Percentage of subjects
Interval 0.2 to 1.15
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Cough, Week 35-48
|
1.94 Percentage of subjects
Interval 1.54 to 2.39
|
1.30 Percentage of subjects
Interval 0.61 to 2.41
|
0.52 Percentage of subjects
Interval 0.19 to 1.14
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Epistaxis, Week 35-35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Epistaxis, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Epistaxis, Week 35-37
|
0.08 Percentage of subjects
Interval 0.0 to 0.48
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 0.69
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Epistaxis, Week 35-38
|
0.06 Percentage of subjects
Interval 0.0 to 0.37
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 0.34
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Epistaxis, Week 35-39
|
0.09 Percentage of subjects
Interval 0.02 to 0.23
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
0.00 Percentage of subjects
Interval 0.0 to 0.24
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Epistaxis, Week 35-40
|
0.10 Percentage of subjects
Interval 0.04 to 0.21
|
0.00 Percentage of subjects
Interval 0.0 to 0.79
|
0.00 Percentage of subjects
Interval 0.0 to 0.17
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Epistaxis, Week 35-41
|
0.09 Percentage of subjects
Interval 0.04 to 0.19
|
0.00 Percentage of subjects
Interval 0.0 to 0.46
|
0.00 Percentage of subjects
Interval 0.0 to 0.15
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Epistaxis, Week 35-42
|
0.09 Percentage of subjects
Interval 0.04 to 0.17
|
0.00 Percentage of subjects
Interval 0.0 to 0.3
|
0.00 Percentage of subjects
Interval 0.0 to 0.13
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Epistaxis, Week 35-43
|
0.08 Percentage of subjects
Interval 0.04 to 0.16
|
0.00 Percentage of subjects
Interval 0.0 to 0.23
|
0.00 Percentage of subjects
Interval 0.0 to 0.13
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Epistaxis, Week 35-44
|
0.09 Percentage of subjects
Interval 0.04 to 0.18
|
0.00 Percentage of subjects
Interval 0.0 to 0.18
|
0.00 Percentage of subjects
Interval 0.0 to 0.11
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Epistaxis, Week 35-45
|
0.09 Percentage of subjects
Interval 0.04 to 0.18
|
0.00 Percentage of subjects
Interval 0.0 to 0.15
|
0.00 Percentage of subjects
Interval 0.0 to 0.1
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Epistaxis, Week 35-46
|
0.09 Percentage of subjects
Interval 0.04 to 0.18
|
0.00 Percentage of subjects
Interval 0.0 to 0.12
|
0.00 Percentage of subjects
Interval 0.0 to 0.09
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Wheezing, Week 35-39
|
0.60 Percentage of subjects
Interval 0.35 to 0.95
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
0.00 Percentage of subjects
Interval 0.0 to 0.24
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Wheezing, Week 35-40
|
0.61 Percentage of subjects
Interval 0.35 to 0.97
|
0.22 Percentage of subjects
Interval 0.01 to 1.19
|
0.00 Percentage of subjects
Interval 0.0 to 0.17
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Wheezing, Week 35-41
|
0.57 Percentage of subjects
Interval 0.31 to 0.94
|
0.37 Percentage of subjects
Interval 0.08 to 1.08
|
0.00 Percentage of subjects
Interval 0.0 to 0.15
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Wheezing, Week 35-42
|
0.54 Percentage of subjects
Interval 0.31 to 0.89
|
0.25 Percentage of subjects
Interval 0.05 to 0.72
|
0.00 Percentage of subjects
Interval 0.0 to 0.13
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Wheezing, Week 35-43
|
0.53 Percentage of subjects
Interval 0.31 to 0.85
|
0.31 Percentage of subjects
Interval 0.09 to 0.77
|
0.00 Percentage of subjects
Interval 0.0 to 0.13
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Wheezing, Week 35-44
|
0.52 Percentage of subjects
Interval 0.31 to 0.81
|
0.48 Percentage of subjects
Interval 0.15 to 1.15
|
0.00 Percentage of subjects
Interval 0.0 to 0.11
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Wheezing, Week 35-45
|
0.51 Percentage of subjects
Interval 0.31 to 0.79
|
0.40 Percentage of subjects
Interval 0.11 to 1.02
|
0.00 Percentage of subjects
Interval 0.0 to 0.1
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Wheezing, Week 35-46
|
0.50 Percentage of subjects
Interval 0.3 to 0.78
|
0.39 Percentage of subjects
Interval 0.1 to 1.01
|
0.00 Percentage of subjects
Interval 0.0 to 0.09
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Wheezing, Week 35-47
|
0.50 Percentage of subjects
Interval 0.3 to 0.78
|
0.40 Percentage of subjects
Interval 0.13 to 0.95
|
0.00 Percentage of subjects
Interval 0.0 to 0.09
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Wheezing, Week 35-48
|
0.49 Percentage of subjects
Interval 0.3 to 0.77
|
0.39 Percentage of subjects
Interval 0.13 to 0.92
|
0.00 Percentage of subjects
Interval 0.0 to 0.09
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Epistaxis, Week 35-47
|
0.09 Percentage of subjects
Interval 0.04 to 0.17
|
0.00 Percentage of subjects
Interval 0.0 to 0.11
|
0.00 Percentage of subjects
Interval 0.0 to 0.09
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Epistaxis, Week 35-48
|
0.09 Percentage of subjects
Interval 0.04 to 0.17
|
0.00 Percentage of subjects
Interval 0.0 to 0.11
|
0.00 Percentage of subjects
Interval 0.0 to 0.09
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Hoarseness, Week 35-35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Hoarseness, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Hoarseness, Week 35-37
|
1.09 Percentage of subjects
Interval 0.72 to 1.59
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 0.69
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Hoarseness, Week 35-38
|
0.96 Percentage of subjects
Interval 0.71 to 1.26
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 0.34
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Hoarseness, Week 35-39
|
0.77 Percentage of subjects
Interval 0.6 to 0.97
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
0.00 Percentage of subjects
Interval 0.0 to 0.24
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Hoarseness, Week 35-40
|
0.72 Percentage of subjects
Interval 0.57 to 0.89
|
0.22 Percentage of subjects
Interval 0.01 to 1.19
|
0.00 Percentage of subjects
Interval 0.0 to 0.17
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Hoarseness, Week 35-41
|
0.70 Percentage of subjects
Interval 0.55 to 0.87
|
0.37 Percentage of subjects
Interval 0.08 to 1.08
|
0.00 Percentage of subjects
Interval 0.0 to 0.15
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Hoarseness, Week 35-42
|
0.67 Percentage of subjects
Interval 0.53 to 0.82
|
0.25 Percentage of subjects
Interval 0.05 to 0.72
|
0.00 Percentage of subjects
Interval 0.0 to 0.13
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Hoarseness, Week 35-43
|
0.67 Percentage of subjects
Interval 0.53 to 0.84
|
0.25 Percentage of subjects
Interval 0.07 to 0.64
|
0.00 Percentage of subjects
Interval 0.0 to 0.13
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Hoarseness, Week 35-44
|
0.65 Percentage of subjects
Interval 0.52 to 0.81
|
0.24 Percentage of subjects
Interval 0.05 to 0.68
|
0.00 Percentage of subjects
Interval 0.0 to 0.11
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Hoarseness, Week 35-45
|
0.65 Percentage of subjects
Interval 0.51 to 0.82
|
0.20 Percentage of subjects
Interval 0.04 to 0.6
|
0.03 Percentage of subjects
Interval 0.0 to 0.15
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Hoarseness, Week 35-46
|
0.64 Percentage of subjects
Interval 0.5 to 0.81
|
0.16 Percentage of subjects
Interval 0.02 to 0.56
|
0.03 Percentage of subjects
Interval 0.0 to 0.15
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Hoarseness, Week 35-47
|
0.64 Percentage of subjects
Interval 0.51 to 0.8
|
0.16 Percentage of subjects
Interval 0.02 to 0.54
|
0.02 Percentage of subjects
Interval 0.0 to 0.14
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Hoarseness, Week 35-48
|
0.63 Percentage of subjects
Interval 0.5 to 0.79
|
0.15 Percentage of subjects
Interval 0.02 to 0.52
|
0.02 Percentage of subjects
Interval 0.0 to 0.14
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Nasal congestion, Week 35-35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Nasal congestion, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Nasal congestion, Week 35-37
|
1.34 Percentage of subjects
Interval 0.92 to 1.87
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 0.69
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Nasal congestion, Week 35-38
|
1.11 Percentage of subjects
Interval 0.81 to 1.48
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.09 Percentage of subjects
Interval 0.0 to 0.74
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Nasal congestion, Week 35-39
|
1.04 Percentage of subjects
Interval 0.74 to 1.41
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
0.06 Percentage of subjects
Interval 0.0 to 0.46
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Nasal congestion, Week 35-40
|
1.01 Percentage of subjects
Interval 0.72 to 1.37
|
0.43 Percentage of subjects
Interval 0.01 to 2.34
|
0.05 Percentage of subjects
Interval 0.0 to 0.28
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Nasal congestion, Week 35-41
|
0.94 Percentage of subjects
Interval 0.67 to 1.29
|
0.62 Percentage of subjects
Interval 0.2 to 1.44
|
0.04 Percentage of subjects
Interval 0.0 to 0.25
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Nasal congestion, Week 35-42
|
0.91 Percentage of subjects
Interval 0.65 to 1.23
|
0.41 Percentage of subjects
Interval 0.13 to 0.95
|
0.07 Percentage of subjects
Interval 0.01 to 0.29
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Nasal congestion, Week 35-43
|
0.88 Percentage of subjects
Interval 0.63 to 1.2
|
0.50 Percentage of subjects
Interval 0.22 to 0.98
|
0.07 Percentage of subjects
Interval 0.01 to 0.27
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Nasal congestion, Week 35-44
|
0.85 Percentage of subjects
Interval 0.61 to 1.17
|
0.43 Percentage of subjects
Interval 0.2 to 0.82
|
0.06 Percentage of subjects
Interval 0.0 to 0.24
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Nasal congestion, Week 35-45
|
0.85 Percentage of subjects
Interval 0.61 to 1.16
|
0.40 Percentage of subjects
Interval 0.18 to 0.79
|
0.08 Percentage of subjects
Interval 0.02 to 0.23
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Nasal congestion, Week 35-46
|
0.85 Percentage of subjects
Interval 0.62 to 1.15
|
0.33 Percentage of subjects
Interval 0.11 to 0.74
|
0.08 Percentage of subjects
Interval 0.02 to 0.22
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Nasal congestion, Week 35-47
|
0.85 Percentage of subjects
Interval 0.61 to 1.16
|
0.31 Percentage of subjects
Interval 0.11 to 0.7
|
0.07 Percentage of subjects
Interval 0.01 to 0.21
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Nasal congestion, Week 35-48
|
0.85 Percentage of subjects
Interval 0.6 to 1.15
|
0.30 Percentage of subjects
Interval 0.1 to 0.68
|
0.07 Percentage of subjects
Interval 0.01 to 0.21
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Oropharyngeal pain, Week 35-35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Oropharyngeal pain, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Oropharyngeal pain, Week 35-37
|
2.27 Percentage of subjects
Interval 1.64 to 3.06
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 0.69
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Oropharyngeal pain, Week 35-38
|
1.80 Percentage of subjects
Interval 1.29 to 2.44
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.09 Percentage of subjects
Interval 0.0 to 0.67
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Oropharyngeal pain, Week 35-39
|
1.70 Percentage of subjects
Interval 1.31 to 2.17
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
0.06 Percentage of subjects
Interval 0.0 to 0.46
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Oropharyngeal pain, Week 35-40
|
1.58 Percentage of subjects
Interval 1.16 to 2.1
|
0.22 Percentage of subjects
Interval 0.01 to 1.19
|
0.09 Percentage of subjects
Interval 0.0 to 0.44
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Oropharyngeal pain, Week 35-41
|
1.53 Percentage of subjects
Interval 1.15 to 2.0
|
0.50 Percentage of subjects
Interval 0.05 to 1.94
|
0.08 Percentage of subjects
Interval 0.0 to 0.36
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Oropharyngeal pain, Week 35-42
|
1.46 Percentage of subjects
Interval 1.07 to 1.94
|
0.41 Percentage of subjects
Interval 0.1 to 1.09
|
0.11 Percentage of subjects
Interval 0.02 to 0.34
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Oropharyngeal pain, Week 35-43
|
1.43 Percentage of subjects
Interval 1.04 to 1.91
|
0.44 Percentage of subjects
Interval 0.09 to 1.27
|
0.10 Percentage of subjects
Interval 0.02 to 0.31
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Oropharyngeal pain, Week 35-44
|
1.41 Percentage of subjects
Interval 1.02 to 1.88
|
0.48 Percentage of subjects
Interval 0.07 to 1.63
|
0.11 Percentage of subjects
Interval 0.02 to 0.33
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Oropharyngeal pain, Week 35-45
|
1.39 Percentage of subjects
Interval 1.01 to 1.87
|
0.48 Percentage of subjects
Interval 0.13 to 1.22
|
0.16 Percentage of subjects
Interval 0.02 to 0.51
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Oropharyngeal pain, Week 35-46
|
1.37 Percentage of subjects
Interval 0.99 to 1.84
|
0.39 Percentage of subjects
Interval 0.08 to 1.15
|
0.15 Percentage of subjects
Interval 0.02 to 0.49
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Oropharyngeal pain, Week 35-47
|
1.34 Percentage of subjects
Interval 0.97 to 1.82
|
0.37 Percentage of subjects
Interval 0.08 to 1.1
|
0.17 Percentage of subjects
Interval 0.02 to 0.6
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Oropharyngeal pain, Week 35-48
|
1.33 Percentage of subjects
Interval 0.96 to 1.8
|
0.36 Percentage of subjects
Interval 0.07 to 1.06
|
0.17 Percentage of subjects
Interval 0.02 to 0.59
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Rhinorrhoea, Week 35-35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Rhinorrhoea, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Rhinorrhoea, Week 35-37
|
3.28 Percentage of subjects
Interval 2.17 to 4.74
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 0.69
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Rhinorrhoea, Week 35-38
|
2.83 Percentage of subjects
Interval 2.07 to 3.78
|
6.25 Percentage of subjects
Interval 0.12 to 31.55
|
0.00 Percentage of subjects
Interval 0.0 to 0.34
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Rhinorrhoea, Week 35-39
|
2.58 Percentage of subjects
Interval 1.91 to 3.41
|
0.82 Percentage of subjects
Interval 0.02 to 4.48
|
0.00 Percentage of subjects
Interval 0.0 to 0.24
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Rhinorrhoea, Week 35-40
|
2.55 Percentage of subjects
Interval 1.91 to 3.34
|
1.08 Percentage of subjects
Interval 0.34 to 2.54
|
0.00 Percentage of subjects
Interval 0.0 to 0.17
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Rhinorrhoea, Week 35-41
|
2.47 Percentage of subjects
Interval 1.83 to 3.26
|
1.36 Percentage of subjects
Interval 0.66 to 2.48
|
0.00 Percentage of subjects
Interval 0.0 to 0.15
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Rhinorrhoea, Week 35-42
|
2.38 Percentage of subjects
Interval 1.74 to 3.16
|
1.07 Percentage of subjects
Interval 0.53 to 1.9
|
0.00 Percentage of subjects
Interval 0.0 to 0.13
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Rhinorrhoea, Week 35-43
|
2.36 Percentage of subjects
Interval 1.7 to 3.19
|
1.19 Percentage of subjects
Interval 0.7 to 1.88
|
0.00 Percentage of subjects
Interval 0.0 to 0.13
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Rhinorrhoea, Week 35-44
|
2.32 Percentage of subjects
Interval 1.67 to 3.13
|
1.16 Percentage of subjects
Interval 0.66 to 1.88
|
0.00 Percentage of subjects
Interval 0.0 to 0.11
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Rhinorrhoea, Week 35-45
|
2.29 Percentage of subjects
Interval 1.64 to 3.1
|
1.05 Percentage of subjects
Interval 0.54 to 1.83
|
0.08 Percentage of subjects
Interval 0.0 to 0.46
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Rhinorrhoea, Week 35-46
|
2.26 Percentage of subjects
Interval 1.61 to 3.09
|
0.88 Percentage of subjects
Interval 0.38 to 1.75
|
0.08 Percentage of subjects
Interval 0.0 to 0.45
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Rhinorrhoea, Week 35-47
|
2.25 Percentage of subjects
Interval 1.6 to 3.07
|
0.87 Percentage of subjects
Interval 0.37 to 1.74
|
0.07 Percentage of subjects
Interval 0.0 to 0.43
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Rhinorrhoea, Week 35-48
|
2.23 Percentage of subjects
Interval 1.58 to 3.05
|
0.85 Percentage of subjects
Interval 0.36 to 1.68
|
0.07 Percentage of subjects
Interval 0.0 to 0.42
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Wheezing, Week 35-35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Wheezing, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Wheezing, Week 35-37
|
0.93 Percentage of subjects
Interval 0.59 to 1.4
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 0.69
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group
Wheezing, Week 35-38
|
0.75 Percentage of subjects
Interval 0.46 to 1.14
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 0.34
|
SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start up to end of the week of interest and were registered in EHR (routine data collection \& card-based ADR reporting) during FU period (from vaccination up to 7 days post-vaccination)
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhoea, nausea, and vomiting. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16433 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=3310 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=4196 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Nausea, Week 35-39
|
0.91 Percentage of subjects
Interval 0.46 to 1.61
|
0.82 Percentage of subjects
Interval 0.02 to 4.48
|
0.00 Percentage of subjects
Interval 0.0 to 0.24
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Nausea, Week 35-40
|
0.84 Percentage of subjects
Interval 0.45 to 1.43
|
0.22 Percentage of subjects
Interval 0.01 to 1.19
|
0.00 Percentage of subjects
Interval 0.0 to 0.17
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Nausea, Week 35-41
|
0.80 Percentage of subjects
Interval 0.44 to 1.34
|
0.12 Percentage of subjects
Interval 0.0 to 0.69
|
0.00 Percentage of subjects
Interval 0.0 to 0.15
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-37
|
2.11 Percentage of subjects
Interval 2.11 to 1.3
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.19 Percentage of subjects
Interval 0.0 to 1.6
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-38
|
1.95 Percentage of subjects
Interval 1.4 to 2.64
|
6.25 Percentage of subjects
Interval 0.12 to 31.55
|
0.09 Percentage of subjects
Interval 0.0 to 0.77
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-39
|
1.76 Percentage of subjects
Interval 1.23 to 2.42
|
0.82 Percentage of subjects
Interval 0.02 to 4.48
|
0.06 Percentage of subjects
Interval 0.0 to 0.52
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-40
|
1.70 Percentage of subjects
Interval 1.28 to 2.22
|
1.08 Percentage of subjects
Interval 0.35 to 2.5
|
0.05 Percentage of subjects
Interval 0.0 to 0.38
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-41
|
1.65 Percentage of subjects
Interval 1.24 to 2.14
|
0.87 Percentage of subjects
Interval 0.35 to 1.78
|
0.04 Percentage of subjects
Interval 0.0 to 0.31
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-42
|
1.61 Percentage of subjects
Interval 1.22 to 2.08
|
0.57 Percentage of subjects
Interval 0.23 to 1.18
|
0.04 Percentage of subjects
Interval 0.0 to 0.28
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-43
|
1.58 Percentage of subjects
Interval 1.2 to 2.05
|
0.44 Percentage of subjects
Interval 0.15 to 0.98
|
0.07 Percentage of subjects
Interval 0.0 to 0.53
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-44
|
1.54 Percentage of subjects
Interval 1.17 to 1.98
|
0.43 Percentage of subjects
Interval 0.1 to 1.19
|
0.06 Percentage of subjects
Interval 0.0 to 0.37
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-45
|
1.55 Percentage of subjects
Interval 1.21 to 1.96
|
0.53 Percentage of subjects
Interval 0.21 to 1.1
|
0.13 Percentage of subjects
Interval 0.0 to 0.76
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-46
|
1.55 Percentage of subjects
Interval 1.21 to 1.95
|
0.46 Percentage of subjects
Interval 0.17 to 0.99
|
0.15 Percentage of subjects
Interval 0.01 to 0.69
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-47
|
1.52 Percentage of subjects
Interval 1.19 to 1.92
|
0.44 Percentage of subjects
Interval 0.16 to 0.95
|
0.14 Percentage of subjects
Interval 0.01 to 0.66
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-48
|
1.51 Percentage of subjects
Interval 1.18 to 1.9
|
0.42 Percentage of subjects
Interval 0.15 to 0.92
|
0.14 Percentage of subjects
Interval 0.01 to 0.66
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Decreased appetite, Week 35-35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Decreased appetite, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Decreased appetite, Week 35-37
|
0.73 Percentage of subjects
Interval 0.43 to 1.15
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 0.69
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Decreased appetite, Week 35-38
|
0.59 Percentage of subjects
Interval 0.4 to 0.84
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 0.34
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Decreased appetite, Week 35-39
|
0.54 Percentage of subjects
Interval 0.31 to 0.86
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
0.00 Percentage of subjects
Interval 0.0 to 0.24
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Decreased appetite, Week 35-40
|
0.50 Percentage of subjects
Interval 0.3 to 0.77
|
0.86 Percentage of subjects
Interval 0.24 to 2.19
|
0.00 Percentage of subjects
Interval 0.0 to 0.17
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Decreased appetite, Week 35-41
|
0.50 Percentage of subjects
Interval 0.32 to 0.75
|
0.62 Percentage of subjects
Interval 0.2 to 1.44
|
0.00 Percentage of subjects
Interval 0.0 to 0.15
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Decreased appetite, Week 35-42
|
0.48 Percentage of subjects
Interval 0.31 to 0.72
|
0.41 Percentage of subjects
Interval 0.13 to 0.95
|
0.00 Percentage of subjects
Interval 0.0 to 0.13
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Decreased appetite, Week 35-43
|
0.46 Percentage of subjects
Interval 0.29 to 0.7
|
0.31 Percentage of subjects
Interval 0.1 to 0.73
|
0.00 Percentage of subjects
Interval 0.0 to 0.13
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Decreased appetite, Week 35-44
|
0.45 Percentage of subjects
Interval 0.28 to 0.68
|
0.24 Percentage of subjects
Interval 0.07 to 0.61
|
0.00 Percentage of subjects
Interval 0.0 to 0.11
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Decreased appetite, Week 35-45
|
0.45 Percentage of subjects
Interval 0.3 to 0.65
|
0.24 Percentage of subjects
Interval 0.09 to 0.53
|
0.00 Percentage of subjects
Interval 0.0 to 0.1
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Decreased appetite, Week 35-46
|
0.46 Percentage of subjects
Interval 0.3 to 0.66
|
0.20 Percentage of subjects
Interval 0.06 to 0.47
|
0.00 Percentage of subjects
Interval 0.0 to 0.09
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Decreased appetite, Week 35-47
|
0.45 Percentage of subjects
Interval 0.3 to 0.65
|
0.19 Percentage of subjects
Interval 0.06 to 0.45
|
0.00 Percentage of subjects
Interval 0.0 to 0.09
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Decreased appetite, Week 35-48
|
0.44 Percentage of subjects
Interval 0.3 to 0.64
|
0.18 Percentage of subjects
Interval 0.06 to 0.43
|
0.00 Percentage of subjects
Interval 0.0 to 0.09
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Diarrhoea, Week 35-35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Diarrhoea, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Diarrhoea, Week 35-37
|
0.97 Percentage of subjects
Interval 0.58 to 1.54
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.19 Percentage of subjects
Interval 0.0 to 1.6
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Diarrhoea, Week 35-38
|
0.86 Percentage of subjects
Interval 0.63 to 1.15
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.09 Percentage of subjects
Interval 0.0 to 0.77
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Diarrhoea, Week 35-39
|
0.78 Percentage of subjects
Interval 0.59 to 1.02
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
0.06 Percentage of subjects
Interval 0.0 to 0.52
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Diarrhoea, Week 35-40
|
0.76 Percentage of subjects
Interval 0.6 to 0.95
|
0.00 Percentage of subjects
Interval 0.0 to 0.79
|
0.05 Percentage of subjects
Interval 0.0 to 0.38
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Diarrhoea, Week 35-41
|
0.75 Percentage of subjects
Interval 0.6 to 0.93
|
0.00 Percentage of subjects
Interval 0.0 to 0.46
|
0.04 Percentage of subjects
Interval 0.0 to 0.31
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Diarrhoea, Week 35-42
|
0.73 Percentage of subjects
Interval 0.59 to 0.9
|
0.00 Percentage of subjects
Interval 0.0 to 0.3
|
0.04 Percentage of subjects
Interval 0.0 to 0.28
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Diarrhoea, Week 35-43
|
0.72 Percentage of subjects
Interval 0.58 to 0.88
|
0.00 Percentage of subjects
Interval 0.0 to 0.23
|
0.07 Percentage of subjects
Interval 0.0 to 0.53
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Diarrhoea, Week 35-44
|
0.70 Percentage of subjects
Interval 0.56 to 0.85
|
0.05 Percentage of subjects
Interval 0.0 to 0.27
|
0.06 Percentage of subjects
Interval 0.0 to 0.37
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Diarrhoea, Week 35-45
|
0.70 Percentage of subjects
Interval 0.56 to 0.85
|
0.08 Percentage of subjects
Interval 0.01 to 0.34
|
0.06 Percentage of subjects
Interval 0.0 to 0.46
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Diarrhoea, Week 35-46
|
0.70 Percentage of subjects
Interval 0.56 to 0.86
|
0.07 Percentage of subjects
Interval 0.0 to 0.31
|
0.10 Percentage of subjects
Interval 0.01 to 0.41
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Diarrhoea, Week 35-47
|
0.69 Percentage of subjects
Interval 0.55 to 0.85
|
0.06 Percentage of subjects
Interval 0.0 to 0.3
|
0.10 Percentage of subjects
Interval 0.01 to 0.4
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Diarrhoea, Week 35-48
|
0.68 Percentage of subjects
Interval 0.55 to 0.84
|
0.06 Percentage of subjects
Interval 0.0 to 0.29
|
0.10 Percentage of subjects
Interval 0.01 to 0.39
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Nausea, Week 35-35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Nausea, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Nausea, Week 35-37
|
0.97 Percentage of subjects
Interval 0.49 to 1.72
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 0.69
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Nausea, Week 35-38
|
1.01 Percentage of subjects
Interval 0.49 to 1.86
|
6.25 Percentage of subjects
Interval 0.12 to 31.55
|
0.00 Percentage of subjects
Interval 0.0 to 0.34
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Nausea, Week 35-42
|
0.77 Percentage of subjects
Interval 0.42 to 1.29
|
0.08 Percentage of subjects
Interval 0.0 to 0.46
|
0.00 Percentage of subjects
Interval 0.0 to 0.13
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Nausea, Week 35-43
|
0.76 Percentage of subjects
Interval 0.42 to 1.27
|
0.06 Percentage of subjects
Interval 0.0 to 0.35
|
0.00 Percentage of subjects
Interval 0.0 to 0.13
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Nausea, Week 35-44
|
0.75 Percentage of subjects
Interval 0.42 to 1.22
|
0.10 Percentage of subjects
Interval 0.01 to 0.4
|
0.00 Percentage of subjects
Interval 0.0 to 0.11
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Nausea, Week 35-45
|
0.75 Percentage of subjects
Interval 0.44 to 1.19
|
0.16 Percentage of subjects
Interval 0.04 to 0.41
|
0.03 Percentage of subjects
Interval 0.0 to 0.15
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Nausea, Week 35-46
|
0.74 Percentage of subjects
Interval 0.43 to 1.17
|
0.13 Percentage of subjects
Interval 0.04 to 0.34
|
0.03 Percentage of subjects
Interval 0.0 to 0.15
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Nausea, Week 35-47
|
0.72 Percentage of subjects
Interval 0.42 to 1.15
|
0.12 Percentage of subjects
Interval 0.03 to 0.32
|
0.03 Percentage of subjects
Interval 0.0 to 0.14
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Nausea, Week 35-48
|
0.72 Percentage of subjects
Interval 0.42 to 1.14
|
0.12 Percentage of subjects
Interval 0.03 to 0.31
|
0.03 Percentage of subjects
Interval 0.0 to 0.14
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Vomiting, Week 35-35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Vomiting, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Vomiting, Week 35-37
|
0.12 Percentage of subjects
Interval 0.02 to 0.38
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 0.69
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Vomiting, Week 35-38
|
0.17 Percentage of subjects
Interval 0.08 to 0.33
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 0.34
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Vomiting, Week 35-39
|
0.18 Percentage of subjects
Interval 0.11 to 0.29
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
0.00 Percentage of subjects
Interval 0.0 to 0.24
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Vomiting, Week 35-40
|
0.16 Percentage of subjects
Interval 0.09 to 0.25
|
0.00 Percentage of subjects
Interval 0.0 to 0.79
|
0.00 Percentage of subjects
Interval 0.0 to 0.17
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Vomiting, Week 35-41
|
0.18 Percentage of subjects
Interval 0.11 to 0.26
|
0.12 Percentage of subjects
Interval 0.0 to 0.69
|
0.00 Percentage of subjects
Interval 0.0 to 0.15
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Vomiting, Week 35-42
|
0.19 Percentage of subjects
Interval 0.12 to 0.27
|
0.08 Percentage of subjects
Interval 0.0 to 0.46
|
0.00 Percentage of subjects
Interval 0.0 to 0.13
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Vomiting, Week 35-43
|
0.19 Percentage of subjects
Interval 0.12 to 0.27
|
0.06 Percentage of subjects
Interval 0.0 to 0.35
|
0.00 Percentage of subjects
Interval 0.0 to 0.13
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Vomiting, Week 35-44
|
0.18 Percentage of subjects
Interval 0.12 to 0.27
|
0.05 Percentage of subjects
Interval 0.0 to 0.27
|
0.00 Percentage of subjects
Interval 0.0 to 0.11
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Vomiting, Week 35-45
|
0.19 Percentage of subjects
Interval 0.12 to 0.28
|
0.04 Percentage of subjects
Interval 0.0 to 0.22
|
0.05 Percentage of subjects
Interval 0.0 to 0.31
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Vomiting, Week 35-46
|
0.19 Percentage of subjects
Interval 0.12 to 0.28
|
0.07 Percentage of subjects
Interval 0.01 to 0.24
|
0.05 Percentage of subjects
Interval 0.0 to 0.3
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Vomiting, Week 35-47
|
0.18 Percentage of subjects
Interval 0.12 to 0.27
|
0.06 Percentage of subjects
Interval 0.01 to 0.22
|
0.05 Percentage of subjects
Interval 0.0 to 0.29
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group
Vomiting, Week 35-48
|
0.18 Percentage of subjects
Interval 0.12 to 0.27
|
0.06 Percentage of subjects
Interval 0.01 to 0.22
|
0.05 Percentage of subjects
Interval 0.0 to 0.28
|
SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start up to end of the week of interest and were registered in EHR (routine data collection \& card-based ADR reporting) during FU period (from vaccination up to 7 days post-vaccination)
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16433 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=3310 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=4196 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-37
|
0.69 Percentage of subjects
Interval 0.01 to 4.09
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 0.69
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-38
|
0.63 Percentage of subjects
Interval 0.04 to 2.86
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.09 Percentage of subjects
Interval 0.0 to 0.53
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-39
|
0.54 Percentage of subjects
Interval 0.04 to 2.29
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
0.06 Percentage of subjects
Interval 0.0 to 0.37
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-40
|
0.52 Percentage of subjects
Interval 0.04 to 2.16
|
0.43 Percentage of subjects
Interval 0.02 to 2.14
|
0.05 Percentage of subjects
Interval 0.0 to 0.29
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-41
|
0.48 Percentage of subjects
Interval 0.04 to 1.91
|
0.62 Percentage of subjects
Interval 0.06 to 2.42
|
0.04 Percentage of subjects
Interval 0.0 to 0.24
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-42
|
0.45 Percentage of subjects
Interval 0.04 to 1.82
|
0.49 Percentage of subjects
Interval 0.12 to 1.34
|
0.04 Percentage of subjects
Interval 0.0 to 0.22
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-43
|
0.44 Percentage of subjects
Interval 0.04 to 1.76
|
0.37 Percentage of subjects
Interval 0.09 to 1.0
|
0.03 Percentage of subjects
Interval 0.0 to 0.2
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-44
|
0.43 Percentage of subjects
Interval 0.04 to 1.68
|
0.43 Percentage of subjects
Interval 0.07 to 1.42
|
0.03 Percentage of subjects
Interval 0.0 to 0.18
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-45
|
0.43 Percentage of subjects
Interval 0.04 to 1.63
|
0.36 Percentage of subjects
Interval 0.05 to 1.23
|
0.05 Percentage of subjects
Interval 0.01 to 0.19
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-46
|
0.42 Percentage of subjects
Interval 0.04 to 1.63
|
0.29 Percentage of subjects
Interval 0.03 to 1.14
|
0.05 Percentage of subjects
Interval 0.01 to 0.18
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-47
|
0.42 Percentage of subjects
Interval 0.04 to 1.61
|
0.28 Percentage of subjects
Interval 0.03 to 1.09
|
0.05 Percentage of subjects
Interval 0.01 to 0.17
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-48
|
0.41 Percentage of subjects
Interval 0.04 to 1.59
|
0.27 Percentage of subjects
Interval 0.03 to 1.05
|
0.05 Percentage of subjects
Interval 0.01 to 0.17
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Anaphylactic reactions, Week 35-35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Anaphylactic reactions, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Anaphylactic reactions, Week 35-37
|
0.61 Percentage of subjects
Interval 0.01 to 4.06
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 0.69
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Anaphylactic reactions, Week 35-38
|
0.52 Percentage of subjects
Interval 0.01 to 3.09
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 0.34
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Anaphylactic reactions, Week 35-39
|
0.42 Percentage of subjects
Interval 0.01 to 2.37
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
0.00 Percentage of subjects
Interval 0.0 to 0.24
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Anaphylactic reactions, Week 35-40
|
0.38 Percentage of subjects
Interval 0.01 to 2.25
|
0.43 Percentage of subjects
Interval 0.02 to 2.14
|
0.00 Percentage of subjects
Interval 0.0 to 0.17
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Anaphylactic reactions, Week 35-41
|
0.33 Percentage of subjects
Interval 0.0 to 2.04
|
0.50 Percentage of subjects
Interval 0.05 to 1.94
|
0.00 Percentage of subjects
Interval 0.0 to 0.15
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Anaphylactic reactions, Week 35-42
|
0.31 Percentage of subjects
Interval 0.0 to 1.93
|
0.33 Percentage of subjects
Interval 0.04 to 1.21
|
0.00 Percentage of subjects
Interval 0.0 to 0.13
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Anaphylactic reactions, Week 35-43
|
0.30 Percentage of subjects
Interval 0.0 to 1.86
|
0.25 Percentage of subjects
Interval 0.03 to 0.93
|
0.00 Percentage of subjects
Interval 0.0 to 0.13
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Anaphylactic reactions, Week 35-44
|
0.29 Percentage of subjects
Interval 0.0 to 1.78
|
0.34 Percentage of subjects
Interval 0.03 to 1.39
|
0.00 Percentage of subjects
Interval 0.0 to 0.11
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Anaphylactic reactions, Week 35-45
|
0.28 Percentage of subjects
Interval 0.0 to 1.74
|
0.28 Percentage of subjects
Interval 0.02 to 1.2
|
0.03 Percentage of subjects
Interval 0.0 to 0.15
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Anaphylactic reactions, Week 35-46
|
0.28 Percentage of subjects
Interval 0.0 to 1.74
|
0.23 Percentage of subjects
Interval 0.01 to 1.1
|
0.03 Percentage of subjects
Interval 0.0 to 0.15
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Anaphylactic reactions, Week 35-47
|
0.28 Percentage of subjects
Interval 0.0 to 1.72
|
0.22 Percentage of subjects
Interval 0.01 to 1.05
|
0.02 Percentage of subjects
Interval 0.0 to 0.14
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Anaphylactic reactions, Week 35-48
|
0.27 Percentage of subjects
Interval 0.0 to 1.7
|
0.21 Percentage of subjects
Interval 0.01 to 1.02
|
0.02 Percentage of subjects
Interval 0.0 to 0.14
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Facial oedema, Week 35-35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Facial oedema, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Facial oedema, Week 35-37
|
0.04 Percentage of subjects
Interval 0.0 to 0.27
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 0.69
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Facial oedema, Week 35-38
|
0.06 Percentage of subjects
Interval 0.01 to 0.22
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 0.34
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Facial oedema, Week 35-39
|
0.05 Percentage of subjects
Interval 0.01 to 0.17
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
0.00 Percentage of subjects
Interval 0.0 to 0.24
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Facial oedema, Week 35-40
|
0.04 Percentage of subjects
Interval 0.01 to 0.15
|
0.00 Percentage of subjects
Interval 0.0 to 0.79
|
0.00 Percentage of subjects
Interval 0.0 to 0.17
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Facial oedema, Week 35-41
|
0.05 Percentage of subjects
Interval 0.01 to 0.14
|
0.00 Percentage of subjects
Interval 0.0 to 0.46
|
0.00 Percentage of subjects
Interval 0.0 to 0.15
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Facial oedema, Week 35-42
|
0.04 Percentage of subjects
Interval 0.01 to 0.13
|
0.00 Percentage of subjects
Interval 0.0 to 0.3
|
0.00 Percentage of subjects
Interval 0.0 to 0.13
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Facial oedema, Week 35-43
|
0.04 Percentage of subjects
Interval 0.01 to 0.12
|
0.00 Percentage of subjects
Interval 0.0 to 0.23
|
0.00 Percentage of subjects
Interval 0.0 to 0.13
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Hypersensitivity reactions, Week 35-37
|
0.08 Percentage of subjects
Interval 0.01 to 0.29
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 0.69
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Facial oedema, Week 35-44
|
0.05 Percentage of subjects
Interval 0.01 to 0.12
|
0.00 Percentage of subjects
Interval 0.0 to 0.18
|
0.00 Percentage of subjects
Interval 0.0 to 0.11
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Facial oedema, Week 35-45
|
0.05 Percentage of subjects
Interval 0.02 to 0.12
|
0.00 Percentage of subjects
Interval 0.0 to 0.15
|
0.00 Percentage of subjects
Interval 0.0 to 0.1
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Facial oedema, Week 35-46
|
0.05 Percentage of subjects
Interval 0.02 to 0.12
|
0.00 Percentage of subjects
Interval 0.0 to 0.12
|
0.00 Percentage of subjects
Interval 0.0 to 0.09
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Facial oedema, Week 35-47
|
0.05 Percentage of subjects
Interval 0.02 to 0.11
|
0.00 Percentage of subjects
Interval 0.0 to 0.11
|
0.00 Percentage of subjects
Interval 0.0 to 0.09
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Facial oedema, Week 35-48
|
0.05 Percentage of subjects
Interval 0.02 to 0.11
|
0.00 Percentage of subjects
Interval 0.0 to 0.11
|
0.00 Percentage of subjects
Interval 0.0 to 0.09
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Hypersensitivity reactions, Week 35-35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Hypersensitivity reactions, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Hypersensitivity reactions, Week 35-38
|
0.10 Percentage of subjects
Interval 0.03 to 0.23
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.09 Percentage of subjects
Interval 0.0 to 0.53
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Hypersensitivity reactions, Week 35-39
|
0.09 Percentage of subjects
Interval 0.03 to 0.18
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
0.06 Percentage of subjects
Interval 0.0 to 0.37
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Hypersensitivity reactions, Week 35-40
|
0.11 Percentage of subjects
Interval 0.05 to 0.23
|
0.00 Percentage of subjects
Interval 0.0 to 0.79
|
0.05 Percentage of subjects
Interval 0.0 to 0.29
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Hypersensitivity reactions, Week 35-41
|
0.13 Percentage of subjects
Interval 0.06 to 0.25
|
0.12 Percentage of subjects
Interval 0.0 to 0.69
|
0.04 Percentage of subjects
Interval 0.0 to 0.24
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Hypersensitivity reactions, Week 35-42
|
0.12 Percentage of subjects
Interval 0.06 to 0.23
|
0.16 Percentage of subjects
Interval 0.02 to 0.59
|
0.04 Percentage of subjects
Interval 0.0 to 0.22
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Hypersensitivity reactions, Week 35-43
|
0.12 Percentage of subjects
Interval 0.05 to 0.22
|
0.12 Percentage of subjects
Interval 0.02 to 0.45
|
0.03 Percentage of subjects
Interval 0.0 to 0.2
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Hypersensitivity reactions, Week 35-44
|
0.12 Percentage of subjects
Interval 0.06 to 0.21
|
0.10 Percentage of subjects
Interval 0.01 to 0.35
|
0.03 Percentage of subjects
Interval 0.0 to 0.18
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Hypersensitivity reactions, Week 35-45
|
0.11 Percentage of subjects
Interval 0.06 to 0.2
|
0.08 Percentage of subjects
Interval 0.01 to 0.29
|
0.03 Percentage of subjects
Interval 0.0 to 0.17
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Hypersensitivity reactions, Week 35-46
|
0.11 Percentage of subjects
Interval 0.06 to 0.2
|
0.07 Percentage of subjects
Interval 0.01 to 0.24
|
0.03 Percentage of subjects
Interval 0.0 to 0.16
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Hypersensitivity reactions, Week 35-47
|
0.11 Percentage of subjects
Interval 0.06 to 0.2
|
0.06 Percentage of subjects
Interval 0.01 to 0.22
|
0.02 Percentage of subjects
Interval 0.0 to 0.16
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group
Hypersensitivity reactions, Week 35-48
|
0.11 Percentage of subjects
Interval 0.06 to 0.19
|
0.06 Percentage of subjects
Interval 0.01 to 0.22
|
0.02 Percentage of subjects
Interval 0.0 to 0.15
|
SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start up to end of the week of interest and were registered in EHR (routine data collection \& card-based ADR reporting) during FU period (from vaccination up to 7 days post-vaccination)
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The cumulative incidence rates AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16433 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=3310 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=4196 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group
Week 35-35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group
Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group
Week 35-37
|
0.77 Percentage of subjects
Interval 0.46 to 1.2
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 0.69
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group
Week 35-38
|
0.65 Percentage of subjects
Interval 0.38 to 1.04
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.19 Percentage of subjects
Interval 0.02 to 0.69
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group
Week 35-39
|
0.52 Percentage of subjects
Interval 0.34 to 0.77
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
0.13 Percentage of subjects
Interval 0.01 to 0.49
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group
Week 35-40
|
0.54 Percentage of subjects
Interval 0.38 to 0.73
|
0.22 Percentage of subjects
Interval 0.01 to 1.19
|
0.14 Percentage of subjects
Interval 0.03 to 0.41
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group
Week 35-41
|
0.48 Percentage of subjects
Interval 0.34 to 0.67
|
0.37 Percentage of subjects
Interval 0.08 to 1.08
|
0.12 Percentage of subjects
Interval 0.02 to 0.34
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group
Week 35-42
|
0.46 Percentage of subjects
Interval 0.33 to 0.62
|
0.25 Percentage of subjects
Interval 0.05 to 0.72
|
0.11 Percentage of subjects
Interval 0.02 to 0.31
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group
Week 35-43
|
0.46 Percentage of subjects
Interval 0.33 to 0.63
|
0.31 Percentage of subjects
Interval 0.1 to 0.73
|
0.10 Percentage of subjects
Interval 0.02 to 0.3
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group
Week 35-44
|
0.47 Percentage of subjects
Interval 0.34 to 0.63
|
0.29 Percentage of subjects
Interval 0.11 to 0.63
|
0.09 Percentage of subjects
Interval 0.02 to 0.26
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group
Week 35-45
|
0.46 Percentage of subjects
Interval 0.33 to 0.62
|
0.24 Percentage of subjects
Interval 0.09 to 0.53
|
0.08 Percentage of subjects
Interval 0.01 to 0.25
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group
Week 35-46
|
0.46 Percentage of subjects
Interval 0.33 to 0.63
|
0.23 Percentage of subjects
Interval 0.09 to 0.47
|
0.08 Percentage of subjects
Interval 0.01 to 0.24
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group
Week 35-47
|
0.45 Percentage of subjects
Interval 0.32 to 0.62
|
0.25 Percentage of subjects
Interval 0.11 to 0.49
|
0.07 Percentage of subjects
Interval 0.01 to 0.23
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group
Week 35-48
|
0.45 Percentage of subjects
Interval 0.32 to 0.62
|
0.27 Percentage of subjects
Interval 0.12 to 0.52
|
0.07 Percentage of subjects
Interval 0.01 to 0.23
|
SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start up to end of the week of interest and were registered in EHR (routine data collection \& card-based ADR reporting) during FU period (from vaccination up to 7 days post-vaccination)
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy and muscle aches/myalgia. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16433 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=3310 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=4196 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Arthropathy, Week 35-45
|
0.91 Percentage of subjects
Interval 0.6 to 1.32
|
0.28 Percentage of subjects
Interval 0.02 to 1.2
|
0.03 Percentage of subjects
Interval 0.0 to 0.17
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Arthropathy, Week 35-48
|
0.87 Percentage of subjects
Interval 0.57 to 1.27
|
0.21 Percentage of subjects
Interval 0.01 to 1.02
|
0.02 Percentage of subjects
Interval 0.0 to 0.15
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Myalgia, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Myalgia, Week 35-37
|
3.77 Percentage of subjects
Interval 2.67 to 5.16
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.38 Percentage of subjects
Interval 0.05 to 1.35
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Myalgia, Week 35-38
|
3.41 Percentage of subjects
Interval 2.53 to 4.48
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.28 Percentage of subjects
Interval 0.06 to 0.83
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Myalgia, Week 35-39
|
3.21 Percentage of subjects
Interval 2.6 to 3.92
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
0.45 Percentage of subjects
Interval 0.18 to 0.92
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Myalgia, Week 35-40
|
3.07 Percentage of subjects
Interval 2.51 to 3.72
|
0.86 Percentage of subjects
Interval 0.03 to 4.26
|
0.47 Percentage of subjects
Interval 0.17 to 1.01
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Myalgia, Week 35-41
|
2.98 Percentage of subjects
Interval 2.42 to 3.62
|
0.50 Percentage of subjects
Interval 0.05 to 1.94
|
0.39 Percentage of subjects
Interval 0.13 to 0.9
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Myalgia, Week 35-42
|
2.90 Percentage of subjects
Interval 2.33 to 3.58
|
0.49 Percentage of subjects
Interval 0.06 to 1.81
|
0.36 Percentage of subjects
Interval 0.12 to 0.84
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Myalgia, Week 35-43
|
2.91 Percentage of subjects
Interval 2.32 to 3.6
|
0.44 Percentage of subjects
Interval 0.1 to 1.22
|
0.41 Percentage of subjects
Interval 0.14 to 0.92
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Myalgia, Week 35-45
|
2.83 Percentage of subjects
Interval 2.27 to 3.49
|
0.61 Percentage of subjects
Interval 0.1 to 1.97
|
0.34 Percentage of subjects
Interval 0.11 to 0.79
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Myalgia, Week 35-46
|
2.80 Percentage of subjects
Interval 2.24 to 3.45
|
0.52 Percentage of subjects
Interval 0.06 to 1.97
|
0.38 Percentage of subjects
Interval 0.14 to 0.82
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Arthropathy, Week 35-38
|
1.23 Percentage of subjects
Interval 0.81 to 1.77
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.09 Percentage of subjects
Interval 0.0 to 0.53
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Arthropathy, Week 35-39
|
1.08 Percentage of subjects
Interval 0.7 to 1.59
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
0.06 Percentage of subjects
Interval 0.0 to 0.37
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Arthropathy, Week 35-40
|
1.03 Percentage of subjects
Interval 0.66 to 1.52
|
0.65 Percentage of subjects
Interval 0.03 to 3.2
|
0.05 Percentage of subjects
Interval 0.0 to 0.29
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Arthropathy, Week 35-42
|
0.93 Percentage of subjects
Interval 0.61 to 1.36
|
0.33 Percentage of subjects
Interval 0.04 to 1.21
|
0.04 Percentage of subjects
Interval 0.0 to 0.22
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Arthropathy, Week 35-43
|
0.93 Percentage of subjects
Interval 0.61 to 1.37
|
0.25 Percentage of subjects
Interval 0.03 to 0.93
|
0.03 Percentage of subjects
Interval 0.0 to 0.2
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Arthropathy, Week 35-44
|
0.92 Percentage of subjects
Interval 0.6 to 1.34
|
0.34 Percentage of subjects
Interval 0.03 to 1.39
|
0.03 Percentage of subjects
Interval 0.0 to 0.18
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Arthropathy, Week 35-41
|
0.97 Percentage of subjects
Interval 0.63 to 1.43
|
0.37 Percentage of subjects
Interval 0.04 to 1.45
|
0.04 Percentage of subjects
Interval 0.0 to 0.24
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Arthropathy, Week 35-46
|
0.89 Percentage of subjects
Interval 0.58 to 1.3
|
0.23 Percentage of subjects
Interval 0.01 to 1.1
|
0.03 Percentage of subjects
Interval 0.0 to 0.16
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Arthropathy, Week 35-47
|
0.88 Percentage of subjects
Interval 0.57 to 1.28
|
0.22 Percentage of subjects
Interval 0.01 to 1.05
|
0.02 Percentage of subjects
Interval 0.0 to 0.16
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-37
|
4.25 Percentage of subjects
Interval 3.33 to 5.34
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.38 Percentage of subjects
Interval 0.05 to 1.35
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-38
|
3.79 Percentage of subjects
Interval 2.92 to 4.83
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.37 Percentage of subjects
Interval 0.1 to 0.96
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-39
|
3.59 Percentage of subjects
Interval 2.91 to 4.37
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
0.51 Percentage of subjects
Interval 0.22 to 1.01
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-40
|
3.41 Percentage of subjects
Interval 2.8 to 4.12
|
0.86 Percentage of subjects
Interval 0.03 to 4.26
|
0.51 Percentage of subjects
Interval 0.21 to 1.03
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-41
|
3.30 Percentage of subjects
Interval 2.7 to 3.99
|
0.50 Percentage of subjects
Interval 0.05 to 1.94
|
0.43 Percentage of subjects
Interval 0.16 to 0.93
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-42
|
3.21 Percentage of subjects
Interval 2.58 to 3.94
|
0.49 Percentage of subjects
Interval 0.06 to 1.81
|
0.40 Percentage of subjects
Interval 0.15 to 0.86
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-43
|
3.21 Percentage of subjects
Interval 2.57 to 3.97
|
0.44 Percentage of subjects
Interval 0.1 to 1.22
|
0.44 Percentage of subjects
Interval 0.17 to 0.92
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-44
|
3.15 Percentage of subjects
Interval 2.5 to 3.91
|
0.63 Percentage of subjects
Interval 0.08 to 2.19
|
0.37 Percentage of subjects
Interval 0.12 to 0.88
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-45
|
3.13 Percentage of subjects
Interval 2.51 to 3.85
|
0.61 Percentage of subjects
Interval 0.1 to 1.97
|
0.36 Percentage of subjects
Interval 0.13 to 0.81
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-46
|
3.09 Percentage of subjects
Interval 2.48 to 3.81
|
0.52 Percentage of subjects
Interval 0.06 to 1.97
|
0.40 Percentage of subjects
Interval 0.16 to 0.83
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-47
|
3.08 Percentage of subjects
Interval 2.46 to 3.79
|
0.50 Percentage of subjects
Interval 0.05 to 1.89
|
0.39 Percentage of subjects
Interval 0.15 to 0.8
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-48
|
3.05 Percentage of subjects
Interval 2.43 to 3.77
|
0.54 Percentage of subjects
Interval 0.07 to 1.91
|
0.38 Percentage of subjects
Interval 0.15 to 0.8
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Arthropathy, Week 35-35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Arthropathy, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Arthropathy, Week 35-37
|
1.42 Percentage of subjects
Interval 0.99 to 1.97
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 0.69
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Myalgia, Week 35-35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Myalgia, Week 35-44
|
2.84 Percentage of subjects
Interval 2.25 to 3.54
|
0.63 Percentage of subjects
Interval 0.08 to 2.19
|
0.34 Percentage of subjects
Interval 0.09 to 0.87
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Myalgia, Week 35-47
|
2.79 Percentage of subjects
Interval 2.23 to 3.44
|
0.50 Percentage of subjects
Interval 0.05 to 1.89
|
0.36 Percentage of subjects
Interval 0.13 to 0.79
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group
Myalgia, Week 35-48
|
2.76 Percentage of subjects
Interval 2.2 to 3.42
|
0.54 Percentage of subjects
Interval 0.07 to 1.91
|
0.36 Percentage of subjects
Interval 0.13 to 0.78
|
SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start up to end of the week of interest and were registered in EHR (routine data collection \& card-based ADR reporting) during FU period (from vaccination up to 7 days post-vaccination)
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16433 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=3310 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=4196 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-37
|
0.28 Percentage of subjects
Interval 0.11 to 0.58
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 0.69
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Bell's palsy, Week 35-40
|
0.01 Percentage of subjects
Interval 0.0 to 0.06
|
0.00 Percentage of subjects
Interval 0.0 to 0.79
|
0.00 Percentage of subjects
Interval 0.0 to 0.17
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-38
|
0.29 Percentage of subjects
Interval 0.16 to 0.47
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 0.34
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-39
|
0.26 Percentage of subjects
Interval 0.15 to 0.41
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
0.00 Percentage of subjects
Interval 0.0 to 0.24
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-40
|
0.21 Percentage of subjects
Interval 0.11 to 0.36
|
0.22 Percentage of subjects
Interval 0.01 to 1.19
|
0.00 Percentage of subjects
Interval 0.0 to 0.17
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-41
|
0.21 Percentage of subjects
Interval 0.12 to 0.33
|
0.25 Percentage of subjects
Interval 0.02 to 0.97
|
0.04 Percentage of subjects
Interval 0.0 to 0.31
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-42
|
0.19 Percentage of subjects
Interval 0.11 to 0.32
|
0.16 Percentage of subjects
Interval 0.02 to 0.6
|
0.04 Percentage of subjects
Interval 0.0 to 0.28
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-43
|
0.19 Percentage of subjects
Interval 0.1 to 0.31
|
0.12 Percentage of subjects
Interval 0.01 to 0.47
|
0.03 Percentage of subjects
Interval 0.0 to 0.27
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-44
|
0.18 Percentage of subjects
Interval 0.1 to 0.31
|
0.10 Percentage of subjects
Interval 0.01 to 0.4
|
0.03 Percentage of subjects
Interval 0.0 to 0.18
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-45
|
0.18 Percentage of subjects
Interval 0.1 to 0.3
|
0.08 Percentage of subjects
Interval 0.01 to 0.34
|
0.03 Percentage of subjects
Interval 0.0 to 0.15
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-46
|
0.17 Percentage of subjects
Interval 0.1 to 0.29
|
0.07 Percentage of subjects
Interval 0.0 to 0.31
|
0.03 Percentage of subjects
Interval 0.0 to 0.15
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-47
|
0.17 Percentage of subjects
Interval 0.09 to 0.29
|
0.09 Percentage of subjects
Interval 0.02 to 0.27
|
0.02 Percentage of subjects
Interval 0.0 to 0.14
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Any, Week 35-48
|
0.17 Percentage of subjects
Interval 0.09 to 0.29
|
0.09 Percentage of subjects
Interval 0.02 to 0.26
|
0.02 Percentage of subjects
Interval 0.0 to 0.14
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Bell's palsy, Week 35-35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Bell's palsy, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Bell's palsy, Week 35-37
|
0.00 Percentage of subjects
Interval 0.0 to 0.15
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 0.69
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Bell's palsy, Week 35-38
|
0.00 Percentage of subjects
Interval 0.0 to 0.07
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 0.34
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Bell's palsy, Week 35-39
|
0.01 Percentage of subjects
Interval 0.0 to 0.08
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
0.00 Percentage of subjects
Interval 0.0 to 0.24
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Bell's palsy, Week 35-41
|
0.01 Percentage of subjects
Interval 0.0 to 0.06
|
0.00 Percentage of subjects
Interval 0.0 to 0.46
|
0.00 Percentage of subjects
Interval 0.0 to 0.15
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Bell's palsy, Week 35-42
|
0.01 Percentage of subjects
Interval 0.0 to 0.05
|
0.00 Percentage of subjects
Interval 0.0 to 0.3
|
0.00 Percentage of subjects
Interval 0.0 to 0.13
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Bell's palsy, Week 35-43
|
0.01 Percentage of subjects
Interval 0.0 to 0.05
|
0.00 Percentage of subjects
Interval 0.0 to 0.23
|
0.00 Percentage of subjects
Interval 0.0 to 0.13
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Bell's palsy, Week 35-44
|
0.01 Percentage of subjects
Interval 0.0 to 0.05
|
0.00 Percentage of subjects
Interval 0.0 to 0.18
|
0.00 Percentage of subjects
Interval 0.0 to 0.11
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Bell's palsy, Week 35-45
|
0.01 Percentage of subjects
Interval 0.0 to 0.05
|
0.00 Percentage of subjects
Interval 0.0 to 0.15
|
0.00 Percentage of subjects
Interval 0.0 to 0.1
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Bell's palsy, Week 35-46
|
0.01 Percentage of subjects
Interval 0.0 to 0.05
|
0.00 Percentage of subjects
Interval 0.0 to 0.12
|
0.00 Percentage of subjects
Interval 0.0 to 0.09
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Bell's palsy, Week 35-47
|
0.01 Percentage of subjects
Interval 0.0 to 0.04
|
0.00 Percentage of subjects
Interval 0.0 to 0.11
|
0.00 Percentage of subjects
Interval 0.0 to 0.09
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Bell's palsy, Week 35-48
|
0.01 Percentage of subjects
Interval 0.0 to 0.04
|
0.00 Percentage of subjects
Interval 0.0 to 0.11
|
0.00 Percentage of subjects
Interval 0.0 to 0.09
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Guillain-Barre Syndrome, Week 35-35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Guillain-Barre Syndrome, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Guillain-Barre Syndrome, Week 35-37
|
0.00 Percentage of subjects
Interval 0.0 to 0.15
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 0.69
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Guillain-Barre Syndrome, Week 35-38
|
0.00 Percentage of subjects
Interval 0.0 to 0.07
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 0.34
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Guillain-Barre Syndrome, Week 35-39
|
0.00 Percentage of subjects
Interval 0.0 to 0.04
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
0.00 Percentage of subjects
Interval 0.0 to 0.24
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Guillain-Barre Syndrome, Week 35-40
|
0.00 Percentage of subjects
Interval 0.0 to 0.03
|
0.00 Percentage of subjects
Interval 0.0 to 0.79
|
0.00 Percentage of subjects
Interval 0.0 to 0.17
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Guillain-Barre Syndrome, Week 35-41
|
0.00 Percentage of subjects
Interval 0.0 to 0.03
|
0.00 Percentage of subjects
Interval 0.0 to 0.46
|
0.00 Percentage of subjects
Interval 0.0 to 0.15
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Guillain-Barre Syndrome, Week 35-42
|
0.00 Percentage of subjects
Interval 0.0 to 0.03
|
0.00 Percentage of subjects
Interval 0.0 to 0.3
|
0.00 Percentage of subjects
Interval 0.0 to 0.13
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Guillain-Barre Syndrome, Week 35-43
|
0.00 Percentage of subjects
Interval 0.0 to 0.03
|
0.00 Percentage of subjects
Interval 0.0 to 0.23
|
0.00 Percentage of subjects
Interval 0.0 to 0.13
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Guillain-Barre Syndrome, Week 35-44
|
0.00 Percentage of subjects
Interval 0.0 to 0.02
|
0.00 Percentage of subjects
Interval 0.0 to 0.18
|
0.00 Percentage of subjects
Interval 0.0 to 0.11
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Guillain-Barre Syndrome, Week 35-45
|
0.00 Percentage of subjects
Interval 0.0 to 0.02
|
0.00 Percentage of subjects
Interval 0.0 to 0.15
|
0.00 Percentage of subjects
Interval 0.0 to 0.1
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Guillain-Barre Syndrome, Week 35-46
|
0.00 Percentage of subjects
Interval 0.0 to 0.02
|
0.00 Percentage of subjects
Interval 0.0 to 0.12
|
0.00 Percentage of subjects
Interval 0.0 to 0.09
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Guillain-Barre Syndrome, Week 35-47
|
0.00 Percentage of subjects
Interval 0.0 to 0.02
|
0.00 Percentage of subjects
Interval 0.0 to 0.11
|
0.00 Percentage of subjects
Interval 0.0 to 0.09
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Guillain-Barre Syndrome, Week 35-48
|
0.00 Percentage of subjects
Interval 0.0 to 0.02
|
0.00 Percentage of subjects
Interval 0.0 to 0.11
|
0.00 Percentage of subjects
Interval 0.0 to 0.09
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Peripheral tremor, Week 35-35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Peripheral tremor, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Peripheral tremor, Week 35-37
|
0.24 Percentage of subjects
Interval 0.09 to 0.53
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 0.69
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Peripheral tremor, Week 35-38
|
0.27 Percentage of subjects
Interval 0.15 to 0.45
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 0.34
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Peripheral tremor, Week 35-39
|
0.24 Percentage of subjects
Interval 0.12 to 0.41
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
0.00 Percentage of subjects
Interval 0.0 to 0.24
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Peripheral tremor, Week 35-40
|
0.19 Percentage of subjects
Interval 0.09 to 0.35
|
0.22 Percentage of subjects
Interval 0.01 to 1.19
|
0.00 Percentage of subjects
Interval 0.0 to 0.17
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Peripheral tremor, Week 35-41
|
0.19 Percentage of subjects
Interval 0.1 to 0.32
|
0.25 Percentage of subjects
Interval 0.02 to 0.97
|
0.00 Percentage of subjects
Interval 0.0 to 0.15
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Peripheral tremor, Week 35-42
|
0.18 Percentage of subjects
Interval 0.09 to 0.31
|
0.16 Percentage of subjects
Interval 0.02 to 0.6
|
0.00 Percentage of subjects
Interval 0.0 to 0.13
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Peripheral tremor, Week 35-43
|
0.17 Percentage of subjects
Interval 0.09 to 0.3
|
0.12 Percentage of subjects
Interval 0.01 to 0.47
|
0.00 Percentage of subjects
Interval 0.0 to 0.13
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Peripheral tremor, Week 35-44
|
0.17 Percentage of subjects
Interval 0.09 to 0.3
|
0.10 Percentage of subjects
Interval 0.01 to 0.4
|
0.00 Percentage of subjects
Interval 0.0 to 0.11
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Peripheral tremor, Week 35-45
|
0.17 Percentage of subjects
Interval 0.09 to 0.29
|
0.08 Percentage of subjects
Interval 0.01 to 0.34
|
0.00 Percentage of subjects
Interval 0.0 to 0.1
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Peripheral tremor, Week 35-46
|
0.16 Percentage of subjects
Interval 0.08 to 0.28
|
0.07 Percentage of subjects
Interval 0.0 to 0.31
|
0.00 Percentage of subjects
Interval 0.0 to 0.09
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Peripheral tremor, Week 35-47
|
0.16 Percentage of subjects
Interval 0.08 to 0.28
|
0.06 Percentage of subjects
Interval 0.0 to 0.3
|
0.00 Percentage of subjects
Interval 0.0 to 0.09
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Peripheral tremor, Week 35-48
|
0.16 Percentage of subjects
Interval 0.08 to 0.28
|
0.06 Percentage of subjects
Interval 0.0 to 0.29
|
0.00 Percentage of subjects
Interval 0.0 to 0.09
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Seizure / Febrile convulsions, Week 35-35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Seizure / Febrile convulsions, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Seizure / Febrile convulsions, Week 35-37
|
0.04 Percentage of subjects
Interval 0.0 to 0.25
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 0.69
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Seizure / Febrile convulsions, Week 35-38
|
0.02 Percentage of subjects
Interval 0.0 to 0.11
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 0.34
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Seizure / Febrile convulsions, Week 35-39
|
0.01 Percentage of subjects
Interval 0.0 to 0.07
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
0.00 Percentage of subjects
Interval 0.0 to 0.24
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Seizure / Febrile convulsions, Week 35-40
|
0.01 Percentage of subjects
Interval 0.0 to 0.06
|
0.00 Percentage of subjects
Interval 0.0 to 0.79
|
0.00 Percentage of subjects
Interval 0.0 to 0.17
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Seizure / Febrile convulsions, Week 35-41
|
0.01 Percentage of subjects
Interval 0.0 to 0.05
|
0.00 Percentage of subjects
Interval 0.0 to 0.46
|
0.04 Percentage of subjects
Interval 0.0 to 0.31
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Seizure / Febrile convulsions, Week 35-42
|
0.01 Percentage of subjects
Interval 0.0 to 0.05
|
0.00 Percentage of subjects
Interval 0.0 to 0.3
|
0.04 Percentage of subjects
Interval 0.0 to 0.28
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Seizure / Febrile convulsions, Week 35-43
|
0.01 Percentage of subjects
Interval 0.0 to 0.04
|
0.00 Percentage of subjects
Interval 0.0 to 0.23
|
0.03 Percentage of subjects
Interval 0.0 to 0.27
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Seizure / Febrile convulsions, Week 35-44
|
0.01 Percentage of subjects
Interval 0.0 to 0.04
|
0.00 Percentage of subjects
Interval 0.0 to 0.18
|
0.03 Percentage of subjects
Interval 0.0 to 0.18
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Seizure / Febrile convulsions, Week 35-45
|
0.01 Percentage of subjects
Interval 0.0 to 0.04
|
0.00 Percentage of subjects
Interval 0.0 to 0.15
|
0.03 Percentage of subjects
Interval 0.0 to 0.15
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Seizure / Febrile convulsions, Week 35-46
|
0.01 Percentage of subjects
Interval 0.0 to 0.04
|
0.00 Percentage of subjects
Interval 0.0 to 0.12
|
0.03 Percentage of subjects
Interval 0.0 to 0.15
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Seizure / Febrile convulsions, Week 35-47
|
0.01 Percentage of subjects
Interval 0.0 to 0.04
|
0.03 Percentage of subjects
Interval 0.0 to 0.23
|
0.02 Percentage of subjects
Interval 0.0 to 0.14
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group
Seizure / Febrile convulsions, Week 35-48
|
0.01 Percentage of subjects
Interval 0.0 to 0.04
|
0.03 Percentage of subjects
Interval 0.0 to 0.22
|
0.02 Percentage of subjects
Interval 0.0 to 0.14
|
SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start up to end of the week of interest and were registered in EHR (routine data collection \& card-based ADR reporting) during FU period (from vaccination up to 7 days post-vaccination)
SAEs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The cumulative incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16433 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=3310 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=4196 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine Group
Week 35-45
|
0.14 Percentage of subjects
Interval 0.06 to 0.28
|
0.12 Percentage of subjects
Interval 0.01 to 0.44
|
0.21 Percentage of subjects
Interval 0.04 to 0.6
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine Group
Week 35-35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine Group
Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine Group
Week 35-37
|
0.12 Percentage of subjects
Interval 0.02 to 0.37
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.19 Percentage of subjects
Interval 0.0 to 1.49
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine Group
Week 35-38
|
0.15 Percentage of subjects
Interval 0.06 to 0.34
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.28 Percentage of subjects
Interval 0.06 to 0.81
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine Group
Week 35-39
|
0.12 Percentage of subjects
Interval 0.06 to 0.21
|
0.00 Percentage of subjects
Interval 0.0 to 2.98
|
0.19 Percentage of subjects
Interval 0.04 to 0.56
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine Group
Week 35-40
|
0.13 Percentage of subjects
Interval 0.07 to 0.22
|
0.00 Percentage of subjects
Interval 0.0 to 0.79
|
0.19 Percentage of subjects
Interval 0.03 to 0.57
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine Group
Week 35-43
|
0.13 Percentage of subjects
Interval 0.06 to 0.26
|
0.06 Percentage of subjects
Interval 0.0 to 0.35
|
0.20 Percentage of subjects
Interval 0.04 to 0.61
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine Group
Week 35-41
|
0.13 Percentage of subjects
Interval 0.06 to 0.23
|
0.00 Percentage of subjects
Interval 0.0 to 0.46
|
0.24 Percentage of subjects
Interval 0.04 to 0.73
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine Group
Week 35-42
|
0.12 Percentage of subjects
Interval 0.06 to 0.22
|
0.08 Percentage of subjects
Interval 0.0 to 0.46
|
0.22 Percentage of subjects
Interval 0.04 to 0.65
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine Group
Week 35-44
|
0.14 Percentage of subjects
Interval 0.05 to 0.3
|
0.10 Percentage of subjects
Interval 0.01 to 0.35
|
0.23 Percentage of subjects
Interval 0.06 to 0.62
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine Group
Week 35-46
|
0.15 Percentage of subjects
Interval 0.06 to 0.31
|
0.10 Percentage of subjects
Interval 0.01 to 0.37
|
0.23 Percentage of subjects
Interval 0.06 to 0.59
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine Group
Week 35-47
|
0.15 Percentage of subjects
Interval 0.06 to 0.31
|
0.09 Percentage of subjects
Interval 0.01 to 0.35
|
0.24 Percentage of subjects
Interval 0.07 to 0.61
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine Group
Week 35-48
|
0.15 Percentage of subjects
Interval 0.06 to 0.33
|
0.09 Percentage of subjects
Interval 0.01 to 0.34
|
0.24 Percentage of subjects
Interval 0.07 to 0.6
|
SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in EHR (combining routine data collection and card-based ADR reporting system) during the safety follow-up period (from vaccination up to 7 days post-vaccination).
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16433 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=3310 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=4196 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
1.59 Percentage of subjects
Interval 0.04 to 8.53
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
2.10 Percentage of subjects
Interval 0.43 to 6.01
|
20.00 Percentage of subjects
Interval 0.0 to 96.43
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.98 Percentage of subjects
Interval 0.0 to 10.39
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
—
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 38
|
10.81 Percentage of subjects
Interval 7.35 to 15.18
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.61 Percentage of subjects
Interval 0.01 to 3.6
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
>65 years, Week 46
|
6.14 Percentage of subjects
Interval 1.96 to 13.99
|
5.41 Percentage of subjects
Interval 0.0 to 68.0
|
9.38 Percentage of subjects
Interval 1.29 to 28.96
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 37
|
11.82 Percentage of subjects
Interval 9.2 to 14.88
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
2.63 Percentage of subjects
Interval 0.72 to 6.6
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 39
|
11.52 Percentage of subjects
Interval 9.9 to 13.3
|
10.00 Percentage of subjects
Interval 0.11 to 50.09
|
0.68 Percentage of subjects
Interval 0.0 to 4.8
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 40
|
10.39 Percentage of subjects
Interval 5.89 to 16.65
|
11.11 Percentage of subjects
Interval 0.19 to 51.15
|
1.54 Percentage of subjects
Interval 0.32 to 4.43
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 41
|
7.72 Percentage of subjects
Interval 4.87 to 11.5
|
6.38 Percentage of subjects
Interval 2.38 to 13.38
|
0.91 Percentage of subjects
Interval 0.02 to 5.16
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 42
|
5.63 Percentage of subjects
Interval 2.28 to 11.3
|
1.82 Percentage of subjects
Interval 0.22 to 6.41
|
3.70 Percentage of subjects
Interval 0.5 to 12.3
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 43
|
5.88 Percentage of subjects
Interval 1.87 to 13.42
|
7.56 Percentage of subjects
Interval 3.52 to 13.87
|
1.16 Percentage of subjects
Interval 0.03 to 6.31
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 44
|
5.43 Percentage of subjects
Interval 2.05 to 11.35
|
17.72 Percentage of subjects
Interval 10.04 to 27.94
|
1.27 Percentage of subjects
Interval 0.03 to 7.12
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 45
|
6.25 Percentage of subjects
Interval 3.31 to 10.57
|
3.64 Percentage of subjects
Interval 0.0 to 99.6
|
6.02 Percentage of subjects
Interval 1.48 to 15.53
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 46
|
7.62 Percentage of subjects
Interval 4.08 to 12.77
|
7.84 Percentage of subjects
Interval 1.88 to 20.13
|
0.00 Percentage of subjects
Interval 0.0 to 8.81
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 47
|
5.48 Percentage of subjects
Interval 1.98 to 11.73
|
7.69 Percentage of subjects
Interval 0.78 to 26.63
|
1.59 Percentage of subjects
Interval 0.01 to 11.07
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 4.11
|
10.34 Percentage of subjects
Interval 2.07 to 27.92
|
0.00 Percentage of subjects
Interval 0.0 to 12.34
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
>65 years, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
1.96 Percentage of subjects
Interval 0.0 to 18.8
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
>65 years, Week 37
|
11.64 Percentage of subjects
Interval 9.86 to 13.62
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.63 Percentage of subjects
Interval 0.02 to 3.5
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
>65 years, Week 38
|
9.77 Percentage of subjects
Interval 7.54 to 12.39
|
16.67 Percentage of subjects
Interval 0.0 to 91.51
|
1.86 Percentage of subjects
Interval 0.75 to 3.79
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
>65 years, Week 39
|
9.31 Percentage of subjects
Interval 7.76 to 11.06
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
2.97 Percentage of subjects
Interval 0.96 to 6.82
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
>65 years, Week 40
|
9.75 Percentage of subjects
Interval 6.13 to 14.53
|
7.14 Percentage of subjects
Interval 1.5 to 19.48
|
1.37 Percentage of subjects
Interval 0.22 to 4.43
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
>65 years, Week 41
|
9.04 Percentage of subjects
Interval 6.57 to 12.05
|
8.86 Percentage of subjects
Interval 3.64 to 17.41
|
0.65 Percentage of subjects
Interval 0.0 to 4.69
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
>65 years, Week 42
|
5.12 Percentage of subjects
Interval 2.52 to 9.12
|
6.15 Percentage of subjects
Interval 1.7 to 15.01
|
0.00 Percentage of subjects
Interval 0.0 to 3.03
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
>65 years, Week 43
|
6.20 Percentage of subjects
Interval 2.56 to 12.27
|
6.10 Percentage of subjects
Interval 0.0 to 86.17
|
1.54 Percentage of subjects
Interval 0.01 to 11.02
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
>65 years, Week 44
|
6.28 Percentage of subjects
Interval 1.99 to 14.32
|
9.38 Percentage of subjects
Interval 3.52 to 19.3
|
0.00 Percentage of subjects
Interval 0.0 to 4.99
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
>65 years, Week 45
|
7.21 Percentage of subjects
Interval 2.71 to 14.98
|
18.92 Percentage of subjects
Interval 0.0 to 100.0
|
0.00 Percentage of subjects
Interval 0.0 to 6.06
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
>65 years, Week 47
|
2.83 Percentage of subjects
Interval 0.59 to 8.05
|
3.70 Percentage of subjects
Interval 0.0 to 99.88
|
3.33 Percentage of subjects
Interval 0.08 to 17.37
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
>65 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
9.09 Percentage of subjects
Interval 0.0 to 100.0
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 37
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
4.83 Percentage of subjects
Interval 2.34 to 8.7
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
4.07 Percentage of subjects
Interval 0.99 to 10.69
|
0.00 Percentage of subjects
Interval 0.0 to 7.71
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
1.56 Percentage of subjects
Interval 0.29 to 4.72
|
5.88 Percentage of subjects
Interval 0.0 to 69.4
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 44
|
—
|
2.94 Percentage of subjects
Interval 0.1 to 14.43
|
0.00 Percentage of subjects
Interval 0.0 to 2.48
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 45
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.82
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 46
|
50.00 Percentage of subjects
Interval 1.26 to 98.74
|
0.99 Percentage of subjects
Interval 0.04 to 4.97
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 47
|
—
|
1.39 Percentage of subjects
Interval 0.04 to 7.5
|
0.00 Percentage of subjects
Interval 0.0 to 9.03
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 48
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 37
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
—
|
—
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 38
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
—
|
—
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
—
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 40
|
33.33 Percentage of subjects
Interval 0.0 to 100.0
|
19.05 Percentage of subjects
Interval 3.24 to 49.67
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 41
|
50.00 Percentage of subjects
Interval 1.26 to 98.74
|
0.00 Percentage of subjects
Interval 0.0 to 11.57
|
0.00 Percentage of subjects
Interval 0.0 to 6.49
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 12.34
|
0.00 Percentage of subjects
Interval 0.0 to 14.82
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 13.72
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 44
|
16.67 Percentage of subjects
Interval 0.02 to 81.43
|
2.02 Percentage of subjects
Interval 0.16 to 8.11
|
0.40 Percentage of subjects
Interval 0.01 to 2.22
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 46
|
20.00 Percentage of subjects
Interval 0.02 to 88.39
|
0.36 Percentage of subjects
Interval 0.01 to 2.02
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 47
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
1.61 Percentage of subjects
Interval 0.0 to 29.53
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
—
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 37
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
—
|
—
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 38
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
—
|
—
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 39
|
7.14 Percentage of subjects
Interval 0.02 to 44.9
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
11.11 Percentage of subjects
Interval 0.19 to 51.19
|
50.00 Percentage of subjects
Interval 1.26 to 98.74
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 41
|
10.00 Percentage of subjects
Interval 0.0 to 71.81
|
5.88 Percentage of subjects
Interval 0.02 to 38.78
|
0.00 Percentage of subjects
Interval 0.0 to 10.89
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 13.72
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
3.75 Percentage of subjects
Interval 0.78 to 10.57
|
4.39 Percentage of subjects
Interval 2.03 to 8.17
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
—
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 36
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start up to end of the week of interest and were registered in EHR (routine data collection \& card-based ADR reporting) during FU period (from vaccination up to 7 days post-vaccination)
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16433 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=3310 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=4196 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
6 month to 5 years, Week 35-44
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
3.00 Percentage of subjects
Interval 1.44 to 5.47
|
0.87 Percentage of subjects
Interval 0.08 to 3.41
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
6 month to 5 years, Week 35-48
|
10.00 Percentage of subjects
Interval 0.14 to 48.28
|
2.27 Percentage of subjects
Interval 1.11 to 4.1
|
0.70 Percentage of subjects
Interval 0.06 to 2.86
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-41
|
6.90 Percentage of subjects
Interval 0.06 to 39.08
|
5.56 Percentage of subjects
Interval 0.29 to 23.48
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-42
|
5.88 Percentage of subjects
Interval 0.15 to 28.66
|
4.00 Percentage of subjects
Interval 0.25 to 16.69
|
0.00 Percentage of subjects
Interval 0.0 to 4.11
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-40
|
2.22 Percentage of subjects
Interval 0.02 to 14.79
|
7.14 Percentage of subjects
Interval 0.04 to 41.49
|
33.33 Percentage of subjects
Interval 0.0 to 99.94
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-41
|
3.64 Percentage of subjects
Interval 0.02 to 23.48
|
6.45 Percentage of subjects
Interval 0.34 to 26.78
|
2.86 Percentage of subjects
Interval 0.07 to 14.92
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-47
|
2.44 Percentage of subjects
Interval 0.02 to 15.79
|
2.73 Percentage of subjects
Interval 0.89 to 6.26
|
3.82 Percentage of subjects
Interval 1.85 to 6.91
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Weeks 35-36
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Weeks 35-37
|
11.82 Percentage of subjects
Interval 9.2 to 14.88
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
2.47 Percentage of subjects
Interval 0.68 to 6.2
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Weeks 35-38
|
11.27 Percentage of subjects
Interval 8.66 to 14.35
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
1.53 Percentage of subjects
Interval 0.5 to 3.54
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Weeks 35-39
|
11.39 Percentage of subjects
Interval 9.78 to 13.16
|
5.88 Percentage of subjects
Interval 0.15 to 28.69
|
1.27 Percentage of subjects
Interval 0.44 to 2.84
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Weeks 35-40
|
11.19 Percentage of subjects
Interval 9.16 to 13.49
|
10.00 Percentage of subjects
Interval 4.42 to 18.76
|
1.35 Percentage of subjects
Interval 0.62 to 2.54
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Weeks 35-45
|
9.68 Percentage of subjects
Interval 7.6 to 12.11
|
7.64 Percentage of subjects
Interval 5.53 to 10.22
|
1.81 Percentage of subjects
Interval 0.67 to 3.87
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
6 month to 5 years, Week 35-37
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
6 month to 5 years, Week 35-38
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
6 month to 5 years, Week 35-39
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
1.59 Percentage of subjects
Interval 0.04 to 8.53
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
6 month to 5 years, Week 35-40
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
4.07 Percentage of subjects
Interval 1.83 to 7.72
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
6 month to 5 years, Week 35-41
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
4.07 Percentage of subjects
Interval 1.86 to 7.64
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
6 month to 5 years, Week 35-42
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
3.25 Percentage of subjects
Interval 1.55 to 5.94
|
1.27 Percentage of subjects
Interval 0.0 to 13.35
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
6 month to 5 years, Week 35-43
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
3.02 Percentage of subjects
Interval 1.53 to 5.32
|
2.38 Percentage of subjects
Interval 0.02 to 15.91
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
6 month to 5 years, Week 35-45
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
2.64 Percentage of subjects
Interval 1.2 to 4.98
|
0.86 Percentage of subjects
Interval 0.08 to 3.38
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
6 month to 5 years, Week 35-46
|
10.00 Percentage of subjects
Interval 0.14 to 48.28
|
2.37 Percentage of subjects
Interval 1.12 to 4.39
|
0.82 Percentage of subjects
Interval 0.08 to 3.22
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
6 month to 5 years, Week 35-47
|
10.00 Percentage of subjects
Interval 0.14 to 48.28
|
2.32 Percentage of subjects
Interval 1.14 to 4.17
|
0.71 Percentage of subjects
Interval 0.06 to 2.91
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-37
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
—
|
—
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-38
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
—
|
—
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-39
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
—
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-40
|
3.70 Percentage of subjects
Interval 0.0 to 39.49
|
9.52 Percentage of subjects
Interval 0.71 to 34.64
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-43
|
5.71 Percentage of subjects
Interval 0.17 to 27.21
|
3.20 Percentage of subjects
Interval 0.17 to 14.11
|
0.00 Percentage of subjects
Interval 0.0 to 3.81
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-44
|
7.32 Percentage of subjects
Interval 0.36 to 30.38
|
2.68 Percentage of subjects
Interval 0.32 to 9.4
|
0.29 Percentage of subjects
Interval 0.01 to 1.61
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-45
|
7.14 Percentage of subjects
Interval 0.32 to 30.34
|
2.15 Percentage of subjects
Interval 0.11 to 9.76
|
0.29 Percentage of subjects
Interval 0.01 to 1.61
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-46
|
8.51 Percentage of subjects
Interval 1.98 to 21.99
|
1.33 Percentage of subjects
Interval 0.1 to 5.51
|
0.28 Percentage of subjects
Interval 0.01 to 1.55
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-47
|
8.51 Percentage of subjects
Interval 1.98 to 21.99
|
1.30 Percentage of subjects
Interval 0.1 to 5.37
|
0.48 Percentage of subjects
Interval 0.06 to 1.71
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-48
|
8.33 Percentage of subjects
Interval 2.04 to 21.11
|
1.26 Percentage of subjects
Interval 0.09 to 5.27
|
0.48 Percentage of subjects
Interval 0.06 to 1.71
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-37
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
—
|
—
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-38
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
—
|
—
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-39
|
2.63 Percentage of subjects
Interval 0.01 to 18.97
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-42
|
3.39 Percentage of subjects
Interval 0.03 to 20.78
|
4.17 Percentage of subjects
Interval 0.48 to 14.52
|
2.86 Percentage of subjects
Interval 0.07 to 14.92
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-43
|
3.28 Percentage of subjects
Interval 0.03 to 20.21
|
3.28 Percentage of subjects
Interval 0.33 to 12.04
|
2.78 Percentage of subjects
Interval 0.07 to 14.53
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-44
|
3.23 Percentage of subjects
Interval 0.03 to 19.93
|
2.33 Percentage of subjects
Interval 0.22 to 8.82
|
2.00 Percentage of subjects
Interval 0.05 to 10.65
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-45
|
2.86 Percentage of subjects
Interval 0.03 to 17.61
|
3.01 Percentage of subjects
Interval 0.99 to 6.89
|
3.92 Percentage of subjects
Interval 1.9 to 7.09
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-46
|
2.63 Percentage of subjects
Interval 0.02 to 16.58
|
2.81 Percentage of subjects
Interval 0.92 to 6.43
|
3.89 Percentage of subjects
Interval 1.88 to 7.04
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-48
|
2.33 Percentage of subjects
Interval 0.02 to 15.01
|
2.72 Percentage of subjects
Interval 0.89 to 6.23
|
3.82 Percentage of subjects
Interval 1.85 to 6.91
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Weeks 35-41
|
10.69 Percentage of subjects
Interval 8.73 to 12.91
|
8.05 Percentage of subjects
Interval 4.47 to 13.13
|
1.29 Percentage of subjects
Interval 0.62 to 2.35
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Weeks 35-42
|
10.31 Percentage of subjects
Interval 8.26 to 12.66
|
5.63 Percentage of subjects
Interval 3.25 to 8.99
|
1.51 Percentage of subjects
Interval 0.81 to 2.57
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Weeks 35-43
|
10.11 Percentage of subjects
Interval 8.02 to 12.52
|
6.20 Percentage of subjects
Interval 4.05 to 9.02
|
1.48 Percentage of subjects
Interval 0.81 to 2.47
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Weeks 35-44
|
9.83 Percentage of subjects
Interval 7.72 to 12.29
|
8.09 Percentage of subjects
Interval 5.82 to 10.9
|
1.46 Percentage of subjects
Interval 0.73 to 2.61
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Weeks 35-46
|
9.60 Percentage of subjects
Interval 7.52 to 12.04
|
7.65 Percentage of subjects
Interval 5.64 to 10.11
|
1.74 Percentage of subjects
Interval 0.65 to 3.73
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Weeks 35-47
|
9.50 Percentage of subjects
Interval 7.43 to 11.92
|
7.66 Percentage of subjects
Interval 5.7 to 10.02
|
1.74 Percentage of subjects
Interval 0.7 to 3.55
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Weeks 35-48
|
9.36 Percentage of subjects
Interval 7.29 to 11.78
|
7.77 Percentage of subjects
Interval 5.84 to 10.1
|
1.70 Percentage of subjects
Interval 0.69 to 3.46
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
>65 years, Weeks 35-35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
>65 years, Weeks 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
1.92 Percentage of subjects
Interval 0.0 to 17.19
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
>65 years, Weeks 35-37
|
11.64 Percentage of subjects
Interval 9.86 to 13.61
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.81 Percentage of subjects
Interval 0.12 to 2.67
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
>65 years, Weeks 35-38
|
10.67 Percentage of subjects
Interval 8.97 to 12.56
|
11.11 Percentage of subjects
Interval 0.03 to 62.14
|
1.34 Percentage of subjects
Interval 0.59 to 2.6
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
>65 years, Weeks 35-39
|
10.09 Percentage of subjects
Interval 8.5 to 11.87
|
6.25 Percentage of subjects
Interval 0.16 to 30.23
|
1.85 Percentage of subjects
Interval 0.73 to 3.81
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
>65 years, Weeks 35-40
|
10.03 Percentage of subjects
Interval 8.24 to 12.06
|
6.90 Percentage of subjects
Interval 1.91 to 16.73
|
1.73 Percentage of subjects
Interval 0.67 to 3.6
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
>65 years, Weeks 35-41
|
9.91 Percentage of subjects
Interval 8.1 to 11.98
|
8.03 Percentage of subjects
Interval 4.08 to 13.91
|
1.62 Percentage of subjects
Interval 0.67 to 3.28
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
>65 years, Weeks 35-42
|
9.63 Percentage of subjects
Interval 7.8 to 11.71
|
7.43 Percentage of subjects
Interval 4.22 to 11.95
|
1.51 Percentage of subjects
Interval 0.61 to 3.08
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
>65 years, Weeks 35-43
|
9.53 Percentage of subjects
Interval 7.73 to 11.58
|
7.04 Percentage of subjects
Interval 4.35 to 10.67
|
1.51 Percentage of subjects
Interval 0.63 to 3.01
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
>65 years, Weeks 35-44
|
9.39 Percentage of subjects
Interval 7.61 to 11.42
|
7.47 Percentage of subjects
Interval 4.94 to 10.76
|
1.45 Percentage of subjects
Interval 0.61 to 2.89
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
>65 years, Weeks 35-45
|
9.34 Percentage of subjects
Interval 7.58 to 11.34
|
8.57 Percentage of subjects
Interval 5.97 to 11.83
|
1.41 Percentage of subjects
Interval 0.59 to 2.82
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
>65 years, Weeks 35-46
|
9.30 Percentage of subjects
Interval 7.55 to 11.31
|
8.29 Percentage of subjects
Interval 5.84 to 11.35
|
1.54 Percentage of subjects
Interval 0.71 to 2.89
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
>65 years, Weeks 35-47
|
9.24 Percentage of subjects
Interval 7.47 to 11.25
|
8.02 Percentage of subjects
Interval 5.68 to 10.93
|
1.57 Percentage of subjects
Interval 0.75 to 2.86
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group
>65 years, Weeks 35-48
|
9.19 Percentage of subjects
Interval 7.42 to 11.22
|
8.07 Percentage of subjects
Interval 5.77 to 10.91
|
1.56 Percentage of subjects
Interval 0.75 to 2.85
|
SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in EHR (combining routine data collection and card-based ADR reporting system) during the safety follow-up period (from vaccination up to 7 days post-vaccination).
AEIs reported here are derived from 2 data sources - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years, and \>65 years. Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with seasonal influenza vaccine Vaccination of subjects happened between weeks 35 and 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16433 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=3310 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=4196 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 37
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
1.45 Percentage of subjects
Interval 0.3 to 4.18
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 2.95
|
0.00 Percentage of subjects
Interval 0.0 to 7.71
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 1.9
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 2.55
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 44
|
—
|
0.49 Percentage of subjects
Interval 0.01 to 2.7
|
0.00 Percentage of subjects
Interval 0.0 to 2.48
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 45
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.82
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.49 Percentage of subjects
Interval 0.0 to 4.44
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 47
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 4.99
|
0.00 Percentage of subjects
Interval 0.0 to 9.03
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 48
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 37
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
—
|
—
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 38
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
—
|
—
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
—
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
4.76 Percentage of subjects
Interval 0.03 to 29.74
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 11.57
|
0.00 Percentage of subjects
Interval 0.0 to 6.49
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 12.34
|
0.00 Percentage of subjects
Interval 0.0 to 14.82
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 13.72
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 3.66
|
0.00 Percentage of subjects
Interval 0.0 to 1.47
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 3.55
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 1.34
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 47
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
—
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 37
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
—
|
—
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 38
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
—
|
—
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
0.00 Percentage of subjects
Interval 0.0 to 10.89
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
—
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 13.72
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 4.51
|
0.49 Percentage of subjects
Interval 0.01 to 2.69
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
—
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 36
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 37
|
0.56 Percentage of subjects
Interval 0.15 to 1.42
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 2.4
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 38
|
0.81 Percentage of subjects
Interval 0.13 to 2.66
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 2.22
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 39
|
0.71 Percentage of subjects
Interval 0.28 to 1.46
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 2.48
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 40
|
0.81 Percentage of subjects
Interval 0.07 to 3.27
|
1.59 Percentage of subjects
Interval 0.04 to 8.63
|
0.00 Percentage of subjects
Interval 0.0 to 1.87
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 41
|
0.31 Percentage of subjects
Interval 0.02 to 1.39
|
0.00 Percentage of subjects
Interval 0.0 to 3.85
|
0.00 Percentage of subjects
Interval 0.0 to 3.3
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 1.03
|
0.00 Percentage of subjects
Interval 0.0 to 3.3
|
0.00 Percentage of subjects
Interval 0.0 to 4.45
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 43
|
0.45 Percentage of subjects
Interval 0.01 to 2.91
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
0.00 Percentage of subjects
Interval 0.0 to 4.2
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 44
|
0.32 Percentage of subjects
Interval 0.01 to 1.77
|
0.00 Percentage of subjects
Interval 0.0 to 4.56
|
0.00 Percentage of subjects
Interval 0.0 to 4.56
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 45
|
0.45 Percentage of subjects
Interval 0.0 to 3.26
|
0.00 Percentage of subjects
Interval 0.0 to 6.49
|
0.00 Percentage of subjects
Interval 0.0 to 4.35
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 46
|
0.45 Percentage of subjects
Interval 0.0 to 3.36
|
0.00 Percentage of subjects
Interval 0.0 to 6.98
|
0.00 Percentage of subjects
Interval 0.0 to 8.81
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 47
|
0.68 Percentage of subjects
Interval 0.0 to 4.94
|
2.56 Percentage of subjects
Interval 0.0 to 25.31
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 4.11
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 12.34
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 6.98
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 37
|
0.40 Percentage of subjects
Interval 0.16 to 0.83
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 1.16
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 38
|
0.43 Percentage of subjects
Interval 0.18 to 0.84
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 0.97
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 39
|
0.41 Percentage of subjects
Interval 0.12 to 1.01
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.30 Percentage of subjects
Interval 0.0 to 2.21
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 40
|
0.23 Percentage of subjects
Interval 0.05 to 0.67
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
0.00 Percentage of subjects
Interval 0.0 to 1.01
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 41
|
0.39 Percentage of subjects
Interval 0.09 to 1.11
|
2.53 Percentage of subjects
Interval 0.31 to 8.85
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 0.67
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 3.03
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 43
|
0.36 Percentage of subjects
Interval 0.0 to 2.44
|
0.00 Percentage of subjects
Interval 0.0 to 4.4
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 44
|
0.23 Percentage of subjects
Interval 0.01 to 1.29
|
1.56 Percentage of subjects
Interval 0.0 to 64.84
|
0.00 Percentage of subjects
Interval 0.0 to 4.99
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 1.65
|
0.00 Percentage of subjects
Interval 0.0 to 9.49
|
0.00 Percentage of subjects
Interval 0.0 to 6.06
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 46
|
0.88 Percentage of subjects
Interval 0.01 to 6.2
|
0.00 Percentage of subjects
Interval 0.0 to 9.49
|
0.00 Percentage of subjects
Interval 0.0 to 10.89
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 3.42
|
0.00 Percentage of subjects
Interval 0.0 to 12.77
|
0.00 Percentage of subjects
Interval 0.0 to 11.57
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 15.44
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start up to end of the week of interest and were registered in EHR (routine data collection \& card-based ADR reporting) during FU period (from vaccination up to 7 days post-vaccination)
AEIs reported here are derived from 2 data sources - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12, 13 to 17, 18 to 65, and \>65 years. Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between weeks 35 and 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16433 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=3310 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=4196 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-39
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-41
|
0.00 Percentage of subjects
Interval 0.0 to 6.49
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 10.0
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-42
|
0.00 Percentage of subjects
Interval 0.0 to 6.06
|
0.00 Percentage of subjects
Interval 0.0 to 7.4
|
0.00 Percentage of subjects
Interval 0.0 to 10.0
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-43
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-44
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
0.00 Percentage of subjects
Interval 0.0 to 4.2
|
0.00 Percentage of subjects
Interval 0.0 to 7.11
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-45
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
0.00 Percentage of subjects
Interval 0.0 to 2.2
|
0.39 Percentage of subjects
Interval 0.01 to 2.17
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-46
|
0.00 Percentage of subjects
Interval 0.0 to 4.74
|
0.00 Percentage of subjects
Interval 0.0 to 2.05
|
0.39 Percentage of subjects
Interval 0.01 to 2.15
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-47
|
0.00 Percentage of subjects
Interval 0.0 to 4.4
|
0.00 Percentage of subjects
Interval 0.0 to 2.0
|
0.38 Percentage of subjects
Interval 0.01 to 2.11
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-48
|
0.00 Percentage of subjects
Interval 0.0 to 4.2
|
0.00 Percentage of subjects
Interval 0.0 to 1.98
|
0.38 Percentage of subjects
Interval 0.01 to 2.11
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-36
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-37
|
0.56 Percentage of subjects
Interval 0.15 to 1.42
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 2.25
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-38
|
0.70 Percentage of subjects
Interval 0.22 to 1.64
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.00 Percentage of subjects
Interval 0.0 to 1.13
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-39
|
0.70 Percentage of subjects
Interval 0.28 to 1.45
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.78
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-40
|
0.72 Percentage of subjects
Interval 0.33 to 1.37
|
1.25 Percentage of subjects
Interval 0.03 to 6.77
|
0.00 Percentage of subjects
Interval 0.0 to 0.55
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-41
|
0.66 Percentage of subjects
Interval 0.33 to 1.18
|
0.57 Percentage of subjects
Interval 0.01 to 3.16
|
0.00 Percentage of subjects
Interval 0.0 to 0.47
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-42
|
0.61 Percentage of subjects
Interval 0.3 to 1.12
|
0.35 Percentage of subjects
Interval 0.01 to 1.95
|
0.00 Percentage of subjects
Interval 0.0 to 0.43
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-43
|
0.61 Percentage of subjects
Interval 0.29 to 1.13
|
0.25 Percentage of subjects
Interval 0.01 to 1.37
|
0.00 Percentage of subjects
Interval 0.0 to 0.39
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-44
|
0.59 Percentage of subjects
Interval 0.28 to 1.08
|
0.21 Percentage of subjects
Interval 0.01 to 1.15
|
0.00 Percentage of subjects
Interval 0.0 to 0.36
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-45
|
0.58 Percentage of subjects
Interval 0.28 to 1.07
|
0.19 Percentage of subjects
Interval 0.0 to 1.03
|
0.00 Percentage of subjects
Interval 0.0 to 0.33
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-47
|
0.58 Percentage of subjects
Interval 0.28 to 1.06
|
0.32 Percentage of subjects
Interval 0.04 to 1.15
|
0.00 Percentage of subjects
Interval 0.0 to 0.3
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-48
|
0.57 Percentage of subjects
Interval 0.28 to 1.05
|
0.30 Percentage of subjects
Interval 0.04 to 1.1
|
0.00 Percentage of subjects
Interval 0.0 to 0.3
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-37
|
0.40 Percentage of subjects
Interval 0.16 to 0.83
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 0.99
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-37
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-38
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-39
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-40
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
1.11 Percentage of subjects
Interval 0.14 to 3.88
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-41
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.76 Percentage of subjects
Interval 0.06 to 3.15
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-42
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.51 Percentage of subjects
Interval 0.02 to 2.44
|
0.00 Percentage of subjects
Interval 0.0 to 4.56
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-43
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.41 Percentage of subjects
Interval 0.01 to 2.18
|
0.00 Percentage of subjects
Interval 0.0 to 4.3
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-44
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.43 Percentage of subjects
Interval 0.04 to 1.68
|
0.00 Percentage of subjects
Interval 0.0 to 1.58
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-45
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.38 Percentage of subjects
Interval 0.03 to 1.53
|
0.00 Percentage of subjects
Interval 0.0 to 1.57
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-46
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.40 Percentage of subjects
Interval 0.06 to 1.29
|
0.00 Percentage of subjects
Interval 0.0 to 1.51
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-47
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.37 Percentage of subjects
Interval 0.06 to 1.22
|
0.00 Percentage of subjects
Interval 0.0 to 1.3
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-48
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.37 Percentage of subjects
Interval 0.06 to 1.19
|
0.00 Percentage of subjects
Interval 0.0 to 1.28
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-37
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
—
|
—
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-38
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
—
|
—
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-39
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
—
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-40
|
0.00 Percentage of subjects
Interval 0.0 to 12.77
|
2.38 Percentage of subjects
Interval 0.03 to 14.41
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-41
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
1.39 Percentage of subjects
Interval 0.01 to 9.21
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-42
|
0.00 Percentage of subjects
Interval 0.0 to 10.28
|
1.00 Percentage of subjects
Interval 0.01 to 6.59
|
0.00 Percentage of subjects
Interval 0.0 to 4.11
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-43
|
0.00 Percentage of subjects
Interval 0.0 to 10.0
|
0.80 Percentage of subjects
Interval 0.01 to 5.53
|
0.00 Percentage of subjects
Interval 0.0 to 3.81
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-44
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
0.45 Percentage of subjects
Interval 0.0 to 3.38
|
0.00 Percentage of subjects
Interval 0.0 to 1.07
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-45
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
0.31 Percentage of subjects
Interval 0.0 to 2.5
|
0.00 Percentage of subjects
Interval 0.0 to 1.06
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-46
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
0.17 Percentage of subjects
Interval 0.0 to 1.44
|
0.00 Percentage of subjects
Interval 0.0 to 1.03
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-47
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
0.16 Percentage of subjects
Interval 0.0 to 1.4
|
0.00 Percentage of subjects
Interval 0.0 to 0.87
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-48
|
0.00 Percentage of subjects
Interval 0.0 to 7.4
|
0.16 Percentage of subjects
Interval 0.0 to 1.37
|
0.00 Percentage of subjects
Interval 0.0 to 0.87
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-37
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
—
|
—
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-38
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
—
|
—
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-40
|
0.00 Percentage of subjects
Interval 0.0 to 7.87
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-46
|
0.58 Percentage of subjects
Interval 0.26 to 1.1
|
0.17 Percentage of subjects
Interval 0.0 to 0.94
|
0.00 Percentage of subjects
Interval 0.0 to 0.32
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-38
|
0.42 Percentage of subjects
Interval 0.23 to 0.68
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
0.00 Percentage of subjects
Interval 0.0 to 0.49
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-39
|
0.41 Percentage of subjects
Interval 0.25 to 0.65
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.09 Percentage of subjects
Interval 0.0 to 0.67
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-40
|
0.38 Percentage of subjects
Interval 0.24 to 0.58
|
0.00 Percentage of subjects
Interval 0.0 to 6.16
|
0.07 Percentage of subjects
Interval 0.0 to 0.52
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-41
|
0.38 Percentage of subjects
Interval 0.25 to 0.56
|
1.46 Percentage of subjects
Interval 0.18 to 5.17
|
0.06 Percentage of subjects
Interval 0.0 to 0.47
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-42
|
0.36 Percentage of subjects
Interval 0.23 to 0.54
|
0.99 Percentage of subjects
Interval 0.12 to 3.53
|
0.06 Percentage of subjects
Interval 0.0 to 0.43
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-43
|
0.36 Percentage of subjects
Interval 0.22 to 0.55
|
0.70 Percentage of subjects
Interval 0.09 to 2.52
|
0.06 Percentage of subjects
Interval 0.0 to 0.42
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-44
|
0.36 Percentage of subjects
Interval 0.22 to 0.54
|
0.86 Percentage of subjects
Interval 0.18 to 2.5
|
0.05 Percentage of subjects
Interval 0.0 to 0.4
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-45
|
0.35 Percentage of subjects
Interval 0.22 to 0.53
|
0.78 Percentage of subjects
Interval 0.16 to 2.26
|
0.05 Percentage of subjects
Interval 0.0 to 0.39
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-46
|
0.35 Percentage of subjects
Interval 0.22 to 0.55
|
0.71 Percentage of subjects
Interval 0.15 to 2.06
|
0.05 Percentage of subjects
Interval 0.0 to 0.38
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-47
|
0.35 Percentage of subjects
Interval 0.21 to 0.54
|
0.67 Percentage of subjects
Interval 0.14 to 1.94
|
0.05 Percentage of subjects
Interval 0.0 to 0.37
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-48
|
0.35 Percentage of subjects
Interval 0.21 to 0.54
|
0.64 Percentage of subjects
Interval 0.13 to 1.85
|
0.05 Percentage of subjects
Interval 0.0 to 0.37
|
SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in EHR (combining routine data collection and card-based ADR reporting system) during the safety follow-up period (from vaccination up to 7 days post-vaccination).
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Local symptoms include local erythema. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16433 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=3310 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=4196 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 46
|
2.24 Percentage of subjects
Interval 0.3 to 7.65
|
3.92 Percentage of subjects
Interval 0.48 to 13.46
|
0.00 Percentage of subjects
Interval 0.0 to 8.81
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 11.57
|
0.00 Percentage of subjects
Interval 0.0 to 6.49
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 12.34
|
0.00 Percentage of subjects
Interval 0.0 to 14.82
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 13.72
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 3.66
|
0.00 Percentage of subjects
Interval 0.0 to 1.47
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 3.55
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 1.34
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 47
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
—
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 37
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
—
|
—
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 38
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
—
|
—
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
0.00 Percentage of subjects
Interval 0.0 to 10.89
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
—
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 13.72
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 1.78
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
—
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 36
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 37
|
3.06 Percentage of subjects
Interval 1.93 to 4.6
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.66 Percentage of subjects
Interval 0.02 to 3.61
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 38
|
3.14 Percentage of subjects
Interval 1.56 to 5.58
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 2.22
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 39
|
2.19 Percentage of subjects
Interval 1.37 to 3.32
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 2.48
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 40
|
3.10 Percentage of subjects
Interval 0.67 to 8.64
|
1.59 Percentage of subjects
Interval 0.04 to 8.63
|
0.00 Percentage of subjects
Interval 0.0 to 1.87
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 41
|
1.26 Percentage of subjects
Interval 0.55 to 2.47
|
2.13 Percentage of subjects
Interval 0.26 to 7.48
|
0.00 Percentage of subjects
Interval 0.0 to 3.3
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 42
|
0.85 Percentage of subjects
Interval 0.06 to 3.51
|
0.00 Percentage of subjects
Interval 0.0 to 3.3
|
0.00 Percentage of subjects
Interval 0.0 to 4.45
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 43
|
0.45 Percentage of subjects
Interval 0.01 to 2.91
|
1.68 Percentage of subjects
Interval 0.2 to 5.94
|
0.00 Percentage of subjects
Interval 0.0 to 4.2
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 44
|
2.24 Percentage of subjects
Interval 0.76 to 5.02
|
1.27 Percentage of subjects
Interval 0.03 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 4.56
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 45
|
0.45 Percentage of subjects
Interval 0.0 to 3.33
|
0.00 Percentage of subjects
Interval 0.0 to 6.49
|
0.00 Percentage of subjects
Interval 0.0 to 4.35
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 47
|
2.05 Percentage of subjects
Interval 0.1 to 9.4
|
0.00 Percentage of subjects
Interval 0.0 to 9.03
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 4.11
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 12.34
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
>65 years, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 6.98
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
>65 years, Week 37
|
1.44 Percentage of subjects
Interval 0.34 to 3.9
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 1.16
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
>65 years, Week 38
|
0.96 Percentage of subjects
Interval 0.52 to 1.62
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 0.97
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
>65 years, Week 39
|
1.83 Percentage of subjects
Interval 1.25 to 2.59
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.00 Percentage of subjects
Interval 0.0 to 1.09
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
>65 years, Week 40
|
1.30 Percentage of subjects
Interval 0.44 to 2.97
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
0.00 Percentage of subjects
Interval 0.0 to 1.01
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
>65 years, Week 41
|
1.57 Percentage of subjects
Interval 0.9 to 2.54
|
1.27 Percentage of subjects
Interval 0.03 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
>65 years, Week 42
|
0.37 Percentage of subjects
Interval 0.0 to 2.81
|
3.08 Percentage of subjects
Interval 0.37 to 10.68
|
0.00 Percentage of subjects
Interval 0.0 to 3.03
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
>65 years, Week 43
|
0.36 Percentage of subjects
Interval 0.0 to 2.55
|
1.22 Percentage of subjects
Interval 0.0 to 72.65
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
>65 years, Week 44
|
0.47 Percentage of subjects
Interval 0.02 to 2.39
|
3.13 Percentage of subjects
Interval 0.0 to 46.96
|
0.00 Percentage of subjects
Interval 0.0 to 4.99
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
>65 years, Week 45
|
1.35 Percentage of subjects
Interval 0.09 to 5.79
|
5.41 Percentage of subjects
Interval 0.0 to 99.64
|
0.00 Percentage of subjects
Interval 0.0 to 6.06
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
>65 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
2.70 Percentage of subjects
Interval 0.0 to 99.94
|
0.00 Percentage of subjects
Interval 0.0 to 10.89
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
>65 years, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 3.42
|
0.00 Percentage of subjects
Interval 0.0 to 12.77
|
0.00 Percentage of subjects
Interval 0.0 to 11.57
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
>65 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 15.44
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 37
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 1.77
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 2.95
|
0.00 Percentage of subjects
Interval 0.0 to 7.71
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 1.9
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 2.55
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 44
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 2.48
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 45
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.82
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 1.8
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 47
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 4.99
|
0.00 Percentage of subjects
Interval 0.0 to 9.03
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 48
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 37
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
—
|
—
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 38
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
—
|
—
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
—
|
SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start up to end of the week of interest and were registered in EHR (routine data collection \& card-based ADR reporting) during FU period (from vaccination up to 7 days post-vaccination)
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Local symptoms include local erythema. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16433 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=3310 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=4196 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-47
|
1.29 Percentage of subjects
Interval 0.9 to 1.79
|
2.00 Percentage of subjects
Interval 0.92 to 3.77
|
0.00 Percentage of subjects
Interval 0.0 to 0.19
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-44
|
1.32 Percentage of subjects
Interval 0.92 to 1.83
|
1.72 Percentage of subjects
Interval 0.64 to 3.71
|
0.00 Percentage of subjects
Interval 0.0 to 0.2
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-45
|
1.32 Percentage of subjects
Interval 0.92 to 1.83
|
2.08 Percentage of subjects
Interval 0.9 to 4.05
|
0.00 Percentage of subjects
Interval 0.0 to 0.19
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-46
|
1.31 Percentage of subjects
Interval 0.91 to 1.81
|
2.13 Percentage of subjects
Interval 0.98 to 4.01
|
0.00 Percentage of subjects
Interval 0.0 to 0.19
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-48
|
1.29 Percentage of subjects
Interval 0.9 to 1.78
|
1.91 Percentage of subjects
Interval 0.88 to 3.6
|
0.00 Percentage of subjects
Interval 0.0 to 0.19
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-37
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-38
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-39
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-40
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 1.36
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-41
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 0.93
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-42
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.00 Percentage of subjects
Interval 0.0 to 0.63
|
0.00 Percentage of subjects
Interval 0.0 to 4.56
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-43
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 0.51
|
0.00 Percentage of subjects
Interval 0.0 to 4.3
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-44
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 0.4
|
0.00 Percentage of subjects
Interval 0.0 to 1.58
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-45
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 0.35
|
0.00 Percentage of subjects
Interval 0.0 to 1.57
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-46
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.29
|
0.00 Percentage of subjects
Interval 0.0 to 1.51
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-47
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.28
|
0.00 Percentage of subjects
Interval 0.0 to 1.3
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-48
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.27
|
0.00 Percentage of subjects
Interval 0.0 to 1.28
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-37
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
—
|
—
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-38
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
—
|
—
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-39
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
—
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-40
|
0.00 Percentage of subjects
Interval 0.0 to 12.77
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-41
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 4.99
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-42
|
0.00 Percentage of subjects
Interval 0.0 to 10.28
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 4.11
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-43
|
0.00 Percentage of subjects
Interval 0.0 to 10.0
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.00 Percentage of subjects
Interval 0.0 to 3.81
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-44
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
0.00 Percentage of subjects
Interval 0.0 to 1.63
|
0.00 Percentage of subjects
Interval 0.0 to 1.07
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-45
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
0.00 Percentage of subjects
Interval 0.0 to 1.13
|
0.00 Percentage of subjects
Interval 0.0 to 1.06
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-46
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
0.00 Percentage of subjects
Interval 0.0 to 0.61
|
0.00 Percentage of subjects
Interval 0.0 to 1.03
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-47
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
0.00 Percentage of subjects
Interval 0.0 to 0.6
|
0.00 Percentage of subjects
Interval 0.0 to 0.87
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-48
|
0.00 Percentage of subjects
Interval 0.0 to 7.4
|
0.00 Percentage of subjects
Interval 0.0 to 0.58
|
0.00 Percentage of subjects
Interval 0.0 to 0.87
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-37
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
—
|
—
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-38
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
—
|
—
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-39
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-40
|
0.00 Percentage of subjects
Interval 0.0 to 7.87
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-41
|
0.00 Percentage of subjects
Interval 0.0 to 6.49
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 10.0
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-42
|
0.00 Percentage of subjects
Interval 0.0 to 6.06
|
0.00 Percentage of subjects
Interval 0.0 to 7.4
|
0.00 Percentage of subjects
Interval 0.0 to 10.0
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-43
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-44
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
0.00 Percentage of subjects
Interval 0.0 to 4.2
|
0.00 Percentage of subjects
Interval 0.0 to 7.11
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-45
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
0.00 Percentage of subjects
Interval 0.0 to 2.2
|
0.00 Percentage of subjects
Interval 0.0 to 1.44
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-46
|
0.00 Percentage of subjects
Interval 0.0 to 4.74
|
0.00 Percentage of subjects
Interval 0.0 to 2.05
|
0.00 Percentage of subjects
Interval 0.0 to 1.43
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-47
|
0.00 Percentage of subjects
Interval 0.0 to 4.4
|
0.00 Percentage of subjects
Interval 0.0 to 2.0
|
0.00 Percentage of subjects
Interval 0.0 to 1.4
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-48
|
0.00 Percentage of subjects
Interval 0.0 to 4.2
|
0.00 Percentage of subjects
Interval 0.0 to 1.98
|
0.00 Percentage of subjects
Interval 0.0 to 1.4
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-36
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-37
|
3.06 Percentage of subjects
Interval 1.93 to 4.6
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.62 Percentage of subjects
Interval 0.02 to 3.39
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-38
|
3.10 Percentage of subjects
Interval 1.96 to 4.65
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.31 Percentage of subjects
Interval 0.01 to 1.7
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-39
|
2.67 Percentage of subjects
Interval 1.74 to 3.92
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
0.21 Percentage of subjects
Interval 0.0 to 1.23
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-40
|
2.76 Percentage of subjects
Interval 1.61 to 4.38
|
1.25 Percentage of subjects
Interval 0.03 to 6.77
|
0.15 Percentage of subjects
Interval 0.0 to 0.95
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-41
|
2.54 Percentage of subjects
Interval 1.56 to 3.9
|
1.72 Percentage of subjects
Interval 0.36 to 4.96
|
0.13 Percentage of subjects
Interval 0.0 to 0.83
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-42
|
2.41 Percentage of subjects
Interval 1.5 to 3.66
|
1.06 Percentage of subjects
Interval 0.22 to 3.06
|
0.12 Percentage of subjects
Interval 0.0 to 0.77
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-43
|
2.33 Percentage of subjects
Interval 1.45 to 3.52
|
1.24 Percentage of subjects
Interval 0.4 to 2.87
|
0.11 Percentage of subjects
Interval 0.0 to 0.71
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-44
|
2.32 Percentage of subjects
Interval 1.5 to 3.42
|
1.24 Percentage of subjects
Interval 0.46 to 2.69
|
0.10 Percentage of subjects
Interval 0.0 to 0.66
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-45
|
2.24 Percentage of subjects
Interval 1.46 to 3.28
|
1.12 Percentage of subjects
Interval 0.41 to 2.42
|
0.09 Percentage of subjects
Interval 0.0 to 0.61
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-46
|
2.24 Percentage of subjects
Interval 1.48 to 3.25
|
1.36 Percentage of subjects
Interval 0.59 to 2.66
|
0.09 Percentage of subjects
Interval 0.0 to 0.59
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-47
|
2.24 Percentage of subjects
Interval 1.5 to 3.2
|
1.28 Percentage of subjects
Interval 0.55 to 2.5
|
0.08 Percentage of subjects
Interval 0.0 to 0.57
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-48
|
2.21 Percentage of subjects
Interval 1.48 to 3.16
|
1.22 Percentage of subjects
Interval 0.53 to 2.39
|
0.08 Percentage of subjects
Interval 0.0 to 0.56
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-37
|
1.44 Percentage of subjects
Interval 0.34 to 3.89
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 0.99
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-38
|
1.19 Percentage of subjects
Interval 0.49 to 2.42
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
0.00 Percentage of subjects
Interval 0.0 to 0.49
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-39
|
1.46 Percentage of subjects
Interval 0.86 to 2.33
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 0.34
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-40
|
1.44 Percentage of subjects
Interval 0.91 to 2.16
|
0.00 Percentage of subjects
Interval 0.0 to 6.16
|
0.00 Percentage of subjects
Interval 0.0 to 0.25
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-41
|
1.45 Percentage of subjects
Interval 0.97 to 2.09
|
0.73 Percentage of subjects
Interval 0.02 to 4.0
|
0.00 Percentage of subjects
Interval 0.0 to 0.23
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-42
|
1.39 Percentage of subjects
Interval 0.96 to 1.94
|
1.49 Percentage of subjects
Interval 0.31 to 4.28
|
0.00 Percentage of subjects
Interval 0.0 to 0.21
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-43
|
1.36 Percentage of subjects
Interval 0.94 to 1.89
|
1.41 Percentage of subjects
Interval 0.39 to 3.57
|
0.00 Percentage of subjects
Interval 0.0 to 0.21
|
SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in EHR (combining routine data collection and card-based ADR reporting system) during the safety follow-up period (from vaccination up to 7 days post-vaccination).
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16433 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=3310 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=4196 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 37
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.48 Percentage of subjects
Interval 0.01 to 2.66
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 2.95
|
0.00 Percentage of subjects
Interval 0.0 to 7.71
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 1.9
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 2.55
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 44
|
—
|
0.49 Percentage of subjects
Interval 0.01 to 2.7
|
0.00 Percentage of subjects
Interval 0.0 to 2.48
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 45
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.82
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 1.8
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 47
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 4.99
|
0.00 Percentage of subjects
Interval 0.0 to 9.03
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 48
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 37
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
—
|
—
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 38
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
—
|
—
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
—
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
9.52 Percentage of subjects
Interval 1.17 to 30.38
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 11.57
|
0.00 Percentage of subjects
Interval 0.0 to 6.49
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 12.34
|
0.00 Percentage of subjects
Interval 0.0 to 14.82
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 13.72
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 3.66
|
0.00 Percentage of subjects
Interval 0.0 to 1.47
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.98 Percentage of subjects
Interval 0.0 to 10.39
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 1.34
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 47
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
—
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 37
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
—
|
—
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 38
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
—
|
—
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
0.00 Percentage of subjects
Interval 0.0 to 10.89
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
—
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 13.72
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
1.25 Percentage of subjects
Interval 0.03 to 6.77
|
1.95 Percentage of subjects
Interval 0.53 to 4.92
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
—
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 36
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 37
|
3.76 Percentage of subjects
Interval 2.09 to 6.18
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.66 Percentage of subjects
Interval 0.0 to 5.33
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 38
|
3.60 Percentage of subjects
Interval 2.41 to 5.17
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 2.22
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 39
|
4.45 Percentage of subjects
Interval 3.38 to 5.75
|
10.00 Percentage of subjects
Interval 0.11 to 50.09
|
0.00 Percentage of subjects
Interval 0.0 to 2.48
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 40
|
3.10 Percentage of subjects
Interval 1.98 to 4.62
|
4.76 Percentage of subjects
Interval 0.1 to 24.55
|
0.00 Percentage of subjects
Interval 0.0 to 1.87
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 41
|
1.57 Percentage of subjects
Interval 0.76 to 2.88
|
2.13 Percentage of subjects
Interval 0.26 to 7.48
|
0.00 Percentage of subjects
Interval 0.0 to 3.3
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 42
|
2.82 Percentage of subjects
Interval 0.89 to 6.58
|
0.91 Percentage of subjects
Interval 0.02 to 4.96
|
0.00 Percentage of subjects
Interval 0.0 to 4.45
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 43
|
0.45 Percentage of subjects
Interval 0.0 to 3.1
|
1.68 Percentage of subjects
Interval 0.2 to 5.94
|
0.00 Percentage of subjects
Interval 0.0 to 4.2
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 44
|
1.92 Percentage of subjects
Interval 0.71 to 4.13
|
7.59 Percentage of subjects
Interval 2.84 to 15.8
|
0.00 Percentage of subjects
Interval 0.0 to 4.56
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 45
|
1.79 Percentage of subjects
Interval 0.26 to 5.92
|
1.82 Percentage of subjects
Interval 0.0 to 93.05
|
1.20 Percentage of subjects
Interval 0.03 to 6.53
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 46
|
1.35 Percentage of subjects
Interval 0.28 to 3.89
|
3.92 Percentage of subjects
Interval 0.03 to 24.66
|
0.00 Percentage of subjects
Interval 0.0 to 8.81
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 47
|
0.68 Percentage of subjects
Interval 0.02 to 3.78
|
0.00 Percentage of subjects
Interval 0.0 to 9.03
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 4.11
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 12.34
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
>65 years, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 6.98
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
>65 years, Week 37
|
4.15 Percentage of subjects
Interval 3.26 to 5.2
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 1.16
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
>65 years, Week 38
|
3.04 Percentage of subjects
Interval 2.26 to 4.01
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 0.97
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
>65 years, Week 39
|
2.73 Percentage of subjects
Interval 1.86 to 3.85
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.59 Percentage of subjects
Interval 0.07 to 2.13
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
>65 years, Week 40
|
2.53 Percentage of subjects
Interval 1.58 to 3.83
|
4.76 Percentage of subjects
Interval 0.58 to 16.16
|
0.00 Percentage of subjects
Interval 0.0 to 1.01
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
>65 years, Week 41
|
2.26 Percentage of subjects
Interval 1.44 to 3.37
|
2.53 Percentage of subjects
Interval 0.31 to 8.85
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
>65 years, Week 42
|
0.91 Percentage of subjects
Interval 0.11 to 3.23
|
1.54 Percentage of subjects
Interval 0.04 to 8.28
|
0.00 Percentage of subjects
Interval 0.0 to 3.03
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
>65 years, Week 43
|
3.28 Percentage of subjects
Interval 1.5 to 6.18
|
2.44 Percentage of subjects
Interval 0.0 to 92.92
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
>65 years, Week 44
|
1.86 Percentage of subjects
Interval 0.54 to 4.58
|
1.56 Percentage of subjects
Interval 0.0 to 64.84
|
0.00 Percentage of subjects
Interval 0.0 to 4.99
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
>65 years, Week 45
|
1.35 Percentage of subjects
Interval 0.11 to 5.51
|
8.11 Percentage of subjects
Interval 0.32 to 34.78
|
0.00 Percentage of subjects
Interval 0.0 to 6.06
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
>65 years, Week 46
|
0.88 Percentage of subjects
Interval 0.01 to 6.2
|
0.00 Percentage of subjects
Interval 0.0 to 9.49
|
0.00 Percentage of subjects
Interval 0.0 to 10.89
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
>65 years, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 3.42
|
0.00 Percentage of subjects
Interval 0.0 to 12.77
|
0.00 Percentage of subjects
Interval 0.0 to 11.57
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
>65 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 15.44
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start up to end of the week of interest and were registered in EHR (routine data collection \& card-based ADR reporting) during FU period (from vaccination up to 7 days post-vaccination)
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16433 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=3310 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=4196 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-43
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.14 Percentage of subjects
Interval 0.0 to 0.76
|
0.00 Percentage of subjects
Interval 0.0 to 4.3
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-37
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-38
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-39
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-40
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.37 Percentage of subjects
Interval 0.01 to 2.05
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-41
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.25 Percentage of subjects
Interval 0.01 to 1.41
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-42
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.17 Percentage of subjects
Interval 0.0 to 0.95
|
0.00 Percentage of subjects
Interval 0.0 to 4.56
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-44
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.21 Percentage of subjects
Interval 0.03 to 0.77
|
0.00 Percentage of subjects
Interval 0.0 to 1.58
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-45
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.19 Percentage of subjects
Interval 0.02 to 0.69
|
0.00 Percentage of subjects
Interval 0.0 to 1.57
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-46
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.16 Percentage of subjects
Interval 0.02 to 0.6
|
0.00 Percentage of subjects
Interval 0.0 to 1.51
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-47
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.15 Percentage of subjects
Interval 0.02 to 0.57
|
0.00 Percentage of subjects
Interval 0.0 to 1.3
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-48
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.15 Percentage of subjects
Interval 0.02 to 0.55
|
0.00 Percentage of subjects
Interval 0.0 to 1.28
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-37
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
—
|
—
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-38
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
—
|
—
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-39
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
—
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-40
|
0.00 Percentage of subjects
Interval 0.0 to 12.77
|
4.76 Percentage of subjects
Interval 0.58 to 16.16
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-41
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
2.78 Percentage of subjects
Interval 0.31 to 10.01
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-42
|
0.00 Percentage of subjects
Interval 0.0 to 10.28
|
2.00 Percentage of subjects
Interval 0.24 to 7.04
|
0.00 Percentage of subjects
Interval 0.0 to 4.11
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-43
|
0.00 Percentage of subjects
Interval 0.0 to 10.0
|
1.60 Percentage of subjects
Interval 0.19 to 5.66
|
0.00 Percentage of subjects
Interval 0.0 to 3.81
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-44
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
0.89 Percentage of subjects
Interval 0.06 to 3.76
|
0.00 Percentage of subjects
Interval 0.0 to 1.07
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-45
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
0.92 Percentage of subjects
Interval 0.02 to 4.97
|
0.00 Percentage of subjects
Interval 0.0 to 1.06
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-46
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
0.50 Percentage of subjects
Interval 0.01 to 2.97
|
0.00 Percentage of subjects
Interval 0.0 to 1.03
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-47
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
0.49 Percentage of subjects
Interval 0.01 to 2.9
|
0.00 Percentage of subjects
Interval 0.0 to 0.87
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-48
|
0.00 Percentage of subjects
Interval 0.0 to 7.4
|
0.47 Percentage of subjects
Interval 0.01 to 2.83
|
0.00 Percentage of subjects
Interval 0.0 to 0.87
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-37
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
—
|
—
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-38
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
—
|
—
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-39
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-40
|
0.00 Percentage of subjects
Interval 0.0 to 7.87
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-41
|
0.00 Percentage of subjects
Interval 0.0 to 6.49
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 10.0
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-42
|
0.00 Percentage of subjects
Interval 0.0 to 6.06
|
0.00 Percentage of subjects
Interval 0.0 to 7.4
|
0.00 Percentage of subjects
Interval 0.0 to 10.0
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-43
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-44
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
0.00 Percentage of subjects
Interval 0.0 to 4.2
|
0.00 Percentage of subjects
Interval 0.0 to 7.11
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-45
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
0.60 Percentage of subjects
Interval 0.02 to 3.31
|
1.57 Percentage of subjects
Interval 0.43 to 3.97
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-46
|
0.00 Percentage of subjects
Interval 0.0 to 4.74
|
0.56 Percentage of subjects
Interval 0.01 to 3.09
|
1.56 Percentage of subjects
Interval 0.43 to 3.94
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-47
|
0.00 Percentage of subjects
Interval 0.0 to 4.4
|
0.55 Percentage of subjects
Interval 0.01 to 3.01
|
1.53 Percentage of subjects
Interval 0.42 to 3.86
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-48
|
0.00 Percentage of subjects
Interval 0.0 to 4.2
|
0.54 Percentage of subjects
Interval 0.01 to 2.99
|
1.53 Percentage of subjects
Interval 0.42 to 3.86
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-36
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-37
|
3.76 Percentage of subjects
Interval 2.09 to 6.18
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.62 Percentage of subjects
Interval 0.0 to 5.0
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-38
|
3.67 Percentage of subjects
Interval 2.38 to 5.4
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.31 Percentage of subjects
Interval 0.0 to 2.44
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-39
|
4.04 Percentage of subjects
Interval 3.08 to 5.19
|
5.88 Percentage of subjects
Interval 0.15 to 28.69
|
0.21 Percentage of subjects
Interval 0.0 to 1.62
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-40
|
3.86 Percentage of subjects
Interval 3.01 to 4.85
|
5.00 Percentage of subjects
Interval 1.38 to 12.31
|
0.15 Percentage of subjects
Interval 0.0 to 1.15
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-41
|
3.52 Percentage of subjects
Interval 2.67 to 4.55
|
3.45 Percentage of subjects
Interval 1.28 to 7.35
|
0.13 Percentage of subjects
Interval 0.0 to 0.97
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-42
|
3.47 Percentage of subjects
Interval 2.65 to 4.46
|
2.46 Percentage of subjects
Interval 1.0 to 5.01
|
0.12 Percentage of subjects
Interval 0.0 to 0.89
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-43
|
3.34 Percentage of subjects
Interval 2.51 to 4.35
|
2.23 Percentage of subjects
Interval 1.03 to 4.2
|
0.11 Percentage of subjects
Interval 0.0 to 0.8
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-44
|
3.25 Percentage of subjects
Interval 2.43 to 4.25
|
3.11 Percentage of subjects
Interval 1.75 to 5.08
|
0.10 Percentage of subjects
Interval 0.0 to 0.73
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-45
|
3.19 Percentage of subjects
Interval 2.42 to 4.12
|
2.98 Percentage of subjects
Interval 1.71 to 4.79
|
0.18 Percentage of subjects
Interval 0.0 to 1.28
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-46
|
3.12 Percentage of subjects
Interval 2.34 to 4.07
|
3.06 Percentage of subjects
Interval 1.82 to 4.8
|
0.17 Percentage of subjects
Interval 0.0 to 1.24
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-47
|
3.06 Percentage of subjects
Interval 2.29 to 3.99
|
2.87 Percentage of subjects
Interval 1.71 to 4.5
|
0.17 Percentage of subjects
Interval 0.0 to 1.17
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-48
|
3.01 Percentage of subjects
Interval 2.25 to 3.94
|
2.74 Percentage of subjects
Interval 1.63 to 4.3
|
0.16 Percentage of subjects
Interval 0.0 to 1.14
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-37
|
4.15 Percentage of subjects
Interval 3.26 to 5.19
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 0.99
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-38
|
3.57 Percentage of subjects
Interval 2.89 to 4.37
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
0.00 Percentage of subjects
Interval 0.0 to 0.49
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-39
|
3.22 Percentage of subjects
Interval 2.42 to 4.19
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.18 Percentage of subjects
Interval 0.02 to 0.67
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-40
|
3.10 Percentage of subjects
Interval 2.31 to 4.05
|
3.45 Percentage of subjects
Interval 0.42 to 11.91
|
0.14 Percentage of subjects
Interval 0.02 to 0.5
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-41
|
3.00 Percentage of subjects
Interval 2.27 to 3.88
|
2.92 Percentage of subjects
Interval 0.8 to 7.31
|
0.12 Percentage of subjects
Interval 0.02 to 0.45
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-42
|
2.87 Percentage of subjects
Interval 2.13 to 3.78
|
2.48 Percentage of subjects
Interval 0.81 to 5.68
|
0.12 Percentage of subjects
Interval 0.01 to 0.42
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-43
|
2.89 Percentage of subjects
Interval 2.13 to 3.81
|
2.46 Percentage of subjects
Interval 1.0 to 5.01
|
0.11 Percentage of subjects
Interval 0.01 to 0.4
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-44
|
2.84 Percentage of subjects
Interval 2.1 to 3.75
|
2.30 Percentage of subjects
Interval 0.97 to 4.55
|
0.11 Percentage of subjects
Interval 0.01 to 0.39
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-45
|
2.81 Percentage of subjects
Interval 2.07 to 3.71
|
2.86 Percentage of subjects
Interval 1.43 to 5.05
|
0.10 Percentage of subjects
Interval 0.01 to 0.38
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-46
|
2.79 Percentage of subjects
Interval 2.04 to 3.71
|
2.61 Percentage of subjects
Interval 1.31 to 4.62
|
0.10 Percentage of subjects
Interval 0.01 to 0.37
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-47
|
2.76 Percentage of subjects
Interval 2.01 to 3.68
|
2.45 Percentage of subjects
Interval 1.23 to 4.34
|
0.10 Percentage of subjects
Interval 0.01 to 0.36
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-48
|
2.74 Percentage of subjects
Interval 2.0 to 3.67
|
2.34 Percentage of subjects
Interval 1.17 to 4.14
|
0.10 Percentage of subjects
Interval 0.01 to 0.36
|
SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in EHR (combining routine data collection and card-based ADR reporting system) during the safety follow-up period (from vaccination up to 7 days post-vaccination).
AEIs reported are derived from 2 data sources: ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12, 13 to 17, 18 to 65, and \>65 years. Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhea, and wheezing. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator = the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator = the number of subjects from the denominator who reported any AEIs in EHR (routine data collection + card-based ADR reporting system) within 7 days following vaccination with seasonal influenza vaccine Vaccination happened between weeks 35 and 48, of 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16433 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=3310 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=4196 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 37
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
1.59 Percentage of subjects
Interval 0.04 to 8.53
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
3.38 Percentage of subjects
Interval 1.37 to 6.84
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
3.25 Percentage of subjects
Interval 0.68 to 9.19
|
0.00 Percentage of subjects
Interval 0.0 to 7.71
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
1.04 Percentage of subjects
Interval 0.07 to 4.4
|
5.88 Percentage of subjects
Interval 0.0 to 69.4
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.70 Percentage of subjects
Interval 0.0 to 5.22
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 44
|
—
|
2.45 Percentage of subjects
Interval 0.08 to 12.11
|
0.00 Percentage of subjects
Interval 0.0 to 2.48
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 45
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.82
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 46
|
50.00 Percentage of subjects
Interval 1.26 to 98.74
|
0.00 Percentage of subjects
Interval 0.0 to 1.8
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 47
|
—
|
1.39 Percentage of subjects
Interval 0.04 to 7.5
|
0.00 Percentage of subjects
Interval 0.0 to 9.03
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 48
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 37
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
—
|
—
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 38
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
—
|
—
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
—
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 40
|
33.33 Percentage of subjects
Interval 0.0 to 100.0
|
14.29 Percentage of subjects
Interval 3.05 to 36.34
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 41
|
50.00 Percentage of subjects
Interval 1.26 to 98.74
|
0.00 Percentage of subjects
Interval 0.0 to 11.57
|
0.00 Percentage of subjects
Interval 0.0 to 6.49
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 12.34
|
0.00 Percentage of subjects
Interval 0.0 to 14.82
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 13.72
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 44
|
16.67 Percentage of subjects
Interval 0.02 to 81.43
|
2.02 Percentage of subjects
Interval 0.16 to 8.11
|
0.40 Percentage of subjects
Interval 0.01 to 2.22
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 3.55
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 46
|
20.00 Percentage of subjects
Interval 0.02 to 88.39
|
0.36 Percentage of subjects
Interval 0.01 to 2.02
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 47
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
1.61 Percentage of subjects
Interval 0.0 to 29.53
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
—
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 37
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
—
|
—
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 38
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
—
|
—
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 39
|
7.14 Percentage of subjects
Interval 0.02 to 44.9
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
11.11 Percentage of subjects
Interval 0.19 to 51.19
|
50.00 Percentage of subjects
Interval 1.26 to 98.74
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
5.88 Percentage of subjects
Interval 0.02 to 38.78
|
0.00 Percentage of subjects
Interval 0.0 to 10.89
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
—
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 13.72
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
1.25 Percentage of subjects
Interval 0.03 to 6.77
|
1.95 Percentage of subjects
Interval 0.53 to 4.92
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
—
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 36
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 37
|
6.54 Percentage of subjects
Interval 4.34 to 9.38
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
1.32 Percentage of subjects
Interval 0.12 to 5.14
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 38
|
4.53 Percentage of subjects
Interval 2.66 to 7.17
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 2.22
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 39
|
5.72 Percentage of subjects
Interval 4.51 to 7.15
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.68 Percentage of subjects
Interval 0.0 to 4.8
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 40
|
3.78 Percentage of subjects
Interval 2.49 to 5.47
|
1.59 Percentage of subjects
Interval 0.04 to 8.63
|
1.03 Percentage of subjects
Interval 0.12 to 3.66
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 41
|
4.25 Percentage of subjects
Interval 2.7 to 6.33
|
4.26 Percentage of subjects
Interval 1.17 to 10.54
|
0.91 Percentage of subjects
Interval 0.02 to 5.16
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 42
|
2.25 Percentage of subjects
Interval 0.95 to 4.48
|
0.00 Percentage of subjects
Interval 0.0 to 3.3
|
3.70 Percentage of subjects
Interval 0.5 to 12.3
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 43
|
1.81 Percentage of subjects
Interval 0.29 to 5.76
|
6.72 Percentage of subjects
Interval 2.81 to 13.18
|
0.00 Percentage of subjects
Interval 0.0 to 4.2
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 44
|
2.56 Percentage of subjects
Interval 0.98 to 5.37
|
6.33 Percentage of subjects
Interval 2.09 to 14.16
|
1.27 Percentage of subjects
Interval 0.03 to 7.12
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 45
|
2.68 Percentage of subjects
Interval 0.66 to 7.09
|
1.82 Percentage of subjects
Interval 0.0 to 93.05
|
4.82 Percentage of subjects
Interval 1.32 to 11.92
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 46
|
2.24 Percentage of subjects
Interval 0.43 to 6.6
|
5.88 Percentage of subjects
Interval 0.04 to 35.34
|
0.00 Percentage of subjects
Interval 0.0 to 8.81
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 47
|
4.11 Percentage of subjects
Interval 0.7 to 12.51
|
0.00 Percentage of subjects
Interval 0.0 to 9.03
|
1.59 Percentage of subjects
Interval 0.01 to 11.07
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 4.11
|
6.90 Percentage of subjects
Interval 0.0 to 53.09
|
0.00 Percentage of subjects
Interval 0.0 to 12.34
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
1.96 Percentage of subjects
Interval 0.0 to 18.8
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 37
|
6.46 Percentage of subjects
Interval 4.99 to 8.19
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.32 Percentage of subjects
Interval 0.01 to 1.76
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 38
|
5.07 Percentage of subjects
Interval 3.95 to 6.39
|
16.67 Percentage of subjects
Interval 0.0 to 91.51
|
0.80 Percentage of subjects
Interval 0.05 to 3.59
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 39
|
4.60 Percentage of subjects
Interval 3.57 to 5.83
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
1.48 Percentage of subjects
Interval 0.27 to 4.53
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 40
|
6.14 Percentage of subjects
Interval 3.57 to 9.75
|
4.76 Percentage of subjects
Interval 0.58 to 16.16
|
0.82 Percentage of subjects
Interval 0.13 to 2.66
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 41
|
4.91 Percentage of subjects
Interval 3.32 to 6.96
|
5.06 Percentage of subjects
Interval 1.4 to 12.46
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 42
|
2.74 Percentage of subjects
Interval 1.09 to 5.62
|
1.54 Percentage of subjects
Interval 0.04 to 8.28
|
0.00 Percentage of subjects
Interval 0.0 to 3.03
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 43
|
3.65 Percentage of subjects
Interval 1.37 to 7.71
|
2.44 Percentage of subjects
Interval 0.0 to 92.92
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 44
|
3.26 Percentage of subjects
Interval 0.66 to 9.32
|
7.81 Percentage of subjects
Interval 0.28 to 34.3
|
0.00 Percentage of subjects
Interval 0.0 to 4.99
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 45
|
1.80 Percentage of subjects
Interval 0.29 to 5.74
|
8.11 Percentage of subjects
Interval 0.0 to 99.99
|
0.00 Percentage of subjects
Interval 0.0 to 6.06
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 46
|
2.63 Percentage of subjects
Interval 0.5 to 7.81
|
0.00 Percentage of subjects
Interval 0.0 to 9.49
|
0.00 Percentage of subjects
Interval 0.0 to 10.89
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 47
|
0.94 Percentage of subjects
Interval 0.01 to 5.69
|
3.70 Percentage of subjects
Interval 0.0 to 99.88
|
3.33 Percentage of subjects
Interval 0.08 to 17.37
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 15.44
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start up to end of the week of interest and were registered in EHR (routine data collection \& card-based ADR reporting) during FU period (from vaccination up to 7 days post-vaccination)
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12, 13 to 17, 18 to 65, and \>65 years. Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhea, and wheezing. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (routine data collection + ADR) within 7 days following vaccination with seasonal influenza vaccine Vaccination of the subjects happened between weeks 35 and 48, 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16433 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=3310 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=4196 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-37
|
6.54 Percentage of subjects
Interval 6.54 to 6.54
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
1.23 Percentage of subjects
Interval 0.11 to 4.82
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-44
|
1.61 Percentage of subjects
Interval 0.02 to 10.31
|
2.33 Percentage of subjects
Interval 0.22 to 8.82
|
2.00 Percentage of subjects
Interval 0.05 to 10.65
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-45
|
1.43 Percentage of subjects
Interval 0.02 to 9.07
|
1.81 Percentage of subjects
Interval 0.37 to 5.19
|
1.96 Percentage of subjects
Interval 0.64 to 4.52
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-46
|
1.32 Percentage of subjects
Interval 0.01 to 8.53
|
1.69 Percentage of subjects
Interval 0.35 to 4.85
|
1.95 Percentage of subjects
Interval 0.63 to 4.48
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-47
|
1.22 Percentage of subjects
Interval 0.01 to 8.11
|
1.64 Percentage of subjects
Interval 0.34 to 4.72
|
1.91 Percentage of subjects
Interval 0.62 to 4.4
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-48
|
1.16 Percentage of subjects
Interval 0.01 to 7.7
|
1.63 Percentage of subjects
Interval 0.34 to 4.69
|
1.91 Percentage of subjects
Interval 0.62 to 4.4
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-36
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-37
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-38
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-39
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
1.59 Percentage of subjects
Interval 0.04 to 8.53
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-40
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
2.96 Percentage of subjects
Interval 1.29 to 5.75
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-41
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
3.05 Percentage of subjects
Interval 1.58 to 5.28
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-42
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
2.39 Percentage of subjects
Interval 1.23 to 4.17
|
1.27 Percentage of subjects
Interval 0.0 to 13.35
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-43
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
2.06 Percentage of subjects
Interval 0.98 to 3.79
|
1.19 Percentage of subjects
Interval 0.0 to 12.33
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-44
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
2.15 Percentage of subjects
Interval 0.91 to 4.23
|
0.43 Percentage of subjects
Interval 0.0 to 4.99
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-45
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
1.89 Percentage of subjects
Interval 0.76 to 3.85
|
0.43 Percentage of subjects
Interval 0.0 to 4.96
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-46
|
10.00 Percentage of subjects
Interval 0.14 to 48.28
|
1.58 Percentage of subjects
Interval 0.58 to 3.43
|
0.41 Percentage of subjects
Interval 0.0 to 4.74
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-47
|
10.00 Percentage of subjects
Interval 0.14 to 48.28
|
1.57 Percentage of subjects
Interval 0.62 to 3.25
|
0.35 Percentage of subjects
Interval 0.0 to 4.0
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-48
|
10.00 Percentage of subjects
Interval 0.14 to 48.28
|
1.54 Percentage of subjects
Interval 0.61 to 3.18
|
0.35 Percentage of subjects
Interval 0.0 to 3.96
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-37
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
—
|
—
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-38
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
—
|
—
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-39
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
—
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-40
|
3.70 Percentage of subjects
Interval 0.0 to 39.49
|
7.14 Percentage of subjects
Interval 0.82 to 24.02
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-41
|
6.90 Percentage of subjects
Interval 0.06 to 39.08
|
4.17 Percentage of subjects
Interval 0.33 to 16.27
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-42
|
5.88 Percentage of subjects
Interval 0.15 to 28.66
|
3.00 Percentage of subjects
Interval 0.28 to 11.33
|
0.00 Percentage of subjects
Interval 0.0 to 4.11
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-43
|
5.71 Percentage of subjects
Interval 0.17 to 27.21
|
2.40 Percentage of subjects
Interval 0.19 to 9.55
|
0.00 Percentage of subjects
Interval 0.0 to 3.81
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-44
|
7.32 Percentage of subjects
Interval 0.36 to 30.38
|
2.23 Percentage of subjects
Interval 0.34 to 7.26
|
0.29 Percentage of subjects
Interval 0.01 to 1.61
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-45
|
7.14 Percentage of subjects
Interval 0.32 to 30.34
|
1.53 Percentage of subjects
Interval 0.12 to 6.28
|
0.29 Percentage of subjects
Interval 0.01 to 1.6
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-46
|
8.51 Percentage of subjects
Interval 1.98 to 21.99
|
1.00 Percentage of subjects
Interval 0.12 to 3.53
|
0.28 Percentage of subjects
Interval 0.01 to 1.55
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-47
|
8.51 Percentage of subjects
Interval 1.98 to 21.99
|
0.98 Percentage of subjects
Interval 0.12 to 3.44
|
0.48 Percentage of subjects
Interval 0.06 to 1.71
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-48
|
8.33 Percentage of subjects
Interval 2.04 to 21.11
|
0.95 Percentage of subjects
Interval 0.11 to 3.4
|
0.48 Percentage of subjects
Interval 0.06 to 1.71
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-37
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
—
|
—
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-38
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
—
|
—
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-39
|
2.63 Percentage of subjects
Interval 0.01 to 18.97
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-40
|
2.22 Percentage of subjects
Interval 0.02 to 14.79
|
7.14 Percentage of subjects
Interval 0.04 to 41.49
|
33.33 Percentage of subjects
Interval 0.0 to 99.94
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-41
|
1.82 Percentage of subjects
Interval 0.01 to 12.25
|
6.45 Percentage of subjects
Interval 0.34 to 26.78
|
2.86 Percentage of subjects
Interval 0.07 to 14.92
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-42
|
1.69 Percentage of subjects
Interval 0.02 to 10.77
|
4.17 Percentage of subjects
Interval 0.48 to 14.52
|
2.86 Percentage of subjects
Interval 0.07 to 14.92
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-43
|
1.64 Percentage of subjects
Interval 0.02 to 10.46
|
3.28 Percentage of subjects
Interval 0.33 to 12.04
|
2.78 Percentage of subjects
Interval 0.07 to 14.53
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-38
|
5.45 Percentage of subjects
Interval 3.66 to 7.76
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.61 Percentage of subjects
Interval 0.07 to 2.2
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-39
|
5.58 Percentage of subjects
Interval 4.62 to 6.66
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
0.63 Percentage of subjects
Interval 0.13 to 1.84
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-40
|
5.22 Percentage of subjects
Interval 4.42 to 6.12
|
1.25 Percentage of subjects
Interval 0.03 to 6.77
|
0.75 Percentage of subjects
Interval 0.22 to 1.83
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-41
|
5.08 Percentage of subjects
Interval 4.4 to 5.83
|
2.87 Percentage of subjects
Interval 0.94 to 6.58
|
0.77 Percentage of subjects
Interval 0.26 to 1.76
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-42
|
4.87 Percentage of subjects
Interval 4.12 to 5.71
|
1.76 Percentage of subjects
Interval 0.57 to 4.06
|
1.05 Percentage of subjects
Interval 0.48 to 1.99
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-43
|
4.73 Percentage of subjects
Interval 4.0 to 5.55
|
3.23 Percentage of subjects
Interval 1.43 to 6.19
|
0.95 Percentage of subjects
Interval 0.44 to 1.8
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-44
|
4.60 Percentage of subjects
Interval 3.87 to 5.43
|
3.73 Percentage of subjects
Interval 1.6 to 7.3
|
0.98 Percentage of subjects
Interval 0.4 to 1.97
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-45
|
4.52 Percentage of subjects
Interval 3.84 to 5.29
|
3.54 Percentage of subjects
Interval 1.54 to 6.85
|
1.26 Percentage of subjects
Interval 0.39 to 3.02
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-46
|
4.43 Percentage of subjects
Interval 3.81 to 5.13
|
3.74 Percentage of subjects
Interval 2.33 to 5.67
|
1.22 Percentage of subjects
Interval 0.38 to 2.9
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-47
|
4.43 Percentage of subjects
Interval 3.79 to 5.13
|
3.51 Percentage of subjects
Interval 2.21 to 5.26
|
1.24 Percentage of subjects
Interval 0.42 to 2.8
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-48
|
4.36 Percentage of subjects
Interval 3.73 to 5.06
|
3.66 Percentage of subjects
Interval 2.31 to 5.48
|
1.21 Percentage of subjects
Interval 0.42 to 2.72
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
1.92 Percentage of subjects
Interval 0.0 to 17.19
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-37
|
6.45 Percentage of subjects
Interval 4.99 to 8.19
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.54 Percentage of subjects
Interval 0.07 to 1.94
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-38
|
5.74 Percentage of subjects
Interval 4.95 to 6.61
|
11.11 Percentage of subjects
Interval 0.03 to 62.14
|
0.67 Percentage of subjects
Interval 0.1 to 2.22
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-39
|
5.25 Percentage of subjects
Interval 4.38 to 6.23
|
6.25 Percentage of subjects
Interval 0.16 to 30.23
|
0.92 Percentage of subjects
Interval 0.15 to 2.98
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-40
|
5.40 Percentage of subjects
Interval 4.33 to 6.66
|
5.17 Percentage of subjects
Interval 1.08 to 14.38
|
0.90 Percentage of subjects
Interval 0.16 to 2.77
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-41
|
5.35 Percentage of subjects
Interval 4.25 to 6.63
|
5.11 Percentage of subjects
Interval 2.08 to 10.24
|
0.81 Percentage of subjects
Interval 0.14 to 2.52
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-42
|
5.19 Percentage of subjects
Interval 4.07 to 6.51
|
3.96 Percentage of subjects
Interval 1.73 to 7.65
|
0.75 Percentage of subjects
Interval 0.13 to 2.36
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-43
|
5.15 Percentage of subjects
Interval 4.02 to 6.47
|
3.52 Percentage of subjects
Interval 1.7 to 6.38
|
0.73 Percentage of subjects
Interval 0.13 to 2.28
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-44
|
5.06 Percentage of subjects
Interval 3.96 to 6.37
|
4.31 Percentage of subjects
Interval 2.43 to 7.01
|
0.70 Percentage of subjects
Interval 0.12 to 2.19
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-45
|
4.99 Percentage of subjects
Interval 3.89 to 6.29
|
4.68 Percentage of subjects
Interval 2.79 to 7.29
|
0.68 Percentage of subjects
Interval 0.12 to 2.12
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-46
|
4.97 Percentage of subjects
Interval 3.85 to 6.28
|
4.27 Percentage of subjects
Interval 2.55 to 6.66
|
0.67 Percentage of subjects
Interval 0.12 to 2.09
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-47
|
4.92 Percentage of subjects
Interval 3.81 to 6.24
|
4.23 Percentage of subjects
Interval 2.57 to 6.53
|
0.71 Percentage of subjects
Interval 0.16 to 1.97
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-48
|
4.90 Percentage of subjects
Interval 3.79 to 6.22
|
4.03 Percentage of subjects
Interval 2.45 to 6.23
|
0.70 Percentage of subjects
Interval 0.16 to 1.96
|
SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in EHR (combining routine data collection and card-based ADR reporting system) during the safety follow-up period (from vaccination up to 7 days post-vaccination).
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhea, nausea, and vomiting. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16433 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=3310 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=4196 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 month to 5 years, Week 37
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 month to 5 years, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 month to 5 years, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.97 Percentage of subjects
Interval 0.12 to 3.45
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 month to 5 years, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 2.95
|
0.00 Percentage of subjects
Interval 0.0 to 7.71
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 month to 5 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 1.9
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 month to 5 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 2.55
|
20.00 Percentage of subjects
Interval 0.0 to 96.43
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 month to 5 years, Week 44
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 2.48
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 month to 5 years, Week 45
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.82
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 month to 5 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.49 Percentage of subjects
Interval 0.0 to 3.54
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 month to 5 years, Week 47
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 4.99
|
0.00 Percentage of subjects
Interval 0.0 to 9.03
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 month to 5 years, Week 48
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 37
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
—
|
—
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 38
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
—
|
—
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
—
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 11.57
|
0.00 Percentage of subjects
Interval 0.0 to 6.49
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 12.34
|
0.00 Percentage of subjects
Interval 0.0 to 14.82
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 13.72
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 3.66
|
0.00 Percentage of subjects
Interval 0.0 to 1.47
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.98 Percentage of subjects
Interval 0.0 to 10.39
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 1.34
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 47
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
—
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 37
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
—
|
—
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 38
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
—
|
—
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
0.00 Percentage of subjects
Interval 0.0 to 10.89
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
—
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 13.72
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
1.25 Percentage of subjects
Interval 0.03 to 6.77
|
1.46 Percentage of subjects
Interval 0.3 to 4.22
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
—
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 36
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 37
|
1.95 Percentage of subjects
Interval 0.56 to 4.8
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.66 Percentage of subjects
Interval 0.0 to 5.33
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 38
|
1.98 Percentage of subjects
Interval 0.89 to 3.76
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 2.22
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 39
|
1.98 Percentage of subjects
Interval 0.91 to 3.72
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 2.48
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 40
|
1.62 Percentage of subjects
Interval 0.46 to 4.04
|
3.17 Percentage of subjects
Interval 0.07 to 16.81
|
0.00 Percentage of subjects
Interval 0.0 to 1.87
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 41
|
1.10 Percentage of subjects
Interval 0.44 to 2.26
|
0.00 Percentage of subjects
Interval 0.0 to 3.85
|
0.00 Percentage of subjects
Interval 0.0 to 3.3
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 42
|
1.41 Percentage of subjects
Interval 0.3 to 4.02
|
0.00 Percentage of subjects
Interval 0.0 to 3.3
|
0.00 Percentage of subjects
Interval 0.0 to 4.45
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 43
|
0.45 Percentage of subjects
Interval 0.01 to 2.91
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
0.00 Percentage of subjects
Interval 0.0 to 4.2
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 44
|
0.64 Percentage of subjects
Interval 0.03 to 3.11
|
1.27 Percentage of subjects
Interval 0.03 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 4.56
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 45
|
1.34 Percentage of subjects
Interval 0.11 to 5.42
|
1.82 Percentage of subjects
Interval 0.0 to 93.05
|
0.00 Percentage of subjects
Interval 0.0 to 4.35
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 1.64
|
0.00 Percentage of subjects
Interval 0.0 to 6.98
|
0.00 Percentage of subjects
Interval 0.0 to 8.81
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 2.49
|
0.00 Percentage of subjects
Interval 0.0 to 9.03
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 4.11
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 12.34
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 6.98
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 37
|
2.19 Percentage of subjects
Interval 1.07 to 3.94
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 1.16
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 38
|
1.76 Percentage of subjects
Interval 1.14 to 2.6
|
16.67 Percentage of subjects
Interval 0.0 to 91.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.97
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 39
|
1.27 Percentage of subjects
Interval 0.88 to 1.77
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.00 Percentage of subjects
Interval 0.0 to 1.09
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 40
|
1.38 Percentage of subjects
Interval 0.73 to 2.37
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
0.00 Percentage of subjects
Interval 0.0 to 1.01
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 41
|
1.38 Percentage of subjects
Interval 0.56 to 2.81
|
2.53 Percentage of subjects
Interval 0.31 to 8.85
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 42
|
0.91 Percentage of subjects
Interval 0.24 to 2.35
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 3.03
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 43
|
1.09 Percentage of subjects
Interval 0.21 to 3.24
|
0.00 Percentage of subjects
Interval 0.0 to 4.4
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 44
|
0.70 Percentage of subjects
Interval 0.11 to 2.27
|
1.56 Percentage of subjects
Interval 0.0 to 64.84
|
0.00 Percentage of subjects
Interval 0.0 to 4.99
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 45
|
2.70 Percentage of subjects
Interval 0.54 to 7.83
|
2.70 Percentage of subjects
Interval 0.0 to 93.12
|
0.00 Percentage of subjects
Interval 0.0 to 6.06
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 46
|
4.39 Percentage of subjects
Interval 0.58 to 14.55
|
0.00 Percentage of subjects
Interval 0.0 to 9.49
|
3.13 Percentage of subjects
Interval 0.08 to 16.22
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 3.42
|
0.00 Percentage of subjects
Interval 0.0 to 12.77
|
0.00 Percentage of subjects
Interval 0.0 to 11.57
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 15.44
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start up to end of the week of interest and were registered in EHR (routine data collection \& card-based ADR reporting) during FU period (from vaccination up to 7 days post-vaccination)
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhoea, nausea and vomiting. The cumulative incidence rates of AEIs expressed as a cumulative percentage of subjects, were estimated as follows: The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system); The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine. Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16433 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=3310 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=4196 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-46
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.24 Percentage of subjects
Interval 0.03 to 0.87
|
0.41 Percentage of subjects
Interval 0.01 to 2.27
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-38
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
—
|
—
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-45
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
0.31 Percentage of subjects
Interval 0.0 to 2.5
|
0.00 Percentage of subjects
Interval 0.0 to 1.06
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-40
|
0.00 Percentage of subjects
Interval 0.0 to 7.87
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-41
|
0.00 Percentage of subjects
Interval 0.0 to 6.49
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 10.0
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-42
|
0.00 Percentage of subjects
Interval 0.0 to 6.06
|
0.00 Percentage of subjects
Interval 0.0 to 7.4
|
0.00 Percentage of subjects
Interval 0.0 to 10.0
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-43
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-44
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
0.00 Percentage of subjects
Interval 0.0 to 4.2
|
0.00 Percentage of subjects
Interval 0.0 to 7.11
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-45
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
0.60 Percentage of subjects
Interval 0.02 to 3.31
|
1.18 Percentage of subjects
Interval 0.24 to 3.4
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-46
|
0.00 Percentage of subjects
Interval 0.0 to 4.74
|
0.56 Percentage of subjects
Interval 0.01 to 3.09
|
1.17 Percentage of subjects
Interval 0.24 to 3.37
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-47
|
0.00 Percentage of subjects
Interval 0.0 to 4.4
|
0.55 Percentage of subjects
Interval 0.01 to 3.01
|
1.15 Percentage of subjects
Interval 0.24 to 3.31
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-48
|
0.00 Percentage of subjects
Interval 0.0 to 4.2
|
0.54 Percentage of subjects
Interval 0.01 to 2.99
|
1.15 Percentage of subjects
Interval 0.24 to 3.31
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-36
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-37
|
1.95 Percentage of subjects
Interval 0.56 to 4.8
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.62 Percentage of subjects
Interval 0.0 to 5.0
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-38
|
1.96 Percentage of subjects
Interval 0.76 to 4.1
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.31 Percentage of subjects
Interval 0.0 to 2.44
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-39
|
1.97 Percentage of subjects
Interval 1.01 to 3.45
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
0.21 Percentage of subjects
Interval 0.0 to 1.62
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-40
|
1.90 Percentage of subjects
Interval 1.14 to 2.97
|
2.50 Percentage of subjects
Interval 0.3 to 8.74
|
0.15 Percentage of subjects
Interval 0.0 to 1.15
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-41
|
1.78 Percentage of subjects
Interval 1.09 to 2.76
|
1.15 Percentage of subjects
Interval 0.14 to 4.09
|
0.13 Percentage of subjects
Interval 0.0 to 0.97
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-42
|
1.76 Percentage of subjects
Interval 1.09 to 2.68
|
0.70 Percentage of subjects
Interval 0.09 to 2.52
|
0.12 Percentage of subjects
Interval 0.0 to 0.89
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-43
|
1.70 Percentage of subjects
Interval 1.04 to 2.61
|
0.50 Percentage of subjects
Interval 0.06 to 1.78
|
0.11 Percentage of subjects
Interval 0.0 to 0.8
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-44
|
1.64 Percentage of subjects
Interval 0.99 to 2.53
|
0.62 Percentage of subjects
Interval 0.13 to 1.81
|
0.10 Percentage of subjects
Interval 0.0 to 0.73
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-45
|
1.62 Percentage of subjects
Interval 1.0 to 2.48
|
0.74 Percentage of subjects
Interval 0.2 to 1.9
|
0.09 Percentage of subjects
Interval 0.0 to 0.64
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-46
|
1.56 Percentage of subjects
Interval 0.96 to 2.4
|
0.68 Percentage of subjects
Interval 0.19 to 1.73
|
0.09 Percentage of subjects
Interval 0.0 to 0.62
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-47
|
1.52 Percentage of subjects
Interval 0.93 to 2.34
|
0.64 Percentage of subjects
Interval 0.17 to 1.63
|
0.08 Percentage of subjects
Interval 0.0 to 0.59
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-48
|
1.50 Percentage of subjects
Interval 0.92 to 2.3
|
0.61 Percentage of subjects
Interval 0.17 to 1.55
|
0.08 Percentage of subjects
Interval 0.0 to 0.57
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-37
|
2.19 Percentage of subjects
Interval 1.07 to 3.94
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 0.99
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-38
|
1.97 Percentage of subjects
Interval 1.53 to 2.49
|
11.11 Percentage of subjects
Interval 0.03 to 62.14
|
0.00 Percentage of subjects
Interval 0.0 to 0.49
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-39
|
1.67 Percentage of subjects
Interval 1.29 to 2.12
|
6.25 Percentage of subjects
Interval 0.16 to 30.23
|
0.00 Percentage of subjects
Interval 0.0 to 0.34
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-40
|
1.62 Percentage of subjects
Interval 1.28 to 2.03
|
1.72 Percentage of subjects
Interval 0.04 to 9.24
|
0.00 Percentage of subjects
Interval 0.0 to 0.25
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-41
|
1.59 Percentage of subjects
Interval 1.24 to 2.01
|
2.19 Percentage of subjects
Interval 0.45 to 6.27
|
0.00 Percentage of subjects
Interval 0.0 to 0.23
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-42
|
1.55 Percentage of subjects
Interval 1.22 to 1.94
|
1.49 Percentage of subjects
Interval 0.31 to 4.28
|
0.00 Percentage of subjects
Interval 0.0 to 0.21
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-43
|
1.54 Percentage of subjects
Interval 1.21 to 1.93
|
1.06 Percentage of subjects
Interval 0.22 to 3.06
|
0.00 Percentage of subjects
Interval 0.0 to 0.21
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-44
|
1.50 Percentage of subjects
Interval 1.2 to 1.86
|
1.15 Percentage of subjects
Interval 0.31 to 2.92
|
0.00 Percentage of subjects
Interval 0.0 to 0.2
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-45
|
1.53 Percentage of subjects
Interval 1.23 to 1.88
|
1.30 Percentage of subjects
Interval 0.42 to 3.0
|
0.00 Percentage of subjects
Interval 0.0 to 0.19
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-46
|
1.56 Percentage of subjects
Interval 1.24 to 1.93
|
1.18 Percentage of subjects
Interval 0.39 to 2.74
|
0.05 Percentage of subjects
Interval 0.0 to 0.38
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-47
|
1.54 Percentage of subjects
Interval 1.23 to 1.91
|
1.11 Percentage of subjects
Interval 0.36 to 2.58
|
0.05 Percentage of subjects
Interval 0.0 to 0.37
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-48
|
1.54 Percentage of subjects
Interval 1.22 to 1.9
|
1.06 Percentage of subjects
Interval 0.35 to 2.46
|
0.05 Percentage of subjects
Interval 0.0 to 0.37
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-37
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-38
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-39
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-40
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.74 Percentage of subjects
Interval 0.09 to 2.65
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-41
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.51 Percentage of subjects
Interval 0.04 to 2.11
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-42
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.34 Percentage of subjects
Interval 0.02 to 1.63
|
0.00 Percentage of subjects
Interval 0.0 to 4.56
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-43
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.27 Percentage of subjects
Interval 0.01 to 1.45
|
1.19 Percentage of subjects
Interval 0.0 to 11.17
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-44
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.21 Percentage of subjects
Interval 0.0 to 1.24
|
0.43 Percentage of subjects
Interval 0.01 to 2.39
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-45
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.19 Percentage of subjects
Interval 0.0 to 1.12
|
0.43 Percentage of subjects
Interval 0.01 to 2.37
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-47
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.22 Percentage of subjects
Interval 0.03 to 0.83
|
0.35 Percentage of subjects
Interval 0.01 to 1.96
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-48
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.22 Percentage of subjects
Interval 0.02 to 0.82
|
0.35 Percentage of subjects
Interval 0.01 to 1.93
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-37
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
—
|
—
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-39
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
—
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-40
|
0.00 Percentage of subjects
Interval 0.0 to 12.77
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-41
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 4.99
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-42
|
0.00 Percentage of subjects
Interval 0.0 to 10.28
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 4.11
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-43
|
0.00 Percentage of subjects
Interval 0.0 to 10.0
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.00 Percentage of subjects
Interval 0.0 to 3.81
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-44
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
0.00 Percentage of subjects
Interval 0.0 to 1.63
|
0.00 Percentage of subjects
Interval 0.0 to 1.07
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-46
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
0.17 Percentage of subjects
Interval 0.0 to 1.44
|
0.00 Percentage of subjects
Interval 0.0 to 1.03
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-47
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
0.16 Percentage of subjects
Interval 0.0 to 1.4
|
0.00 Percentage of subjects
Interval 0.0 to 0.87
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-48
|
0.00 Percentage of subjects
Interval 0.0 to 7.4
|
0.16 Percentage of subjects
Interval 0.0 to 1.37
|
0.00 Percentage of subjects
Interval 0.0 to 0.87
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-37
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
—
|
—
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-38
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
—
|
—
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-39
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in EHR (combining routine data collection and card-based ADR reporting system) during the safety follow-up period (from vaccination up to 7 days post-vaccination).
AEIs reported here are derived from 2 data sources: ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between weeks 35 and 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16433 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=3310 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=4196 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 2.95
|
0.00 Percentage of subjects
Interval 0.0 to 7.71
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 39
|
0.78 Percentage of subjects
Interval 0.08 to 2.91
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 2.48
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 37
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 1.77
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.52 Percentage of subjects
Interval 0.01 to 3.43
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 2.55
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 44
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 2.48
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 45
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.82
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 1.8
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 47
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 4.99
|
0.00 Percentage of subjects
Interval 0.0 to 9.03
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 48
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 37
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
—
|
—
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 38
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
—
|
—
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
—
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 11.57
|
0.00 Percentage of subjects
Interval 0.0 to 6.49
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 12.34
|
0.00 Percentage of subjects
Interval 0.0 to 14.82
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 13.72
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 3.66
|
0.00 Percentage of subjects
Interval 0.0 to 1.47
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 3.55
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 1.34
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 47
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
—
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 37
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
—
|
—
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 38
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
—
|
—
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
0.00 Percentage of subjects
Interval 0.0 to 10.89
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
—
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 13.72
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 1.78
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
—
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 36
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 37
|
0.70 Percentage of subjects
Interval 0.04 to 3.03
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 2.4
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 38
|
0.81 Percentage of subjects
Interval 0.06 to 3.39
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 2.22
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 40
|
0.27 Percentage of subjects
Interval 0.03 to 0.97
|
3.17 Percentage of subjects
Interval 0.07 to 16.81
|
0.00 Percentage of subjects
Interval 0.0 to 1.87
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 41
|
0.31 Percentage of subjects
Interval 0.01 to 1.85
|
1.06 Percentage of subjects
Interval 0.03 to 5.79
|
0.00 Percentage of subjects
Interval 0.0 to 3.3
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 1.03
|
0.00 Percentage of subjects
Interval 0.0 to 3.3
|
0.00 Percentage of subjects
Interval 0.0 to 4.45
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 1.66
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
0.00 Percentage of subjects
Interval 0.0 to 4.2
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 1.17
|
3.80 Percentage of subjects
Interval 0.62 to 11.76
|
0.00 Percentage of subjects
Interval 0.0 to 4.56
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 45
|
0.45 Percentage of subjects
Interval 0.0 to 3.33
|
0.00 Percentage of subjects
Interval 0.0 to 6.49
|
1.20 Percentage of subjects
Interval 0.03 to 6.53
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 46
|
0.45 Percentage of subjects
Interval 0.0 to 3.36
|
0.00 Percentage of subjects
Interval 0.0 to 6.98
|
0.00 Percentage of subjects
Interval 0.0 to 8.81
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 2.49
|
0.00 Percentage of subjects
Interval 0.0 to 9.03
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 4.11
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 12.34
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 6.98
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 37
|
0.69 Percentage of subjects
Interval 0.01 to 4.78
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 1.16
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 38
|
0.48 Percentage of subjects
Interval 0.08 to 1.56
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.27 Percentage of subjects
Interval 0.01 to 1.51
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 39
|
0.22 Percentage of subjects
Interval 0.02 to 0.96
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.00 Percentage of subjects
Interval 0.0 to 1.09
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 40
|
0.54 Percentage of subjects
Interval 0.02 to 2.62
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
0.00 Percentage of subjects
Interval 0.0 to 1.01
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 41
|
0.20 Percentage of subjects
Interval 0.01 to 0.93
|
2.53 Percentage of subjects
Interval 0.31 to 8.85
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 0.67
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 3.03
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 43
|
0.36 Percentage of subjects
Interval 0.0 to 2.55
|
0.00 Percentage of subjects
Interval 0.0 to 4.4
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 44
|
0.47 Percentage of subjects
Interval 0.02 to 2.39
|
0.00 Percentage of subjects
Interval 0.0 to 5.6
|
0.00 Percentage of subjects
Interval 0.0 to 4.99
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 1.65
|
0.00 Percentage of subjects
Interval 0.0 to 9.49
|
0.00 Percentage of subjects
Interval 0.0 to 6.06
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.00 Percentage of subjects
Interval 0.0 to 9.49
|
0.00 Percentage of subjects
Interval 0.0 to 10.89
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 3.42
|
0.00 Percentage of subjects
Interval 0.0 to 12.77
|
0.00 Percentage of subjects
Interval 0.0 to 11.57
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 15.44
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start up to end of the week of interest and were registered in EHR (routine data collection \& card-based ADR reporting) during FU period (from vaccination up to 7 days post-vaccination)
AEIs reported here are derived from 2 data sources: ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between weeks 35 and 48 of 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16433 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=3310 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=4196 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-39
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-40
|
0.00 Percentage of subjects
Interval 0.0 to 7.87
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-48
|
0.49 Percentage of subjects
Interval 0.06 to 1.76
|
0.91 Percentage of subjects
Interval 0.34 to 1.98
|
0.08 Percentage of subjects
Interval 0.0 to 0.57
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-37
|
0.69 Percentage of subjects
Interval 0.01 to 4.77
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 0.99
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-38
|
0.58 Percentage of subjects
Interval 0.03 to 2.8
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
0.13 Percentage of subjects
Interval 0.0 to 0.74
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-41
|
0.42 Percentage of subjects
Interval 0.03 to 1.85
|
1.46 Percentage of subjects
Interval 0.18 to 5.17
|
0.06 Percentage of subjects
Interval 0.0 to 0.37
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-43
|
0.39 Percentage of subjects
Interval 0.03 to 1.71
|
0.70 Percentage of subjects
Interval 0.09 to 2.52
|
0.06 Percentage of subjects
Interval 0.0 to 0.33
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-44
|
0.40 Percentage of subjects
Interval 0.03 to 1.62
|
0.57 Percentage of subjects
Interval 0.07 to 2.06
|
0.05 Percentage of subjects
Interval 0.0 to 0.32
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-46
|
0.38 Percentage of subjects
Interval 0.03 to 1.57
|
0.47 Percentage of subjects
Interval 0.06 to 1.7
|
0.05 Percentage of subjects
Interval 0.0 to 0.31
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-47
|
0.38 Percentage of subjects
Interval 0.03 to 1.57
|
0.45 Percentage of subjects
Interval 0.05 to 1.6
|
0.05 Percentage of subjects
Interval 0.0 to 0.3
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-48
|
0.38 Percentage of subjects
Interval 0.03 to 1.57
|
0.42 Percentage of subjects
Interval 0.05 to 1.53
|
0.05 Percentage of subjects
Interval 0.0 to 0.3
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-48
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.07 Percentage of subjects
Interval 0.0 to 0.54
|
0.00 Percentage of subjects
Interval 0.0 to 1.28
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-37
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
—
|
—
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-38
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
—
|
—
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-39
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
—
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-40
|
0.00 Percentage of subjects
Interval 0.0 to 12.77
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-41
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 4.99
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-42
|
0.00 Percentage of subjects
Interval 0.0 to 10.28
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 4.11
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-43
|
0.00 Percentage of subjects
Interval 0.0 to 10.0
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.00 Percentage of subjects
Interval 0.0 to 3.81
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-44
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
0.00 Percentage of subjects
Interval 0.0 to 1.63
|
0.00 Percentage of subjects
Interval 0.0 to 1.07
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-45
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
0.00 Percentage of subjects
Interval 0.0 to 1.13
|
0.00 Percentage of subjects
Interval 0.0 to 1.06
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-46
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
0.00 Percentage of subjects
Interval 0.0 to 0.61
|
0.00 Percentage of subjects
Interval 0.0 to 1.03
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-47
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
0.00 Percentage of subjects
Interval 0.0 to 0.6
|
0.00 Percentage of subjects
Interval 0.0 to 0.87
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-48
|
0.00 Percentage of subjects
Interval 0.0 to 7.4
|
0.00 Percentage of subjects
Interval 0.0 to 0.58
|
0.00 Percentage of subjects
Interval 0.0 to 0.87
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-37
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
—
|
—
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-38
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
—
|
—
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-41
|
0.00 Percentage of subjects
Interval 0.0 to 6.49
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 10.0
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-42
|
0.00 Percentage of subjects
Interval 0.0 to 6.06
|
0.00 Percentage of subjects
Interval 0.0 to 7.4
|
0.00 Percentage of subjects
Interval 0.0 to 10.0
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-43
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-44
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
0.00 Percentage of subjects
Interval 0.0 to 4.2
|
0.00 Percentage of subjects
Interval 0.0 to 7.11
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-45
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
0.00 Percentage of subjects
Interval 0.0 to 2.2
|
0.00 Percentage of subjects
Interval 0.0 to 1.44
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-46
|
0.00 Percentage of subjects
Interval 0.0 to 4.74
|
0.00 Percentage of subjects
Interval 0.0 to 2.05
|
0.00 Percentage of subjects
Interval 0.0 to 1.43
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-47
|
0.00 Percentage of subjects
Interval 0.0 to 4.4
|
0.00 Percentage of subjects
Interval 0.0 to 2.0
|
0.00 Percentage of subjects
Interval 0.0 to 1.4
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-48
|
0.00 Percentage of subjects
Interval 0.0 to 4.2
|
0.00 Percentage of subjects
Interval 0.0 to 1.98
|
0.00 Percentage of subjects
Interval 0.0 to 1.4
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-36
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-37
|
0.70 Percentage of subjects
Interval 0.04 to 3.03
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 2.25
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-38
|
0.76 Percentage of subjects
Interval 0.06 to 3.1
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.00 Percentage of subjects
Interval 0.0 to 1.13
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-39
|
0.77 Percentage of subjects
Interval 0.08 to 2.9
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.78
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-40
|
0.67 Percentage of subjects
Interval 0.08 to 2.42
|
2.50 Percentage of subjects
Interval 0.3 to 8.74
|
0.00 Percentage of subjects
Interval 0.0 to 0.55
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-41
|
0.62 Percentage of subjects
Interval 0.08 to 2.13
|
1.72 Percentage of subjects
Interval 0.36 to 4.96
|
0.00 Percentage of subjects
Interval 0.0 to 0.47
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-42
|
0.57 Percentage of subjects
Interval 0.07 to 2.02
|
1.06 Percentage of subjects
Interval 0.22 to 3.06
|
0.00 Percentage of subjects
Interval 0.0 to 0.43
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-43
|
0.55 Percentage of subjects
Interval 0.07 to 1.95
|
0.74 Percentage of subjects
Interval 0.15 to 2.16
|
0.00 Percentage of subjects
Interval 0.0 to 0.39
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-44
|
0.51 Percentage of subjects
Interval 0.06 to 1.87
|
1.24 Percentage of subjects
Interval 0.46 to 2.69
|
0.00 Percentage of subjects
Interval 0.0 to 0.36
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-45
|
0.51 Percentage of subjects
Interval 0.07 to 1.79
|
1.12 Percentage of subjects
Interval 0.41 to 2.42
|
0.09 Percentage of subjects
Interval 0.0 to 0.64
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-46
|
0.51 Percentage of subjects
Interval 0.06 to 1.83
|
1.02 Percentage of subjects
Interval 0.38 to 2.21
|
0.09 Percentage of subjects
Interval 0.0 to 0.62
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-47
|
0.50 Percentage of subjects
Interval 0.06 to 1.78
|
0.96 Percentage of subjects
Interval 0.35 to 2.07
|
0.08 Percentage of subjects
Interval 0.0 to 0.59
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-39
|
0.43 Percentage of subjects
Interval 0.02 to 2.0
|
2.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.09 Percentage of subjects
Interval 0.0 to 0.52
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-40
|
0.45 Percentage of subjects
Interval 0.02 to 2.08
|
0.00 Percentage of subjects
Interval 0.0 to 6.16
|
0.07 Percentage of subjects
Interval 0.0 to 0.41
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-42
|
0.39 Percentage of subjects
Interval 0.02 to 1.77
|
0.99 Percentage of subjects
Interval 0.12 to 3.53
|
0.06 Percentage of subjects
Interval 0.0 to 0.34
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-45
|
0.39 Percentage of subjects
Interval 0.03 to 1.59
|
0.52 Percentage of subjects
Interval 0.06 to 1.86
|
0.05 Percentage of subjects
Interval 0.0 to 0.31
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-37
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-38
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-39
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-40
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 1.36
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-41
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 0.93
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-42
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.17 Percentage of subjects
Interval 0.0 to 1.26
|
0.00 Percentage of subjects
Interval 0.0 to 4.56
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-43
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.14 Percentage of subjects
Interval 0.0 to 1.01
|
0.00 Percentage of subjects
Interval 0.0 to 4.3
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-44
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.11 Percentage of subjects
Interval 0.0 to 0.77
|
0.00 Percentage of subjects
Interval 0.0 to 1.58
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-45
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.09 Percentage of subjects
Interval 0.0 to 0.68
|
0.00 Percentage of subjects
Interval 0.0 to 1.57
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-46
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.08 Percentage of subjects
Interval 0.0 to 0.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.51
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-47
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.07 Percentage of subjects
Interval 0.0 to 0.56
|
0.00 Percentage of subjects
Interval 0.0 to 1.3
|
SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in EHR (combining routine data collection and card-based ADR reporting system) during the safety follow-up period (from vaccination up to 7 days post-vaccination).
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16433 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=3310 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=4196 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 44
|
—
|
0.49 Percentage of subjects
Interval 0.01 to 2.7
|
0.00 Percentage of subjects
Interval 0.0 to 2.48
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 45
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.82
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 1.8
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 47
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 4.99
|
0.00 Percentage of subjects
Interval 0.0 to 9.03
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 48
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 37
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
—
|
—
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 38
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
—
|
—
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
—
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 11.57
|
0.00 Percentage of subjects
Interval 0.0 to 6.49
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 12.34
|
0.00 Percentage of subjects
Interval 0.0 to 14.82
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 13.72
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 3.66
|
0.00 Percentage of subjects
Interval 0.0 to 1.47
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 3.55
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 1.34
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 47
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
—
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 37
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
1.40 Percentage of subjects
Interval 0.17 to 4.96
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.48 Percentage of subjects
Interval 0.01 to 2.66
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.81 Percentage of subjects
Interval 0.01 to 5.15
|
0.00 Percentage of subjects
Interval 0.0 to 7.71
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 1.9
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 37
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
—
|
—
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 38
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
—
|
—
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
0.00 Percentage of subjects
Interval 0.0 to 10.89
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 13.72
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
—
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 1.78
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
—
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 36
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 37
|
0.97 Percentage of subjects
Interval 0.3 to 2.34
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 2.4
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 38
|
0.93 Percentage of subjects
Interval 0.16 to 2.88
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 2.22
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 40
|
0.54 Percentage of subjects
Interval 0.22 to 1.1
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
0.27 Percentage of subjects
Interval 0.01 to 1.52
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 39
|
0.57 Percentage of subjects
Interval 0.24 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 2.48
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 40
|
0.67 Percentage of subjects
Interval 0.22 to 1.57
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
0.00 Percentage of subjects
Interval 0.0 to 1.87
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 0.58
|
0.00 Percentage of subjects
Interval 0.0 to 3.85
|
0.00 Percentage of subjects
Interval 0.0 to 3.3
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 1.03
|
0.00 Percentage of subjects
Interval 0.0 to 3.3
|
0.00 Percentage of subjects
Interval 0.0 to 4.45
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 43
|
0.90 Percentage of subjects
Interval 0.08 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
0.00 Percentage of subjects
Interval 0.0 to 4.2
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 3.42
|
0.00 Percentage of subjects
Interval 0.0 to 12.77
|
0.00 Percentage of subjects
Interval 0.0 to 11.57
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 41
|
0.20 Percentage of subjects
Interval 0.02 to 0.71
|
1.27 Percentage of subjects
Interval 0.03 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 44
|
0.64 Percentage of subjects
Interval 0.06 to 2.51
|
0.00 Percentage of subjects
Interval 0.0 to 4.56
|
0.00 Percentage of subjects
Interval 0.0 to 4.56
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 42
|
0.18 Percentage of subjects
Interval 0.0 to 1.3
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 3.03
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
4.55 Percentage of subjects
Interval 0.0 to 99.99
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 1.63
|
0.00 Percentage of subjects
Interval 0.0 to 6.49
|
0.00 Percentage of subjects
Interval 0.0 to 4.35
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 46
|
0.90 Percentage of subjects
Interval 0.07 to 3.65
|
0.00 Percentage of subjects
Interval 0.0 to 6.98
|
0.00 Percentage of subjects
Interval 0.0 to 8.81
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 2.49
|
2.56 Percentage of subjects
Interval 0.06 to 13.48
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 4.11
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 12.34
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 6.98
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 37
|
0.69 Percentage of subjects
Interval 0.36 to 1.21
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 1.16
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 43
|
0.36 Percentage of subjects
Interval 0.0 to 2.68
|
0.00 Percentage of subjects
Interval 0.0 to 4.4
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 38
|
0.37 Percentage of subjects
Interval 0.15 to 0.77
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.53 Percentage of subjects
Interval 0.05 to 2.02
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 44
|
0.47 Percentage of subjects
Interval 0.06 to 1.67
|
0.00 Percentage of subjects
Interval 0.0 to 5.6
|
0.00 Percentage of subjects
Interval 0.0 to 4.99
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 45
|
0.45 Percentage of subjects
Interval 0.0 to 2.99
|
0.00 Percentage of subjects
Interval 0.0 to 9.49
|
0.00 Percentage of subjects
Interval 0.0 to 6.06
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
2.70 Percentage of subjects
Interval 0.0 to 82.29
|
0.00 Percentage of subjects
Interval 0.0 to 10.89
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 39
|
0.26 Percentage of subjects
Interval 0.1 to 0.55
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.00 Percentage of subjects
Interval 0.0 to 1.09
|
SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start up to end of the week of interest and were registered in EHR (routine data collection \& card-based ADR reporting) during FU period (from vaccination up to 7 days post-vaccination)
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16433 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=3310 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=4196 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-38
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-39
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-40
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.37 Percentage of subjects
Interval 0.01 to 2.05
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-42
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.34 Percentage of subjects
Interval 0.04 to 1.23
|
0.00 Percentage of subjects
Interval 0.0 to 4.56
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-43
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.55 Percentage of subjects
Interval 0.15 to 1.4
|
0.00 Percentage of subjects
Interval 0.0 to 4.3
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-44
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.54 Percentage of subjects
Interval 0.17 to 1.25
|
0.00 Percentage of subjects
Interval 0.0 to 1.58
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-48
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.37 Percentage of subjects
Interval 0.12 to 0.87
|
0.00 Percentage of subjects
Interval 0.0 to 1.28
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-39
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
—
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-41
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 4.99
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-43
|
0.00 Percentage of subjects
Interval 0.0 to 10.0
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.00 Percentage of subjects
Interval 0.0 to 3.81
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-44
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
0.00 Percentage of subjects
Interval 0.0 to 1.63
|
0.00 Percentage of subjects
Interval 0.0 to 1.07
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-45
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
0.00 Percentage of subjects
Interval 0.0 to 1.13
|
0.00 Percentage of subjects
Interval 0.0 to 1.06
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-47
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
0.00 Percentage of subjects
Interval 0.0 to 0.6
|
0.00 Percentage of subjects
Interval 0.0 to 0.87
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-48
|
0.00 Percentage of subjects
Interval 0.0 to 7.4
|
0.00 Percentage of subjects
Interval 0.0 to 0.58
|
0.00 Percentage of subjects
Interval 0.0 to 0.87
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-37
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
—
|
—
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-39
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-41
|
0.00 Percentage of subjects
Interval 0.0 to 6.49
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 10.0
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-42
|
0.00 Percentage of subjects
Interval 0.0 to 6.06
|
0.00 Percentage of subjects
Interval 0.0 to 7.4
|
0.00 Percentage of subjects
Interval 0.0 to 10.0
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-43
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-44
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
0.00 Percentage of subjects
Interval 0.0 to 4.2
|
0.00 Percentage of subjects
Interval 0.0 to 7.11
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-46
|
0.00 Percentage of subjects
Interval 0.0 to 4.74
|
0.00 Percentage of subjects
Interval 0.0 to 2.05
|
0.00 Percentage of subjects
Interval 0.0 to 1.43
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-47
|
0.00 Percentage of subjects
Interval 0.0 to 4.4
|
0.00 Percentage of subjects
Interval 0.0 to 2.0
|
0.00 Percentage of subjects
Interval 0.0 to 1.4
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-37
|
0.97 Percentage of subjects
Interval 0.3 to 2.34
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 2.25
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-41
|
0.64 Percentage of subjects
Interval 0.35 to 1.07
|
0.00 Percentage of subjects
Interval 0.0 to 2.1
|
0.00 Percentage of subjects
Interval 0.0 to 0.47
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-42
|
0.59 Percentage of subjects
Interval 0.33 to 0.98
|
0.00 Percentage of subjects
Interval 0.0 to 1.29
|
0.00 Percentage of subjects
Interval 0.0 to 0.43
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-43
|
0.61 Percentage of subjects
Interval 0.36 to 0.96
|
0.00 Percentage of subjects
Interval 0.0 to 0.91
|
0.00 Percentage of subjects
Interval 0.0 to 0.39
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-44
|
0.61 Percentage of subjects
Interval 0.37 to 0.95
|
0.00 Percentage of subjects
Interval 0.0 to 0.76
|
0.00 Percentage of subjects
Interval 0.0 to 0.36
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-45
|
0.58 Percentage of subjects
Interval 0.35 to 0.91
|
0.00 Percentage of subjects
Interval 0.0 to 0.68
|
0.00 Percentage of subjects
Interval 0.0 to 0.33
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-47
|
0.58 Percentage of subjects
Interval 0.35 to 0.9
|
0.16 Percentage of subjects
Interval 0.0 to 0.89
|
0.00 Percentage of subjects
Interval 0.0 to 0.3
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-48
|
0.57 Percentage of subjects
Interval 0.35 to 0.89
|
0.15 Percentage of subjects
Interval 0.0 to 0.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.3
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-37
|
0.69 Percentage of subjects
Interval 0.36 to 1.2
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 0.99
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-40
|
0.44 Percentage of subjects
Interval 0.3 to 0.61
|
0.00 Percentage of subjects
Interval 0.0 to 6.16
|
0.21 Percentage of subjects
Interval 0.04 to 0.6
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-41
|
0.41 Percentage of subjects
Interval 0.28 to 0.57
|
0.73 Percentage of subjects
Interval 0.02 to 4.0
|
0.19 Percentage of subjects
Interval 0.04 to 0.55
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-42
|
0.39 Percentage of subjects
Interval 0.28 to 0.54
|
0.50 Percentage of subjects
Interval 0.01 to 2.73
|
0.17 Percentage of subjects
Interval 0.04 to 0.51
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-43
|
0.39 Percentage of subjects
Interval 0.28 to 0.54
|
0.35 Percentage of subjects
Interval 0.01 to 1.95
|
0.17 Percentage of subjects
Interval 0.03 to 0.49
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-44
|
0.40 Percentage of subjects
Interval 0.28 to 0.54
|
0.29 Percentage of subjects
Interval 0.01 to 1.59
|
0.16 Percentage of subjects
Interval 0.03 to 0.47
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-45
|
0.40 Percentage of subjects
Interval 0.28 to 0.54
|
0.26 Percentage of subjects
Interval 0.01 to 1.44
|
0.16 Percentage of subjects
Interval 0.03 to 0.46
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-46
|
0.39 Percentage of subjects
Interval 0.28 to 0.53
|
0.47 Percentage of subjects
Interval 0.06 to 1.7
|
0.15 Percentage of subjects
Interval 0.03 to 0.45
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-47
|
0.39 Percentage of subjects
Interval 0.28 to 0.53
|
0.45 Percentage of subjects
Interval 0.05 to 1.6
|
0.15 Percentage of subjects
Interval 0.03 to 0.44
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-48
|
0.39 Percentage of subjects
Interval 0.28 to 0.53
|
0.64 Percentage of subjects
Interval 0.05 to 2.56
|
0.15 Percentage of subjects
Interval 0.03 to 0.44
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-37
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-41
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.51 Percentage of subjects
Interval 0.06 to 1.83
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-45
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.47 Percentage of subjects
Interval 0.15 to 1.1
|
0.00 Percentage of subjects
Interval 0.0 to 1.57
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-46
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.40 Percentage of subjects
Interval 0.13 to 0.92
|
0.00 Percentage of subjects
Interval 0.0 to 1.51
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-47
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.37 Percentage of subjects
Interval 0.12 to 0.87
|
0.00 Percentage of subjects
Interval 0.0 to 1.3
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-37
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
—
|
—
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-38
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
—
|
—
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-40
|
0.00 Percentage of subjects
Interval 0.0 to 12.77
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-42
|
0.00 Percentage of subjects
Interval 0.0 to 10.28
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 4.11
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-46
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
0.00 Percentage of subjects
Interval 0.0 to 0.61
|
0.00 Percentage of subjects
Interval 0.0 to 1.03
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-38
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
—
|
—
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-40
|
0.00 Percentage of subjects
Interval 0.0 to 7.87
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-45
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
0.00 Percentage of subjects
Interval 0.0 to 2.2
|
0.00 Percentage of subjects
Interval 0.0 to 1.44
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-48
|
0.00 Percentage of subjects
Interval 0.0 to 4.2
|
0.00 Percentage of subjects
Interval 0.0 to 1.98
|
0.00 Percentage of subjects
Interval 0.0 to 1.4
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-36
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-38
|
0.95 Percentage of subjects
Interval 0.34 to 2.08
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.00 Percentage of subjects
Interval 0.0 to 1.13
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-39
|
0.77 Percentage of subjects
Interval 0.38 to 1.38
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.78
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-40
|
0.75 Percentage of subjects
Interval 0.39 to 1.29
|
0.00 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.55
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-46
|
0.60 Percentage of subjects
Interval 0.36 to 0.92
|
0.00 Percentage of subjects
Interval 0.0 to 0.63
|
0.00 Percentage of subjects
Interval 0.0 to 0.32
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-38
|
0.53 Percentage of subjects
Interval 0.32 to 0.82
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
0.27 Percentage of subjects
Interval 0.03 to 1.03
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-39
|
0.41 Percentage of subjects
Interval 0.27 to 0.61
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.18 Percentage of subjects
Interval 0.02 to 0.73
|
SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in EHR (combining routine data collection and card-based ADR reporting system) during the safety follow-up period (from vaccination up to 7 days post-vaccination).
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16433 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=3310 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=4196 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 37
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 1.77
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 2.95
|
0.00 Percentage of subjects
Interval 0.0 to 7.71
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 1.9
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 2.55
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 44
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 2.48
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 45
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.82
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 1.8
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 47
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 4.99
|
0.00 Percentage of subjects
Interval 0.0 to 9.03
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 48
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 37
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
—
|
—
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
—
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 3.66
|
0.00 Percentage of subjects
Interval 0.0 to 1.47
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 3.55
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 47
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 38
|
3.72 Percentage of subjects
Interval 2.55 to 5.22
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.61 Percentage of subjects
Interval 0.01 to 3.6
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 38
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
—
|
—
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 11.57
|
0.00 Percentage of subjects
Interval 0.0 to 6.49
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 12.34
|
0.00 Percentage of subjects
Interval 0.0 to 14.82
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 13.72
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 1.34
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
—
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 37
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
—
|
—
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 38
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
—
|
—
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 41
|
10.00 Percentage of subjects
Interval 0.0 to 71.81
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
0.00 Percentage of subjects
Interval 0.0 to 10.89
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 41
|
2.36 Percentage of subjects
Interval 0.99 to 4.7
|
0.00 Percentage of subjects
Interval 0.0 to 3.85
|
0.00 Percentage of subjects
Interval 0.0 to 3.3
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 42
|
2.25 Percentage of subjects
Interval 0.62 to 5.66
|
0.91 Percentage of subjects
Interval 0.02 to 4.96
|
0.00 Percentage of subjects
Interval 0.0 to 4.45
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
—
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 13.72
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 4.51
|
0.49 Percentage of subjects
Interval 0.01 to 2.69
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
—
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 36
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 37
|
5.29 Percentage of subjects
Interval 3.3 to 7.98
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.66 Percentage of subjects
Interval 0.02 to 3.61
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 39
|
3.96 Percentage of subjects
Interval 3.0 to 5.11
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 2.48
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 40
|
3.37 Percentage of subjects
Interval 2.11 to 5.1
|
4.76 Percentage of subjects
Interval 0.1 to 24.55
|
0.51 Percentage of subjects
Interval 0.01 to 2.82
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 43
|
4.52 Percentage of subjects
Interval 1.78 to 9.28
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
1.16 Percentage of subjects
Interval 0.03 to 6.31
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 44
|
1.28 Percentage of subjects
Interval 0.25 to 3.78
|
5.06 Percentage of subjects
Interval 0.82 to 15.56
|
0.00 Percentage of subjects
Interval 0.0 to 4.56
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 45
|
2.23 Percentage of subjects
Interval 0.47 to 6.33
|
1.82 Percentage of subjects
Interval 0.0 to 93.05
|
0.00 Percentage of subjects
Interval 0.0 to 4.35
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 46
|
2.24 Percentage of subjects
Interval 0.73 to 5.15
|
1.96 Percentage of subjects
Interval 0.02 to 12.89
|
0.00 Percentage of subjects
Interval 0.0 to 8.81
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 47
|
2.05 Percentage of subjects
Interval 0.43 to 5.89
|
0.00 Percentage of subjects
Interval 0.0 to 9.03
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 4.11
|
3.45 Percentage of subjects
Interval 0.0 to 94.8
|
0.00 Percentage of subjects
Interval 0.0 to 12.34
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 6.98
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 37
|
3.86 Percentage of subjects
Interval 2.98 to 4.91
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.32 Percentage of subjects
Interval 0.01 to 1.76
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 38
|
3.26 Percentage of subjects
Interval 2.29 to 4.49
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.27 Percentage of subjects
Interval 0.01 to 1.51
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 39
|
3.03 Percentage of subjects
Interval 2.26 to 3.97
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
1.19 Percentage of subjects
Interval 0.32 to 3.01
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 40
|
2.23 Percentage of subjects
Interval 1.04 to 4.13
|
2.38 Percentage of subjects
Interval 0.06 to 12.57
|
0.55 Percentage of subjects
Interval 0.07 to 1.97
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 41
|
2.55 Percentage of subjects
Interval 1.49 to 4.08
|
0.00 Percentage of subjects
Interval 0.0 to 4.56
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 42
|
1.83 Percentage of subjects
Interval 0.75 to 3.69
|
1.54 Percentage of subjects
Interval 0.04 to 8.28
|
0.00 Percentage of subjects
Interval 0.0 to 3.03
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 43
|
2.19 Percentage of subjects
Interval 0.81 to 4.71
|
1.22 Percentage of subjects
Interval 0.0 to 92.27
|
1.54 Percentage of subjects
Interval 0.01 to 11.02
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 44
|
2.33 Percentage of subjects
Interval 0.54 to 6.33
|
3.13 Percentage of subjects
Interval 0.0 to 88.31
|
0.00 Percentage of subjects
Interval 0.0 to 4.99
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 45
|
3.15 Percentage of subjects
Interval 0.79 to 8.23
|
2.70 Percentage of subjects
Interval 0.0 to 99.67
|
0.00 Percentage of subjects
Interval 0.0 to 6.06
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.00 Percentage of subjects
Interval 0.0 to 9.49
|
6.25 Percentage of subjects
Interval 0.77 to 20.81
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 47
|
1.89 Percentage of subjects
Interval 0.14 to 7.77
|
0.00 Percentage of subjects
Interval 0.0 to 12.77
|
0.00 Percentage of subjects
Interval 0.0 to 11.57
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
4.55 Percentage of subjects
Interval 0.0 to 99.99
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start up to end of the week of interest and were registered in EHR (routine data collection \& card-based ADR reporting) during FU period (from vaccination up to 7 days post-vaccination)
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy and muscle aches/myalgia. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16433 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=3310 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=4196 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-41
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 0.93
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-41
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 4.99
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-45
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
0.00 Percentage of subjects
Interval 0.0 to 1.13
|
0.00 Percentage of subjects
Interval 0.0 to 1.06
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-38
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
—
|
—
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-39
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-44
|
1.61 Percentage of subjects
Interval 0.02 to 10.31
|
0.00 Percentage of subjects
Interval 0.0 to 4.2
|
0.00 Percentage of subjects
Interval 0.0 to 7.11
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-45
|
1.43 Percentage of subjects
Interval 0.02 to 9.07
|
0.00 Percentage of subjects
Interval 0.0 to 2.2
|
0.39 Percentage of subjects
Interval 0.01 to 2.17
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-41
|
3.80 Percentage of subjects
Interval 3.16 to 4.53
|
1.72 Percentage of subjects
Interval 0.36 to 4.96
|
0.39 Percentage of subjects
Interval 0.04 to 1.44
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-44
|
3.57 Percentage of subjects
Interval 2.77 to 4.54
|
1.66 Percentage of subjects
Interval 0.72 to 3.24
|
0.39 Percentage of subjects
Interval 0.05 to 1.37
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-45
|
3.52 Percentage of subjects
Interval 2.78 to 4.4
|
1.68 Percentage of subjects
Interval 0.77 to 3.16
|
0.36 Percentage of subjects
Interval 0.04 to 1.3
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-46
|
3.47 Percentage of subjects
Interval 2.74 to 4.33
|
1.70 Percentage of subjects
Interval 0.82 to 3.11
|
0.35 Percentage of subjects
Interval 0.04 to 1.27
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-47
|
3.43 Percentage of subjects
Interval 2.7 to 4.3
|
1.59 Percentage of subjects
Interval 0.77 to 2.91
|
0.33 Percentage of subjects
Interval 0.04 to 1.21
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-48
|
3.38 Percentage of subjects
Interval 2.66 to 4.24
|
1.68 Percentage of subjects
Interval 0.84 to 2.98
|
0.32 Percentage of subjects
Interval 0.04 to 1.2
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-37
|
3.86 Percentage of subjects
Interval 2.98 to 4.91
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.27 Percentage of subjects
Interval 0.01 to 1.5
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-38
|
3.55 Percentage of subjects
Interval 2.79 to 4.44
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
0.27 Percentage of subjects
Interval 0.01 to 1.45
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-39
|
3.33 Percentage of subjects
Interval 2.59 to 4.2
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.55 Percentage of subjects
Interval 0.13 to 1.51
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-40
|
3.14 Percentage of subjects
Interval 2.47 to 3.93
|
1.72 Percentage of subjects
Interval 0.04 to 9.24
|
0.55 Percentage of subjects
Interval 0.16 to 1.39
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-41
|
3.07 Percentage of subjects
Interval 2.43 to 3.82
|
0.73 Percentage of subjects
Interval 0.02 to 4.0
|
0.50 Percentage of subjects
Interval 0.14 to 1.26
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-42
|
2.99 Percentage of subjects
Interval 2.36 to 3.74
|
0.99 Percentage of subjects
Interval 0.12 to 3.53
|
0.46 Percentage of subjects
Interval 0.13 to 1.18
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-43
|
2.97 Percentage of subjects
Interval 2.33 to 3.73
|
1.06 Percentage of subjects
Interval 0.22 to 3.06
|
0.50 Percentage of subjects
Interval 0.18 to 1.1
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-44
|
2.94 Percentage of subjects
Interval 2.33 to 3.66
|
1.44 Percentage of subjects
Interval 0.47 to 3.32
|
0.48 Percentage of subjects
Interval 0.17 to 1.06
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-45
|
2.95 Percentage of subjects
Interval 2.35 to 3.65
|
1.56 Percentage of subjects
Interval 0.57 to 3.36
|
0.47 Percentage of subjects
Interval 0.17 to 1.03
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-46
|
2.91 Percentage of subjects
Interval 2.31 to 3.62
|
1.42 Percentage of subjects
Interval 0.52 to 3.07
|
0.56 Percentage of subjects
Interval 0.24 to 1.12
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-47
|
2.90 Percentage of subjects
Interval 2.3 to 3.61
|
1.34 Percentage of subjects
Interval 0.49 to 2.89
|
0.56 Percentage of subjects
Interval 0.24 to 1.1
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-48
|
2.89 Percentage of subjects
Interval 2.29 to 3.6
|
1.49 Percentage of subjects
Interval 0.6 to 3.04
|
0.55 Percentage of subjects
Interval 0.24 to 1.1
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-42
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.00 Percentage of subjects
Interval 0.0 to 0.63
|
0.00 Percentage of subjects
Interval 0.0 to 4.56
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-43
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 0.51
|
0.00 Percentage of subjects
Interval 0.0 to 4.3
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-44
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 0.4
|
0.00 Percentage of subjects
Interval 0.0 to 1.58
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-45
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 0.35
|
0.00 Percentage of subjects
Interval 0.0 to 1.57
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-46
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.29
|
0.00 Percentage of subjects
Interval 0.0 to 1.51
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-47
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.28
|
0.00 Percentage of subjects
Interval 0.0 to 1.3
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-48
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.27
|
0.00 Percentage of subjects
Interval 0.0 to 1.28
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-37
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
—
|
—
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-38
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
—
|
—
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-39
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
—
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-40
|
0.00 Percentage of subjects
Interval 0.0 to 12.77
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-42
|
0.00 Percentage of subjects
Interval 0.0 to 10.28
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 4.11
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-43
|
0.00 Percentage of subjects
Interval 0.0 to 10.0
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.00 Percentage of subjects
Interval 0.0 to 3.81
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-44
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
0.00 Percentage of subjects
Interval 0.0 to 1.63
|
0.00 Percentage of subjects
Interval 0.0 to 1.07
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-46
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
0.00 Percentage of subjects
Interval 0.0 to 0.61
|
0.00 Percentage of subjects
Interval 0.0 to 1.03
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-47
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
0.00 Percentage of subjects
Interval 0.0 to 0.6
|
0.00 Percentage of subjects
Interval 0.0 to 0.87
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-48
|
0.00 Percentage of subjects
Interval 0.0 to 7.4
|
0.00 Percentage of subjects
Interval 0.0 to 7.4
|
0.00 Percentage of subjects
Interval 0.0 to 0.87
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-37
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
—
|
—
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-40
|
0.00 Percentage of subjects
Interval 0.0 to 7.87
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-41
|
1.82 Percentage of subjects
Interval 0.01 to 12.25
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 10.0
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-37
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-38
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-39
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-40
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 1.36
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-42
|
1.69 Percentage of subjects
Interval 0.02 to 10.77
|
0.00 Percentage of subjects
Interval 0.0 to 7.4
|
0.00 Percentage of subjects
Interval 0.0 to 10.0
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-43
|
1.64 Percentage of subjects
Interval 0.02 to 10.46
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-46
|
1.32 Percentage of subjects
Interval 0.01 to 8.53
|
0.00 Percentage of subjects
Interval 0.0 to 2.05
|
0.39 Percentage of subjects
Interval 0.01 to 2.15
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-47
|
1.22 Percentage of subjects
Interval 0.01 to 8.11
|
0.00 Percentage of subjects
Interval 0.0 to 2.0
|
0.38 Percentage of subjects
Interval 0.01 to 2.11
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-48
|
1.16 Percentage of subjects
Interval 0.01 to 7.7
|
0.00 Percentage of subjects
Interval 0.0 to 1.98
|
0.38 Percentage of subjects
Interval 0.01 to 2.11
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-36
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-37
|
5.29 Percentage of subjects
Interval 3.3 to 7.98
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.62 Percentage of subjects
Interval 0.02 to 3.39
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-38
|
4.43 Percentage of subjects
Interval 3.14 to 6.06
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.61 Percentage of subjects
Interval 0.02 to 3.25
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-39
|
4.21 Percentage of subjects
Interval 3.48 to 5.04
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
0.42 Percentage of subjects
Interval 0.01 to 2.46
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-40
|
4.04 Percentage of subjects
Interval 3.42 to 4.74
|
3.75 Percentage of subjects
Interval 0.78 to 10.57
|
0.45 Percentage of subjects
Interval 0.05 to 1.61
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-42
|
3.68 Percentage of subjects
Interval 2.98 to 4.5
|
1.41 Percentage of subjects
Interval 0.39 to 3.57
|
0.35 Percentage of subjects
Interval 0.03 to 1.35
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-43
|
3.72 Percentage of subjects
Interval 2.96 to 4.61
|
0.99 Percentage of subjects
Interval 0.99 to 2.52
|
0.42 Percentage of subjects
Interval 0.06 to 1.46
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in EHR (combining routine data collection and card-based ADR reporting system) during the safety follow-up period (from vaccination up to 7 days post-vaccination).
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between weeks 35 and 48 of 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16433 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=3310 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=4196 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 37
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 1.77
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 2.95
|
0.00 Percentage of subjects
Interval 0.0 to 7.71
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 1.9
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 2.55
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 44
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 2.48
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 37
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
—
|
—
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 38
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
—
|
—
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
—
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 11.57
|
0.00 Percentage of subjects
Interval 0.0 to 6.49
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 12.34
|
0.00 Percentage of subjects
Interval 0.0 to 14.82
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 13.72
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 3.66
|
0.00 Percentage of subjects
Interval 0.0 to 1.47
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 3.55
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 1.34
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 47
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
—
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 37
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
—
|
—
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 38
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
—
|
—
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
0.00 Percentage of subjects
Interval 0.0 to 10.89
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
—
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 13.72
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 1.78
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
—
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 36
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 37
|
0.28 Percentage of subjects
Interval 0.03 to 1.0
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 2.4
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 38
|
0.35 Percentage of subjects
Interval 0.04 to 1.25
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 2.22
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 39
|
0.28 Percentage of subjects
Interval 0.02 to 1.17
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 2.48
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 0.5
|
1.59 Percentage of subjects
Interval 0.04 to 8.63
|
0.00 Percentage of subjects
Interval 0.0 to 1.87
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 41
|
0.16 Percentage of subjects
Interval 0.0 to 0.93
|
1.06 Percentage of subjects
Interval 0.03 to 5.79
|
0.00 Percentage of subjects
Interval 0.0 to 3.3
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 1.03
|
0.00 Percentage of subjects
Interval 0.0 to 3.3
|
0.00 Percentage of subjects
Interval 0.0 to 4.45
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 1.66
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
0.00 Percentage of subjects
Interval 0.0 to 4.2
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 1.17
|
0.00 Percentage of subjects
Interval 0.0 to 4.56
|
0.00 Percentage of subjects
Interval 0.0 to 4.56
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 1.63
|
0.00 Percentage of subjects
Interval 0.0 to 6.49
|
0.00 Percentage of subjects
Interval 0.0 to 4.35
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 1.64
|
0.00 Percentage of subjects
Interval 0.0 to 6.98
|
0.00 Percentage of subjects
Interval 0.0 to 8.81
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 2.49
|
2.56 Percentage of subjects
Interval 0.0 to 25.31
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 4.11
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 12.34
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 6.98
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 37
|
0.29 Percentage of subjects
Interval 0.09 to 0.67
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 1.16
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 38
|
0.27 Percentage of subjects
Interval 0.07 to 0.72
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 0.97
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 39
|
0.19 Percentage of subjects
Interval 0.06 to 0.44
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.00 Percentage of subjects
Interval 0.0 to 1.09
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 0.28
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
0.00 Percentage of subjects
Interval 0.0 to 1.01
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 41
|
0.20 Percentage of subjects
Interval 0.0 to 1.2
|
0.00 Percentage of subjects
Interval 0.0 to 4.56
|
0.65 Percentage of subjects
Interval 0.0 to 4.69
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 0.67
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
0.00 Percentage of subjects
Interval 0.0 to 3.03
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 1.34
|
0.00 Percentage of subjects
Interval 0.0 to 4.4
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 44
|
0.23 Percentage of subjects
Interval 0.0 to 1.9
|
0.00 Percentage of subjects
Interval 0.0 to 5.6
|
0.00 Percentage of subjects
Interval 0.0 to 4.99
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 1.65
|
0.00 Percentage of subjects
Interval 0.0 to 9.49
|
0.00 Percentage of subjects
Interval 0.0 to 6.06
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.00 Percentage of subjects
Interval 0.0 to 9.49
|
0.00 Percentage of subjects
Interval 0.0 to 10.89
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 3.42
|
0.00 Percentage of subjects
Interval 0.0 to 12.77
|
0.00 Percentage of subjects
Interval 0.0 to 11.57
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 15.44
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 45
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.82
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 1.8
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 47
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 4.99
|
0.00 Percentage of subjects
Interval 0.0 to 9.03
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 48
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start up to end of the week of interest and were registered in EHR (routine data collection \& card-based ADR reporting) during FU period (from vaccination up to 7 days post-vaccination)
AEIs reported here are derived from 2 data sources: ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between weeks 35 and 48 of 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16433 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=3310 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=4196 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-47
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.28
|
0.00 Percentage of subjects
Interval 0.0 to 1.3
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-44
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
0.00 Percentage of subjects
Interval 0.0 to 1.63
|
0.00 Percentage of subjects
Interval 0.0 to 1.07
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-45
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
0.00 Percentage of subjects
Interval 0.0 to 1.13
|
0.00 Percentage of subjects
Interval 0.0 to 1.06
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-37
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
—
|
—
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-42
|
0.21 Percentage of subjects
Interval 0.06 to 0.52
|
0.70 Percentage of subjects
Interval 0.09 to 2.52
|
0.00 Percentage of subjects
Interval 0.0 to 0.43
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-37
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-38
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-39
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-40
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 1.36
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-41
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 0.93
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-42
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.00 Percentage of subjects
Interval 0.0 to 0.63
|
0.00 Percentage of subjects
Interval 0.0 to 4.56
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-43
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 0.51
|
0.00 Percentage of subjects
Interval 0.0 to 4.3
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-44
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 0.4
|
0.00 Percentage of subjects
Interval 0.0 to 1.58
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-45
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 0.35
|
0.00 Percentage of subjects
Interval 0.0 to 1.57
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-46
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.29
|
0.00 Percentage of subjects
Interval 0.0 to 1.51
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-48
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.27
|
0.00 Percentage of subjects
Interval 0.0 to 1.28
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-37
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
—
|
—
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-38
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
—
|
—
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-39
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
—
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-40
|
0.00 Percentage of subjects
Interval 0.0 to 12.77
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-41
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 4.99
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-42
|
0.00 Percentage of subjects
Interval 0.0 to 10.28
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 4.11
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-43
|
0.00 Percentage of subjects
Interval 0.0 to 10.0
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.00 Percentage of subjects
Interval 0.0 to 3.81
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-46
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
0.00 Percentage of subjects
Interval 0.0 to 0.61
|
0.00 Percentage of subjects
Interval 0.0 to 1.03
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-47
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
0.00 Percentage of subjects
Interval 0.0 to 0.6
|
0.00 Percentage of subjects
Interval 0.0 to 0.87
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-48
|
0.00 Percentage of subjects
Interval 0.0 to 7.4
|
0.00 Percentage of subjects
Interval 0.0 to 0.58
|
0.00 Percentage of subjects
Interval 0.0 to 0.87
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-38
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
—
|
—
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-39
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-40
|
0.00 Percentage of subjects
Interval 0.0 to 7.87
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-41
|
0.00 Percentage of subjects
Interval 0.0 to 6.49
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 10.0
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-42
|
0.00 Percentage of subjects
Interval 0.0 to 6.06
|
0.00 Percentage of subjects
Interval 0.0 to 7.4
|
0.00 Percentage of subjects
Interval 0.0 to 10.0
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-43
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-44
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
0.00 Percentage of subjects
Interval 0.0 to 4.2
|
0.00 Percentage of subjects
Interval 0.0 to 7.11
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-45
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
0.00 Percentage of subjects
Interval 0.0 to 2.2
|
0.00 Percentage of subjects
Interval 0.0 to 1.44
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-46
|
0.00 Percentage of subjects
Interval 0.0 to 4.74
|
0.00 Percentage of subjects
Interval 0.0 to 2.05
|
0.00 Percentage of subjects
Interval 0.0 to 1.43
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-47
|
0.00 Percentage of subjects
Interval 0.0 to 4.4
|
0.00 Percentage of subjects
Interval 0.0 to 2.0
|
0.00 Percentage of subjects
Interval 0.0 to 1.4
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-48
|
0.00 Percentage of subjects
Interval 0.0 to 4.2
|
0.00 Percentage of subjects
Interval 0.0 to 1.98
|
0.00 Percentage of subjects
Interval 0.0 to 1.4
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-36
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-37
|
0.28 Percentage of subjects
Interval 0.03 to 1.0
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 2.25
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-38
|
0.32 Percentage of subjects
Interval 0.07 to 0.88
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.00 Percentage of subjects
Interval 0.0 to 1.13
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-39
|
0.30 Percentage of subjects
Interval 0.11 to 0.67
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
0.00 Percentage of subjects
Interval 0.0 to 0.78
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-40
|
0.24 Percentage of subjects
Interval 0.07 to 0.6
|
1.25 Percentage of subjects
Interval 0.03 to 6.77
|
0.00 Percentage of subjects
Interval 0.0 to 0.55
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-41
|
0.23 Percentage of subjects
Interval 0.07 to 0.55
|
1.15 Percentage of subjects
Interval 0.14 to 4.09
|
0.00 Percentage of subjects
Interval 0.0 to 0.47
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-43
|
0.20 Percentage of subjects
Interval 0.06 to 0.5
|
0.50 Percentage of subjects
Interval 0.06 to 1.78
|
0.00 Percentage of subjects
Interval 0.0 to 0.39
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-44
|
0.19 Percentage of subjects
Interval 0.05 to 0.48
|
0.41 Percentage of subjects
Interval 0.05 to 1.49
|
0.00 Percentage of subjects
Interval 0.0 to 0.36
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-45
|
0.18 Percentage of subjects
Interval 0.05 to 0.46
|
0.37 Percentage of subjects
Interval 0.05 to 1.34
|
0.00 Percentage of subjects
Interval 0.0 to 0.33
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-46
|
0.18 Percentage of subjects
Interval 0.05 to 0.44
|
0.34 Percentage of subjects
Interval 0.04 to 1.22
|
0.00 Percentage of subjects
Interval 0.0 to 0.32
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-47
|
0.17 Percentage of subjects
Interval 0.05 to 0.43
|
0.48 Percentage of subjects
Interval 0.1 to 1.39
|
0.00 Percentage of subjects
Interval 0.0 to 0.3
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-48
|
0.17 Percentage of subjects
Interval 0.05 to 0.43
|
0.46 Percentage of subjects
Interval 0.09 to 1.33
|
0.00 Percentage of subjects
Interval 0.0 to 0.3
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-37
|
0.29 Percentage of subjects
Interval 0.09 to 0.67
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 0.99
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-38
|
0.28 Percentage of subjects
Interval 0.13 to 0.51
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
0.00 Percentage of subjects
Interval 0.0 to 0.49
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-39
|
0.24 Percentage of subjects
Interval 0.13 to 0.4
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 0.34
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-40
|
0.20 Percentage of subjects
Interval 0.11 to 0.33
|
0.00 Percentage of subjects
Interval 0.0 to 6.16
|
0.00 Percentage of subjects
Interval 0.0 to 0.25
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-41
|
0.20 Percentage of subjects
Interval 0.11 to 0.33
|
0.00 Percentage of subjects
Interval 0.0 to 2.66
|
0.06 Percentage of subjects
Interval 0.0 to 0.51
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-42
|
0.19 Percentage of subjects
Interval 0.1 to 0.32
|
0.00 Percentage of subjects
Interval 0.0 to 1.81
|
0.06 Percentage of subjects
Interval 0.0 to 0.47
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-43
|
0.18 Percentage of subjects
Interval 0.1 to 0.31
|
0.00 Percentage of subjects
Interval 0.0 to 1.29
|
0.06 Percentage of subjects
Interval 0.0 to 0.46
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-44
|
0.18 Percentage of subjects
Interval 0.1 to 0.31
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
0.05 Percentage of subjects
Interval 0.0 to 0.43
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-45
|
0.18 Percentage of subjects
Interval 0.09 to 0.31
|
0.00 Percentage of subjects
Interval 0.0 to 0.95
|
0.05 Percentage of subjects
Interval 0.0 to 0.42
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-46
|
0.18 Percentage of subjects
Interval 0.09 to 0.3
|
0.00 Percentage of subjects
Interval 0.0 to 0.87
|
0.05 Percentage of subjects
Interval 0.0 to 0.41
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-47
|
0.17 Percentage of subjects
Interval 0.09 to 0.3
|
0.00 Percentage of subjects
Interval 0.0 to 0.82
|
0.05 Percentage of subjects
Interval 0.0 to 0.4
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-48
|
0.17 Percentage of subjects
Interval 0.09 to 0.3
|
0.00 Percentage of subjects
Interval 0.0 to 0.78
|
0.05 Percentage of subjects
Interval 0.0 to 0.4
|
SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in EHR (combining routine data collection and card-based ADR reporting system) during the safety follow-up period (from vaccination up to 7 days post-vaccination).
"SAEs reported here are derived from 2 sources of data - ADR cards and SAEs routinely collected from GPs. SAE data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. The weekly incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017"
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16433 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=3310 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=4196 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
>65 years, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 3.42
|
0.00 Percentage of subjects
Interval 0.0 to 12.77
|
3.33 Percentage of subjects
Interval 0.04 to 19.38
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 37
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 1.77
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 2.95
|
0.00 Percentage of subjects
Interval 0.0 to 7.71
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 1.9
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 2.55
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 44
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 1.79
|
0.00 Percentage of subjects
Interval 0.0 to 2.48
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 45
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 2.82
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 1.8
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 47
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 4.99
|
0.00 Percentage of subjects
Interval 0.0 to 9.03
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 48
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 37
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
—
|
—
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 38
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
—
|
—
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
—
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 11.57
|
0.00 Percentage of subjects
Interval 0.0 to 6.49
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 12.34
|
0.00 Percentage of subjects
Interval 0.0 to 14.82
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 13.72
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 3.66
|
0.00 Percentage of subjects
Interval 0.0 to 1.47
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 3.55
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 1.34
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 47
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 21.8
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
—
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 37
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
—
|
—
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 38
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
—
|
—
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
0.00 Percentage of subjects
Interval 0.0 to 10.89
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
—
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 13.72
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 4.51
|
0.00 Percentage of subjects
Interval 0.0 to 1.78
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 48
|
25.00 Percentage of subjects
Interval 0.63 to 80.59
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
—
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 36
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 37
|
0.14 Percentage of subjects
Interval 0.0 to 0.95
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 2.4
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 38
|
0.00 Percentage of subjects
Interval 0.0 to 0.43
|
0.00 Percentage of subjects
Interval 0.0 to 60.24
|
0.61 Percentage of subjects
Interval 0.01 to 3.47
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 0.26
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 2.48
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 40
|
0.27 Percentage of subjects
Interval 0.03 to 0.98
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
0.00 Percentage of subjects
Interval 0.0 to 1.87
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 0.58
|
0.00 Percentage of subjects
Interval 0.0 to 3.85
|
1.82 Percentage of subjects
Interval 0.22 to 6.41
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 1.03
|
0.00 Percentage of subjects
Interval 0.0 to 3.3
|
0.00 Percentage of subjects
Interval 0.0 to 4.45
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 1.66
|
0.00 Percentage of subjects
Interval 0.0 to 3.05
|
0.00 Percentage of subjects
Interval 0.0 to 4.2
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 1.17
|
1.27 Percentage of subjects
Interval 0.0 to 19.0
|
0.00 Percentage of subjects
Interval 0.0 to 4.56
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 1.63
|
0.00 Percentage of subjects
Interval 0.0 to 6.49
|
0.00 Percentage of subjects
Interval 0.0 to 4.35
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 46
|
0.45 Percentage of subjects
Interval 0.01 to 2.58
|
0.00 Percentage of subjects
Interval 0.0 to 6.98
|
0.00 Percentage of subjects
Interval 0.0 to 8.81
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 2.49
|
0.00 Percentage of subjects
Interval 0.0 to 9.03
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 4.11
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 12.34
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
>65 years, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 6.98
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
>65 years, Week 37
|
0.12 Percentage of subjects
Interval 0.01 to 0.42
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.32 Percentage of subjects
Interval 0.0 to 2.6
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
>65 years, Week 38
|
0.27 Percentage of subjects
Interval 0.06 to 0.75
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.27 Percentage of subjects
Interval 0.0 to 1.83
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
>65 years, Week 39
|
0.11 Percentage of subjects
Interval 0.02 to 0.35
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.00 Percentage of subjects
Interval 0.0 to 1.09
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
>65 years, Week 40
|
0.15 Percentage of subjects
Interval 0.01 to 0.62
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
0.27 Percentage of subjects
Interval 0.0 to 2.12
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
>65 years, Week 41
|
0.20 Percentage of subjects
Interval 0.01 to 0.94
|
0.00 Percentage of subjects
Interval 0.0 to 4.56
|
0.00 Percentage of subjects
Interval 0.0 to 2.35
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
>65 years, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 0.67
|
1.54 Percentage of subjects
Interval 0.04 to 8.28
|
0.00 Percentage of subjects
Interval 0.0 to 3.03
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
>65 years, Week 43
|
0.73 Percentage of subjects
Interval 0.01 to 4.84
|
0.00 Percentage of subjects
Interval 0.0 to 4.4
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
>65 years, Week 44
|
0.47 Percentage of subjects
Interval 0.0 to 3.34
|
0.00 Percentage of subjects
Interval 0.0 to 5.6
|
2.78 Percentage of subjects
Interval 0.31 to 9.95
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
>65 years, Week 45
|
0.45 Percentage of subjects
Interval 0.0 to 3.24
|
2.70 Percentage of subjects
Interval 0.0 to 93.12
|
0.00 Percentage of subjects
Interval 0.0 to 6.06
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
>65 years, Week 46
|
0.88 Percentage of subjects
Interval 0.01 to 5.78
|
0.00 Percentage of subjects
Interval 0.0 to 9.49
|
3.13 Percentage of subjects
Interval 0.08 to 16.22
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
>65 years, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 15.44
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start up to end of the week of interest and were registered in EHR (routine data collection \& card-based ADR reporting) during FU period (from vaccination up to 7 days post-vaccination)
SAEs reported here are derived from 2 sources of data - ADR cards and SAEs routinely collected from GPs. SAE data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and \>65 years. The cumulative incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16433 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=3310 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=4196 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-42
|
0.00 Percentage of subjects
Interval 0.0 to 6.06
|
0.00 Percentage of subjects
Interval 0.0 to 7.4
|
0.00 Percentage of subjects
Interval 0.0 to 10.0
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-37
|
0.14 Percentage of subjects
Interval 0.0 to 0.95
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 2.25
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-45
|
0.05 Percentage of subjects
Interval 0.01 to 0.16
|
0.19 Percentage of subjects
Interval 0.0 to 1.89
|
0.27 Percentage of subjects
Interval 0.03 to 1.05
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-38
|
0.19 Percentage of subjects
Interval 0.06 to 0.45
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
0.27 Percentage of subjects
Interval 0.02 to 1.22
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-37
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-38
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-39
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-40
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 1.36
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-41
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 0.93
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-42
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.00 Percentage of subjects
Interval 0.0 to 0.63
|
0.00 Percentage of subjects
Interval 0.0 to 4.56
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-43
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 0.51
|
0.00 Percentage of subjects
Interval 0.0 to 4.3
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-44
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 0.4
|
0.00 Percentage of subjects
Interval 0.0 to 1.58
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-45
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
0.00 Percentage of subjects
Interval 0.0 to 0.35
|
0.00 Percentage of subjects
Interval 0.0 to 1.57
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-46
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.29
|
0.00 Percentage of subjects
Interval 0.0 to 1.51
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-47
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.28
|
0.00 Percentage of subjects
Interval 0.0 to 1.3
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
6 months to 5 years, Week 35-48
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
0.00 Percentage of subjects
Interval 0.0 to 0.27
|
0.00 Percentage of subjects
Interval 0.0 to 1.28
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-37
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
—
|
—
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-38
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
—
|
—
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-39
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
—
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-40
|
0.00 Percentage of subjects
Interval 0.0 to 12.77
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-41
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 4.99
|
0.00 Percentage of subjects
Interval 0.0 to 5.52
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-42
|
0.00 Percentage of subjects
Interval 0.0 to 10.28
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 4.11
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-43
|
0.00 Percentage of subjects
Interval 0.0 to 10.0
|
0.00 Percentage of subjects
Interval 0.0 to 2.91
|
0.00 Percentage of subjects
Interval 0.0 to 3.81
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-44
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
0.00 Percentage of subjects
Interval 0.0 to 1.63
|
0.00 Percentage of subjects
Interval 0.0 to 1.07
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-45
|
0.00 Percentage of subjects
Interval 0.0 to 8.41
|
0.00 Percentage of subjects
Interval 0.0 to 1.13
|
0.00 Percentage of subjects
Interval 0.0 to 1.06
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-46
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
0.00 Percentage of subjects
Interval 0.0 to 0.61
|
0.00 Percentage of subjects
Interval 0.0 to 1.03
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-47
|
0.00 Percentage of subjects
Interval 0.0 to 7.55
|
0.00 Percentage of subjects
Interval 0.0 to 0.6
|
0.00 Percentage of subjects
Interval 0.0 to 0.87
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
6 - 12 years, Week 35-48
|
0.00 Percentage of subjects
Interval 0.0 to 7.4
|
0.00 Percentage of subjects
Interval 0.0 to 0.58
|
0.00 Percentage of subjects
Interval 0.0 to 0.87
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-37
|
0.00 Percentage of subjects
Interval 0.0 to 36.94
|
—
|
—
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-38
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
—
|
—
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-39
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-40
|
0.00 Percentage of subjects
Interval 0.0 to 7.87
|
0.00 Percentage of subjects
Interval 0.0 to 23.16
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-41
|
0.00 Percentage of subjects
Interval 0.0 to 6.49
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 10.0
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-43
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
0.00 Percentage of subjects
Interval 0.0 to 5.87
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-44
|
0.00 Percentage of subjects
Interval 0.0 to 5.78
|
0.00 Percentage of subjects
Interval 0.0 to 4.2
|
0.00 Percentage of subjects
Interval 0.0 to 7.11
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-45
|
0.00 Percentage of subjects
Interval 0.0 to 5.13
|
0.00 Percentage of subjects
Interval 0.0 to 2.2
|
0.00 Percentage of subjects
Interval 0.0 to 1.44
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-46
|
0.00 Percentage of subjects
Interval 0.0 to 4.74
|
0.00 Percentage of subjects
Interval 0.0 to 2.05
|
0.00 Percentage of subjects
Interval 0.0 to 1.43
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-47
|
0.00 Percentage of subjects
Interval 0.0 to 4.4
|
0.00 Percentage of subjects
Interval 0.0 to 2.0
|
0.00 Percentage of subjects
Interval 0.0 to 1.4
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
13 - 17 years, Week 35-48
|
1.16 Percentage of subjects
Interval 0.03 to 6.31
|
0.00 Percentage of subjects
Interval 0.0 to 1.98
|
0.00 Percentage of subjects
Interval 0.0 to 1.4
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-36
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 30.85
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-38
|
0.06 Percentage of subjects
Interval 0.0 to 0.45
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.31 Percentage of subjects
Interval 0.0 to 1.91
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-39
|
0.03 Percentage of subjects
Interval 0.0 to 0.03
|
0.00 Percentage of subjects
Interval 0.0 to 19.51
|
0.21 Percentage of subjects
Interval 0.0 to 1.31
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-40
|
0.08 Percentage of subjects
Interval 0.02 to 0.24
|
0.00 Percentage of subjects
Interval 0.0 to 4.51
|
0.15 Percentage of subjects
Interval 0.0 to 0.97
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-41
|
0.07 Percentage of subjects
Interval 0.01 to 0.21
|
0.00 Percentage of subjects
Interval 0.0 to 2.1
|
0.39 Percentage of subjects
Interval 0.04 to 1.5
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-42
|
0.06 Percentage of subjects
Interval 0.01 to 0.19
|
0.00 Percentage of subjects
Interval 0.0 to 1.29
|
0.35 Percentage of subjects
Interval 0.04 to 1.33
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-43
|
0.06 Percentage of subjects
Interval 0.01 to 0.18
|
0.00 Percentage of subjects
Interval 0.0 to 0.91
|
0.32 Percentage of subjects
Interval 0.03 to 1.22
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-44
|
0.06 Percentage of subjects
Interval 0.01 to 0.17
|
0.21 Percentage of subjects
Interval 0.0 to 2.26
|
0.29 Percentage of subjects
Interval 0.03 to 1.13
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-46
|
0.07 Percentage of subjects
Interval 0.01 to 0.22
|
0.17 Percentage of subjects
Interval 0.0 to 1.64
|
0.26 Percentage of subjects
Interval 0.03 to 1.01
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-47
|
0.07 Percentage of subjects
Interval 0.01 to 0.21
|
0.16 Percentage of subjects
Interval 0.0 to 1.51
|
0.25 Percentage of subjects
Interval 0.02 to 0.95
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
18 - 65 years, Week 35-48
|
0.07 Percentage of subjects
Interval 0.01 to 0.21
|
0.15 Percentage of subjects
Interval 0.0 to 1.42
|
0.24 Percentage of subjects
Interval 0.02 to 0.93
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-37
|
0.12 Percentage of subjects
Interval 0.01 to 0.42
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.27 Percentage of subjects
Interval 0.0 to 2.23
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-39
|
0.16 Percentage of subjects
Interval 0.07 to 0.29
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.18 Percentage of subjects
Interval 0.01 to 0.85
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-40
|
0.16 Percentage of subjects
Interval 0.08 to 0.28
|
0.00 Percentage of subjects
Interval 0.0 to 6.16
|
0.21 Percentage of subjects
Interval 0.04 to 0.64
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-41
|
0.16 Percentage of subjects
Interval 0.07 to 0.31
|
0.00 Percentage of subjects
Interval 0.0 to 2.66
|
0.19 Percentage of subjects
Interval 0.03 to 0.58
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-42
|
0.14 Percentage of subjects
Interval 0.07 to 0.29
|
0.50 Percentage of subjects
Interval 0.01 to 2.73
|
0.17 Percentage of subjects
Interval 0.03 to 0.53
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-43
|
0.17 Percentage of subjects
Interval 0.07 to 0.35
|
0.35 Percentage of subjects
Interval 0.01 to 1.95
|
0.17 Percentage of subjects
Interval 0.03 to 0.51
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-44
|
0.18 Percentage of subjects
Interval 0.06 to 0.41
|
0.29 Percentage of subjects
Interval 0.01 to 1.59
|
0.27 Percentage of subjects
Interval 0.07 to 0.68
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-45
|
0.19 Percentage of subjects
Interval 0.07 to 0.4
|
0.52 Percentage of subjects
Interval 0.06 to 1.86
|
0.26 Percentage of subjects
Interval 0.07 to 0.66
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-46
|
0.20 Percentage of subjects
Interval 0.07 to 0.42
|
0.47 Percentage of subjects
Interval 0.06 to 1.7
|
0.31 Percentage of subjects
Interval 0.11 to 0.68
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-47
|
0.19 Percentage of subjects
Interval 0.07 to 0.41
|
0.45 Percentage of subjects
Interval 0.05 to 1.6
|
0.35 Percentage of subjects
Interval 0.12 to 0.81
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group
>65 years, Week 35-48
|
0.19 Percentage of subjects
Interval 0.07 to 0.41
|
0.43 Percentage of subjects
Interval 0.05 to 1.53
|
0.35 Percentage of subjects
Interval 0.12 to 0.81
|
SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in EHR (combining routine data collection and card-based ADR reporting system) during the safety follow-up period (from vaccination up to 7 days post-vaccination).
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16433 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=3310 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=4196 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group and United Kingdom Chief Medical Officer (UK CMO)-Specified Risk Status
At risk, Week 38
|
9.76 Percentage of subjects
Interval 7.27 to 12.76
|
14.29 Percentage of subjects
Interval 0.0 to 90.97
|
1.61 Percentage of subjects
Interval 0.7 to 3.14
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group and United Kingdom Chief Medical Officer (UK CMO)-Specified Risk Status
At risk, Week 35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group and United Kingdom Chief Medical Officer (UK CMO)-Specified Risk Status
At risk, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
1.69 Percentage of subjects
Interval 0.0 to 16.08
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group and United Kingdom Chief Medical Officer (UK CMO)-Specified Risk Status
At risk, Week 37
|
11.44 Percentage of subjects
Interval 9.28 to 13.9
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.68 Percentage of subjects
Interval 0.01 to 4.04
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group and United Kingdom Chief Medical Officer (UK CMO)-Specified Risk Status
At risk, Week 39
|
9.72 Percentage of subjects
Interval 8.38 to 11.18
|
2.06 Percentage of subjects
Interval 0.25 to 7.25
|
2.46 Percentage of subjects
Interval 0.94 to 5.16
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group and United Kingdom Chief Medical Officer (UK CMO)-Specified Risk Status
At risk, Week 40
|
9.78 Percentage of subjects
Interval 5.87 to 15.06
|
7.35 Percentage of subjects
Interval 4.71 to 10.82
|
1.72 Percentage of subjects
Interval 0.5 to 4.22
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group and United Kingdom Chief Medical Officer (UK CMO)-Specified Risk Status
At risk, Week 41
|
8.79 Percentage of subjects
Interval 6.62 to 11.38
|
5.96 Percentage of subjects
Interval 2.86 to 10.77
|
0.30 Percentage of subjects
Interval 0.0 to 2.16
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group and United Kingdom Chief Medical Officer (UK CMO)-Specified Risk Status
At risk, Week 42
|
5.58 Percentage of subjects
Interval 3.15 to 9.07
|
2.53 Percentage of subjects
Interval 1.14 to 4.8
|
1.89 Percentage of subjects
Interval 0.23 to 6.66
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group and United Kingdom Chief Medical Officer (UK CMO)-Specified Risk Status
At risk, Week 43
|
6.26 Percentage of subjects
Interval 2.99 to 11.35
|
4.28 Percentage of subjects
Interval 1.91 to 8.16
|
1.52 Percentage of subjects
Interval 0.11 to 6.34
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group and United Kingdom Chief Medical Officer (UK CMO)-Specified Risk Status
At risk, Week 44
|
6.17 Percentage of subjects
Interval 2.44 to 12.51
|
4.80 Percentage of subjects
Interval 1.53 to 11.02
|
0.19 Percentage of subjects
Interval 0.0 to 1.08
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group and United Kingdom Chief Medical Officer (UK CMO)-Specified Risk Status
At risk, Week 45
|
6.04 Percentage of subjects
Interval 2.99 to 10.69
|
2.97 Percentage of subjects
Interval 0.05 to 16.62
|
2.61 Percentage of subjects
Interval 0.35 to 8.77
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group and United Kingdom Chief Medical Officer (UK CMO)-Specified Risk Status
At risk, Week 46
|
5.95 Percentage of subjects
Interval 2.73 to 11.05
|
1.07 Percentage of subjects
Interval 0.06 to 4.86
|
3.85 Percentage of subjects
Interval 0.36 to 14.33
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group and United Kingdom Chief Medical Officer (UK CMO)-Specified Risk Status
At risk, Week 47
|
3.77 Percentage of subjects
Interval 1.3 to 8.36
|
2.19 Percentage of subjects
Interval 0.45 to 6.27
|
1.14 Percentage of subjects
Interval 0.06 to 5.29
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group and United Kingdom Chief Medical Officer (UK CMO)-Specified Risk Status
At risk, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
4.76 Percentage of subjects
Interval 0.38 to 18.41
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group and United Kingdom Chief Medical Officer (UK CMO)-Specified Risk Status
Not at risk, Week 36
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group and United Kingdom Chief Medical Officer (UK CMO)-Specified Risk Status
Not at risk, Week 37
|
15.04 Percentage of subjects
Interval 9.43 to 22.26
|
—
|
9.68 Percentage of subjects
Interval 2.04 to 25.75
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group and United Kingdom Chief Medical Officer (UK CMO)-Specified Risk Status
Not at risk, Week 38
|
13.94 Percentage of subjects
Interval 9.05 to 20.18
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group and United Kingdom Chief Medical Officer (UK CMO)-Specified Risk Status
Not at risk, Week 39
|
13.53 Percentage of subjects
Interval 9.92 to 17.85
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group and United Kingdom Chief Medical Officer (UK CMO)-Specified Risk Status
Not at risk, Week 40
|
12.00 Percentage of subjects
Interval 6.25 to 20.24
|
6.90 Percentage of subjects
Interval 0.85 to 22.77
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group and United Kingdom Chief Medical Officer (UK CMO)-Specified Risk Status
Not at risk, Week 41
|
6.71 Percentage of subjects
Interval 1.53 to 17.74
|
2.44 Percentage of subjects
Interval 0.06 to 12.86
|
1.56 Percentage of subjects
Interval 0.01 to 10.47
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group and United Kingdom Chief Medical Officer (UK CMO)-Specified Risk Status
Not at risk, Week 42
|
2.27 Percentage of subjects
Interval 0.26 to 8.11
|
0.00 Percentage of subjects
Interval 0.0 to 6.38
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group and United Kingdom Chief Medical Officer (UK CMO)-Specified Risk Status
Not at risk, Week 43
|
3.85 Percentage of subjects
Interval 0.33 to 14.73
|
5.45 Percentage of subjects
Interval 0.66 to 18.46
|
3.13 Percentage of subjects
Interval 0.08 to 16.22
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group and United Kingdom Chief Medical Officer (UK CMO)-Specified Risk Status
Not at risk, Week 44
|
4.35 Percentage of subjects
Interval 0.91 to 12.18
|
14.81 Percentage of subjects
Interval 3.75 to 35.25
|
2.17 Percentage of subjects
Interval 0.06 to 11.53
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group and United Kingdom Chief Medical Officer (UK CMO)-Specified Risk Status
Not at risk, Week 45
|
9.46 Percentage of subjects
Interval 3.89 to 18.52
|
4.00 Percentage of subjects
Interval 1.1 to 9.93
|
4.68 Percentage of subjects
Interval 2.36 to 8.22
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group and United Kingdom Chief Medical Officer (UK CMO)-Specified Risk Status
Not at risk, Week 46
|
12.35 Percentage of subjects
Interval 2.91 to 30.79
|
3.70 Percentage of subjects
Interval 0.24 to 15.41
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group and United Kingdom Chief Medical Officer (UK CMO)-Specified Risk Status
Not at risk, Week 47
|
6.52 Percentage of subjects
Interval 1.37 to 17.9
|
9.52 Percentage of subjects
Interval 1.17 to 30.38
|
4.17 Percentage of subjects
Interval 0.02 to 27.48
|
|
Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group and United Kingdom Chief Medical Officer (UK CMO)-Specified Risk Status
Not at risk, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
6.25 Percentage of subjects
Interval 0.0 to 64.4
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start up to end of the week of interest and were registered in EHR (routine data collection \& card-based ADR reporting) during FU period (from vaccination up to 7 days post-vaccination)
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16433 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=3310 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=4196 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
1.67 Percentage of subjects
Interval 0.0 to 14.74
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-37
|
11.43 Percentage of subjects
Interval 9.27 to 13.9
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.80 Percentage of subjects
Interval 0.08 to 3.04
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-38
|
10.56 Percentage of subjects
Interval 8.59 to 12.79
|
7.69 Percentage of subjects
Interval 0.08 to 41.17
|
1.20 Percentage of subjects
Interval 0.59 to 2.19
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-39
|
10.19 Percentage of subjects
Interval 8.58 to 11.99
|
2.73 Percentage of subjects
Interval 0.34 to 9.45
|
1.59 Percentage of subjects
Interval 0.75 to 2.95
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-40
|
10.12 Percentage of subjects
Interval 8.28 to 12.21
|
6.15 Percentage of subjects
Interval 4.03 to 8.91
|
1.63 Percentage of subjects
Interval 0.71 to 3.15
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-41
|
9.95 Percentage of subjects
Interval 8.12 to 12.04
|
6.07 Percentage of subjects
Interval 3.78 to 9.16
|
1.43 Percentage of subjects
Interval 0.61 to 2.85
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-42
|
9.67 Percentage of subjects
Interval 7.83 to 11.79
|
4.90 Percentage of subjects
Interval 2.99 to 7.53
|
1.47 Percentage of subjects
Interval 0.64 to 2.88
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-43
|
9.56 Percentage of subjects
Interval 7.73 to 11.66
|
4.76 Percentage of subjects
Interval 2.94 to 7.23
|
1.47 Percentage of subjects
Interval 0.66 to 2.82
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-44
|
9.40 Percentage of subjects
Interval 7.56 to 11.5
|
4.77 Percentage of subjects
Interval 2.7 to 7.73
|
1.27 Percentage of subjects
Interval 0.6 to 2.34
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-45
|
9.31 Percentage of subjects
Interval 7.5 to 11.38
|
4.51 Percentage of subjects
Interval 2.26 to 7.96
|
1.31 Percentage of subjects
Interval 0.67 to 2.32
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-46
|
9.25 Percentage of subjects
Interval 7.44 to 11.32
|
3.89 Percentage of subjects
Interval 1.61 to 7.74
|
1.37 Percentage of subjects
Interval 0.73 to 2.33
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-47
|
9.17 Percentage of subjects
Interval 7.35 to 11.26
|
3.80 Percentage of subjects
Interval 1.6 to 7.52
|
1.36 Percentage of subjects
Interval 0.73 to 2.31
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-48
|
9.10 Percentage of subjects
Interval 7.28 to 11.2
|
3.83 Percentage of subjects
Interval 1.61 to 7.58
|
1.35 Percentage of subjects
Interval 0.72 to 2.29
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-36
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-37
|
15.04 Percentage of subjects
Interval 9.43 to 22.26
|
—
|
9.09 Percentage of subjects
Interval 1.92 to 24.33
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-38
|
14.43 Percentage of subjects
Interval 10.64 to 18.94
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
3.95 Percentage of subjects
Interval 0.82 to 11.11
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-39
|
13.95 Percentage of subjects
Interval 10.83 to 17.57
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
2.63 Percentage of subjects
Interval 0.55 to 7.5
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-40
|
13.53 Percentage of subjects
Interval 10.44 to 17.13
|
4.88 Percentage of subjects
Interval 0.6 to 16.53
|
1.69 Percentage of subjects
Interval 0.3 to 5.19
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-41
|
12.38 Percentage of subjects
Interval 9.23 to 16.15
|
3.66 Percentage of subjects
Interval 0.76 to 10.32
|
1.66 Percentage of subjects
Interval 0.45 to 4.19
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-42
|
11.55 Percentage of subjects
Interval 8.6 to 15.08
|
2.17 Percentage of subjects
Interval 0.45 to 6.22
|
1.48 Percentage of subjects
Interval 0.41 to 3.75
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-43
|
11.19 Percentage of subjects
Interval 8.25 to 14.73
|
3.11 Percentage of subjects
Interval 1.13 to 6.7
|
1.66 Percentage of subjects
Interval 0.54 to 3.82
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-44
|
10.79 Percentage of subjects
Interval 7.93 to 14.25
|
5.67 Percentage of subjects
Interval 2.91 to 9.8
|
1.72 Percentage of subjects
Interval 0.64 to 3.71
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-45
|
10.71 Percentage of subjects
Interval 8.05 to 13.89
|
5.19 Percentage of subjects
Interval 3.1 to 8.07
|
2.92 Percentage of subjects
Interval 1.21 to 5.82
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-46
|
10.81 Percentage of subjects
Interval 8.35 to 13.71
|
4.84 Percentage of subjects
Interval 2.37 to 8.64
|
2.82 Percentage of subjects
Interval 1.13 to 5.77
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-47
|
10.67 Percentage of subjects
Interval 8.29 to 13.46
|
5.04 Percentage of subjects
Interval 2.58 to 8.76
|
2.88 Percentage of subjects
Interval 1.27 to 5.53
|
|
Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-48
|
10.44 Percentage of subjects
Interval 8.07 to 13.22
|
5.08 Percentage of subjects
Interval 2.5 to 9.05
|
2.85 Percentage of subjects
Interval 1.25 to 5.51
|
SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in EHR (combining routine data collection and card-based ADR reporting system) during the safety follow-up period (from vaccination up to 7 days post-vaccination).
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16433 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=3310 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=4196 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 6.06
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 37
|
0.39 Percentage of subjects
Interval 0.16 to 0.76
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 0.84
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 38
|
0.46 Percentage of subjects
Interval 0.18 to 0.99
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.00 Percentage of subjects
Interval 0.0 to 0.74
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 39
|
0.50 Percentage of subjects
Interval 0.21 to 1.02
|
0.00 Percentage of subjects
Interval 0.0 to 3.73
|
0.22 Percentage of subjects
Interval 0.0 to 1.63
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 40
|
0.37 Percentage of subjects
Interval 0.13 to 0.84
|
1.28 Percentage of subjects
Interval 0.12 to 4.96
|
0.00 Percentage of subjects
Interval 0.0 to 0.7
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 41
|
0.40 Percentage of subjects
Interval 0.15 to 0.87
|
0.66 Percentage of subjects
Interval 0.08 to 2.37
|
0.00 Percentage of subjects
Interval 0.0 to 1.1
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 0.45
|
0.00 Percentage of subjects
Interval 0.0 to 1.03
|
0.00 Percentage of subjects
Interval 0.0 to 1.72
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 43
|
0.45 Percentage of subjects
Interval 0.05 to 1.62
|
0.00 Percentage of subjects
Interval 0.0 to 1.12
|
0.00 Percentage of subjects
Interval 0.0 to 2.76
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 44
|
0.29 Percentage of subjects
Interval 0.02 to 1.34
|
0.48 Percentage of subjects
Interval 0.06 to 1.72
|
0.00 Percentage of subjects
Interval 0.0 to 0.71
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 45
|
0.26 Percentage of subjects
Interval 0.0 to 1.93
|
0.00 Percentage of subjects
Interval 0.0 to 1.21
|
0.00 Percentage of subjects
Interval 0.0 to 3.16
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 46
|
0.37 Percentage of subjects
Interval 0.0 to 2.71
|
0.21 Percentage of subjects
Interval 0.0 to 2.05
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 47
|
0.47 Percentage of subjects
Interval 0.0 to 3.37
|
0.73 Percentage of subjects
Interval 0.01 to 4.77
|
0.00 Percentage of subjects
Interval 0.0 to 2.09
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.00 Percentage of subjects
Interval 0.0 to 4.3
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 36
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 37
|
1.50 Percentage of subjects
Interval 0.18 to 5.33
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 38
|
1.82 Percentage of subjects
Interval 0.3 to 5.77
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 39
|
0.59 Percentage of subjects
Interval 0.07 to 2.11
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 40
|
1.14 Percentage of subjects
Interval 0.02 to 6.55
|
3.45 Percentage of subjects
Interval 0.09 to 17.76
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 2.22
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
0.00 Percentage of subjects
Interval 0.0 to 5.6
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 4.11
|
0.00 Percentage of subjects
Interval 0.0 to 6.38
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 6.49
|
0.00 Percentage of subjects
Interval 0.0 to 10.89
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 5.21
|
0.00 Percentage of subjects
Interval 0.0 to 6.6
|
0.00 Percentage of subjects
Interval 0.0 to 7.71
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.43 Percentage of subjects
Interval 0.01 to 2.35
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 46
|
1.23 Percentage of subjects
Interval 0.0 to 9.48
|
0.00 Percentage of subjects
Interval 0.0 to 3.36
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 7.71
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
|
Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start up to end of the week of interest and were registered in EHR (routine data collection \& card-based ADR reporting) during FU period (from vaccination up to 7 days post-vaccination)
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16433 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=3310 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=4196 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.96
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-37
|
0.39 Percentage of subjects
Interval 0.16 to 0.76
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 0.74
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-38
|
0.43 Percentage of subjects
Interval 0.26 to 0.65
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 0.37
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-39
|
0.46 Percentage of subjects
Interval 0.25 to 0.77
|
0.00 Percentage of subjects
Interval 0.0 to 3.3
|
0.07 Percentage of subjects
Interval 0.0 to 0.5
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-40
|
0.44 Percentage of subjects
Interval 0.27 to 0.68
|
0.95 Percentage of subjects
Interval 0.03 to 4.78
|
0.05 Percentage of subjects
Interval 0.0 to 0.38
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-41
|
0.44 Percentage of subjects
Interval 0.29 to 0.64
|
0.83 Percentage of subjects
Interval 0.18 to 2.32
|
0.04 Percentage of subjects
Interval 0.0 to 0.32
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-42
|
0.41 Percentage of subjects
Interval 0.26 to 0.61
|
0.56 Percentage of subjects
Interval 0.09 to 1.77
|
0.04 Percentage of subjects
Interval 0.0 to 0.29
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-43
|
0.41 Percentage of subjects
Interval 0.26 to 0.61
|
0.43 Percentage of subjects
Interval 0.06 to 1.48
|
0.04 Percentage of subjects
Interval 0.0 to 0.28
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-44
|
0.41 Percentage of subjects
Interval 0.26 to 0.6
|
0.44 Percentage of subjects
Interval 0.11 to 1.19
|
0.03 Percentage of subjects
Interval 0.0 to 0.23
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-45
|
0.40 Percentage of subjects
Interval 0.26 to 0.6
|
0.38 Percentage of subjects
Interval 0.08 to 1.07
|
0.03 Percentage of subjects
Interval 0.0 to 0.23
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-46
|
0.40 Percentage of subjects
Interval 0.26 to 0.6
|
0.35 Percentage of subjects
Interval 0.08 to 0.95
|
0.03 Percentage of subjects
Interval 0.0 to 0.22
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-47
|
0.40 Percentage of subjects
Interval 0.26 to 0.59
|
0.37 Percentage of subjects
Interval 0.11 to 0.88
|
0.03 Percentage of subjects
Interval 0.0 to 0.21
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-48
|
0.40 Percentage of subjects
Interval 0.26 to 0.59
|
0.35 Percentage of subjects
Interval 0.11 to 0.85
|
0.03 Percentage of subjects
Interval 0.0 to 0.21
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-36
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-37
|
1.50 Percentage of subjects
Interval 0.18 to 5.33
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 10.58
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-38
|
1.68 Percentage of subjects
Interval 0.36 to 4.74
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 4.74
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-39
|
1.10 Percentage of subjects
Interval 0.32 to 2.7
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-40
|
1.11 Percentage of subjects
Interval 0.34 to 2.63
|
2.44 Percentage of subjects
Interval 0.06 to 12.86
|
0.00 Percentage of subjects
Interval 0.0 to 2.06
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-41
|
0.92 Percentage of subjects
Interval 0.27 to 2.25
|
1.22 Percentage of subjects
Interval 0.03 to 6.61
|
0.00 Percentage of subjects
Interval 0.0 to 1.52
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-42
|
0.85 Percentage of subjects
Interval 0.24 to 2.11
|
0.72 Percentage of subjects
Interval 0.02 to 3.97
|
0.00 Percentage of subjects
Interval 0.0 to 1.36
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-43
|
0.81 Percentage of subjects
Interval 0.22 to 2.05
|
0.52 Percentage of subjects
Interval 0.01 to 2.85
|
0.00 Percentage of subjects
Interval 0.0 to 1.21
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-44
|
0.76 Percentage of subjects
Interval 0.2 to 1.98
|
0.40 Percentage of subjects
Interval 0.01 to 2.23
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-45
|
0.71 Percentage of subjects
Interval 0.18 to 1.87
|
0.29 Percentage of subjects
Interval 0.01 to 1.6
|
0.17 Percentage of subjects
Interval 0.0 to 0.95
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-46
|
0.75 Percentage of subjects
Interval 0.16 to 2.11
|
0.22 Percentage of subjects
Interval 0.01 to 1.22
|
0.17 Percentage of subjects
Interval 0.0 to 0.92
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-47
|
0.72 Percentage of subjects
Interval 0.16 to 2.03
|
0.21 Percentage of subjects
Interval 0.01 to 1.16
|
0.16 Percentage of subjects
Interval 0.0 to 0.89
|
|
Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-48
|
0.71 Percentage of subjects
Interval 0.15 to 1.99
|
0.20 Percentage of subjects
Interval 0.01 to 1.13
|
0.16 Percentage of subjects
Interval 0.0 to 0.88
|
SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in EHR (combining routine data collection and card-based ADR reporting system) during the safety follow-up period (from vaccination up to 7 days post-vaccination).
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Local symptoms include local erythema. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16433 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=3310 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=4196 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 6.06
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 37
|
1.71 Percentage of subjects
Interval 0.61 to 3.77
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 0.84
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 38
|
1.35 Percentage of subjects
Interval 0.69 to 2.37
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.00 Percentage of subjects
Interval 0.0 to 0.74
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 39
|
1.80 Percentage of subjects
Interval 1.28 to 2.45
|
0.00 Percentage of subjects
Interval 0.0 to 3.73
|
0.00 Percentage of subjects
Interval 0.0 to 0.82
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 40
|
1.70 Percentage of subjects
Interval 0.71 to 3.39
|
0.32 Percentage of subjects
Interval 0.0 to 2.1
|
0.00 Percentage of subjects
Interval 0.0 to 0.7
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 41
|
1.53 Percentage of subjects
Interval 0.97 to 2.29
|
0.99 Percentage of subjects
Interval 0.14 to 3.38
|
0.00 Percentage of subjects
Interval 0.0 to 1.1
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 42
|
0.61 Percentage of subjects
Interval 0.1 to 1.96
|
0.56 Percentage of subjects
Interval 0.06 to 2.06
|
0.00 Percentage of subjects
Interval 0.0 to 1.72
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 43
|
0.45 Percentage of subjects
Interval 0.05 to 1.66
|
0.61 Percentage of subjects
Interval 0.04 to 2.64
|
0.00 Percentage of subjects
Interval 0.0 to 2.76
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 44
|
0.88 Percentage of subjects
Interval 0.13 to 2.95
|
0.48 Percentage of subjects
Interval 0.06 to 1.72
|
0.00 Percentage of subjects
Interval 0.0 to 0.71
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 45
|
1.05 Percentage of subjects
Interval 0.2 to 3.17
|
0.66 Percentage of subjects
Interval 0.0 to 4.55
|
0.00 Percentage of subjects
Interval 0.0 to 3.16
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 46
|
0.74 Percentage of subjects
Interval 0.09 to 2.7
|
0.21 Percentage of subjects
Interval 0.0 to 2.0
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 47
|
0.94 Percentage of subjects
Interval 0.05 to 4.24
|
0.00 Percentage of subjects
Interval 0.0 to 2.66
|
0.00 Percentage of subjects
Interval 0.0 to 2.09
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.00 Percentage of subjects
Interval 0.0 to 4.3
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 36
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 37
|
5.26 Percentage of subjects
Interval 1.54 to 12.59
|
—
|
3.23 Percentage of subjects
Interval 0.08 to 16.7
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 38
|
6.06 Percentage of subjects
Interval 2.82 to 11.16
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 39
|
3.53 Percentage of subjects
Interval 1.49 to 6.97
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 40
|
4.57 Percentage of subjects
Interval 1.62 to 9.92
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 41
|
0.61 Percentage of subjects
Interval 0.0 to 4.32
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
0.00 Percentage of subjects
Interval 0.0 to 5.6
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 4.11
|
0.00 Percentage of subjects
Interval 0.0 to 6.38
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
1.82 Percentage of subjects
Interval 0.05 to 9.72
|
0.00 Percentage of subjects
Interval 0.0 to 10.89
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 44
|
4.35 Percentage of subjects
Interval 0.91 to 12.18
|
1.85 Percentage of subjects
Interval 0.05 to 9.89
|
0.00 Percentage of subjects
Interval 0.0 to 7.71
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 1.56
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 46
|
3.70 Percentage of subjects
Interval 0.08 to 19.4
|
1.85 Percentage of subjects
Interval 0.01 to 13.63
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 47
|
2.17 Percentage of subjects
Interval 0.01 to 16.04
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
|
Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start up to end of the week of interest and were registered in EHR (routine data collection \& card-based ADR reporting) during FU period (from vaccination up to 7 days post-vaccination)
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Local symptoms include local erythema. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16433 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=3310 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=4196 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.96
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-37
|
1.71 Percentage of subjects
Interval 0.61 to 3.77
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 0.74
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-38
|
1.52 Percentage of subjects
Interval 0.82 to 2.57
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 0.37
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-39
|
1.64 Percentage of subjects
Interval 1.07 to 2.42
|
0.00 Percentage of subjects
Interval 0.0 to 3.3
|
0.00 Percentage of subjects
Interval 0.0 to 0.25
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-40
|
1.65 Percentage of subjects
Interval 1.09 to 2.41
|
0.24 Percentage of subjects
Interval 0.01 to 1.31
|
0.00 Percentage of subjects
Interval 0.0 to 0.19
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-41
|
1.64 Percentage of subjects
Interval 1.13 to 2.29
|
0.55 Percentage of subjects
Interval 0.04 to 2.31
|
0.00 Percentage of subjects
Interval 0.0 to 0.16
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-42
|
1.57 Percentage of subjects
Interval 1.13 to 2.07
|
0.56 Percentage of subjects
Interval 0.05 to 2.2
|
0.00 Percentage of subjects
Interval 0.0 to 0.15
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-43
|
1.53 Percentage of subjects
Interval 1.11 to 2.03
|
0.57 Percentage of subjects
Interval 0.05 to 2.27
|
0.00 Percentage of subjects
Interval 0.0 to 0.14
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-44
|
1.50 Percentage of subjects
Interval 1.09 to 2.02
|
0.55 Percentage of subjects
Interval 0.07 to 1.95
|
0.00 Percentage of subjects
Interval 0.0 to 0.12
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-45
|
1.49 Percentage of subjects
Interval 1.09 to 1.99
|
0.56 Percentage of subjects
Interval 0.11 to 1.7
|
0.00 Percentage of subjects
Interval 0.0 to 0.11
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-46
|
1.48 Percentage of subjects
Interval 1.08 to 1.96
|
0.50 Percentage of subjects
Interval 0.07 to 1.74
|
0.00 Percentage of subjects
Interval 0.0 to 0.11
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-47
|
1.47 Percentage of subjects
Interval 1.08 to 1.95
|
0.48 Percentage of subjects
Interval 0.06 to 1.65
|
0.00 Percentage of subjects
Interval 0.0 to 0.1
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-48
|
1.46 Percentage of subjects
Interval 1.07 to 1.94
|
0.46 Percentage of subjects
Interval 0.06 to 1.6
|
0.00 Percentage of subjects
Interval 0.0 to 0.1
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-36
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-37
|
5.26 Percentage of subjects
Interval 1.54 to 12.59
|
—
|
3.03 Percentage of subjects
Interval 0.08 to 15.76
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-38
|
5.70 Percentage of subjects
Interval 2.72 to 10.36
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
1.32 Percentage of subjects
Interval 0.03 to 7.11
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-39
|
4.55 Percentage of subjects
Interval 2.27 to 8.04
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
0.88 Percentage of subjects
Interval 0.01 to 5.49
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-40
|
4.55 Percentage of subjects
Interval 2.58 to 7.37
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
0.56 Percentage of subjects
Interval 0.0 to 3.91
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-41
|
3.89 Percentage of subjects
Interval 2.24 to 6.23
|
0.00 Percentage of subjects
Interval 0.0 to 4.4
|
0.41 Percentage of subjects
Interval 0.0 to 2.93
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-42
|
3.57 Percentage of subjects
Interval 2.12 to 5.59
|
0.00 Percentage of subjects
Interval 0.0 to 2.64
|
0.37 Percentage of subjects
Interval 0.0 to 2.63
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-43
|
3.40 Percentage of subjects
Interval 2.06 to 5.26
|
0.52 Percentage of subjects
Interval 0.01 to 2.85
|
0.33 Percentage of subjects
Interval 0.0 to 2.35
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-44
|
3.46 Percentage of subjects
Interval 2.21 to 5.14
|
0.81 Percentage of subjects
Interval 0.1 to 2.89
|
0.29 Percentage of subjects
Interval 0.0 to 2.09
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-45
|
3.25 Percentage of subjects
Interval 2.08 to 4.82
|
0.58 Percentage of subjects
Interval 0.07 to 2.07
|
0.17 Percentage of subjects
Interval 0.0 to 1.48
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-46
|
3.28 Percentage of subjects
Interval 2.27 to 4.57
|
0.88 Percentage of subjects
Interval 0.24 to 2.24
|
0.17 Percentage of subjects
Interval 0.0 to 1.42
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-47
|
3.24 Percentage of subjects
Interval 2.26 to 4.5
|
0.84 Percentage of subjects
Interval 0.23 to 2.14
|
0.16 Percentage of subjects
Interval 0.0 to 1.37
|
|
Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-48
|
3.17 Percentage of subjects
Interval 2.2 to 4.41
|
0.81 Percentage of subjects
Interval 0.22 to 2.07
|
0.16 Percentage of subjects
Interval 0.0 to 1.35
|
SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in EHR (combining routine data collection and card-based ADR reporting system) during the safety follow-up period (from vaccination up to 7 days post-vaccination).
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16433 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=3310 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=4196 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 6.06
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 37
|
3.98 Percentage of subjects
Interval 3.21 to 4.89
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 0.84
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 38
|
3.20 Percentage of subjects
Interval 2.36 to 4.25
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.00 Percentage of subjects
Interval 0.0 to 0.74
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 39
|
3.12 Percentage of subjects
Interval 2.3 to 4.14
|
1.03 Percentage of subjects
Interval 0.03 to 5.61
|
0.45 Percentage of subjects
Interval 0.05 to 1.6
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 40
|
2.55 Percentage of subjects
Interval 1.89 to 3.37
|
2.56 Percentage of subjects
Interval 0.56 to 7.1
|
0.00 Percentage of subjects
Interval 0.0 to 0.7
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 41
|
2.00 Percentage of subjects
Interval 1.23 to 3.06
|
1.32 Percentage of subjects
Interval 0.18 to 4.5
|
0.00 Percentage of subjects
Interval 0.0 to 1.1
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 42
|
1.70 Percentage of subjects
Interval 0.59 to 3.8
|
0.56 Percentage of subjects
Interval 0.06 to 2.06
|
0.00 Percentage of subjects
Interval 0.0 to 1.72
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 43
|
2.24 Percentage of subjects
Interval 0.84 to 4.75
|
0.92 Percentage of subjects
Interval 0.06 to 3.95
|
0.00 Percentage of subjects
Interval 0.0 to 2.76
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 44
|
2.06 Percentage of subjects
Interval 0.81 to 4.27
|
1.44 Percentage of subjects
Interval 0.23 to 4.65
|
0.00 Percentage of subjects
Interval 0.0 to 0.71
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 45
|
1.57 Percentage of subjects
Interval 0.42 to 4.04
|
1.32 Percentage of subjects
Interval 0.06 to 6.37
|
0.00 Percentage of subjects
Interval 0.0 to 3.16
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 46
|
0.74 Percentage of subjects
Interval 0.09 to 2.7
|
0.21 Percentage of subjects
Interval 0.0 to 2.0
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 1.72
|
0.00 Percentage of subjects
Interval 0.0 to 2.66
|
0.00 Percentage of subjects
Interval 0.0 to 2.09
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.00 Percentage of subjects
Interval 0.0 to 4.3
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 36
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 37
|
4.51 Percentage of subjects
Interval 1.67 to 9.56
|
—
|
3.23 Percentage of subjects
Interval 0.02 to 21.72
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 38
|
3.03 Percentage of subjects
Interval 0.99 to 6.93
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 39
|
5.29 Percentage of subjects
Interval 2.04 to 10.94
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 40
|
4.57 Percentage of subjects
Interval 1.9 to 9.06
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 41
|
1.83 Percentage of subjects
Interval 0.23 to 6.42
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
0.00 Percentage of subjects
Interval 0.0 to 5.6
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 42
|
1.14 Percentage of subjects
Interval 0.01 to 7.02
|
0.00 Percentage of subjects
Interval 0.0 to 6.38
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
1.82 Percentage of subjects
Interval 0.05 to 9.72
|
0.00 Percentage of subjects
Interval 0.0 to 10.89
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 5.21
|
3.70 Percentage of subjects
Interval 0.16 to 16.98
|
0.00 Percentage of subjects
Interval 0.0 to 7.71
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 45
|
1.35 Percentage of subjects
Interval 0.01 to 9.52
|
2.00 Percentage of subjects
Interval 0.1 to 9.21
|
2.13 Percentage of subjects
Interval 0.69 to 4.9
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 46
|
2.47 Percentage of subjects
Interval 0.12 to 11.36
|
0.93 Percentage of subjects
Interval 0.0 to 9.43
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 47
|
2.17 Percentage of subjects
Interval 0.06 to 11.53
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
|
Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start up to end of the week of interest and were registered in EHR (routine data collection \& card-based ADR reporting) during FU period (from vaccination up to 7 days post-vaccination)
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16433 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=3310 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=4196 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.96
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-37
|
3.98 Percentage of subjects
Interval 3.21 to 4.89
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 0.74
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-38
|
3.57 Percentage of subjects
Interval 2.77 to 4.53
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 0.37
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-39
|
3.38 Percentage of subjects
Interval 2.56 to 4.36
|
0.91 Percentage of subjects
Interval 0.02 to 4.96
|
0.14 Percentage of subjects
Interval 0.02 to 0.5
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-40
|
3.23 Percentage of subjects
Interval 2.49 to 4.12
|
2.13 Percentage of subjects
Interval 0.63 to 5.14
|
0.10 Percentage of subjects
Interval 0.01 to 0.37
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-41
|
3.08 Percentage of subjects
Interval 2.37 to 3.93
|
1.79 Percentage of subjects
Interval 0.53 to 4.37
|
0.09 Percentage of subjects
Interval 0.01 to 0.31
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-42
|
2.99 Percentage of subjects
Interval 2.26 to 3.87
|
1.39 Percentage of subjects
Interval 0.39 to 3.47
|
0.08 Percentage of subjects
Interval 0.01 to 0.29
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-43
|
2.96 Percentage of subjects
Interval 2.23 to 3.86
|
1.28 Percentage of subjects
Interval 0.3 to 3.51
|
0.08 Percentage of subjects
Interval 0.01 to 0.27
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-44
|
2.92 Percentage of subjects
Interval 2.18 to 3.82
|
1.32 Percentage of subjects
Interval 0.29 to 3.68
|
0.06 Percentage of subjects
Interval 0.01 to 0.23
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-45
|
2.88 Percentage of subjects
Interval 2.15 to 3.78
|
1.32 Percentage of subjects
Interval 0.33 to 3.49
|
0.06 Percentage of subjects
Interval 0.01 to 0.22
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-46
|
2.85 Percentage of subjects
Interval 2.12 to 3.74
|
1.12 Percentage of subjects
Interval 0.2 to 3.43
|
0.06 Percentage of subjects
Interval 0.01 to 0.22
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-47
|
2.81 Percentage of subjects
Interval 2.08 to 3.7
|
1.06 Percentage of subjects
Interval 0.19 to 3.26
|
0.06 Percentage of subjects
Interval 0.01 to 0.2
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-48
|
2.78 Percentage of subjects
Interval 2.06 to 3.68
|
1.03 Percentage of subjects
Interval 0.19 to 3.15
|
0.06 Percentage of subjects
Interval 0.01 to 0.2
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-36
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-37
|
4.51 Percentage of subjects
Interval 1.67 to 9.56
|
—
|
3.03 Percentage of subjects
Interval 0.01 to 20.77
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-38
|
3.69 Percentage of subjects
Interval 1.86 to 6.51
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
1.32 Percentage of subjects
Interval 0.01 to 9.66
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-39
|
4.55 Percentage of subjects
Interval 2.51 to 7.51
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
0.88 Percentage of subjects
Interval 0.01 to 6.17
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-40
|
4.55 Percentage of subjects
Interval 2.93 to 6.7
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
0.56 Percentage of subjects
Interval 0.0 to 4.02
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-41
|
4.09 Percentage of subjects
Interval 2.49 to 6.31
|
0.00 Percentage of subjects
Interval 0.0 to 4.4
|
0.41 Percentage of subjects
Interval 0.0 to 2.67
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-42
|
3.85 Percentage of subjects
Interval 2.32 to 5.97
|
0.00 Percentage of subjects
Interval 0.0 to 2.64
|
0.37 Percentage of subjects
Interval 0.0 to 2.46
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-43
|
3.67 Percentage of subjects
Interval 2.21 to 5.7
|
0.52 Percentage of subjects
Interval 0.01 to 2.85
|
0.33 Percentage of subjects
Interval 0.0 to 2.19
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-44
|
3.46 Percentage of subjects
Interval 2.05 to 5.43
|
1.21 Percentage of subjects
Interval 0.25 to 3.51
|
0.29 Percentage of subjects
Interval 0.0 to 1.77
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-45
|
3.33 Percentage of subjects
Interval 2.06 to 5.08
|
1.44 Percentage of subjects
Interval 0.47 to 3.33
|
1.03 Percentage of subjects
Interval 0.14 to 3.49
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-46
|
3.28 Percentage of subjects
Interval 2.05 to 4.95
|
1.32 Percentage of subjects
Interval 0.43 to 3.06
|
1.00 Percentage of subjects
Interval 0.13 to 3.44
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-47
|
3.24 Percentage of subjects
Interval 2.09 to 4.79
|
1.26 Percentage of subjects
Interval 0.4 to 2.97
|
0.96 Percentage of subjects
Interval 0.12 to 3.36
|
|
Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-48
|
3.17 Percentage of subjects
Interval 2.04 to 4.69
|
1.22 Percentage of subjects
Interval 0.38 to 2.91
|
0.95 Percentage of subjects
Interval 0.12 to 3.35
|
SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in EHR (combining routine data collection and card-based ADR reporting system) during the safety follow-up period (from vaccination up to 7 days post-vaccination).
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16433 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=3310 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=4196 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
1.69 Percentage of subjects
Interval 0.0 to 16.08
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 37
|
6.34 Percentage of subjects
Interval 5.19 to 7.65
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.46 Percentage of subjects
Interval 0.01 to 2.71
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 38
|
4.86 Percentage of subjects
Interval 3.62 to 6.37
|
14.29 Percentage of subjects
Interval 0.0 to 90.97
|
0.60 Percentage of subjects
Interval 0.03 to 2.75
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 39
|
4.71 Percentage of subjects
Interval 3.97 to 5.55
|
1.03 Percentage of subjects
Interval 0.03 to 5.61
|
1.34 Percentage of subjects
Interval 0.35 to 3.48
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 40
|
5.47 Percentage of subjects
Interval 3.22 to 8.62
|
4.15 Percentage of subjects
Interval 2.16 to 7.15
|
1.15 Percentage of subjects
Interval 0.41 to 2.55
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 41
|
4.79 Percentage of subjects
Interval 3.67 to 6.14
|
3.97 Percentage of subjects
Interval 2.07 to 6.84
|
0.00 Percentage of subjects
Interval 0.0 to 1.1
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 42
|
2.79 Percentage of subjects
Interval 1.54 to 4.63
|
0.84 Percentage of subjects
Interval 0.17 to 2.44
|
1.89 Percentage of subjects
Interval 0.23 to 6.66
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 43
|
3.13 Percentage of subjects
Interval 1.02 to 7.19
|
2.75 Percentage of subjects
Interval 0.81 to 6.65
|
0.00 Percentage of subjects
Interval 0.0 to 2.76
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 44
|
3.23 Percentage of subjects
Interval 1.03 to 7.47
|
3.12 Percentage of subjects
Interval 1.08 to 6.91
|
0.19 Percentage of subjects
Interval 0.0 to 1.08
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 45
|
1.57 Percentage of subjects
Interval 0.3 to 4.67
|
1.32 Percentage of subjects
Interval 0.01 to 8.97
|
1.74 Percentage of subjects
Interval 0.21 to 6.14
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 46
|
1.86 Percentage of subjects
Interval 0.41 to 5.21
|
0.21 Percentage of subjects
Interval 0.0 to 2.0
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 47
|
2.36 Percentage of subjects
Interval 0.33 to 7.88
|
1.46 Percentage of subjects
Interval 0.18 to 5.17
|
1.14 Percentage of subjects
Interval 0.06 to 5.29
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
1.19 Percentage of subjects
Interval 0.01 to 7.8
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 36
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 37
|
8.27 Percentage of subjects
Interval 4.2 to 14.32
|
—
|
3.23 Percentage of subjects
Interval 0.02 to 21.72
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 38
|
4.85 Percentage of subjects
Interval 2.12 to 9.33
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 39
|
7.94 Percentage of subjects
Interval 4.2 to 13.4
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 40
|
3.43 Percentage of subjects
Interval 1.27 to 7.31
|
3.45 Percentage of subjects
Interval 0.09 to 17.76
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 41
|
3.66 Percentage of subjects
Interval 1.33 to 7.88
|
2.44 Percentage of subjects
Interval 0.06 to 12.86
|
1.56 Percentage of subjects
Interval 0.01 to 10.47
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 4.11
|
0.00 Percentage of subjects
Interval 0.0 to 6.38
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
3.64 Percentage of subjects
Interval 0.44 to 12.53
|
0.00 Percentage of subjects
Interval 0.0 to 10.89
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 44
|
1.45 Percentage of subjects
Interval 0.01 to 10.55
|
7.41 Percentage of subjects
Interval 2.06 to 17.89
|
2.17 Percentage of subjects
Interval 0.06 to 11.53
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 45
|
5.41 Percentage of subjects
Interval 5.41 to 14.52
|
1.00 Percentage of subjects
Interval 0.03 to 5.45
|
2.55 Percentage of subjects
Interval 0.94 to 5.47
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 46
|
6.17 Percentage of subjects
Interval 1.5 to 15.96
|
2.78 Percentage of subjects
Interval 0.15 to 12.35
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 47
|
4.35 Percentage of subjects
Interval 0.33 to 17.06
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
4.17 Percentage of subjects
Interval 0.02 to 27.48
|
|
Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
6.25 Percentage of subjects
Interval 0.0 to 64.4
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start up to end of the week of interest and were registered in EHR (routine data collection \& card-based ADR reporting) during FU period (from vaccination up to 7 days post-vaccination)
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16433 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=3310 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=4196 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-47
|
4.71 Percentage of subjects
Interval 3.8 to 5.77
|
2.16 Percentage of subjects
Interval 0.98 to 4.1
|
0.77 Percentage of subjects
Interval 0.32 to 1.55
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-48
|
4.68 Percentage of subjects
Interval 3.76 to 5.74
|
2.13 Percentage of subjects
Interval 0.96 to 4.06
|
0.76 Percentage of subjects
Interval 0.31 to 1.53
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-36
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-37
|
8.27 Percentage of subjects
Interval 4.2 to 14.32
|
—
|
3.03 Percentage of subjects
Interval 0.01 to 20.77
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-38
|
6.38 Percentage of subjects
Interval 3.88 to 9.78
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
1.32 Percentage of subjects
Interval 0.01 to 8.76
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-39
|
7.21 Percentage of subjects
Interval 5.08 to 9.87
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
0.88 Percentage of subjects
Interval 0.01 to 5.83
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-40
|
6.40 Percentage of subjects
Interval 4.46 to 8.83
|
2.44 Percentage of subjects
Interval 0.06 to 12.86
|
0.56 Percentage of subjects
Interval 0.0 to 3.88
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-41
|
5.94 Percentage of subjects
Interval 4.35 to 7.88
|
2.44 Percentage of subjects
Interval 0.3 to 8.53
|
0.83 Percentage of subjects
Interval 0.08 to 3.19
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-42
|
5.45 Percentage of subjects
Interval 3.94 to 7.31
|
1.45 Percentage of subjects
Interval 0.18 to 5.14
|
0.74 Percentage of subjects
Interval 0.08 to 2.76
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-43
|
5.19 Percentage of subjects
Interval 3.75 to 6.98
|
2.07 Percentage of subjects
Interval 0.57 to 5.22
|
0.66 Percentage of subjects
Interval 0.07 to 2.52
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-44
|
4.97 Percentage of subjects
Interval 3.59 to 6.7
|
3.24 Percentage of subjects
Interval 1.41 to 6.28
|
0.86 Percentage of subjects
Interval 0.18 to 2.5
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-45
|
5.00 Percentage of subjects
Interval 3.77 to 6.49
|
2.59 Percentage of subjects
Interval 1.19 to 4.87
|
1.54 Percentage of subjects
Interval 0.57 to 3.34
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-46
|
5.07 Percentage of subjects
Interval 3.96 to 6.38
|
2.64 Percentage of subjects
Interval 1.37 to 4.56
|
1.50 Percentage of subjects
Interval 0.53 to 3.3
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-47
|
5.05 Percentage of subjects
Interval 3.96 to 6.33
|
2.52 Percentage of subjects
Interval 1.31 to 4.36
|
1.60 Percentage of subjects
Interval 0.64 to 3.28
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-48
|
4.94 Percentage of subjects
Interval 3.87 to 6.2
|
2.64 Percentage of subjects
Interval 1.31 to 4.72
|
1.58 Percentage of subjects
Interval 0.63 to 3.25
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
1.67 Percentage of subjects
Interval 0.0 to 14.74
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-37
|
6.34 Percentage of subjects
Interval 5.19 to 7.65
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.60 Percentage of subjects
Interval 0.08 to 2.12
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-38
|
5.56 Percentage of subjects
Interval 4.76 to 6.45
|
7.69 Percentage of subjects
Interval 0.08 to 41.17
|
0.60 Percentage of subjects
Interval 0.13 to 1.73
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-39
|
5.19 Percentage of subjects
Interval 4.45 to 6.02
|
1.82 Percentage of subjects
Interval 0.22 to 6.41
|
0.83 Percentage of subjects
Interval 0.21 to 2.21
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-40
|
5.24 Percentage of subjects
Interval 4.33 to 6.29
|
3.55 Percentage of subjects
Interval 1.86 to 6.08
|
0.92 Percentage of subjects
Interval 0.25 to 2.34
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-41
|
5.19 Percentage of subjects
Interval 4.3 to 6.19
|
3.72 Percentage of subjects
Interval 2.42 to 5.45
|
0.78 Percentage of subjects
Interval 0.2 to 2.05
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-42
|
5.03 Percentage of subjects
Interval 4.13 to 6.06
|
2.78 Percentage of subjects
Interval 1.75 to 4.16
|
0.88 Percentage of subjects
Interval 0.26 to 2.15
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-43
|
4.97 Percentage of subjects
Interval 4.06 to 6.01
|
2.77 Percentage of subjects
Interval 1.75 to 4.16
|
0.83 Percentage of subjects
Interval 0.25 to 2.02
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-44
|
4.89 Percentage of subjects
Interval 3.98 to 5.92
|
2.85 Percentage of subjects
Interval 1.74 to 4.38
|
0.73 Percentage of subjects
Interval 0.24 to 1.67
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-45
|
4.80 Percentage of subjects
Interval 3.9 to 5.83
|
2.63 Percentage of subjects
Interval 1.37 to 4.54
|
0.76 Percentage of subjects
Interval 0.29 to 1.61
|
|
Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-46
|
4.75 Percentage of subjects
Interval 3.83 to 5.81
|
2.19 Percentage of subjects
Interval 0.96 to 4.25
|
0.75 Percentage of subjects
Interval 0.29 to 1.57
|
SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in EHR (combining routine data collection and card-based ADR reporting system) during the safety follow-up period (from vaccination up to 7 days post-vaccination).
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhea, nausea, and vomiting. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16433 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=3310 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=4196 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 6.06
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 37
|
2.10 Percentage of subjects
Interval 1.36 to 3.09
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 0.84
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 38
|
1.74 Percentage of subjects
Interval 0.95 to 2.9
|
14.29 Percentage of subjects
Interval 0.0 to 90.97
|
0.00 Percentage of subjects
Interval 0.0 to 0.74
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 39
|
1.46 Percentage of subjects
Interval 0.97 to 2.1
|
0.00 Percentage of subjects
Interval 0.0 to 3.73
|
0.00 Percentage of subjects
Interval 0.0 to 0.82
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 40
|
1.54 Percentage of subjects
Interval 0.97 to 2.32
|
1.28 Percentage of subjects
Interval 0.35 to 3.24
|
0.00 Percentage of subjects
Interval 0.0 to 0.7
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 41
|
1.26 Percentage of subjects
Interval 0.62 to 2.28
|
0.66 Percentage of subjects
Interval 0.08 to 2.37
|
0.00 Percentage of subjects
Interval 0.0 to 1.1
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 42
|
1.09 Percentage of subjects
Interval 0.5 to 2.06
|
0.00 Percentage of subjects
Interval 0.0 to 1.03
|
0.00 Percentage of subjects
Interval 0.0 to 1.72
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 43
|
0.89 Percentage of subjects
Interval 0.24 to 2.28
|
0.00 Percentage of subjects
Interval 0.0 to 1.12
|
0.76 Percentage of subjects
Interval 0.0 to 5.65
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 44
|
0.73 Percentage of subjects
Interval 0.24 to 1.71
|
0.24 Percentage of subjects
Interval 0.0 to 1.48
|
0.00 Percentage of subjects
Interval 0.0 to 0.71
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 45
|
2.10 Percentage of subjects
Interval 0.56 to 5.34
|
0.66 Percentage of subjects
Interval 0.0 to 4.55
|
0.87 Percentage of subjects
Interval 0.02 to 4.75
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 46
|
1.86 Percentage of subjects
Interval 0.2 to 6.79
|
0.21 Percentage of subjects
Interval 0.0 to 1.71
|
1.28 Percentage of subjects
Interval 0.01 to 8.31
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 1.72
|
0.00 Percentage of subjects
Interval 0.0 to 2.66
|
0.00 Percentage of subjects
Interval 0.0 to 2.09
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.00 Percentage of subjects
Interval 0.0 to 4.3
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 36
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 37
|
2.26 Percentage of subjects
Interval 0.23 to 8.42
|
—
|
3.23 Percentage of subjects
Interval 0.02 to 21.72
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 38
|
3.03 Percentage of subjects
Interval 0.99 to 6.93
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 39
|
2.06 Percentage of subjects
Interval 0.68 to 4.71
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 40
|
0.57 Percentage of subjects
Interval 0.01 to 3.31
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 41
|
1.22 Percentage of subjects
Interval 0.03 to 6.81
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
0.00 Percentage of subjects
Interval 0.0 to 5.6
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 42
|
1.14 Percentage of subjects
Interval 0.01 to 7.91
|
0.00 Percentage of subjects
Interval 0.0 to 6.38
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 6.49
|
0.00 Percentage of subjects
Interval 0.0 to 10.89
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 5.21
|
1.85 Percentage of subjects
Interval 0.05 to 9.89
|
0.00 Percentage of subjects
Interval 0.0 to 7.71
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 45
|
1.35 Percentage of subjects
Interval 0.03 to 7.3
|
2.00 Percentage of subjects
Interval 0.1 to 9.21
|
0.85 Percentage of subjects
Interval 0.1 to 3.04
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 4.45
|
0.00 Percentage of subjects
Interval 0.0 to 3.36
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 7.71
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
|
Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start up to end of the week of interest and were registered in EHR (routine data collection \& card-based ADR reporting) during FU period (from vaccination up to 7 days post-vaccination)
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhea, nausea, and vomiting. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16433 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=3310 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=4196 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.96
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-37
|
2.10 Percentage of subjects
Interval 1.36 to 3.09
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 0.74
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-38
|
1.91 Percentage of subjects
Interval 1.42 to 2.5
|
7.69 Percentage of subjects
Interval 0.08 to 41.17
|
0.00 Percentage of subjects
Interval 0.0 to 0.37
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-39
|
1.71 Percentage of subjects
Interval 1.24 to 2.31
|
0.91 Percentage of subjects
Interval 0.02 to 4.96
|
0.00 Percentage of subjects
Interval 0.0 to 0.25
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-40
|
1.68 Percentage of subjects
Interval 1.29 to 2.16
|
1.18 Percentage of subjects
Interval 0.38 to 2.74
|
0.00 Percentage of subjects
Interval 0.0 to 0.19
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-41
|
1.63 Percentage of subjects
Interval 1.24 to 2.11
|
0.97 Percentage of subjects
Interval 0.35 to 2.1
|
0.00 Percentage of subjects
Interval 0.0 to 0.16
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-42
|
1.60 Percentage of subjects
Interval 1.22 to 2.05
|
0.65 Percentage of subjects
Interval 0.23 to 1.42
|
0.00 Percentage of subjects
Interval 0.0 to 0.15
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-43
|
1.57 Percentage of subjects
Interval 1.2 to 2.02
|
0.50 Percentage of subjects
Interval 0.16 to 1.17
|
0.04 Percentage of subjects
Interval 0.0 to 0.3
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-44
|
1.53 Percentage of subjects
Interval 1.18 to 1.96
|
0.44 Percentage of subjects
Interval 0.1 to 1.23
|
0.03 Percentage of subjects
Interval 0.0 to 0.2
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-45
|
1.55 Percentage of subjects
Interval 1.22 to 1.94
|
0.47 Percentage of subjects
Interval 0.16 to 1.05
|
0.06 Percentage of subjects
Interval 0.0 to 0.39
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-46
|
1.55 Percentage of subjects
Interval 1.23 to 1.94
|
0.42 Percentage of subjects
Interval 0.15 to 0.93
|
0.09 Percentage of subjects
Interval 0.01 to 0.37
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-47
|
1.53 Percentage of subjects
Interval 1.2 to 1.92
|
0.40 Percentage of subjects
Interval 0.15 to 0.88
|
0.09 Percentage of subjects
Interval 0.01 to 0.36
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-48
|
1.52 Percentage of subjects
Interval 1.19 to 1.9
|
0.39 Percentage of subjects
Interval 0.14 to 0.85
|
0.08 Percentage of subjects
Interval 0.01 to 0.35
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-36
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-37
|
2.26 Percentage of subjects
Interval 0.23 to 8.42
|
—
|
3.03 Percentage of subjects
Interval 0.01 to 20.77
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-38
|
2.68 Percentage of subjects
Interval 0.87 to 6.18
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
1.32 Percentage of subjects
Interval 0.01 to 9.66
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-39
|
2.35 Percentage of subjects
Interval 0.93 to 4.85
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
0.88 Percentage of subjects
Interval 0.01 to 6.17
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-40
|
1.97 Percentage of subjects
Interval 0.76 to 4.12
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
0.56 Percentage of subjects
Interval 0.0 to 4.02
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-41
|
1.84 Percentage of subjects
Interval 0.79 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 4.4
|
0.41 Percentage of subjects
Interval 0.0 to 2.67
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-42
|
1.78 Percentage of subjects
Interval 0.81 to 3.37
|
0.00 Percentage of subjects
Interval 0.0 to 2.64
|
0.37 Percentage of subjects
Interval 0.0 to 2.46
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-43
|
1.70 Percentage of subjects
Interval 0.77 to 3.23
|
0.00 Percentage of subjects
Interval 0.0 to 1.89
|
0.33 Percentage of subjects
Interval 0.0 to 2.19
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-44
|
1.60 Percentage of subjects
Interval 0.69 to 3.14
|
0.40 Percentage of subjects
Interval 0.01 to 2.23
|
0.29 Percentage of subjects
Interval 0.0 to 1.77
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-45
|
1.59 Percentage of subjects
Interval 0.73 to 2.99
|
0.86 Percentage of subjects
Interval 0.18 to 2.51
|
0.51 Percentage of subjects
Interval 0.07 to 1.75
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-46
|
1.49 Percentage of subjects
Interval 0.67 to 2.84
|
0.66 Percentage of subjects
Interval 0.14 to 1.91
|
0.50 Percentage of subjects
Interval 0.07 to 1.73
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-47
|
1.44 Percentage of subjects
Interval 0.66 to 2.74
|
0.63 Percentage of subjects
Interval 0.13 to 1.83
|
0.48 Percentage of subjects
Interval 0.06 to 1.69
|
|
Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-48
|
1.41 Percentage of subjects
Interval 0.64 to 2.67
|
0.61 Percentage of subjects
Interval 0.13 to 1.77
|
0.47 Percentage of subjects
Interval 0.06 to 1.68
|
SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in EHR (combining routine data collection and card-based ADR reporting system) during the safety follow-up period (from vaccination up to 7 days post-vaccination).
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16433 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=3310 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=4196 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 6.06
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 37
|
0.69 Percentage of subjects
Interval 0.01 to 4.05
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 0.84
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 38
|
0.54 Percentage of subjects
Interval 0.05 to 2.13
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.20 Percentage of subjects
Interval 0.0 to 1.15
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 39
|
0.34 Percentage of subjects
Interval 0.03 to 1.39
|
0.00 Percentage of subjects
Interval 0.0 to 3.73
|
0.00 Percentage of subjects
Interval 0.0 to 0.82
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 40
|
0.48 Percentage of subjects
Interval 0.06 to 1.75
|
0.64 Percentage of subjects
Interval 0.01 to 4.17
|
0.00 Percentage of subjects
Interval 0.0 to 0.7
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 41
|
0.20 Percentage of subjects
Interval 0.04 to 0.6
|
0.99 Percentage of subjects
Interval 0.14 to 3.38
|
0.00 Percentage of subjects
Interval 0.0 to 1.1
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 0.45
|
0.28 Percentage of subjects
Interval 0.0 to 2.18
|
0.00 Percentage of subjects
Interval 0.0 to 1.72
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 43
|
0.22 Percentage of subjects
Interval 0.0 to 1.51
|
0.00 Percentage of subjects
Interval 0.0 to 1.12
|
0.00 Percentage of subjects
Interval 0.0 to 2.76
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 44
|
0.29 Percentage of subjects
Interval 0.02 to 1.34
|
0.24 Percentage of subjects
Interval 0.0 to 1.48
|
0.00 Percentage of subjects
Interval 0.0 to 0.71
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 45
|
0.26 Percentage of subjects
Interval 0.0 to 1.87
|
0.00 Percentage of subjects
Interval 0.0 to 1.21
|
0.00 Percentage of subjects
Interval 0.0 to 3.16
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 46
|
0.37 Percentage of subjects
Interval 0.0 to 2.68
|
0.00 Percentage of subjects
Interval 0.0 to 0.78
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 1.72
|
0.00 Percentage of subjects
Interval 0.0 to 2.66
|
0.00 Percentage of subjects
Interval 0.0 to 2.09
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.00 Percentage of subjects
Interval 0.0 to 4.3
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 36
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 37
|
0.75 Percentage of subjects
Interval 0.01 to 5.16
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 38
|
1.21 Percentage of subjects
Interval 0.15 to 4.31
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 39
|
1.18 Percentage of subjects
Interval 0.17 to 3.93
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 2.09
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 41
|
0.61 Percentage of subjects
Interval 0.01 to 3.69
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
0.00 Percentage of subjects
Interval 0.0 to 5.6
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 4.11
|
0.00 Percentage of subjects
Interval 0.0 to 6.38
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 6.49
|
0.00 Percentage of subjects
Interval 0.0 to 10.89
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 5.21
|
3.70 Percentage of subjects
Interval 0.16 to 16.98
|
0.00 Percentage of subjects
Interval 0.0 to 7.71
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.43 Percentage of subjects
Interval 0.01 to 2.35
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 4.45
|
0.00 Percentage of subjects
Interval 0.0 to 3.36
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 7.71
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
|
Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start up to end of the week of interest and were registered in EHR (routine data collection \& card-based ADR reporting) during FU period (from vaccination up to 7 days post-vaccination)
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16433 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=3310 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=4196 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.96
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-37
|
0.69 Percentage of subjects
Interval 0.01 to 4.05
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 0.74
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-38
|
0.61 Percentage of subjects
Interval 0.03 to 2.87
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.10 Percentage of subjects
Interval 0.0 to 0.57
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-39
|
0.49 Percentage of subjects
Interval 0.03 to 2.21
|
0.00 Percentage of subjects
Interval 0.0 to 3.3
|
0.07 Percentage of subjects
Interval 0.0 to 0.4
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-40
|
0.49 Percentage of subjects
Interval 0.03 to 2.11
|
0.47 Percentage of subjects
Interval 0.01 to 2.52
|
0.05 Percentage of subjects
Interval 0.0 to 0.31
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-41
|
0.46 Percentage of subjects
Interval 0.04 to 1.88
|
0.69 Percentage of subjects
Interval 0.05 to 2.89
|
0.04 Percentage of subjects
Interval 0.0 to 0.26
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-42
|
0.43 Percentage of subjects
Interval 0.03 to 1.79
|
0.56 Percentage of subjects
Interval 0.11 to 1.63
|
0.04 Percentage of subjects
Interval 0.0 to 0.24
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-43
|
0.42 Percentage of subjects
Interval 0.03 to 1.73
|
0.43 Percentage of subjects
Interval 0.09 to 1.23
|
0.04 Percentage of subjects
Interval 0.0 to 0.23
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-44
|
0.41 Percentage of subjects
Interval 0.04 to 1.64
|
0.38 Percentage of subjects
Interval 0.06 to 1.26
|
0.03 Percentage of subjects
Interval 0.0 to 0.2
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-45
|
0.41 Percentage of subjects
Interval 0.04 to 1.59
|
0.33 Percentage of subjects
Interval 0.04 to 1.17
|
0.03 Percentage of subjects
Interval 0.0 to 0.19
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-46
|
0.41 Percentage of subjects
Interval 0.04 to 1.61
|
0.27 Percentage of subjects
Interval 0.02 to 1.07
|
0.03 Percentage of subjects
Interval 0.0 to 0.19
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-47
|
0.40 Percentage of subjects
Interval 0.04 to 1.59
|
0.26 Percentage of subjects
Interval 0.02 to 1.02
|
0.03 Percentage of subjects
Interval 0.0 to 0.18
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-48
|
0.40 Percentage of subjects
Interval 0.04 to 1.57
|
0.25 Percentage of subjects
Interval 0.02 to 0.99
|
0.03 Percentage of subjects
Interval 0.0 to 0.18
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-36
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-37
|
0.75 Percentage of subjects
Interval 0.01 to 5.16
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 10.58
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-38
|
1.01 Percentage of subjects
Interval 0.18 to 3.13
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 4.74
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-39
|
1.10 Percentage of subjects
Interval 0.21 to 3.29
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-40
|
0.86 Percentage of subjects
Interval 0.12 to 2.89
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
0.00 Percentage of subjects
Interval 0.0 to 2.06
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-41
|
0.82 Percentage of subjects
Interval 0.15 to 2.52
|
0.00 Percentage of subjects
Interval 0.0 to 4.4
|
0.00 Percentage of subjects
Interval 0.0 to 1.52
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-42
|
0.75 Percentage of subjects
Interval 0.12 to 2.39
|
0.00 Percentage of subjects
Interval 0.0 to 2.64
|
0.00 Percentage of subjects
Interval 0.0 to 1.36
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-43
|
0.72 Percentage of subjects
Interval 0.11 to 2.31
|
0.00 Percentage of subjects
Interval 0.0 to 1.89
|
0.00 Percentage of subjects
Interval 0.0 to 1.21
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-44
|
0.67 Percentage of subjects
Interval 0.1 to 2.22
|
0.81 Percentage of subjects
Interval 0.1 to 2.89
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-45
|
0.63 Percentage of subjects
Interval 0.09 to 2.11
|
0.58 Percentage of subjects
Interval 0.07 to 2.07
|
0.17 Percentage of subjects
Interval 0.0 to 0.95
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-46
|
0.60 Percentage of subjects
Interval 0.09 to 2.01
|
0.44 Percentage of subjects
Interval 0.05 to 1.58
|
0.17 Percentage of subjects
Interval 0.0 to 0.92
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-47
|
0.58 Percentage of subjects
Interval 0.08 to 1.93
|
0.42 Percentage of subjects
Interval 0.05 to 1.51
|
0.16 Percentage of subjects
Interval 0.0 to 0.89
|
|
Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-48
|
0.56 Percentage of subjects
Interval 0.08 to 1.89
|
0.41 Percentage of subjects
Interval 0.05 to 1.46
|
0.16 Percentage of subjects
Interval 0.0 to 0.88
|
SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in EHR (combining routine data collection and card-based ADR reporting system) during the safety follow-up period (from vaccination up to 7 days post-vaccination).
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16433 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=3310 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=4196 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 41
|
0.13 Percentage of subjects
Interval 0.02 to 0.48
|
0.66 Percentage of subjects
Interval 0.08 to 2.37
|
0.00 Percentage of subjects
Interval 0.0 to 1.1
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 6.06
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 37
|
0.69 Percentage of subjects
Interval 0.39 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 0.84
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 38
|
0.39 Percentage of subjects
Interval 0.19 to 0.71
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.40 Percentage of subjects
Interval 0.04 to 1.53
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 39
|
0.32 Percentage of subjects
Interval 0.16 to 0.55
|
0.00 Percentage of subjects
Interval 0.0 to 3.73
|
0.00 Percentage of subjects
Interval 0.0 to 0.82
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 40
|
0.58 Percentage of subjects
Interval 0.29 to 1.04
|
0.32 Percentage of subjects
Interval 0.01 to 1.77
|
0.19 Percentage of subjects
Interval 0.0 to 1.06
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 42
|
0.12 Percentage of subjects
Interval 0.0 to 0.89
|
0.00 Percentage of subjects
Interval 0.0 to 1.03
|
0.00 Percentage of subjects
Interval 0.0 to 1.72
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 46
|
0.37 Percentage of subjects
Interval 0.0 to 2.54
|
0.21 Percentage of subjects
Interval 0.0 to 1.9
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 1.72
|
0.00 Percentage of subjects
Interval 0.0 to 2.66
|
0.00 Percentage of subjects
Interval 0.0 to 2.09
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
1.19 Percentage of subjects
Interval 0.01 to 7.8
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 36
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 37
|
2.26 Percentage of subjects
Interval 0.47 to 6.45
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 38
|
3.03 Percentage of subjects
Interval 0.44 to 9.92
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 39
|
0.88 Percentage of subjects
Interval 0.13 to 2.92
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 40
|
0.57 Percentage of subjects
Interval 0.0 to 3.97
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 2.22
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
0.00 Percentage of subjects
Interval 0.0 to 5.6
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 4.11
|
0.00 Percentage of subjects
Interval 0.0 to 6.38
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 6.49
|
0.00 Percentage of subjects
Interval 0.0 to 10.89
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 5.21
|
0.00 Percentage of subjects
Interval 0.0 to 6.6
|
0.00 Percentage of subjects
Interval 0.0 to 7.71
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 1.56
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 46
|
1.23 Percentage of subjects
Interval 0.01 to 8.69
|
0.00 Percentage of subjects
Interval 0.0 to 3.36
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 7.71
|
4.76 Percentage of subjects
Interval 0.12 to 23.82
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 43
|
0.67 Percentage of subjects
Interval 0.12 to 2.07
|
0.61 Percentage of subjects
Interval 0.07 to 2.19
|
0.00 Percentage of subjects
Interval 0.0 to 2.76
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 44
|
0.59 Percentage of subjects
Interval 0.12 to 1.7
|
0.24 Percentage of subjects
Interval 0.0 to 1.45
|
0.00 Percentage of subjects
Interval 0.0 to 0.71
|
|
Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 45
|
0.26 Percentage of subjects
Interval 0.0 to 1.82
|
0.00 Percentage of subjects
Interval 0.0 to 1.21
|
0.00 Percentage of subjects
Interval 0.0 to 3.16
|
SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start up to end of the week of interest and were registered in EHR (routine data collection \& card-based ADR reporting) during FU period (from vaccination up to 7 days post-vaccination)
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16433 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=3310 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=4196 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.96
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-37
|
0.69 Percentage of subjects
Interval 0.39 to 1.11
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 0.74
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-38
|
0.53 Percentage of subjects
Interval 0.35 to 0.77
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.20 Percentage of subjects
Interval 0.02 to 0.74
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-39
|
0.44 Percentage of subjects
Interval 0.31 to 0.6
|
0.00 Percentage of subjects
Interval 0.0 to 3.3
|
0.14 Percentage of subjects
Interval 0.01 to 0.53
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-40
|
0.46 Percentage of subjects
Interval 0.34 to 0.61
|
0.24 Percentage of subjects
Interval 0.01 to 1.31
|
0.15 Percentage of subjects
Interval 0.03 to 0.45
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-41
|
0.42 Percentage of subjects
Interval 0.31 to 0.55
|
0.41 Percentage of subjects
Interval 0.09 to 1.2
|
0.13 Percentage of subjects
Interval 0.03 to 0.38
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-42
|
0.40 Percentage of subjects
Interval 0.3 to 0.53
|
0.28 Percentage of subjects
Interval 0.06 to 0.81
|
0.12 Percentage of subjects
Interval 0.02 to 0.35
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-43
|
0.41 Percentage of subjects
Interval 0.31 to 0.54
|
0.36 Percentage of subjects
Interval 0.12 to 0.83
|
0.11 Percentage of subjects
Interval 0.02 to 0.33
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-44
|
0.42 Percentage of subjects
Interval 0.32 to 0.54
|
0.33 Percentage of subjects
Interval 0.12 to 0.71
|
0.09 Percentage of subjects
Interval 0.02 to 0.29
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-45
|
0.42 Percentage of subjects
Interval 0.32 to 0.54
|
0.28 Percentage of subjects
Interval 0.1 to 0.61
|
0.09 Percentage of subjects
Interval 0.02 to 0.28
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-46
|
0.42 Percentage of subjects
Interval 0.32 to 0.54
|
0.27 Percentage of subjects
Interval 0.11 to 0.55
|
0.09 Percentage of subjects
Interval 0.02 to 0.27
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-47
|
0.41 Percentage of subjects
Interval 0.31 to 0.53
|
0.26 Percentage of subjects
Interval 0.1 to 0.53
|
0.09 Percentage of subjects
Interval 0.02 to 0.26
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-48
|
0.41 Percentage of subjects
Interval 0.31 to 0.53
|
0.28 Percentage of subjects
Interval 0.12 to 0.56
|
0.08 Percentage of subjects
Interval 0.02 to 0.26
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-36
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-37
|
2.26 Percentage of subjects
Interval 0.47 to 6.45
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 10.58
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-38
|
2.68 Percentage of subjects
Interval 0.73 to 6.77
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 4.74
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-39
|
1.72 Percentage of subjects
Interval 0.47 to 4.35
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-40
|
1.48 Percentage of subjects
Interval 0.48 to 3.42
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
0.00 Percentage of subjects
Interval 0.0 to 2.06
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-41
|
1.23 Percentage of subjects
Interval 0.41 to 2.79
|
0.00 Percentage of subjects
Interval 0.0 to 4.4
|
0.00 Percentage of subjects
Interval 0.0 to 1.52
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-42
|
1.13 Percentage of subjects
Interval 0.39 to 2.52
|
0.00 Percentage of subjects
Interval 0.0 to 2.64
|
0.00 Percentage of subjects
Interval 0.0 to 1.36
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-43
|
1.07 Percentage of subjects
Interval 0.38 to 2.39
|
0.00 Percentage of subjects
Interval 0.0 to 1.89
|
0.00 Percentage of subjects
Interval 0.0 to 1.21
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-44
|
1.01 Percentage of subjects
Interval 0.35 to 2.27
|
0.00 Percentage of subjects
Interval 0.0 to 1.48
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-45
|
0.95 Percentage of subjects
Interval 0.33 to 2.13
|
0.00 Percentage of subjects
Interval 0.0 to 1.06
|
0.00 Percentage of subjects
Interval 0.0 to 0.63
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-46
|
0.97 Percentage of subjects
Interval 0.39 to 1.98
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.00 Percentage of subjects
Interval 0.0 to 0.61
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-47
|
0.94 Percentage of subjects
Interval 0.37 to 1.93
|
0.21 Percentage of subjects
Interval 0.01 to 1.16
|
0.00 Percentage of subjects
Interval 0.0 to 0.59
|
|
Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-48
|
0.92 Percentage of subjects
Interval 0.36 to 1.9
|
0.20 Percentage of subjects
Interval 0.01 to 1.13
|
0.00 Percentage of subjects
Interval 0.0 to 0.58
|
SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in EHR (combining routine data collection and card-based ADR reporting system) during the safety follow-up period (from vaccination up to 7 days post-vaccination).
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16433 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=3310 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=4196 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 6.06
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 37
|
4.11 Percentage of subjects
Interval 2.99 to 5.51
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.23 Percentage of subjects
Interval 0.0 to 1.36
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 38
|
3.36 Percentage of subjects
Interval 2.39 to 4.57
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.40 Percentage of subjects
Interval 0.05 to 1.44
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 39
|
3.20 Percentage of subjects
Interval 2.58 to 3.93
|
0.00 Percentage of subjects
Interval 0.0 to 3.73
|
0.89 Percentage of subjects
Interval 0.24 to 2.27
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 40
|
2.39 Percentage of subjects
Interval 1.62 to 3.4
|
1.28 Percentage of subjects
Interval 0.01 to 8.23
|
0.57 Percentage of subjects
Interval 0.07 to 2.08
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 41
|
2.53 Percentage of subjects
Interval 1.8 to 3.46
|
0.00 Percentage of subjects
Interval 0.0 to 1.21
|
0.00 Percentage of subjects
Interval 0.0 to 1.1
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 42
|
2.18 Percentage of subjects
Interval 0.95 to 4.26
|
0.56 Percentage of subjects
Interval 0.06 to 2.06
|
0.00 Percentage of subjects
Interval 0.0 to 1.72
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 43
|
3.13 Percentage of subjects
Interval 1.44 to 5.87
|
0.31 Percentage of subjects
Interval 0.0 to 1.95
|
0.76 Percentage of subjects
Interval 0.01 to 5.02
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 44
|
2.06 Percentage of subjects
Interval 0.73 to 4.52
|
0.96 Percentage of subjects
Interval 0.01 to 5.84
|
0.00 Percentage of subjects
Interval 0.0 to 0.71
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 45
|
2.36 Percentage of subjects
Interval 0.7 to 5.7
|
0.66 Percentage of subjects
Interval 0.05 to 2.81
|
0.00 Percentage of subjects
Interval 0.0 to 3.16
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 46
|
1.12 Percentage of subjects
Interval 0.23 to 3.22
|
0.00 Percentage of subjects
Interval 0.0 to 0.78
|
2.56 Percentage of subjects
Interval 0.31 to 8.96
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 47
|
1.89 Percentage of subjects
Interval 0.28 to 6.18
|
0.00 Percentage of subjects
Interval 0.0 to 2.66
|
0.00 Percentage of subjects
Interval 0.0 to 2.09
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
2.38 Percentage of subjects
Interval 0.29 to 8.34
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 36
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 37
|
6.77 Percentage of subjects
Interval 2.22 to 15.15
|
—
|
3.23 Percentage of subjects
Interval 0.08 to 16.7
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 38
|
3.64 Percentage of subjects
Interval 1.16 to 8.42
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 39
|
4.71 Percentage of subjects
Interval 2.21 to 8.64
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 40
|
5.14 Percentage of subjects
Interval 1.78 to 11.28
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 41
|
2.44 Percentage of subjects
Interval 0.64 to 6.27
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
0.00 Percentage of subjects
Interval 0.0 to 5.6
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 4.11
|
0.00 Percentage of subjects
Interval 0.0 to 6.38
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 43
|
3.85 Percentage of subjects
Interval 0.33 to 14.73
|
0.00 Percentage of subjects
Interval 0.0 to 6.49
|
3.13 Percentage of subjects
Interval 0.08 to 16.22
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 5.21
|
3.70 Percentage of subjects
Interval 0.16 to 16.98
|
0.00 Percentage of subjects
Interval 0.0 to 7.71
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 45
|
4.05 Percentage of subjects
Interval 0.52 to 13.69
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.43 Percentage of subjects
Interval 0.01 to 2.35
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 46
|
2.47 Percentage of subjects
Interval 0.07 to 12.65
|
0.93 Percentage of subjects
Interval 0.0 to 9.43
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 47
|
2.17 Percentage of subjects
Interval 0.06 to 11.53
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
|
Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start up to end of the week of interest and were registered in EHR (routine data collection \& card-based ADR reporting) during FU period (from vaccination up to 7 days post-vaccination)
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16433 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=3310 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=4196 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.96
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-37
|
4.11 Percentage of subjects
Interval 2.99 to 5.51
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.20 Percentage of subjects
Interval 0.0 to 1.12
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-38
|
3.71 Percentage of subjects
Interval 2.74 to 4.92
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.30 Percentage of subjects
Interval 0.06 to 0.88
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-39
|
3.49 Percentage of subjects
Interval 2.7 to 4.43
|
0.00 Percentage of subjects
Interval 0.0 to 3.3
|
0.48 Percentage of subjects
Interval 0.18 to 1.03
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-40
|
3.30 Percentage of subjects
Interval 2.62 to 4.1
|
0.95 Percentage of subjects
Interval 0.03 to 5.0
|
0.51 Percentage of subjects
Interval 0.17 to 1.16
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-41
|
3.20 Percentage of subjects
Interval 2.54 to 3.97
|
0.55 Percentage of subjects
Interval 0.04 to 2.31
|
0.43 Percentage of subjects
Interval 0.13 to 1.04
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-42
|
3.14 Percentage of subjects
Interval 2.46 to 3.93
|
0.56 Percentage of subjects
Interval 0.05 to 2.2
|
0.40 Percentage of subjects
Interval 0.12 to 0.96
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-43
|
3.14 Percentage of subjects
Interval 2.46 to 3.94
|
0.50 Percentage of subjects
Interval 0.1 to 1.49
|
0.42 Percentage of subjects
Interval 0.16 to 0.88
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-44
|
3.08 Percentage of subjects
Interval 2.4 to 3.89
|
0.60 Percentage of subjects
Interval 0.07 to 2.19
|
0.35 Percentage of subjects
Interval 0.11 to 0.84
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-45
|
3.07 Percentage of subjects
Interval 2.41 to 3.84
|
0.61 Percentage of subjects
Interval 0.08 to 2.13
|
0.34 Percentage of subjects
Interval 0.1 to 0.81
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-46
|
3.03 Percentage of subjects
Interval 2.38 to 3.8
|
0.50 Percentage of subjects
Interval 0.05 to 1.95
|
0.39 Percentage of subjects
Interval 0.14 to 0.85
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-47
|
3.01 Percentage of subjects
Interval 2.36 to 3.79
|
0.48 Percentage of subjects
Interval 0.04 to 1.86
|
0.37 Percentage of subjects
Interval 0.13 to 0.82
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-48
|
2.99 Percentage of subjects
Interval 2.34 to 3.77
|
0.53 Percentage of subjects
Interval 0.06 to 1.93
|
0.36 Percentage of subjects
Interval 0.13 to 0.81
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-36
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-37
|
6.77 Percentage of subjects
Interval 2.22 to 15.15
|
—
|
15.15 Percentage of subjects
Interval 0.08 to 15.76
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-38
|
5.03 Percentage of subjects
Interval 2.53 to 8.85
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
1.32 Percentage of subjects
Interval 0.03 to 7.11
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-39
|
4.86 Percentage of subjects
Interval 2.85 to 7.68
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
0.88 Percentage of subjects
Interval 0.01 to 5.49
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-40
|
4.92 Percentage of subjects
Interval 3.02 to 7.52
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
0.56 Percentage of subjects
Interval 0.0 to 3.91
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-41
|
4.50 Percentage of subjects
Interval 2.87 to 6.69
|
0.00 Percentage of subjects
Interval 0.0 to 4.4
|
0.41 Percentage of subjects
Interval 0.0 to 2.93
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-42
|
4.13 Percentage of subjects
Interval 2.69 to 6.03
|
0.00 Percentage of subjects
Interval 0.0 to 2.64
|
0.37 Percentage of subjects
Interval 0.0 to 2.63
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-43
|
4.12 Percentage of subjects
Interval 2.71 to 5.98
|
0.00 Percentage of subjects
Interval 0.0 to 1.89
|
0.66 Percentage of subjects
Interval 0.08 to 2.37
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-44
|
3.88 Percentage of subjects
Interval 2.57 to 5.6
|
0.81 Percentage of subjects
Interval 0.1 to 2.89
|
0.57 Percentage of subjects
Interval 0.06 to 2.16
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-45
|
3.89 Percentage of subjects
Interval 2.72 to 5.37
|
0.58 Percentage of subjects
Interval 0.07 to 2.07
|
0.51 Percentage of subjects
Interval 0.11 to 1.5
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-46
|
3.80 Percentage of subjects
Interval 2.78 to 5.07
|
0.66 Percentage of subjects
Interval 0.13 to 1.98
|
0.50 Percentage of subjects
Interval 0.1 to 1.45
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-47
|
3.75 Percentage of subjects
Interval 2.75 to 4.98
|
0.63 Percentage of subjects
Interval 0.12 to 1.92
|
0.48 Percentage of subjects
Interval 0.1 to 1.39
|
|
Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-48
|
3.67 Percentage of subjects
Interval 2.68 to 4.89
|
0.61 Percentage of subjects
Interval 0.11 to 1.88
|
0.47 Percentage of subjects
Interval 0.1 to 1.38
|
SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in EHR (combining routine data collection and card-based ADR reporting system) during the safety follow-up period (from vaccination up to 7 days post-vaccination).
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16433 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=3310 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=4196 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 6.06
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 37
|
0.21 Percentage of subjects
Interval 0.07 to 0.5
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.00 Percentage of subjects
Interval 0.0 to 0.84
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 38
|
0.27 Percentage of subjects
Interval 0.11 to 0.56
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.00 Percentage of subjects
Interval 0.0 to 0.74
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 39
|
0.21 Percentage of subjects
Interval 0.04 to 0.63
|
0.00 Percentage of subjects
Interval 0.0 to 3.73
|
0.00 Percentage of subjects
Interval 0.0 to 0.82
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 0.2
|
0.32 Percentage of subjects
Interval 0.0 to 2.1
|
0.00 Percentage of subjects
Interval 0.0 to 0.7
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 41
|
0.20 Percentage of subjects
Interval 0.03 to 0.66
|
0.33 Percentage of subjects
Interval 0.01 to 1.83
|
0.30 Percentage of subjects
Interval 0.0 to 2.16
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 0.45
|
0.00 Percentage of subjects
Interval 0.0 to 1.03
|
0.00 Percentage of subjects
Interval 0.0 to 1.72
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 0.82
|
0.00 Percentage of subjects
Interval 0.0 to 1.12
|
0.00 Percentage of subjects
Interval 0.0 to 2.76
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 44
|
0.15 Percentage of subjects
Interval 0.0 to 1.16
|
0.00 Percentage of subjects
Interval 0.0 to 0.88
|
0.00 Percentage of subjects
Interval 0.0 to 0.71
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 0.96
|
0.00 Percentage of subjects
Interval 0.0 to 1.21
|
0.00 Percentage of subjects
Interval 0.0 to 3.16
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 1.36
|
0.00 Percentage of subjects
Interval 0.0 to 0.78
|
0.00 Percentage of subjects
Interval 0.0 to 4.62
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 1.72
|
0.00 Percentage of subjects
Interval 0.0 to 2.66
|
0.00 Percentage of subjects
Interval 0.0 to 2.09
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
0.00 Percentage of subjects
Interval 0.0 to 4.3
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 36
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 37
|
1.50 Percentage of subjects
Interval 0.18 to 5.33
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 38
|
0.61 Percentage of subjects
Interval 0.01 to 4.01
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 39
|
0.29 Percentage of subjects
Interval 0.0 to 2.2
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 40
|
0.00 Percentage of subjects
Interval 0.0 to 2.09
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 2.22
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
0.00 Percentage of subjects
Interval 0.0 to 5.6
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 4.11
|
0.00 Percentage of subjects
Interval 0.0 to 6.38
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 6.49
|
0.00 Percentage of subjects
Interval 0.0 to 10.89
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 5.21
|
0.00 Percentage of subjects
Interval 0.0 to 6.6
|
0.00 Percentage of subjects
Interval 0.0 to 7.71
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 1.56
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 4.45
|
0.00 Percentage of subjects
Interval 0.0 to 3.36
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 7.71
|
4.76 Percentage of subjects
Interval 0.12 to 23.82
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
|
Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start up to end of the week of interest and were registered in EHR (routine data collection \& card-based ADR reporting) during FU period (from vaccination up to 7 days post-vaccination)
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16433 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=3310 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=4196 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.96
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-37
|
0.21 Percentage of subjects
Interval 0.07 to 0.5
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.00 Percentage of subjects
Interval 0.0 to 0.74
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-38
|
0.24 Percentage of subjects
Interval 0.13 to 0.43
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.00 Percentage of subjects
Interval 0.0 to 0.25
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-39
|
0.23 Percentage of subjects
Interval 0.1 to 0.44
|
0.00 Percentage of subjects
Interval 0.0 to 3.3
|
0.00 Percentage of subjects
Interval 0.0 to 0.19
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-40
|
0.19 Percentage of subjects
Interval 0.08 to 0.38
|
0.24 Percentage of subjects
Interval 0.01 to 1.31
|
0.00 Percentage of subjects
Interval 0.0 to 0.19
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-41
|
0.19 Percentage of subjects
Interval 0.09 to 0.35
|
0.28 Percentage of subjects
Interval 0.02 to 1.16
|
0.04 Percentage of subjects
Interval 0.0 to 0.35
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-42
|
0.18 Percentage of subjects
Interval 0.08 to 0.33
|
0.19 Percentage of subjects
Interval 0.02 to 0.74
|
0.04 Percentage of subjects
Interval 0.0 to 0.32
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-43
|
0.17 Percentage of subjects
Interval 0.08 to 0.33
|
0.14 Percentage of subjects
Interval 0.01 to 0.57
|
0.04 Percentage of subjects
Interval 0.0 to 0.3
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-44
|
0.17 Percentage of subjects
Interval 0.08 to 0.32
|
0.11 Percentage of subjects
Interval 0.01 to 0.48
|
0.03 Percentage of subjects
Interval 0.0 to 0.2
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-45
|
0.17 Percentage of subjects
Interval 0.08 to 0.31
|
0.09 Percentage of subjects
Interval 0.0 to 0.44
|
0.03 Percentage of subjects
Interval 0.0 to 0.2
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-46
|
0.16 Percentage of subjects
Interval 0.08 to 0.31
|
0.08 Percentage of subjects
Interval 0.0 to 0.4
|
0.03 Percentage of subjects
Interval 0.0 to 0.19
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-47
|
0.16 Percentage of subjects
Interval 0.07 to 0.31
|
0.07 Percentage of subjects
Interval 0.0 to 0.38
|
0.03 Percentage of subjects
Interval 0.0 to 0.18
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-48
|
0.16 Percentage of subjects
Interval 0.07 to 0.3
|
0.07 Percentage of subjects
Interval 0.0 to 0.37
|
0.03 Percentage of subjects
Interval 0.0 to 0.18
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-36
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-37
|
1.50 Percentage of subjects
Interval 0.18 to 5.33
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 10.58
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-38
|
1.01 Percentage of subjects
Interval 0.13 to 3.49
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 4.74
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-39
|
0.63 Percentage of subjects
Interval 0.08 to 2.26
|
0.00 Percentage of subjects
Interval 0.0 to 2.26
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-40
|
0.49 Percentage of subjects
Interval 0.05 to 1.84
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
0.00 Percentage of subjects
Interval 0.0 to 2.06
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-41
|
0.41 Percentage of subjects
Interval 0.04 to 1.57
|
0.00 Percentage of subjects
Interval 0.0 to 4.4
|
0.00 Percentage of subjects
Interval 0.0 to 1.52
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-42
|
0.38 Percentage of subjects
Interval 0.04 to 1.43
|
0.00 Percentage of subjects
Interval 0.0 to 2.64
|
0.00 Percentage of subjects
Interval 0.0 to 1.36
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-43
|
0.36 Percentage of subjects
Interval 0.04 to 1.35
|
0.00 Percentage of subjects
Interval 0.0 to 1.89
|
0.00 Percentage of subjects
Interval 0.0 to 1.21
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-44
|
0.34 Percentage of subjects
Interval 0.03 to 1.28
|
0.00 Percentage of subjects
Interval 0.0 to 1.48
|
0.00 Percentage of subjects
Interval 0.0 to 1.05
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-45
|
0.32 Percentage of subjects
Interval 0.03 to 1.21
|
0.00 Percentage of subjects
Interval 0.0 to 1.06
|
0.00 Percentage of subjects
Interval 0.0 to 0.63
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-46
|
0.30 Percentage of subjects
Interval 0.03 to 1.12
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.00 Percentage of subjects
Interval 0.0 to 0.61
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-47
|
0.29 Percentage of subjects
Interval 0.03 to 1.09
|
0.21 Percentage of subjects
Interval 0.0 to 1.78
|
0.00 Percentage of subjects
Interval 0.0 to 0.59
|
|
Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-48
|
0.28 Percentage of subjects
Interval 0.03 to 1.07
|
0.20 Percentage of subjects
Interval 0.0 to 1.69
|
0.00 Percentage of subjects
Interval 0.0 to 0.58
|
SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in EHR (combining routine data collection and card-based ADR reporting system) during the safety follow-up period (from vaccination up to 7 days post-vaccination).
SAEs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The weekly incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any SAEs in EHR (combining routine data collection and card-based ADR reporting system)within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16433 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=3310 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=4196 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 6.06
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 37
|
0.13 Percentage of subjects
Interval 0.02 to 0.39
|
0.00 Percentage of subjects
Interval 0.0 to 52.18
|
0.23 Percentage of subjects
Interval 0.0 to 1.85
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 38
|
0.19 Percentage of subjects
Interval 0.04 to 0.55
|
0.00 Percentage of subjects
Interval 0.0 to 40.96
|
0.40 Percentage of subjects
Interval 0.05 to 1.44
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 39
|
0.08 Percentage of subjects
Interval 0.01 to 0.24
|
0.00 Percentage of subjects
Interval 0.0 to 3.73
|
0.00 Percentage of subjects
Interval 0.0 to 0.82
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 40
|
0.16 Percentage of subjects
Interval 0.02 to 0.62
|
0.00 Percentage of subjects
Interval 0.0 to 2.1
|
0.19 Percentage of subjects
Interval 0.0 to 1.43
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 41
|
0.13 Percentage of subjects
Interval 0.01 to 0.62
|
0.00 Percentage of subjects
Interval 0.0 to 1.83
|
0.30 Percentage of subjects
Interval 0.0 to 2.28
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 0.45
|
0.28 Percentage of subjects
Interval 0.01 to 1.56
|
0.00 Percentage of subjects
Interval 0.0 to 1.72
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 43
|
0.45 Percentage of subjects
Interval 0.01 to 2.83
|
0.00 Percentage of subjects
Interval 0.0 to 1.12
|
0.00 Percentage of subjects
Interval 0.0 to 2.76
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 44
|
0.29 Percentage of subjects
Interval 0.0 to 2.07
|
0.24 Percentage of subjects
Interval 0.0 to 1.63
|
0.39 Percentage of subjects
Interval 0.0 to 3.12
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 45
|
0.26 Percentage of subjects
Interval 0.0 to 1.93
|
0.33 Percentage of subjects
Interval 0.0 to 2.29
|
0.00 Percentage of subjects
Interval 0.0 to 3.16
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 46
|
0.74 Percentage of subjects
Interval 0.09 to 2.66
|
0.00 Percentage of subjects
Interval 0.0 to 0.78
|
1.28 Percentage of subjects
Interval 0.01 to 8.31
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 1.72
|
0.00 Percentage of subjects
Interval 0.0 to 2.66
|
0.57 Percentage of subjects
Interval 0.0 to 4.84
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 48
|
0.88 Percentage of subjects
Interval 0.01 to 5.39
|
0.00 Percentage of subjects
Interval 0.0 to 4.3
|
0.00 Percentage of subjects
Interval 0.0 to 9.74
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 36
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 37
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 38
|
0.00 Percentage of subjects
Interval 0.0 to 2.21
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 8.22
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 39
|
0.00 Percentage of subjects
Interval 0.0 to 1.08
|
0.00 Percentage of subjects
Interval 0.0 to 33.63
|
0.00 Percentage of subjects
Interval 0.0 to 9.25
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 40
|
0.57 Percentage of subjects
Interval 0.0 to 4.23
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
0.00 Percentage of subjects
Interval 0.0 to 5.69
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 41
|
0.00 Percentage of subjects
Interval 0.0 to 2.22
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
1.56 Percentage of subjects
Interval 0.01 to 10.47
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 42
|
0.00 Percentage of subjects
Interval 0.0 to 4.11
|
0.00 Percentage of subjects
Interval 0.0 to 6.38
|
0.00 Percentage of subjects
Interval 0.0 to 11.94
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 43
|
0.00 Percentage of subjects
Interval 0.0 to 6.85
|
0.00 Percentage of subjects
Interval 0.0 to 6.49
|
0.00 Percentage of subjects
Interval 0.0 to 10.89
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 44
|
0.00 Percentage of subjects
Interval 0.0 to 5.21
|
0.00 Percentage of subjects
Interval 0.0 to 6.6
|
0.00 Percentage of subjects
Interval 0.0 to 7.71
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 45
|
0.00 Percentage of subjects
Interval 0.0 to 4.86
|
0.00 Percentage of subjects
Interval 0.0 to 3.62
|
0.00 Percentage of subjects
Interval 0.0 to 1.56
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 46
|
0.00 Percentage of subjects
Interval 0.0 to 4.45
|
0.00 Percentage of subjects
Interval 0.0 to 3.36
|
0.00 Percentage of subjects
Interval 0.0 to 17.65
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 47
|
0.00 Percentage of subjects
Interval 0.0 to 7.71
|
0.00 Percentage of subjects
Interval 0.0 to 16.11
|
0.00 Percentage of subjects
Interval 0.0 to 14.25
|
|
Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 48
|
0.00 Percentage of subjects
Interval 0.0 to 11.22
|
0.00 Percentage of subjects
Interval 0.0 to 20.59
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
SECONDARY outcome
Timeframe: Within 7 days post vaccinationPopulation: Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start up to end of the week of interest and were registered in EHR (routine data collection \& card-based ADR reporting) during FU period (from vaccination up to 7 days post-vaccination)
SAEs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The cumulative incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system) * The numerator was the number of subjects from the denominator who reported any SAEs in EHR (combining routine data collection and card-based ADR reporting system) Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Outcome measures
| Measure |
Vaccinated_Fluarix Tetra Group
n=16433 Participants
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=3310 Participants
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=4196 Participants
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-40
|
0.13 Percentage of subjects
Interval 0.07 to 0.22
|
0.00 Percentage of subjects
Interval 0.0 to 0.87
|
0.20 Percentage of subjects
Interval 0.04 to 0.62
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-35
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-36
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 97.5
|
0.00 Percentage of subjects
Interval 0.0 to 5.96
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-37
|
0.13 Percentage of subjects
Interval 0.02 to 0.39
|
0.00 Percentage of subjects
Interval 0.0 to 45.93
|
0.22 Percentage of subjects
Interval 0.0 to 1.61
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-38
|
0.16 Percentage of subjects
Interval 0.06 to 0.35
|
0.00 Percentage of subjects
Interval 0.0 to 24.71
|
0.30 Percentage of subjects
Interval 0.06 to 0.88
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-39
|
0.13 Percentage of subjects
Interval 0.06 to 0.23
|
0.00 Percentage of subjects
Interval 0.0 to 3.3
|
0.21 Percentage of subjects
Interval 0.04 to 0.61
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-41
|
0.13 Percentage of subjects
Interval 0.07 to 0.23
|
0.00 Percentage of subjects
Interval 0.0 to 0.51
|
0.22 Percentage of subjects
Interval 0.04 to 0.67
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-42
|
0.12 Percentage of subjects
Interval 0.07 to 0.21
|
0.09 Percentage of subjects
Interval 0.0 to 0.51
|
0.20 Percentage of subjects
Interval 0.04 to 0.59
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-43
|
0.13 Percentage of subjects
Interval 0.06 to 0.25
|
0.07 Percentage of subjects
Interval 0.0 to 0.4
|
0.19 Percentage of subjects
Interval 0.04 to 0.56
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-44
|
0.14 Percentage of subjects
Interval 0.06 to 0.29
|
0.08 Percentage of subjects
Interval 0.01 to 0.4
|
0.22 Percentage of subjects
Interval 0.05 to 0.62
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-45
|
0.15 Percentage of subjects
Interval 0.07 to 0.28
|
0.14 Percentage of subjects
Interval 0.02 to 0.52
|
0.21 Percentage of subjects
Interval 0.05 to 0.6
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-46
|
0.16 Percentage of subjects
Interval 0.07 to 0.31
|
0.12 Percentage of subjects
Interval 0.01 to 0.44
|
0.24 Percentage of subjects
Interval 0.07 to 0.59
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-47
|
0.15 Percentage of subjects
Interval 0.07 to 0.31
|
0.11 Percentage of subjects
Interval 0.01 to 0.42
|
0.26 Percentage of subjects
Interval 0.08 to 0.63
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
At risk, Week 35-48
|
0.16 Percentage of subjects
Interval 0.06 to 0.33
|
0.07 Percentage of subjects
Interval 0.01 to 0.4
|
0.25 Percentage of subjects
Interval 0.07 to 0.62
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-36
|
—
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 84.19
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-37
|
0.00 Percentage of subjects
Interval 0.0 to 2.74
|
—
|
0.00 Percentage of subjects
Interval 0.0 to 10.58
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-38
|
0.00 Percentage of subjects
Interval 0.0 to 1.23
|
0.00 Percentage of subjects
Interval 0.0 to 70.76
|
0.00 Percentage of subjects
Interval 0.0 to 4.74
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-39
|
0.00 Percentage of subjects
Interval 0.0 to 0.58
|
0.00 Percentage of subjects
Interval 0.0 to 26.46
|
0.00 Percentage of subjects
Interval 0.0 to 3.18
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-40
|
0.12 Percentage of subjects
Interval 0.0 to 0.81
|
0.00 Percentage of subjects
Interval 0.0 to 8.6
|
0.00 Percentage of subjects
Interval 0.0 to 2.06
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-41
|
0.10 Percentage of subjects
Interval 0.0 to 0.68
|
0.00 Percentage of subjects
Interval 0.0 to 4.4
|
0.41 Percentage of subjects
Interval 0.0 to 2.77
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-42
|
0.09 Percentage of subjects
Interval 0.0 to 0.62
|
0.00 Percentage of subjects
Interval 0.0 to 2.64
|
0.37 Percentage of subjects
Interval 0.0 to 2.41
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-43
|
0.09 Percentage of subjects
Interval 0.0 to 0.58
|
0.00 Percentage of subjects
Interval 0.0 to 1.89
|
0.33 Percentage of subjects
Interval 0.0 to 2.22
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-44
|
0.08 Percentage of subjects
Interval 0.0 to 0.55
|
0.00 Percentage of subjects
Interval 0.0 to 1.48
|
0.29 Percentage of subjects
Interval 0.0 to 1.97
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-45
|
0.08 Percentage of subjects
Interval 0.0 to 0.52
|
0.00 Percentage of subjects
Interval 0.0 to 1.06
|
0.17 Percentage of subjects
Interval 0.0 to 1.43
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-46
|
0.07 Percentage of subjects
Interval 0.0 to 0.49
|
0.00 Percentage of subjects
Interval 0.0 to 0.81
|
0.17 Percentage of subjects
Interval 0.0 to 1.38
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-47
|
0.07 Percentage of subjects
Interval 0.0 to 0.47
|
0.00 Percentage of subjects
Interval 0.0 to 1.78
|
0.16 Percentage of subjects
Interval 0.0 to 1.32
|
|
Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status
Not at risk, Week 35-48
|
0.07 Percentage of subjects
Interval 0.0 to 0.46
|
0.00 Percentage of subjects
Interval 0.0 to 1.69
|
0.16 Percentage of subjects
Interval 0.0 to 1.3
|
Adverse Events
Vaccinated_Fluarix Tetra Group
Serious events: 25 serious events
Other events: 1514 other events
Deaths: 3 deaths
Vaccinated_Non GSK Group
Serious events: 3 serious events
Other events: 133 other events
Deaths: 0 deaths
Vaccinated_Unknown Brand Group
Serious events: 10 serious events
Other events: 66 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vaccinated_Fluarix Tetra Group
n=16433 participants at risk
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=3310 participants at risk
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=4196 participants at risk
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
0.01%
1/16433 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.00%
0/3310 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.02%
1/4196 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
|
Injury, poisoning and procedural complications
Accidental fall
|
0.03%
5/16433 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.00%
0/3310 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.02%
1/4196 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.01%
1/16433 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.00%
0/3310 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.00%
0/4196 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/16433 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.03%
1/3310 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.00%
0/4196 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
|
Surgical and medical procedures
Blood transfusion
|
0.01%
1/16433 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.00%
0/3310 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.00%
0/4196 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
0.01%
1/16433 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.03%
1/3310 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.00%
0/4196 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
|
General disorders
Chest Pain
|
0.02%
3/16433 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.03%
1/3310 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.00%
0/4196 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
|
Infections and infestations
Chronic Ear Infection
|
0.00%
0/16433 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.00%
0/3310 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.02%
1/4196 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
|
Respiratory, thoracic and mediastinal disorders
COPD
|
0.01%
1/16433 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.00%
0/3310 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.00%
0/4196 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
|
Injury, poisoning and procedural complications
Fracture of bone
|
0.01%
1/16433 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.00%
0/3310 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.00%
0/4196 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
|
General disorders
Frail
|
0.01%
1/16433 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.00%
0/3310 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.00%
0/4196 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
|
Reproductive system and breast disorders
Gynaecological
|
0.01%
1/16433 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.00%
0/3310 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.00%
0/4196 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.01%
1/16433 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.00%
0/3310 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.00%
0/4196 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/16433 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.00%
0/3310 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.02%
1/4196 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/16433 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.00%
0/3310 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.02%
1/4196 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
|
Infections and infestations
Infection of Chronic Wound
|
0.01%
1/16433 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.00%
0/3310 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.02%
1/4196 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/16433 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.00%
0/3310 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.02%
1/4196 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
|
Psychiatric disorders
Self Harm
|
0.00%
0/16433 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.00%
0/3310 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.02%
1/4196 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
|
Immune system disorders
Sensitivity Reaction
|
0.01%
1/16433 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.00%
0/3310 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.00%
0/4196 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
|
Nervous system disorders
Stroke
|
0.01%
1/16433 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.00%
0/3310 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.00%
0/4196 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
|
General disorders
Unknown, non-causal
|
0.03%
5/16433 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.00%
0/3310 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.02%
1/4196 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
|
Infections and infestations
Viral gastroenteritis
|
0.00%
0/16433 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.00%
0/3310 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.02%
1/4196 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
Other adverse events
| Measure |
Vaccinated_Fluarix Tetra Group
n=16433 participants at risk
Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Non GSK Group
n=3310 participants at risk
Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017
|
Vaccinated_Unknown Brand Group
n=4196 participants at risk
Volunteered subjects who received influenza vaccination (GSK or non-GSK brand not known) in 10 volunteer GP practices between 01 September and 30 November 2017
|
|---|---|---|---|
|
General disorders
Fever/pyrexia
|
0.43%
70/16433 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.33%
11/3310 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.05%
2/4196 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
|
General disorders
Local symptoms (i.e. local erythema)
|
1.6%
264/16433 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.51%
17/3310 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.02%
1/4196 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
|
General disorders
Drowsiness
|
0.65%
107/16433 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.21%
7/3310 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.00%
0/4196 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
|
General disorders
Fatigue
|
1.5%
249/16433 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.30%
10/3310 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.07%
3/4196 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
|
General disorders
Headache
|
1.6%
271/16433 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.69%
23/3310 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.14%
6/4196 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
|
General disorders
Irritability
|
0.25%
41/16433 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.12%
4/3310 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.00%
0/4196 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
|
General disorders
Malaise
|
0.02%
3/16433 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.09%
3/3310 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.00%
0/4196 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Conjunctivitis
|
0.32%
53/16433 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.09%
3/3310 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.12%
5/4196 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Coryza
|
1.0%
172/16433 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.36%
12/3310 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.05%
2/4196 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.9%
318/16433 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
1.3%
43/3310 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.52%
22/4196 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.09%
14/16433 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.00%
0/3310 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.00%
0/4196 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.63%
104/16433 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.15%
5/3310 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.02%
1/4196 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.85%
139/16433 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.30%
10/3310 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.07%
3/4196 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.3%
219/16433 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.36%
12/3310 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.17%
7/4196 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
2.2%
366/16433 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.85%
28/3310 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.07%
3/4196 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.49%
81/16433 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.39%
13/3310 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.00%
0/4196 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
|
Gastrointestinal disorders
Decreased appetite
|
0.44%
73/16433 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.18%
6/3310 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.00%
0/4196 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.68%
112/16433 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.06%
2/3310 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.10%
4/4196 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
|
Gastrointestinal disorders
Nausea
|
0.72%
118/16433 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.12%
4/3310 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.02%
1/4196 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
|
Gastrointestinal disorders
Vomiting
|
0.18%
30/16433 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.06%
2/3310 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.05%
2/4196 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
|
Immune system disorders
Anaphylactic reactions
|
0.27%
45/16433 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.21%
7/3310 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.02%
1/4196 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
|
Immune system disorders
Facial oedema
|
0.05%
8/16433 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.00%
0/3310 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.00%
0/4196 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
|
Immune system disorders
Hypersensitivity reactions
|
0.11%
18/16433 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.06%
2/3310 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.02%
1/4196 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.45%
74/16433 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.27%
9/3310 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.07%
3/4196 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.87%
143/16433 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.21%
7/3310 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.02%
1/4196 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
|
Musculoskeletal and connective tissue disorders
Muscle aches / myalgia
|
2.8%
454/16433 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.54%
18/3310 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.36%
15/4196 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
|
Nervous system disorders
Bell's palsy
|
0.01%
1/16433 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.00%
0/3310 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.00%
0/4196 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
|
Nervous system disorders
Peripheral tremor
|
0.16%
26/16433 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.06%
2/3310 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.00%
0/4196 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
|
Nervous system disorders
Seizure / Febrile convulsions
|
0.01%
1/16433 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.03%
1/3310 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
0.02%
1/4196 • AEs were collected during the 7 days post-vaccination period. Vaccination of the subjects happened between week 35 and week 48 of the year 2017 (i.e.: between 01 September 2017 and 30 November 2017)
Medical coding was not performed according to MedDRA dictionary. AE codes were determined using an iterative ontological approach \[de Lusignan, 2015; Liyanage, 2015\] based on the EMA surveillance conditions of interest \[EMA, 2016\]. These conditions were aggregated under broad system categories to facilitate their reporting.
|
Additional Information
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