NCT03278067

Post-authorisation Passive Enhanced Safety Surveillance of Seasonal Influenza Vaccines: Pilot Study in England

Completed Results posted Last updated 13 January 2020

What this trial tests

trial testing Enhanced vaccine safety surveillance in Influenza, Human in 23,939 participants. Completed in 30 November 2017.

Timeline

12 September 2017

Primary endpoint
30 November 2017

30 November 2017

Quick facts

Lead sponsor	GlaxoSmithKline
Status	Completed
Study type	OBSERVATIONAL
Enrollment	23,939
Start date	12 September 2017
Primary completion	30 November 2017
Estimated completion	30 November 2017
Sites	1 location across United Kingdom

Drugs / interventions tested

• Enhanced vaccine safety surveillance

Conditions studied

• Influenza, Human — all drugs for Influenza, Human →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

6 Months and older, any sex, with Influenza, Human. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Weekly Incidence Rates of Any Adverse Events of Interest (AEIs) Reported Via Adverse Drug Reaction (ADR) Card, by Vaccine Group Primary · Within 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

Week 36

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	0.00	0.00 – 97.50
Vaccinated_Non GSK Group	0.00	0.00 – 97.50
Vaccinated_Unknown Brand Group	0.00	0.00 – 70.76

Week 37

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	10.10	8.53 – 11.84
Vaccinated_Non GSK Group	0.00	0.00 – 70.76
Vaccinated_Unknown Brand Group	12.50	1.55 – 38.35

Week 38

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	7.69	5.94 – 9.77
Vaccinated_Non GSK Group	14.29	0.00 – 90.97
Vaccinated_Unknown Brand Group	12.50	1.50 – 38.73

Week 39

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	7.97	7.16 – 8.84
Vaccinated_Non GSK Group	0.00	0.00 – 3.85
Vaccinated_Unknown Brand Group	4.17	0.11 – 21.12

Week 40

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	8.22	4.92 – 12.73
Vaccinated_Non GSK Group	4.75	2.74 – 7.60
Vaccinated_Unknown Brand Group	0.00	0.00 – 11.22

Week 41

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	6.40	4.45 – 8.86
Vaccinated_Non GSK Group	3.25	1.08 – 7.37
Vaccinated_Unknown Brand Group	1.79	0.05 – 9.55

Week 42

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	3.74	1.74 – 6.93
Vaccinated_Non GSK Group	1.25	0.36 – 3.06
Vaccinated_Unknown Brand Group	0.00	0.00 – 19.51

Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group Primary · Within 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

Week 35-36

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	0.00	0.00 – 97.50
Vaccinated_Non GSK Group	0.00	0.00 – 97.50
Vaccinated_Unknown Brand Group	0.00	0.00 – 70.76

Week 35-37

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	10.09	8.52 – 11.84
Vaccinated_Non GSK Group	0.00	0.00 – 60.24
Vaccinated_Unknown Brand Group	10.53	1.30 – 33.14

Week 35-38

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	8.83	7.25 – 10.63
Vaccinated_Non GSK Group	9.09	0.08 – 47.67
Vaccinated_Unknown Brand Group	11.43	3.20 – 26.74

Week 35-39

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	8.45	7.37 – 9.64
Vaccinated_Non GSK Group	0.95	0.02 – 5.19
Vaccinated_Unknown Brand Group	8.47	2.81 – 18.68

Week 35-40

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	8.41	7.29 – 9.63
Vaccinated_Non GSK Group	3.85	2.14 – 6.33
Vaccinated_Unknown Brand Group	5.56	1.83 – 12.49

Week 35-41

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	8.15	7.00 – 9.43
Vaccinated_Non GSK Group	3.59	1.96 – 5.98
Vaccinated_Unknown Brand Group	4.11	1.52 – 8.73

Week 35-42

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	7.87	6.68 – 9.19
Vaccinated_Non GSK Group	2.79	1.49 – 4.74
Vaccinated_Unknown Brand Group	3.68	1.36 – 7.84

Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group Primary · Within 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 happe

Week 36

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	0.00	0.00 – 97.50
Vaccinated_Non GSK Group	0.00	0.00 – 97.50
Vaccinated_Unknown Brand Group	0.00	0.00 – 70.76

Week 37

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	0.45	0.20 – 0.85
Vaccinated_Non GSK Group	0.00	0.00 – 70.76
Vaccinated_Unknown Brand Group	0.00	0.00 – 20.59

Week 38

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	0.51	0.15 – 1.26
Vaccinated_Non GSK Group	0.00	0.00 – 40.96
Vaccinated_Unknown Brand Group	0.00	0.00 – 20.59

Week 39

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	0.46	0.20 – 0.92
Vaccinated_Non GSK Group	0.00	0.00 – 3.85
Vaccinated_Unknown Brand Group	0.00	0.00 – 14.25

Week 40

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	0.34	0.12 – 0.77
Vaccinated_Non GSK Group	1.19	0.09 – 4.96
Vaccinated_Unknown Brand Group	0.00	0.00 – 11.22

Week 41

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	0.36	0.13 – 0.79
Vaccinated_Non GSK Group	0.59	0.07 – 2.12
Vaccinated_Unknown Brand Group	0.00	0.00 – 6.38

Week 42

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	0.00	0.00 – 0.40
Vaccinated_Non GSK Group	0.00	0.00 – 0.92
Vaccinated_Unknown Brand Group	0.00	0.00 – 19.51

Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group Primary · Within 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 subj

Week 35-36

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	0.00	0.00 – 97.50
Vaccinated_Non GSK Group	0.00	0.00 – 97.50
Vaccinated_Unknown Brand Group	0.00	0.00 – 70.76

Week 35-37

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	0.45	0.20 – 0.85
Vaccinated_Non GSK Group	0.00	0.00 – 60.24
Vaccinated_Unknown Brand Group	0.00	0.00 – 17.65

Week 35-38

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	0.48	0.26 – 0.80
Vaccinated_Non GSK Group	0.00	0.00 – 28.49
Vaccinated_Unknown Brand Group	0.00	0.00 – 10.00

Week 35-39

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	0.47	0.24 – 0.83
Vaccinated_Non GSK Group	0.00	0.00 – 3.45
Vaccinated_Unknown Brand Group	0.00	0.00 – 6.06

Week 35-40

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	0.45	0.25 – 0.73
Vaccinated_Non GSK Group	0.90	0.03 – 4.68
Vaccinated_Unknown Brand Group	0.00	0.00 – 4.02

Week 35-41

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	0.44	0.27 – 0.68
Vaccinated_Non GSK Group	0.77	0.16 – 2.23
Vaccinated_Unknown Brand Group	0.00	0.00 – 2.49

Week 35-42

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	0.41	0.24 – 0.65
Vaccinated_Non GSK Group	0.51	0.08 – 1.67
Vaccinated_Unknown Brand Group	0.00	0.00 – 2.24

Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group Primary · Within 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

Week 36

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	0.00	0.00 – 97.50
Vaccinated_Non GSK Group	0.00	0.00 – 97.50
Vaccinated_Unknown Brand Group	0.00	0.00 – 70.76

Week 37

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	1.87	0.78 – 3.72
Vaccinated_Non GSK Group	0.00	0.00 – 70.76
Vaccinated_Unknown Brand Group	6.25	0.16 – 30.23

Week 38

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	1.61	0.84 – 2.79
Vaccinated_Non GSK Group	0.00	0.00 – 40.96
Vaccinated_Unknown Brand Group	0.00	0.00 – 20.59

Week 39

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	1.90	1.23 – 2.79
Vaccinated_Non GSK Group	0.00	0.00 – 3.85
Vaccinated_Unknown Brand Group	0.00	0.00 – 14.25

Week 40

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	1.95	0.77 – 4.02
Vaccinated_Non GSK Group	0.30	0.00 – 1.82
Vaccinated_Unknown Brand Group	0.00	0.00 – 11.22

Week 41

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	1.45	0.93 – 2.15
Vaccinated_Non GSK Group	0.89	0.15 – 2.82
Vaccinated_Unknown Brand Group	0.00	0.00 – 6.38

Week 42

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	0.55	0.09 – 1.78
Vaccinated_Non GSK Group	0.50	0.06 – 1.79
Vaccinated_Unknown Brand Group	0.00	0.00 – 19.51

Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group Primary · Within 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

Week 35-36

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	0.00	0.00 – 97.50
Vaccinated_Non GSK Group	0.00	0.00 – 97.50
Vaccinated_Unknown Brand Group	0.00	0.00 – 70.76

Week 35-37

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	1.86	0.78 – 3.72
Vaccinated_Non GSK Group	0.00	0.00 – 60.24
Vaccinated_Unknown Brand Group	5.26	0.13 – 26.03

Week 35-38

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	1.73	0.99 – 2.81
Vaccinated_Non GSK Group	0.00	0.00 – 28.49
Vaccinated_Unknown Brand Group	2.86	0.07 – 14.92

Week 35-39

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	1.80	1.14 – 2.71
Vaccinated_Non GSK Group	0.00	0.00 – 3.45
Vaccinated_Unknown Brand Group	1.69	0.02 – 10.67

Week 35-40

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	1.83	1.17 – 2.71
Vaccinated_Non GSK Group	0.23	0.01 – 1.25
Vaccinated_Unknown Brand Group	1.11	0.02 – 6.81

Week 35-41

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	1.78	1.20 – 2.54
Vaccinated_Non GSK Group	0.51	0.04 – 2.05
Vaccinated_Unknown Brand Group	0.68	0.01 – 4.24

Week 35-42

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	1.70	1.19 – 2.36
Vaccinated_Non GSK Group	0.51	0.06 – 1.89
Vaccinated_Unknown Brand Group	0.61	0.01 – 3.64

Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group Primary · Within 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

Any, Week 36

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	0.00	0.00 – 97.50
Vaccinated_Non GSK Group	0.00	0.00 – 97.50
Vaccinated_Unknown Brand Group	0.00	0.00 – 70.76

Any, Week 37

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	3.89	3.16 – 4.74
Vaccinated_Non GSK Group	0.00	0.00 – 70.76
Vaccinated_Unknown Brand Group	6.25	0.03 – 39.17

Any, Week 38

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	2.97	2.02 – 4.19
Vaccinated_Non GSK Group	0.00	0.00 – 40.96
Vaccinated_Unknown Brand Group	0.00	0.00 – 20.59

Any, Week 39

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	2.94	2.41 – 3.55
Vaccinated_Non GSK Group	0.00	0.00 – 3.85
Vaccinated_Unknown Brand Group	4.17	0.11 – 21.12

Any, Week 40

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	2.43	1.76 – 3.27
Vaccinated_Non GSK Group	1.48	0.36 – 4.00
Vaccinated_Unknown Brand Group	0.00	0.00 – 11.22

Any, Week 41

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	1.75	1.18 – 2.50
Vaccinated_Non GSK Group	1.18	0.19 – 3.76
Vaccinated_Unknown Brand Group	0.00	0.00 – 6.38

Any, Week 42

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	1.54	0.53 – 3.43
Vaccinated_Non GSK Group	0.25	0.01 – 1.38
Vaccinated_Unknown Brand Group	0.00	0.00 – 19.51

Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group Primary · Within 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

Any, Week 35-36

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	0.00	0.00 – 97.50
Vaccinated_Non GSK Group	0.00	0.00 – 97.50
Vaccinated_Unknown Brand Group	0.00	0.00 – 70.76

Any, Week 35-37

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	3.89	3.15 – 4.74
Vaccinated_Non GSK Group	0.00	0.00 – 60.24
Vaccinated_Unknown Brand Group	5.26	0.06 – 29.55

Any, Week 35-38

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	3.41	2.58 – 4.40
Vaccinated_Non GSK Group	0.00	0.00 – 28.49
Vaccinated_Unknown Brand Group	2.86	0.02 – 18.52

Any, Week 35-39

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	3.20	2.47 – 4.07
Vaccinated_Non GSK Group	0.00	0.00 – 3.45
Vaccinated_Unknown Brand Group	3.39	0.41 – 11.71

Any, Week 35-40

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	3.06	2.39 – 3.85
Vaccinated_Non GSK Group	1.13	0.37 – 2.62
Vaccinated_Unknown Brand Group	2.22	0.27 – 7.80

Any, Week 35-41

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	2.89	2.24 – 3.67
Vaccinated_Non GSK Group	1.15	0.34 – 2.80
Vaccinated_Unknown Brand Group	1.37	0.17 – 4.86

Any, Week 35-42

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	2.81	2.14 – 3.60
Vaccinated_Non GSK Group	0.85	0.27 – 2.00
Vaccinated_Unknown Brand Group	1.23	0.15 – 4.36

Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group Primary · Within 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

Any, Week 36

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	0.00	0.00 – 97.50
Vaccinated_Non GSK Group	0.00	0.00 – 97.50
Vaccinated_Unknown Brand Group	0.00	0.00 – 70.76

Any, Week 37

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	5.76	4.81 – 6.83
Vaccinated_Non GSK Group	0.00	0.00 – 70.76
Vaccinated_Unknown Brand Group	0.00	0.00 – 20.59

Any, Week 38

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	3.88	2.99 – 4.95
Vaccinated_Non GSK Group	14.29	0.00 – 90.97
Vaccinated_Unknown Brand Group	6.25	0.16 – 30.23

Any, Week 39

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	4.23	3.63 – 4.89
Vaccinated_Non GSK Group	0.00	0.00 – 3.85
Vaccinated_Unknown Brand Group	0.00	0.00 – 14.25

Any, Week 40

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	4.57	2.77 – 7.05
Vaccinated_Non GSK Group	2.67	0.48 – 8.06
Vaccinated_Unknown Brand Group	0.00	0.00 – 11.22

Any, Week 41

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	3.32	2.19 – 4.81
Vaccinated_Non GSK Group	2.07	0.75 – 4.49
Vaccinated_Unknown Brand Group	0.00	0.00 – 6.38

Any, Week 42

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	2.09	0.95 – 3.94
Vaccinated_Non GSK Group	0.50	0.06 – 1.79
Vaccinated_Unknown Brand Group	0.00	0.00 – 19.51

Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group Primary · Within 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 th

Any, Week 35-36

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	0.00	0.00 – 97.50
Vaccinated_Non GSK Group	0.00	0.00 – 97.50
Vaccinated_Unknown Brand Group	0.00	0.00 – 70.76

Any, Week 35-37

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	5.76	4.81 – 6.83
Vaccinated_Non GSK Group	0.00	0.00 – 60.24
Vaccinated_Unknown Brand Group	0.00	0.00 – 17.65

Any, Week 35-38

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	4.77	3.99 – 5.65
Vaccinated_Non GSK Group	9.09	0.08 – 47.67
Vaccinated_Unknown Brand Group	2.86	0.05 – 16.10

Any, Week 35-39

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	4.53	3.96 – 5.16
Vaccinated_Non GSK Group	0.95	0.02 – 5.19
Vaccinated_Unknown Brand Group	1.69	0.04 – 9.09

Any, Week 35-40

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	4.54	3.88 – 5.27
Vaccinated_Non GSK Group	2.26	0.44 – 6.66
Vaccinated_Unknown Brand Group	1.11	0.03 – 6.04

Any, Week 35-41

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	4.38	3.71 – 5.14
Vaccinated_Non GSK Group	2.18	0.80 – 4.71
Vaccinated_Unknown Brand Group	0.68	0.01 – 4.40

Any, Week 35-42

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	4.23	3.53 – 5.03
Vaccinated_Non GSK Group	1.61	0.58 – 3.50
Vaccinated_Unknown Brand Group	0.61	0.01 – 4.02

Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group Primary · Within 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

Any, Week 36

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	0.00	0.00 – 97.50
Vaccinated_Non GSK Group	0.00	0.00 – 97.50
Vaccinated_Unknown Brand Group	0.00	0.00 – 70.76

Any, Week 37

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	2.03	1.29 – 3.03
Vaccinated_Non GSK Group	0.00	0.00 – 70.76
Vaccinated_Unknown Brand Group	6.25	0.03 – 39.17

Any, Week 38

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	1.65	0.95 – 2.65
Vaccinated_Non GSK Group	14.29	0.00 – 90.97
Vaccinated_Unknown Brand Group	0.00	0.00 – 20.59

Any, Week 39

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	1.34	0.81 – 2.08
Vaccinated_Non GSK Group	0.00	0.00 – 3.85
Vaccinated_Unknown Brand Group	0.00	0.00 – 14.25

Any, Week 40

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	1.36	0.80 – 2.16
Vaccinated_Non GSK Group	1.19	0.32 – 3.01
Vaccinated_Unknown Brand Group	0.00	0.00 – 11.22

Any, Week 41

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	1.15	0.62 – 1.94
Vaccinated_Non GSK Group	0.59	0.07 – 2.12
Vaccinated_Unknown Brand Group	0.00	0.00 – 6.38

Any, Week 42

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	0.66	0.19 – 1.63
Vaccinated_Non GSK Group	0.00	0.00 – 0.92
Vaccinated_Unknown Brand Group	0.00	0.00 – 19.51

Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group Primary · Within 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 a

Any, Week 35-36

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	0.00	0.00 – 97.50
Vaccinated_Non GSK Group	0.00	0.00 – 97.50
Vaccinated_Unknown Brand Group	0.00	0.00 – 70.76

Any, Week 35-37

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	2.03	1.29 – 3.03
Vaccinated_Non GSK Group	0.00	0.00 – 60.24
Vaccinated_Unknown Brand Group	5.26	0.06 – 29.55

Any, Week 35-38

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	1.83	1.33 – 2.44
Vaccinated_Non GSK Group	9.09	0.08 – 47.67
Vaccinated_Unknown Brand Group	2.86	0.02 – 18.52

Any, Week 35-39

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	1.61	1.11 – 2.26
Vaccinated_Non GSK Group	0.95	0.02 – 5.19
Vaccinated_Unknown Brand Group	1.69	0.01 – 12.12

Any, Week 35-40

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	1.57	1.15 – 2.07
Vaccinated_Non GSK Group	1.13	0.37 – 2.62
Vaccinated_Unknown Brand Group	1.11	0.01 – 7.73

Any, Week 35-41

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	1.51	1.12 – 1.99
Vaccinated_Non GSK Group	0.90	0.35 – 1.87
Vaccinated_Unknown Brand Group	0.68	0.02 – 3.76

Any, Week 35-42

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	1.46	1.09 – 1.91
Vaccinated_Non GSK Group	0.59	0.24 – 1.23
Vaccinated_Unknown Brand Group	0.61	0.02 – 3.37

Adverse events — posted to ClinicalTrials.gov

Time frame: 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). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Vaccinated_Fluarix Tetra Group

Serious: 25/16433 (0%)

Deaths: 3/16433

Vaccinated_Non GSK Group

Serious: 3/3310 (0%)

Deaths: 0/3310

Vaccinated_Unknown Brand Group

Serious: 10/4196 (0%)

Deaths: 0/4196

Serious adverse events (22 terms)

Reaction	System	Vaccinated_Fluarix Tetra G…	Vaccinated_Non GSK Group	Vaccinated_Unknown Brand G…
Accidental fall	Injury, poisoning and procedural complications	—	—	—
Unknown, non-causal	General disorders	—	—	—
Chest Pain	General disorders	—	—	—
Abdominal Pain	Gastrointestinal disorders	—	—	—
Asthma	Respiratory, thoracic and mediastinal disorders	—	—	—
Atrial Fibrillation	Cardiac disorders	—	—	—
Blood transfusion	Surgical and medical procedures	—	—	—
Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
Chronic Ear Infection	Infections and infestations	—	—	—
COPD	Respiratory, thoracic and mediastinal disorders	—	—	—
Fracture of bone	Injury, poisoning and procedural complications	—	—	—
Frail	General disorders	—	—	—
Gynaecological	Reproductive system and breast disorders	—	—	—
Head Injury	Injury, poisoning and procedural complications	—	—	—
Hyperkalemia	Metabolism and nutrition disorders	—	—	—
Hypoglycaemia	Metabolism and nutrition disorders	—	—	—
Infection of Chronic Wound	Infections and infestations	—	—	—
Pneumonia	Infections and infestations	—	—	—
Self Harm	Psychiatric disorders	—	—	—
Sensitivity Reaction	Immune system disorders	—	—	—
Stroke	Nervous system disorders	—	—	—
Viral gastroenteritis	Infections and infestations	—	—	—

Other adverse events (29 terms — click to expand)

Reaction	System	Vaccinated_Fluarix Tetra G…	Vaccinated_Non GSK Group	Vaccinated_Unknown Brand G…
Muscle aches / myalgia	Musculoskeletal and connective tissue disorders	—	—	—
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—
Headache	General disorders	—	—	—
Local symptoms (i.e. local erythema)	General disorders	—	—	—
Fatigue	General disorders	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—
Coryza	Respiratory, thoracic and mediastinal disorders	—	—	—
Arthropathy	Musculoskeletal and connective tissue disorders	—	—	—
Nasal congestion	Respiratory, thoracic and mediastinal disorders	—	—	—
Nausea	Gastrointestinal disorders	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—
Drowsiness	General disorders	—	—	—
Hoarseness	Respiratory, thoracic and mediastinal disorders	—	—	—
Wheezing	Respiratory, thoracic and mediastinal disorders	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—
Decreased appetite	Gastrointestinal disorders	—	—	—
Fever/pyrexia	General disorders	—	—	—
Conjunctivitis	Respiratory, thoracic and mediastinal disorders	—	—	—
Anaphylactic reactions	Immune system disorders	—	—	—
Irritability	General disorders	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—
Peripheral tremor	Nervous system disorders	—	—	—
Hypersensitivity reactions	Immune system disorders	—	—	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—	—	—
Facial oedema	Immune system disorders	—	—	—
Malaise	General disorders	—	—	—
Bell's palsy	Nervous system disorders	—	—	—
Seizure / Febrile convulsions	Nervous system disorders	—	—	—

Most-reported serious reactions: Accidental fall, Unknown, non-causal, Chest Pain, Abdominal Pain, Asthma, Atrial Fibrillation, Blood transfusion, Cancer.

Data from ClinicalTrials.gov NCT03278067 adverse events section.

Sponsor's own description

This pilot study, to be conducted in the 2017/2018 influenza season, is a safety surveillance study using passive surveillance enhanced with a reporting card system to report adverse events of interest (AEIs) after Flu vaccination.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Brand-specific enhanced safety surveillance of GSK's Fluarix Tetra seasonal influenza vaccine in England: 2017/2018 season.
   de Lusignan S, Damaso S, Ferreira F, Byford R, et al · · 2020 · cited 15× · PMID 32118513 · DOI 10.1080/21645515.2019.1705112
2. Challenges in implementing yearly enhanced safety surveillance of influenza vaccination in Europe: lessons learned and future perspectives.
   Dos Santos G. · · 2019 · cited 14× · PMID 31116631 · DOI 10.1080/21645515.2019.1608745
3. Enhanced Safety Surveillance of GSK's Quadrivalent Seasonal Influenza Vaccine in Belgium, Germany, and Spain for the 2018/19 Season: Interim Analysis.
   Dos Santos G, Shende V, Damaso S, Yeakey A. · · 2019 · cited 5× · PMID 31595482 · DOI 10.1007/s12325-019-01105-2