NCT03688620

Enhanced Safety Surveillance of GlaxoSmithKline's (GSK's) Quadrivalent Seasonal Influenza Vaccines During the 2018/19 Influenza Season

Completed Phase 4 Results posted Last updated 5 January 2024

What this trial tests

Phase 4 trial testing Passive enhanced safety surveillance in Influenza, Human in 1,060 participants. Completed in 4 January 2019.

Timeline

5 October 2018

Primary endpoint
4 January 2019

4 January 2019

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	1,060
Start date	5 October 2018
Primary completion	4 January 2019
Estimated completion	4 January 2019
Sites	9 locations across Belgium, Germany, Spain

Drugs / interventions tested

• Passive enhanced 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 Percentage of Subjects Reporting Any AEIs and/or Other Aes, Using ADR Card, Post Dose 1 by Vaccine Group and Overall Secondary · Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards.

Week 40

Group	Value	95% CI
Vaccinated_Influsplit Tetra Group	32.86	12.23 – 59.90
Total Group	32.86	12.23 – 59.90

Week 41

Group	Value	95% CI
Vaccinated_Influsplit Tetra Group	36.26	0.95 – 92.78
Total Group	36.26	0.95 – 92.78

Week 42

Group	Value	95% CI
Vaccinated_AlphaRix Tetra Group	45.39	36.99 – 53.98
Vaccinated_Influsplit Tetra Group	32.56	19.08 – 48.54
Vaccinated_Fluarix Tetra Group	44.23	0.11 – 99.54
Total Group	42.80	35.52 – 50.31

Week 43

Group	Value	95% CI
Vaccinated_AlphaRix Tetra Group	45.16	27.32 – 63.97
Vaccinated_Influsplit Tetra Group	38.46	13.86 – 68.42
Vaccinated_Fluarix Tetra Group	47.44	36.01 – 59.07
Total Group	45.90	36.85 – 55.16

Week 44

Group	Value	95% CI
Vaccinated_AlphaRix Tetra Group	55.56	0.01 – 100
Vaccinated_Influsplit Tetra Group	20.00	4.33 – 48.09
Vaccinated_Fluarix Tetra Group	35.38	7.27 – 74.31
Total Group	39.66	19.21 – 63.16

Week 45

Group	Value	95% CI
Vaccinated_AlphaRix Tetra Group	35.14	0.51 – 94.16
Vaccinated_Influsplit Tetra Group	66.67	40.99 – 86.66
Vaccinated_Fluarix Tetra Group	50.97	22.51 – 78.97
Total Group	47.37	32.15 – 62.96

Week 46

Group	Value	95% CI
Vaccinated_AlphaRix Tetra Group	26.92	11.57 – 47.79
Vaccinated_Influsplit Tetra Group	42.31	23.35 – 63.08
Vaccinated_Fluarix Tetra Group	38.81	27.14 – 51.50
Total Group	36.97	28.01 – 46.66

Week 47

Group	Value	95% CI
Vaccinated_AlphaRix Tetra Group	38.10	18.11 – 61.56
Vaccinated_Influsplit Tetra Group	50.00	1.26 – 98.74
Vaccinated_Fluarix Tetra Group	70.00	0.00 – 100
Total Group	53.49	16.09 – 88.07

Weekly Percentage of Subjects Reporting Any AEIs and/or AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group Secondary · Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52.

Week 46

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	33.33	0.84 – 90.57

Week 47

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	47.37	24.45 – 71.14

Week 48

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	44.00	24.40 – 65.07

Week 49

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	11.76	0.58 – 44.96

Week 50

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	9.52	2.66 – 22.62

Week 51

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	25.00	0.00 – 100

Week 52

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	25.00	0.63 – 80.59

Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall Secondary · Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were diarrhoea, nause

Any,Week 40

Group	Value	95% CI
Vaccinated_Influsplit Tetra Group	2.86	0.12 – 13.38
Total Group	2.86	0.12 – 13.38

Any,Week 41

Group	Value	95% CI
Vaccinated_Influsplit Tetra Group	2.20	0.01 – 16.50
Total Group	2.20	0.01 – 16.50

Any,Week 42

Group	Value	95% CI
Vaccinated_AlphaRix Tetra Group	2.13	0.00 – 57.89
Vaccinated_Influsplit Tetra Group	11.63	0.00 – 97.87
Vaccinated_Fluarix Tetra Group	7.69	0.19 – 36.17
Total Group	5.08	0.60 – 17.38

Any,Week 43

Group	Value	95% CI
Vaccinated_AlphaRix Tetra Group	9.68	2.04 – 25.75
Vaccinated_Influsplit Tetra Group	7.69	0.19 – 36.03
Vaccinated_Fluarix Tetra Group	8.97	0.05 – 50.25
Total Group	9.02	4.59 – 15.56

Any,Week 44

Group	Value	95% CI
Vaccinated_AlphaRix Tetra Group	13.89	0.00 – 87.39
Vaccinated_Influsplit Tetra Group	6.67	0.17 – 31.95
Vaccinated_Fluarix Tetra Group	4.62	0.40 – 17.47
Total Group	7.76	2.02 – 19.22

Any,Week 45

Group	Value	95% CI
Vaccinated_AlphaRix Tetra Group	9.46	3.89 – 18.52
Vaccinated_Influsplit Tetra Group	11.11	1.38 – 34.71
Vaccinated_Fluarix Tetra Group	3.87	0.04 – 23.24
Total Group	6.07	1.97 – 13.71

Any,Week 46

Group	Value	95% CI
Vaccinated_AlphaRix Tetra Group	7.69	0.95 – 25.13
Vaccinated_Influsplit Tetra Group	3.85	0.10 – 19.64
Vaccinated_Fluarix Tetra Group	10.45	1.35 – 32.48
Total Group	8.40	2.93 – 18.07

Any,Week 47

Group	Value	95% CI
Vaccinated_AlphaRix Tetra Group	9.52	1.17 – 30.38
Vaccinated_Influsplit Tetra Group	0.00	0.00 – 84.19
Vaccinated_Fluarix Tetra Group	10.00	1.23 – 31.70
Total Group	9.30	2.59 – 22.14

Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group Secondary · Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were diarrhoea, nausea, and vomiting.

Any,Week 46

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	33.33	0.84 – 90.57

Any,Week 47

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	10.53	0.00 – 91.11

Any,Week 48

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	0.00	0.00 – 13.72

Any,Week 49

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	0.00	0.00 – 10.28

Any,Week 50

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	2.38	0.00 – 58.03

Any,Week 51

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	0.00	0.00 – 26.46

Any,Week 52

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	0.00	0.00 – 60.24

Diarrhoea,Week 46

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	33.33	0.84 – 90.57

Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall Secondary · Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were chills, face oed

Any,Week 40

Group	Value	95% CI
Vaccinated_Influsplit Tetra Group	25.71	16.01 – 37.56
Total Group	25.71	16.01 – 37.56

Any,Week 41

Group	Value	95% CI
Vaccinated_Influsplit Tetra Group	29.67	0.86 – 86.02
Total Group	29.67	0.86 – 86.02

Any,Week 42

Group	Value	95% CI
Vaccinated_AlphaRix Tetra Group	31.21	18.49 – 46.39
Vaccinated_Influsplit Tetra Group	25.58	1.10 – 77.48
Vaccinated_Fluarix Tetra Group	26.92	0.28 – 88.26
Total Group	29.24	23.52 – 35.49

Any,Week 43

Group	Value	95% CI
Vaccinated_AlphaRix Tetra Group	19.35	7.45 – 37.47
Vaccinated_Influsplit Tetra Group	15.38	1.92 – 45.45
Vaccinated_Fluarix Tetra Group	26.92	17.50 – 38.16
Total Group	23.77	15.38 – 33.97

Any,Week 44

Group	Value	95% CI
Vaccinated_AlphaRix Tetra Group	41.67	0.00 – 100
Vaccinated_Influsplit Tetra Group	20.00	4.33 – 48.09
Vaccinated_Fluarix Tetra Group	18.46	2.70 – 50.43
Total Group	25.86	8.25 – 52.11

Any,Week 45

Group	Value	95% CI
Vaccinated_AlphaRix Tetra Group	17.57	0.00 – 96.81
Vaccinated_Influsplit Tetra Group	50.00	26.02 – 73.98
Vaccinated_Fluarix Tetra Group	32.90	6.71 – 70.97
Total Group	29.55	14.19 – 49.27

Any,Week 46

Group	Value	95% CI
Vaccinated_AlphaRix Tetra Group	15.38	4.36 – 34.87
Vaccinated_Influsplit Tetra Group	26.92	11.57 – 47.79
Vaccinated_Fluarix Tetra Group	28.36	13.66 – 47.42
Total Group	25.21	15.92 – 36.52

Any,Week 47

Group	Value	95% CI
Vaccinated_AlphaRix Tetra Group	28.57	11.28 – 52.18
Vaccinated_Influsplit Tetra Group	0.00	0.00 – 84.19
Vaccinated_Fluarix Tetra Group	50.00	3.46 – 96.54
Total Group	37.21	16.09 – 62.67

Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group Secondary · Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were chills, face oedema, fatigue, injection site erythema, injection site pain, inject

Any,Week 46

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	0.00	0.00 – 70.76

Any,Week 47

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	36.84	0.00 – 100

Any,Week 48

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	4.00	0.10 – 20.35

Any,Week 49

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	2.94	0.07 – 15.33

Any,Week 50

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	4.76	0.58 – 16.16

Any,Week 51

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	8.33	0.21 – 38.48

Any,Week 52

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	25.00	0.63 – 80.59

Chills,Week 46

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	0.00	0.00 – 70.76

Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall Secondary · Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were anaphylactic rea

Any,Week 40

Group	Value	95% CI
Vaccinated_Influsplit Tetra Group	0.00	0.00 – 5.13
Total Group	0.00	0.00 – 5.13

Any,Week 41

Group	Value	95% CI
Vaccinated_Influsplit Tetra Group	0.00	0.00 – 3.97
Total Group	0.00	0.00 – 3.97

Any,Week 42

Group	Value	95% CI
Vaccinated_AlphaRix Tetra Group	0.00	0.00 – 2.58
Vaccinated_Influsplit Tetra Group	0.00	0.00 – 8.22
Vaccinated_Fluarix Tetra Group	0.00	0.00 – 6.85
Total Group	0.00	0.00 – 1.55

Any,Week 43

Group	Value	95% CI
Vaccinated_AlphaRix Tetra Group	0.00	0.00 – 11.22
Vaccinated_Influsplit Tetra Group	0.00	0.00 – 24.71
Vaccinated_Fluarix Tetra Group	0.00	0.00 – 4.62
Total Group	0.00	0.00 – 2.98

Any,Week 44

Group	Value	95% CI
Vaccinated_AlphaRix Tetra Group	0.00	0.00 – 9.74
Vaccinated_Influsplit Tetra Group	0.00	0.00 – 21.80
Vaccinated_Fluarix Tetra Group	0.00	0.00 – 5.52
Total Group	0.00	0.00 – 3.13

Any,Week 45

Group	Value	95% CI
Vaccinated_AlphaRix Tetra Group	1.35	0.00 – 21.52
Vaccinated_Influsplit Tetra Group	0.00	0.00 – 18.53
Vaccinated_Fluarix Tetra Group	0.00	0.00 – 2.35
Total Group	0.40	0.00 – 2.98

Any,Week 46

Group	Value	95% CI
Vaccinated_AlphaRix Tetra Group	0.00	0.00 – 13.23
Vaccinated_Influsplit Tetra Group	0.00	0.00 – 13.23
Vaccinated_Fluarix Tetra Group	0.00	0.00 – 5.36
Total Group	0.00	0.00 – 3.05

Any,Week 47

Group	Value	95% CI
Vaccinated_AlphaRix Tetra Group	0.00	0.00 – 16.11
Vaccinated_Influsplit Tetra Group	0.00	0.00 – 84.19
Vaccinated_Fluarix Tetra Group	0.00	0.00 – 16.84
Total Group	0.00	0.00 – 8.22

Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group Secondary · Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52.

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	0	0 – 2.62

Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall Secondary · Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were conjunctivitis a

Any,Week 40

Group	Value	95% CI
Vaccinated_Influsplit Tetra Group	8.57	0.31 – 37.07
Total Group	8.57	0.31 – 37.07

Any,Week 41

Group	Value	95% CI
Vaccinated_Influsplit Tetra Group	8.79	0.32 – 37.74
Total Group	8.79	0.32 – 37.74

Any,Week 42

Group	Value	95% CI
Vaccinated_AlphaRix Tetra Group	0.71	0.01 – 4.40
Vaccinated_Influsplit Tetra Group	4.65	0.00 – 74.17
Vaccinated_Fluarix Tetra Group	1.92	0.05 – 10.26
Total Group	1.69	0.24 – 5.71

Any,Week 43

Group	Value	95% CI
Vaccinated_AlphaRix Tetra Group	6.45	0.79 – 21.42
Vaccinated_Influsplit Tetra Group	7.69	0.19 – 36.03
Vaccinated_Fluarix Tetra Group	5.13	0.75 – 16.35
Total Group	5.74	2.34 – 11.46

Any,Week 44

Group	Value	95% CI
Vaccinated_AlphaRix Tetra Group	8.33	1.75 – 22.47
Vaccinated_Influsplit Tetra Group	6.67	0.17 – 31.95
Vaccinated_Fluarix Tetra Group	6.15	0.05 – 35.17
Total Group	6.90	2.81 – 13.71

Any,Week 45

Group	Value	95% CI
Vaccinated_AlphaRix Tetra Group	9.46	0.00 – 69.82
Vaccinated_Influsplit Tetra Group	11.11	1.38 – 34.71
Vaccinated_Fluarix Tetra Group	5.81	0.09 – 30.59
Total Group	7.29	3.51 – 13.08

Any,Week 46

Group	Value	95% CI
Vaccinated_AlphaRix Tetra Group	3.85	0.10 – 19.64
Vaccinated_Influsplit Tetra Group	7.69	0.95 – 25.13
Vaccinated_Fluarix Tetra Group	8.96	1.32 – 27.23
Total Group	7.56	3.17 – 14.77

Any,Week 47

Group	Value	95% CI
Vaccinated_AlphaRix Tetra Group	4.76	0.12 – 23.82
Vaccinated_Influsplit Tetra Group	0.00	0.00 – 84.19
Vaccinated_Fluarix Tetra Group	15.00	0.01 – 81.57
Total Group	9.30	1.44 – 27.75

Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group Secondary · Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were conjunctivitis and rhinitis.

Any,Week 46

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	0.00	0.00 – 70.76

Any,Week 47

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	0.00	0.00 – 17.65

Any,Week 48

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	12.00	2.55 – 31.22

Any,Week 49

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	0.00	0.00 – 10.28

Any,Week 50

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	2.38	0.06 – 12.57

Any,Week 51

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	0.00	0.00 – 26.46

Any,Week 52

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	0.00	0.00 – 60.24

Conjunctivitis,Week 46

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	0.00	0.00 – 70.76

Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall Secondary · Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card was decreased appetit

Any,Week 40

Group	Value	95% CI
Vaccinated_Influsplit Tetra Group	0.00	0.00 – 5.13
Total Group	0.00	0.00 – 5.13

Any,Week 41

Group	Value	95% CI
Vaccinated_Influsplit Tetra Group	1.10	0.00 – 20.56
Total Group	1.10	0.00 – 20.56

Any,Week 42

Group	Value	95% CI
Vaccinated_AlphaRix Tetra Group	0.71	0.01 – 4.40
Vaccinated_Influsplit Tetra Group	0.00	0.00 – 8.22
Vaccinated_Fluarix Tetra Group	3.85	0.11 – 19.24
Total Group	1.27	0.12 – 4.95

Any,Week 43

Group	Value	95% CI
Vaccinated_AlphaRix Tetra Group	0.00	0.00 – 11.22
Vaccinated_Influsplit Tetra Group	0.00	0.00 – 24.71
Vaccinated_Fluarix Tetra Group	11.54	1.53 – 35.14
Total Group	7.38	0.30 – 31.94

Any,Week 44

Group	Value	95% CI
Vaccinated_AlphaRix Tetra Group	2.78	0.00 – 84.65
Vaccinated_Influsplit Tetra Group	0.00	0.00 – 21.80
Vaccinated_Fluarix Tetra Group	7.69	2.54 – 17.05
Total Group	5.17	1.92 – 10.92

Any,Week 45

Group	Value	95% CI
Vaccinated_AlphaRix Tetra Group	4.05	0.00 – 53.08
Vaccinated_Influsplit Tetra Group	0.00	0.00 – 18.53
Vaccinated_Fluarix Tetra Group	3.87	0.00 – 38.62
Total Group	3.64	0.66 – 10.89

Any,Week 46

Group	Value	95% CI
Vaccinated_AlphaRix Tetra Group	3.85	0.10 – 19.64
Vaccinated_Influsplit Tetra Group	0.00	0.00 – 13.23
Vaccinated_Fluarix Tetra Group	0.00	0.00 – 5.36
Total Group	0.84	0.00 – 7.70

Any,Week 47

Group	Value	95% CI
Vaccinated_AlphaRix Tetra Group	4.76	0.12 – 23.82
Vaccinated_Influsplit Tetra Group	0.00	0.00 – 84.19
Vaccinated_Fluarix Tetra Group	0.00	0.00 – 16.84
Total Group	2.33	0.03 – 14.14

Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group Secondary · Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card was decreased appetite.

Any,Week 46

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	0.00	0.00 – 70.76

Any,Week 47

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	5.26	0.00 – 95.26

Any,Week 48

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	4.00	0.10 – 20.35

Any,Week 49

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	0.00	0.00 – 10.28

Any,Week 50

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	2.38	0.06 – 12.57

Any,Week 51

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	0.00	0.00 – 26.46

Any,Week 52

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	0.00	0.00 – 60.24

Decreased appetite,Week 46

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	0.00	0.00 – 70.76

Adverse events — posted to ClinicalTrials.gov

Time frame: Unsolicited symptoms (i.e. AEIs and/or other AEs) were collected within 7 days post any vaccination. Serious adverse events related to the GSK's quadrivalent seasonal influenza vaccine, were collected over the whole study period (ISO weeks 40-52).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Vaccinated_AlphaRix Tetra Group

Serious: 0/329 (0%)

Deaths: 0/329

Vaccinated_Influsplit Tetra Group

Serious: 0/278 (0%)

Deaths: 0/278

Vaccinated_Fluarix Tetra Group

Serious: 0/453 (0%)

Deaths: 0/453

Other adverse events (86 terms — click to expand)

Reaction	System	Vaccinated_AlphaRix Tetra …	Vaccinated_Influsplit Tetr…	Vaccinated_Fluarix Tetra G…
Injection site pain	General disorders	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	—	—	—
Nasal congestion	Respiratory, thoracic and mediastinal disorders	—	—	—
Pyrexia	General disorders	—	—	—
Fatigue	General disorders	—	—	—
Injection site swelling	General disorders	—	—	—
Headache	Nervous system disorders	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—
Injection site erythema	General disorders	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—
Conjunctivitis	Infections and infestations	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—
Nausea	Gastrointestinal disorders	—	—	—
Rhinitis	Infections and infestations	—	—	—
Chills	General disorders	—	—	—
Irritability	Psychiatric disorders	—	—	—
Dysphonia	Respiratory, thoracic and mediastinal disorders	—	—	—
Arthropathy	Musculoskeletal and connective tissue disorders	—	—	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—
Wheezing	Respiratory, thoracic and mediastinal disorders	—	—	—
Injection site pruritus	General disorders	—	—	—
Heart rate increased	Investigations	—	—	—
Dizziness	Nervous system disorders	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—
Sneezing	Respiratory, thoracic and mediastinal disorders	—	—	—
Vertigo	Ear and labyrinth disorders	—	—	—
Eye pruritus	Eye disorders	—	—	—
Mucous membrane disorder	General disorders	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—
Rheumatic disorder	Musculoskeletal and connective tissue disorders	—	—	—
Erythema	Skin and subcutaneous tissue disorders	—	—	—
Pruritus generalised	Skin and subcutaneous tissue disorders	—	—	—
Ear haemorrhage	Ear and labyrinth disorders	—	—	—
Ear pain	Ear and labyrinth disorders	—	—	—

Data from ClinicalTrials.gov NCT03688620 adverse events section.

Sponsor's own description

The purpose of this study is to comply with the European Medicines Agency (EMA) guidance on enhanced safety surveillance for seasonal influenza vaccines in the European Union (EU) and aims to assess adverse events of interest (AEIs) experienced within 7 days post vaccination with GSK's quadrivalent seasonal influenza vaccine (AlphaRix Tetra in Belgium; Influsplit Tetra in Germany, Fluarix Tetra in Spain).

This study may help to inform decisions regarding future influenza vaccine safety surveillance for influenza vaccines in Europe.

Publications & conference data

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

1. Brand-Specific Enhanced Safety Surveillance of GSK's Quadrivalent Seasonal Influenza Vaccine in Belgium, Germany and Spain for the 2018/2019 Season.
   Dos Santos G, Nguyen BY, Damaso S, Godderis L, et al · · 2020 · cited 8× · PMID 31884676 · DOI 10.1007/s40264-019-00893-4
2. 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
3. Passive enhanced safety surveillance of GSK's quadrivalent seasonal influenza vaccine in Belgium, Germany and Spain, an observational study: protocol for the 2018/2019 influenza season.
   Dos Santos G, Yeakey A, Shende V, Smith K, et al · · 2019 · cited 4× · PMID 31427321 · DOI 10.1136/bmjopen-2018-028043