NCT02893878 is a clinical trial of Vaccine safety surveillance in Influenza, Human, sponsored by GlaxoSmithKline.

Who is sponsoring NCT02893878?

NCT02893878 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT02893878?

Interventions in NCT02893878: Vaccine safety surveillance.

What condition does NCT02893878 study?

NCT02893878 studies Influenza, Human.

Is NCT02893878 still recruiting?

NCT02893878 is currently completed. Last updated 11 February 2019.

Are results published for NCT02893878?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-02-11 · How we verify

NCT02893878

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Post-authorisation Passive Enhanced Safety Surveillance of Seasonal Influenza Vaccines

Completed Results posted Last updated 11 February 2019

What this trial tests

trial testing Vaccine safety surveillance in Influenza, Human in 19,334 participants. Completed in 24 November 2016.

Timeline

12 September 2016

Primary endpoint
24 November 2016

24 November 2016

Quick facts

Lead sponsor	GlaxoSmithKline
Status	Completed
Study type	OBSERVATIONAL
Enrollment	19,334
Start date	12 September 2016
Primary completion	24 November 2016
Estimated completion	24 November 2016
Sites	1 location across United Kingdom

Drugs / interventions tested

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.

Number of Subjects Reporting European Medical Agency (EMA) Defined Adverse Events of Interest (AEIs) (Any) & Onset Dates of AEIs Using a Card Based-adverse Drug Reaction (ADR) Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. Primary · Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome). The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.

Week 37

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	0

Week 38

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	67

Week 39

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	169

Week 40

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	164

Week 41

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	112

Week 42

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	85

Week 43

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	29

Week 44

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	31

Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). Primary · Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Week 37

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	0

Week 38

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	67

Week 39

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	236

Week 40

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	400

Week 41

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	512

Week 42

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	597

Week 43

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	626

Week 44

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	657

Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. Primary · Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.

Week 37

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	0

Week 38

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	4

Week 39

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	15

Week 40

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	8

Week 41

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	10

Week 42

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	9

Week 43

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	3

Week 44

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	2

Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis in a (Cumulative). Primary · Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Week 37

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	0

Week 38

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	4

Week 39

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	19

Week 40

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	27

Week 41

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	37

Week 42

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	46

Week 43

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	49

Week 44

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	51

Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. Primary · Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Local symptoms include local erythema. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.

Week 37

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	0

Week 38

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	16

Week 39

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	20

Week 40

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	24

Week 41

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	28

Week 42

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	15

Week 43

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	6

Week 44

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	7

Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis in a (Cumulative). Primary · Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Week 37

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	0

Week 38

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	16

Week 39

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	36

Week 40

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	60

Week 41

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	88

Week 42

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	103

Week 43

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	109

Week 44

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	116

Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. Primary · Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, irritability and malaise. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.

Any, Week 37

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	0

Any, Week 38

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	20

Any, Week 39

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	47

Any, Week 40

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	43

Any, Week 41

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	25

Any, Week 42

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	20

Any, Week 43

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	3

Any, Week 44

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	6

Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). Primary · Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Any, Week 37

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	0

Any, Week 38

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	20

Any, Week 39

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	67

Any, Week 40

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	110

Any, Week 41

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	135

Any, Week 42

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	155

Any, Week 43

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	158

Any, Week 44

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	164

Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. Primary · Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Respiratory/Miscellaneous AE include any respiratory/miscellaneous AE, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.

Any, Week 37

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	0

Any, Week 38

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	30

Any, Week 39

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	100

Any, Week 40

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	95

Any, Week 41

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	64

Any, Week 42

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	58

Any, Week 43

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	22

Any, Week 44

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	13

Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). Primary · Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Any, Week 37

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	0

Any, Week 38

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	30

Any, Week 39

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	130

Any, Week 40

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	225

Any, Week 41

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	289

Any, Week 42

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	347

Any, Week 43

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	369

Any, Week 44

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	382

Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. Primary · Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Gastrointestinal AEs include any gastrointestinal AEs, decreased appetite, diarrhoea, nausea and vomiting. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.

Any, Week 37

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	0

Any, Week 38

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	15

Any, Week 39

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	29

Any, Week 40

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	29

Any, Week 41

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	21

Any, Week 42

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	18

Any, Week 43

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	6

Any, Week 44

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	4

Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). Primary · Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Any, Week 37

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	0

Any, Week 38

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	15

Any, Week 39

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	44

Any, Week 40

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	73

Any, Week 41

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	94

Any, Week 42

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	112

Any, Week 43

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	118

Any, Week 44

Group	Value	95% CI
Vaccinated_Fluarix Tetra Group	122

Adverse events — posted to ClinicalTrials.gov

Time frame: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Vaccinated_Fluarix Tetra Group

Serious: 0/13861 (0%)

Deaths: —

Vaccinated_Non GSK Group

Serious: 0/2295 (0%)

Deaths: —

Vaccinated_Unknown Group

Serious: 0/3178 (0%)

Deaths: —

Other adverse events (31 terms — click to expand)

Reaction	System	Vaccinated_Fluarix Tetra G…	Vaccinated_Non GSK Group	Vaccinated_Unknown Group
Muscle aches/myalgia	Musculoskeletal and connective tissue disorders	—	—	—
Nasal congestion	General disorders	—	—	—
Rhinorrhoea	General disorders	—	—	—
Cough	General disorders	—	—	—
Headache	General disorders	—	—	—
Fatigue	General disorders	—	—	—
Oropharyngeal pain	General disorders	—	—	—
Fever/pyrexia	General disorders	—	—	—
Local erythema	General disorders	—	—	—
Coryza	General disorders	—	—	—
Arthropathy	Musculoskeletal and connective tissue disorders	—	—	—
Drowsiness	General disorders	—	—	—
Hoarseness	General disorders	—	—	—
Nausea	Gastrointestinal disorders	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—
Wheezing	General disorders	—	—	—
Decreased appetite	Gastrointestinal disorders	—	—	—
Generalised rash	General disorders	—	—	—
Conjunctivitis	General disorders	—	—	—
Peripheral tremor	General disorders	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—
Irritability	General disorders	—	—	—
Rash	General disorders	—	—	—
Hypersensitivity reactions	General disorders	—	—	—
Epistaxis	General disorders	—	—	—
Malaise	General disorders	—	—	—
Seizure / Febrile convulsions	General disorders	—	—	—
Facial oedema	General disorders	—	—	—
Anaphylactic reactions	General disorders	—	—	—
Bell's palsy	Nervous system disorders	—	—	—
Guillain-Barre Syndrome	Nervous system disorders	—	—	—

Data from ClinicalTrials.gov NCT02893878 adverse events section.

Sponsor's own description

The purpose of this 2016/17 pilot study is to improve the combination of a card-based adverse drug reaction (ADR) system and the use of routine data to collect adverse events following vaccination with seasonal influenza vaccines, as per European Medicines Agency (EMA) guidance and Pharmacovigilance Risk Assessment Committee of EMA (PRAC) requirements, and to identify additional data which may need to be collected in order to appropriately address the requirement.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Enhanced passive surveillance of influenza vaccination in England, 2016-2017- an observational study using an adverse events reporting card.
de Lusignan S, Ferreira F, Damaso S, Byford R, et al · · 2019 · cited 19× · PMID 30648923 · DOI 10.1080/21645515.2019.1565258

Verify or expand the search:

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Currently open trials in the same condition.

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Other GlaxoSmithKline trials

Trials by the same sponsor.

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NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02893878 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 11 February 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02893878.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT02893878

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Influenza, Human

Other GlaxoSmithKline trials

Verify against primary sources