N/A
N=19,334
Post-authorisation Passive Enhanced Safety Surveillance of Seasonal Influenza Vaccines
Influenza, Human
Bottom Line
View on ClinicalTrials.gov: NCT02893878 ↗Enrolled (actual)
19,334
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcome: Primary: 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. — 0; 67; 169; 164 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Vaccine safety surveillance (Other)
- Age
- Pediatric, Adult, Older Adult · 0+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
0; 67; 169; 164; 112; 85 | — |
| PRIMARY 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). |
0; 67; 236; 400; 512; 597 | — |
| PRIMARY 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. |
0; 4; 15; 8; 10; 9 | — |
| PRIMARY 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). |
0; 4; 19; 27; 37; 46 | — |
| PRIMARY 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. |
0; 16; 20; 24; 28; 15 | — |
| PRIMARY 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). |
0; 16; 36; 60; 88; 103 | — |
| PRIMARY 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. |
0; 20; 47; 43; 25; 20 | — |
| PRIMARY 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). |
0; 20; 67; 110; 135; 155 | — |
| PRIMARY 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. |
0; 30; 100; 95; 64; 58 | — |
| PRIMARY 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). |
0; 30; 130; 225; 289; 347 | — |
| PRIMARY 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. |
0; 15; 29; 29; 21; 18 | — |
| PRIMARY 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). |
0; 15; 44; 73; 94; 112 | — |
| PRIMARY Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. |
0; 0; 0; 3; 0; 2 | — |
| PRIMARY Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). |
0; 0; 0; 3; 3; 5 | — |
| PRIMARY Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. |
0; 1; 0; 5; 1; 3 | — |
| PRIMARY Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). |
0; 1; 1; 6; 7; 10 | — |
| PRIMARY Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. |
0; 27; 60; 64; 32; 33 | — |
| PRIMARY Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). |
0; 27; 87; 151; 183; 216 | — |
| PRIMARY Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis. |
0; 19; 48; 42; 25; 15 | — |
| PRIMARY Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative). |
0; 19; 67; 109; 134; 149 | — |
| PRIMARY 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 by Age-strata, on a Weekly Basis. |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY 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 by Age-strata, on a Weekly Basis (Cumulative). |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY 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 by Age-strata, on a Weekly Basis. |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY 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 by Age-strata, on a Weekly Basis (Cumulative). |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY 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 by Age-strata, on a Weekly Basis. |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY 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 by Age-strata, on a Weekly Basis (Cumulative). |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY 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 by Age-strata, on a Weekly Basis. |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY 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 by Age-strata, on a Weekly Basis (Cumulative). |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY 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 by Age-strata, on a Weekly Basis. |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY 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 by Age-strata, on a Weekly Basis (Cumulative). |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY 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 by Age-strata, on a Weekly Basis. |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY 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 by Age-strata, on a Weekly Basis (Cumulative). |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis. |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative). |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. |
0; 62; 159; 151; 102; 74 | — |
| PRIMARY Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). |
0; 62; 221; 372; 474; 548 | — |
| PRIMARY 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 by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. |
0; 4; 15; 8; 8; 8 | — |
| PRIMARY 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 by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). |
0; 4; 19; 27; 35; 43 | — |
| PRIMARY 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 by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. |
0; 14; 19; 21; 26; 13 | — |
| PRIMARY 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 by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). |
0; 14; 33; 54; 80; 93 | — |
| PRIMARY 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 by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. |
0; 18; 42; 41; 25; 18 | — |
| PRIMARY 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 by CMO-specified Risk Status, on a Weekly Basis (Cumulative) |
0; 18; 60; 101; 126; 144 | — |
| PRIMARY Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. |
0; 28; 94; 88; 62; 49 | — |
| PRIMARY Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). |
0; 28; 122; 210; 272; 321 | — |
| PRIMARY Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. |
0; 13; 27; 28; 18; 17 | — |
| PRIMARY Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). |
0; 13; 40; 68; 86; 103 | — |
| PRIMARY Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. |
0; 0; 0; 3; 0; 1 | — |
| PRIMARY Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). |
0; 0; 0; 3; 3; 4 | — |
| PRIMARY Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. |
0; 1; 0; 5; 1; 2 | — |
| PRIMARY Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). |
0; 1; 1; 6; 7; 9 | — |
| PRIMARY Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. |
0; 24; 54; 61; 29; 31 | — |
| PRIMARY Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). |
0; 24; 78; 139; 168; 199 | — |
| PRIMARY Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis. |
0; 17; 44; 37; 24; 13 | — |
| PRIMARY Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative). |
0; 17; 61; 98; 122; 135 | — |
| SECONDARY Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. |
0; 0; 0; 87; 4; 7 | — |
| SECONDARY Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). |
0; 0; 0; 87; 4; 7 | — |
| SECONDARY Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. |
0; 0; 0; 8; 2; 2 | — |
| SECONDARY Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). |
0; 0; 0; 8; 2; 2 | — |
| SECONDARY Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. |
0; 0; 0; 16; 0; 0 | — |
| SECONDARY Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative). |
0; 0; 0; 16; 0; 0 | — |
| SECONDARY Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. |
0; 0; 0; 21; 0; 0 | — |
| SECONDARY Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). |
0; 0; 0; 21; 0; 0 | — |
| SECONDARY Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. |
0; 0; 0; 34; 1; 1 | — |
| SECONDARY Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). |
0; 0; 0; 34; 1; 1 | — |
| SECONDARY Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. |
0; 0; 0; 18; 0; 0 | — |
| SECONDARY Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). |
0; 0; 0; 18; 0; 0 | — |
| SECONDARY Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. |
0; 0; 0; 1; 1; 0 | — |
| SECONDARY Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). |
0; 0; 0; 1; 1; 0 | — |
| SECONDARY Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. |
0; 0; 0; 2; 0; 0 | — |
| SECONDARY Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative) |
0; 0; 0; 2; 0; 0 | — |
| SECONDARY Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. |
0; 0; 0; 32; 1; 4 | — |
| SECONDARY Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative). |
0; 0; 0; 32; 1; 4 | — |
| SECONDARY Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis. |
0; 0; 0; 22; 0; 0 | — |
| SECONDARY Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative), |
0; 0; 0; 22; 0; 0 | — |
| SECONDARY Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis. |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative). |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. |
0; 0; 0; 81; 4; 7 | — |
| SECONDARY Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). |
0; 0; 0; 81; 4; 7 | — |
| SECONDARY Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. |
0; 0; 0; 8; 2; 2 | — |
| SECONDARY Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). |
0; 0; 0; 8; 2; 2 | — |
| SECONDARY Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. |
0; 0; 0; 14; 0; 0 | — |
| SECONDARY Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). |
0; 0; 0; 14; 0; 0 | — |
| SECONDARY Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. |
0; 0; 0; 19; 0; 0 | — |
| SECONDARY Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). |
0; 0; 0; 19; 0; 0 | — |
| SECONDARY Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. |
0; 0; 0; 32; 1; 1 | — |
| SECONDARY Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). |
0; 0; 0; 32; 1; 1 | — |
| SECONDARY Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis. |
0; 0; 0; 16; 0; 0 | — |
| SECONDARY Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). |
0; 0; 0; 16; 0; 0 | — |
| SECONDARY Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis |
0; 0; 0; 1; 1; 0 | — |
| SECONDARY Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). |
0; 0; 0; 1; 1; 0 | — |
| SECONDARY Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis |
0; 0; 0; 2; 0; 0 | — |
| SECONDARY Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) |
0; 0; 0; 2; 0; 0 | — |
| SECONDARY Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis |
0; 0; 0; 29; 1; 4 | — |
| SECONDARY Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative) |
0; 0; 0; 29; 1; 4 | — |
| SECONDARY Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis |
0; 0; 0; 19; 0; 0 | — |
| SECONDARY Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative). |
0; 0; 0; 19; 0; 0 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Volunteers receiving an influenza vaccine and receiving an ADR card at the beginning of the 2016/17 season.
Exclusion Criteria
- In the database analysis, registered patients who have explicitly opted out of data sharing will be excluded from the analysis.
Data sourced from ClinicalTrials.gov (NCT02893878). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.