N/A
N=23,939
Post-authorisation Passive Enhanced Safety Surveillance of Seasonal Influenza Vaccines: Pilot Study in England
Influenza, Human
Bottom Line
View on ClinicalTrials.gov: NCT03278067 ↗Enrolled (actual)
23,939
Serious AEs
0.2%
Results posted
Jan 2020
Primary outcome: Primary: Weekly Incidence Rates of Any Adverse Events of Interest (AEIs) Reported Via Adverse Drug Reaction (ADR) Card, by Vaccine Group — 0.00; 0.00; 0.00; 10.10 Percentage of subjects
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Enhanced vaccine safety surveillance (Other)
- Age
- Pediatric, Adult, Older Adult · 0+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Weekly Incidence Rates of Any Adverse Events of Interest (AEIs) Reported Via Adverse Drug Reaction (ADR) Card, by Vaccine Group |
0.00; 0.00; 0.00; 10.10; 0.00; 12.50 | — |
| PRIMARY Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group |
0.00; 0.00; 0.00; 10.09; 0.00; 10.53 | — |
| PRIMARY Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group |
0.00; 0.00; 0.00; 0.45; 0.00; 0.00 | — |
| PRIMARY Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group |
0.00; 0.00; 0.00; 0.45; 0.00; 0.00 | — |
| PRIMARY Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group |
0.00; 0.00; 0.00; 1.87; 0.00; 6.25 | — |
| PRIMARY Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group |
0.00; 0.00; 0.00; 1.86; 0.00; 5.26 | — |
| PRIMARY Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group |
0.00; 0.00; 0.00; 3.89; 0.00; 6.25 | — |
| PRIMARY Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group |
0.00; 0.00; 0.00; 3.89; 0.00; 5.26 | — |
| PRIMARY Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group |
0.00; 0.00; 0.00; 5.76; 0.00; 0.00 | — |
| PRIMARY Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group |
0.00; 0.00; 0.00; 5.76; 0.00; 0.00 | — |
| PRIMARY Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group |
0.00; 0.00; 0.00; 2.03; 0.00; 6.25 | — |
| PRIMARY Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group |
0.00; 0.00; 0.00; 2.03; 0.00; 5.26 | — |
| PRIMARY Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group |
0.00; 0.00; 0.00; 0.65; 0.00; 0.00 | — |
| PRIMARY Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group |
0.00; 0.00; 0.00; 0.65; 0.00; 0.00 | — |
| PRIMARY Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group |
0.00; 0.00; 0.00; 0.53; 0.00; 0.00 | — |
| PRIMARY Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group |
0.00; 0.00; 0.00; 0.53; 0.00; 0.00 | — |
| PRIMARY Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group |
0.00; 0.00; 0.00; 3.65; 0.00; 6.25 | — |
| PRIMARY Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group |
0.00; 0.00; 0.00; 3.65; 0.00; 5.26 | — |
| PRIMARY Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group |
0.00; 0.00; 0.00; 0.28; 0.00; 0.00 | — |
| PRIMARY Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group |
0.00; 0.00; 0.00; 0.28; 0.00; 0.00 | — |
| PRIMARY Weekly Incidence Rates of SAEs Reported Via ADR Card by Vaccine Group |
0.00; 0.00; 0.00; 0.00; 0.00; 0.00 | — |
| PRIMARY Cumulative Incidence Rates of SAEs Reported Via ADR Card by Vaccine Group |
0.00; 0.00; 0.00; 0.00; 0.00; 0.00 | — |
| PRIMARY Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group |
0.00; 0.00; 0.00; 0.00; 3.38; 0.00 | — |
| PRIMARY Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group |
0.00; 0.00; 0.00; 0.00; 2.59; 0.00 | — |
| PRIMARY Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group |
0.00; 0.00; 0.00; 0.00; 1.45; 0.00 | — |
| PRIMARY Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group |
0.00; 0.00; 0.00; 0.00; 1.11; 0.00 | — |
| PRIMARY Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group |
0.00; 0.00; 0.00; 0.00; 0.00; 0.00 | — |
| PRIMARY Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group |
0.00; 0.00; 0.00; 0.00; 0.00; 0.00 | — |
| PRIMARY Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group |
0.00; 0.00; 0.00; 0.00; 0.00; 0.00 | — |
| PRIMARY Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group |
0.00; 0.00; 0.00; 0.00; 0.00; 0.00 | — |
| PRIMARY Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group |
0.00; 0.00; 0.00; 0.00; 2.90; 0.00 | — |
| PRIMARY Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group |
0.00; 0.00; 0.00; 0.00; 2.22; 0.00 | — |
| PRIMARY Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group |
0.00; 0.00; 0.00; 0.00; 0.97; 0.00 | — |
| PRIMARY Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group |
0.00; 0.00; 0.00; 0.00; 0.74; 0.00 | — |
| PRIMARY Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group |
0.00; 0.00; 0.00; 0.00; 0.00; 0.00 | — |
| PRIMARY Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group |
0.00; 0.00; 0.00; 0.00; 0.00; 0.00 | — |
| PRIMARY Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group |
0.00; 0.00; 0.00; 0.00; 0.00; 0.00 | — |
| PRIMARY Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group |
0.00; 0.00; 0.00; 0.00; 0.00; 0.00 | — |
| PRIMARY Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group |
0.00; 0.00; 0.00; 0.00; 0.00; 0.00 | — |
| PRIMARY Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group |
0.00; 0.00; 0.00; 0.00; 0.00; 0.00 | — |
| PRIMARY Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group |
0.00; 0.00; 0.00; 0.00; 0.00; 0.00 | — |
| PRIMARY Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group |
0.00; 0.00; 0.00; 0.00; 0.00; 0.00 | — |
| PRIMARY Weekly Incidence Rates of Serious Adverse Events (SAEs) Reported Via ADR Card, by Vaccine and Age Group |
0.00; 0.00; 0.00; 0.00; 0.00; 0.00 | — |
| PRIMARY Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine and Age Group |
0.00; 0.00; 0.00; 0.00; 0.00; 0.00 | — |
| PRIMARY Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group and United Kingdom Chief Medical Officer (UK CMO)-Specified Risk Status |
0.00; 0.00; 0.00; 9.94; 0.00; 0.00 | — |
| PRIMARY Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status |
0.00; 0.00; 0.00; 9.94; 0.00; 0.00 | — |
| PRIMARY Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status |
0.00; 0.00; 0.00; 0.39; 0.00; 0.00 | — |
| PRIMARY Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status |
0.00; 0.00; 0.00; 0.39; 0.00; 0.00 | — |
| PRIMARY Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status |
0.00; 0.00; 0.00; 1.67; 0.00; 0.00 | — |
| PRIMARY Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status |
0.00; 0.00; 0.00; 1.67; 0.00; 0.00 | — |
| PRIMARY Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status |
0.00; 0.00; 0.00; 3.86; 0.00; 0.00 | — |
| PRIMARY Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status |
0.00; 0.00; 0.00; 3.86; 0.00; 0.00 | — |
| PRIMARY Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status |
0.00; 0.00; 0.00; 5.62; 0.00; 0.00 | — |
| PRIMARY Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status |
0.00; 0.00; 0.00; 5.61; 0.00; 0.00 | — |
| PRIMARY Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status |
0.00; 0.00; 0.00; 2.01; 0.00; 0.00 | — |
| PRIMARY Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status |
0.00; 0.00; 0.00; 2.01; 0.00; 0.00 | — |
| PRIMARY Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status |
0.00; 0.00; 0.00; 0.64; 0.00; 0.00 | — |
| PRIMARY Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status |
0.00; 0.00; 0.00; 0.64; 0.00; 0.00 | — |
| PRIMARY Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status |
0.00; 0.00; 0.00; 0.51; 0.00; 0.00 | — |
| PRIMARY Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status |
0.00; 0.00; 0.00; 0.51; 0.00; 0.00 | — |
| PRIMARY Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status |
0.00; 0.00; 0.00; 3.51; 0.00; 0.00 | — |
| PRIMARY Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status |
0.00; 0.00; 0.00; 3.51; 0.00; 0.00 | — |
| PRIMARY Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status |
0.00; 0.00; 0.00; 0.21; 0.00; 0.00 | — |
| PRIMARY Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status |
0.00; 0.00; 0.00; 0.21; 0.00; 0.00 | — |
| PRIMARY Weekly Incidence Rates of SAEs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status |
0.00; 0.00; 0.00; 0.00; 0.00; 0.00 | — |
| PRIMARY Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status |
0.00; 0.00; 0.00; 0.00; 0.00; 0.00 | — |
| SECONDARY Weekly Incidence Rates of Any AEIs Recorded in Electronic Health Record (EHR), by Vaccine Group |
0.00; 0.00; 0.00; 1.64; 11.63; 0.00 | — |
| SECONDARY Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group |
0.00; 0.00; 0.00; 0.00; 0.45; 0.00 | — |
| SECONDARY Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group |
0.00; 0.00; 0.00; 0.00; 1.91; 0.00 | — |
| SECONDARY Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group |
0.00; 0.00; 0.00; 0.00; 4.01; 0.00 | — |
| SECONDARY Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group |
0.00; 0.00; 0.00; 1.64; 6.45; 0.00 | — |
| SECONDARY Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group |
0.00; 0.00; 0.00; 0.00; 2.11; 0.00 | — |
| SECONDARY Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group |
0.00; 0.00; 0.00; 0.00; 0.69; 0.00 | — |
| SECONDARY Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group |
0.00; 0.00; 0.00; 0.00; 0.77; 0.00 | — |
| SECONDARY Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group |
0.00; 0.00; 0.00; 0.00; 4.26; 0.00 | — |
| SECONDARY Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group |
0.00; 0.00; 0.00; 0.00; 0.28; 0.00 | — |
| SECONDARY Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine Group |
0.00; 0.00; 0.00; 0.00; 0.12; 0.00 | — |
| SECONDARY Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group |
0.00; 0.00; 0.00; 1.61; 11.63; 0.00 | — |
| SECONDARY Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group |
0.00; 0.00; 0.00; 0.00; 0.45; 0.00 | — |
| SECONDARY Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group |
0.00; 0.00; 0.00; 0.00; 1.90; 0.00 | — |
| SECONDARY Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group |
0.00; 0.00; 0.00; 0.00; 4.01; 0.00 | — |
| SECONDARY Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group |
0.00; 0.00; 0.00; 1.61; 6.44; 0.00 | — |
| SECONDARY Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group |
0.00; 0.00; 0.00; 0.00; 2.11; 0.00 | — |
| SECONDARY Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group |
0.00; 0.00; 0.00; 0.00; 0.69; 0.00 | — |
| SECONDARY Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group |
0.00; 0.00; 0.00; 0.00; 0.77; 0.00 | — |
| SECONDARY Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group |
0.00; 0.00; 0.00; 0.00; 4.25; 0.00 | — |
| SECONDARY Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group |
0.00; 0.00; 0.00; 0.00; 0.28; 0.00 | — |
| SECONDARY Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine Group |
0.00; 0.00; 0.00; 0.00; 0.12; 0.00 | — |
| SECONDARY Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group |
0.00; 0.00; 1.59; 0.00; 0.00; 4.83 | — |
| SECONDARY Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group |
0.00; 0.00; 0.00; 1.59; 0.00; 0.00 | — |
| SECONDARY Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group |
0.00; 0.00; 0.00; 0.00; 0.00; 1.45 | — |
| SECONDARY Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group |
0.00; 0.00; 0.00; 0.00; 0.00; 0.00 | — |
| SECONDARY Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group |
0.00; 0.00; 0.00; 0.00; 0.00; 0.00 | — |
| SECONDARY Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group |
0.00; 0.00; 0.00; 0.00; 0.00; 0.00 | — |
| SECONDARY Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group |
0.00; 0.00; 0.00; 0.00; 0.00; 0.48 | — |
| SECONDARY Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group |
0.00; 0.00; 0.00; 0.00; 0.00; 0.00 | — |
| SECONDARY Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group |
0.00; 0.00; 1.59; 0.00; 0.00; 3.38 | — |
| SECONDARY Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group |
0.00; 0.00; 0.00; 1.59; 0.00; 0.00 | — |
| SECONDARY Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group |
0.00; 0.00; 0.00; 0.00; 0.00; 0.97 | — |
| SECONDARY Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group |
0.00; 0.00; 0.00; 0.00; 0.00; 0.00 | — |
| SECONDARY Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group |
0.00; 0.00; 0.00; 0.00; 0.00; 0.00 | — |
| SECONDARY Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group |
0.00; 0.00; 0.00; 0.00; 0.00; 0.00 | — |
| SECONDARY Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group |
0.00; 0.00; 0.00; 0.00; 0.00; 0.48 | — |
| SECONDARY Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group |
0.00; 0.00; 0.00; 0.00; 0.00; 0.00 | — |
| SECONDARY Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group |
0.00; 0.00; 0.00; 0.00; 0.00; 0.00 | — |
| SECONDARY Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group |
0.00; 0.00; 0.00; 0.00; 0.00; 0.00 | — |
| SECONDARY Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group |
0.00; 0.00; 0.00; 0.00; 0.00; 0.00 | — |
| SECONDARY Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group |
0.00; 0.00; 0.00; 0.00; 0.00; 0.00 | — |
| SECONDARY Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group |
0.00; 0.00; 0.00; 0.00; 0.00; 0.00 | — |
| SECONDARY Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group |
0.00; 0.00; 0.00; 0.00; 0.00; 0.00 | — |
| SECONDARY Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group and United Kingdom Chief Medical Officer (UK CMO)-Specified Risk Status |
0.00; 0.00; 0.00; 1.69; 11.44; 0.00 | — |
| SECONDARY Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status |
0.00; 0.00; 0.00; 1.67; 11.43; 0.00 | — |
| SECONDARY Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status |
0.00; 0.00; 0.00; 0.00; 0.39; 0.00 | — |
| SECONDARY Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status |
0.00; 0.00; 0.00; 0.00; 0.39; 0.00 | — |
| SECONDARY Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status |
0.00; 0.00; 0.00; 0.00; 1.71; 0.00 | — |
| SECONDARY Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status |
0.00; 0.00; 0.00; 0.00; 1.71; 0.00 | — |
| SECONDARY Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status |
0.00; 0.00; 0.00; 0.00; 3.98; 0.00 | — |
| SECONDARY Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status |
0.00; 0.00; 0.00; 0.00; 3.98; 0.00 | — |
| SECONDARY Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status |
0.00; 0.00; 0.00; 1.69; 6.34; 0.00 | — |
| SECONDARY Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status |
0.00; 0.00; 0.00; 1.67; 6.34; 0.00 | — |
| SECONDARY Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status |
0.00; 0.00; 0.00; 0.00; 2.10; 0.00 | — |
| SECONDARY Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status |
0.00; 0.00; 0.00; 0.00; 2.10; 0.00 | — |
| SECONDARY Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status |
0.00; 0.00; 0.00; 0.00; 0.69; 0.00 | — |
| SECONDARY Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status |
0.00; 0.00; 0.00; 0.00; 0.69; 0.00 | — |
| SECONDARY Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status |
0.00; 0.00; 0.00; 0.00; 0.69; 0.00 | — |
| SECONDARY Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status |
0.00; 0.00; 0.00; 0.00; 0.69; 0.00 | — |
| SECONDARY Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status |
0.00; 0.00; 0.00; 0.00; 4.11; 0.00 | — |
| SECONDARY Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status |
0.00; 0.00; 0.00; 0.00; 4.11; 0.00 | — |
| SECONDARY Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status |
0.00; 0.00; 0.00; 0.00; 0.21; 0.00 | — |
| SECONDARY Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status |
0.00; 0.00; 0.00; 0.00; 0.21; 0.00 | — |
| SECONDARY Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status |
0.00; 0.00; 0.00; 0.00; 0.13; 0.00 | — |
| SECONDARY Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status |
0.00; 0.00; 0.00; 0.00; 0.13; 0.00 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- All individuals who receive influenza vaccination among the 10 participating GP practices between 1 September and 30 November 2017 are eligible for inclusion in the analysis.
Exclusion Criteria
- Registered patients who have explicitly opted out of data sharing will be excluded from the analysis.
Data sourced from ClinicalTrials.gov (NCT03278067). 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.