GSK Investigational Site
Surrey, GU2 7XH, United Kingdom
NCT Number: NCT03278067
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.
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All sexes
Observational
Surrey, GU2 7XH, United Kingdom
This is the third pilot study following, EPI-FLU-045 VS UK [NCT02567721] and EPI-FLU-046 VS UK [NCT02893878] studies, carried out in the 2 previous influenza seasons (2015/2016 and 2016/2017). This study will collect data about vaccination status and adverse events following influenza immunisation (AEFI) on a weekly basis, from 01 September 2017 onwards, using a customized Adverse Drug Reaction (ADR) Cards and data from Electronic Health Records system for a period of approximately 13 weeks.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Routinely collected primary care data from up to ten general practices to support passive surveillance. Additionally, this passive surveillance will be enhanced by the use of a customized card-based ADR reporting system.
Other names: Data collection
Time frame: Within 7 days post vaccination
The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Local symptoms include local erythema. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Local symptoms include local erythema. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhea, nausea, and vomiting. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhea, nausea and, vomiting. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The weekly incidence rates expressed as the percentage of subjects, of AEIs were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The cumulative incidence rates expressed as the percentage of subjects, of AEIs were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
The weekly incidence rates expressed as the percentage of subjects, of AEIs were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
The weekly incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
The cumulative incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017.
Time frame: Within 7 days post vaccination
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Local symptoms include local erythema. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Local symptoms include local erythema. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhoea, nausea and vomiting. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhea, nausea, and vomiting. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial oedema and hypersensitivity reactions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
SAE data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. The weekly incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
SAE data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. The cumulative incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Local symptoms include local erythema. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Local symptoms include local erythema. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability and malaise. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhea, nausea, and vomiting. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhea, nausea, and vomiting. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
The weekly incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
The cumulative incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from General Practitioners (GPs). The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Local symptoms include local erythema. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhoea, nausea, and vomiting. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
SAEs reported here are derived from 2 sources of data - ADR cards and SAE routinely collected from GPs. The weekly incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
"subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Local symptoms include local erythema. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhoea, nausea, and vomiting. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The cumulative incidence rates AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy and muscle aches/myalgia. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
SAEs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The cumulative incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEIs reported here are derived from 2 data sources - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years, and >65 years. Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of subjects happened between weeks 35 and 48 of the year 2017
Time frame: Within 7 days post vaccination
AEIs reported here are derived from 2 data sources - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12, 13 to 17, 18 to 65, and >65 years. Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between weeks 35 and 48 of the year 2017
Time frame: Within 7 days post vaccination
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Local symptoms include local erythema. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Local symptoms include local erythema. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEIs reported are derived from 2 data sources: ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12, 13 to 17, 18 to 65, and >65 years. Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhea, and wheezing. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination happened between weeks 35 and 48, of 2017
Time frame: Within 7 days post vaccination
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12, 13 to 17, 18 to 65, and >65 years. Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhea, and wheezing. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between weeks 35 and 48, 2017
Time frame: Within 7 days post vaccination
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhea, nausea, and vomiting. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhoea, nausea and vomiting. The cumulative incidence rates of AEIs expressed as a cumulative percentage of subjects, were estimated as follows:
The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system); The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine.
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEIs reported here are derived from 2 data sources: ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between weeks 35 and 48 of the year 2017
Time frame: Within 7 days post vaccination
AEIs reported here are derived from 2 data sources: ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between weeks 35 and 48 of 2017
Time frame: Within 7 days post vaccination
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy and muscle aches/myalgia. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between weeks 35 and 48 of 2017
Time frame: Within 7 days post vaccination
AEIs reported here are derived from 2 data sources: ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between weeks 35 and 48 of 2017
Time frame: Within 7 days post vaccination
"SAEs reported here are derived from 2 sources of data - ADR cards and SAEs routinely collected from GPs. SAE data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. The weekly incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017"
Time frame: Within 7 days post vaccination
SAEs reported here are derived from 2 sources of data - ADR cards and SAEs routinely collected from GPs. SAE data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. The cumulative incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Local symptoms include local erythema. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Local symptoms include local erythema. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Time frame: Within 7 days post vaccination
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhea, nausea, and vomiting. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhea, nausea, and vomiting. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
SAEs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The weekly incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
Time frame: Within 7 days post vaccination
SAEs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The cumulative incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows:
Vaccination of the subjects happened between week 35 and week 48 of the year 2017
GlaxoSmithKline
Industry
Post-authorisation Passive Enhanced Safety Surveillance of Seasonal Influenza Vaccines: Pilot Study in England 2017/18
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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