Post-authorisation Passive Enhanced Safety Surveillance of Seasonal Influenza Vaccines: Pilot Study in England

NCT03278067 | Completed Results

• 1 other identifier: 207781
• Study Type: observational
• Target: 23,939
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Influenza, Human

Keywords

England; Adverse Event of Interest; Seasonal influenza vaccines; Pilot study; Prospective passive enhanced safety surveillance

Outcome Measures

Primary Outcomes (66)

• Weekly Incidence Rates of Any Adverse Events of Interest (AEIs) Reported Via Adverse Drug Reaction (ADR) Card, by Vaccine Group

  The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card 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

  Within 7 days post vaccination

• Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group

  The cumulative incidence rates of AEIs expressed as the 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 received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card 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

  Within 7 days post vaccination

• Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group

  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: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card 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

  Within 7 days post vaccination

• Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group

  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: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card 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

  Within 7 days post vaccination

• Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group

  Local symptoms include local erythema. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card 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

  Within 7 days post vaccination

• Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group

  Local symptoms include local erythema. The cumulative incidence rates of AEIs expressed as the 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 received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card 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

  Within 7 days post vaccination

• Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group

  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: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card 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

  Within 7 days post vaccination

• Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group

  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: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card 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

  Within 7 days post vaccination

• Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group

  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: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card 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

  Within 7 days post vaccination

• Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group

  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: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card 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

  Within 7 days post vaccination

• Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group

  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: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card 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

  Within 7 days post vaccination

• Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group

  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: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card 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

  Within 7 days post vaccination

• Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group

  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: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card 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

  Within 7 days post vaccination

• Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group

  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: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card 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

  Within 7 days post vaccination

• Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group

  The weekly incidence rates expressed as the percentage of subjects, of AEIs were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card 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

  Within 7 days post vaccination

• Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group

  The cumulative incidence rates of AEIs expressed as the 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 received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card 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

  Within 7 days post vaccination

• Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group

  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: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card 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

  Within 7 days post vaccination

• Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group

  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: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card 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

  Within 7 days post vaccination

• Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group

  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: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card 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

  Within 7 days post vaccination

• Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group

  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: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card 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

  Within 7 days post vaccination

• Weekly Incidence Rates of SAEs Reported Via ADR Card by Vaccine Group

  The weekly incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card; * The numerator was the number of subjects from the denominator who reported any SAEs on the ADR card 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

  Within 7 days post vaccination

• Cumulative Incidence Rates of SAEs Reported Via ADR Card by Vaccine Group

  The cumulative incidence rates of SAEs expressed as the 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 received the ADR card; * The numerator was the number of subjects from the denominator who reported any SAEs on the ADR card 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.

  Within 7 days post vaccination

• Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group

  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: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card 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

  Within 7 days post vaccination

• Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group

  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: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card 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

  Within 7 days post vaccination

• Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group

  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: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card 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

  Within 7 days post vaccination

• Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group

  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: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card 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

  Within 7 days post vaccination

• Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group

  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: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card 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

  Within 7 days post vaccination

• Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group

  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: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card 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

  Within 7 days post vaccination

• Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group

  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: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card 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

  Within 7 days post vaccination

• Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group

  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: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card 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

  Within 7 days post vaccination

• Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group

  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: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card 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

  Within 7 days post vaccination

• Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group

  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: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card 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

  Within 7 days post vaccination

• Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group

  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: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card 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

  Within 7 days post vaccination

• Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group

  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: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card 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

  Within 7 days post vaccination

• Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group

  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: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card 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

  Within 7 days post vaccination

• Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group

  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: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card 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

  Within 7 days post vaccination

• Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group

  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: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card 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

  Within 7 days post vaccination

• Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group

  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: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card 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

  Within 7 days post vaccination

• Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group

  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: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card 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

  Within 7 days post vaccination

• Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group

  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: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card 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

  Within 7 days post vaccination

• Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group

  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: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card 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

  Within 7 days post vaccination

• Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group

  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: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card 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

  Within 7 days post vaccination

• Weekly Incidence Rates of Serious Adverse Events (SAEs) Reported Via ADR Card, by Vaccine and Age Group

  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: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any SAEs on the ADR card 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

  Within 7 days post vaccination

• Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine and Age Group

  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: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any SAEs on the ADR card 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

  Within 7 days post vaccination

• Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group and United Kingdom Chief Medical Officer (UK CMO)-Specified Risk Status

  The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card 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

  Within 7 days post vaccination

• Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status

  The cumulative incidence rates of AEIs expressed as the 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 received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card 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

  Within 7 days post vaccination

• Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status

  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: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card 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

  Within 7 days post vaccination

• Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status

  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: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card 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

  Within 7 days post vaccination

• Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status

  Local symptoms include local erythema. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card 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

  Within 7 days post vaccination

• Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status

  Local symptoms include local erythema. The cumulative incidence rates of AEIs expressed as the 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 received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card 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

  Within 7 days post vaccination

• Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status

  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: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card 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

  Within 7 days post vaccination

• Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status

  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: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card 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

  Within 7 days post vaccination

• Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status

  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: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card 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

  Within 7 days post vaccination

• Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status

  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: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card 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

  Within 7 days post vaccination

• Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status

  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: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card 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

  Within 7 days post vaccination

• Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status

  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: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card 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

  Within 7 days post vaccination

• Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status

  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: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card 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

  Within 7 days post vaccination

• Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status

  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: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card 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

  Within 7 days post vaccination

• Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status

  The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card 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

  Within 7 days post vaccination

• Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status

  The cumulative incidence rates of AEIs expressed as the 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 received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card 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

  Within 7 days post vaccination

• Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status

  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: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card 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

  Within 7 days post vaccination

• Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status

  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: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card 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

  Within 7 days post vaccination

• Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status

  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: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card 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

  Within 7 days post vaccination

• Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status

  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: * The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card 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

  Within 7 days post vaccination

• Weekly Incidence Rates of SAEs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status

  The weekly incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows: * The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card * The numerator was the number of subjects from the denominator who reported any SAEs on the ADR card 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

  Within 7 days post vaccination

• Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status

  The cumulative incidence rates of SAEs expressed as the 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 received the ADR card * The numerator was the number of subjects from the denominator who reported any SAEs on the ADR card 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

  Within 7 days post vaccination

Secondary Outcomes (66)

• Weekly Incidence Rates of Any AEIs Recorded in Electronic Health Record (EHR), by Vaccine Group

  Within 7 days post vaccination

• Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group

  Within 7 days post vaccination

• Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group

  Within 7 days post vaccination

• Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group

  Within 7 days post vaccination

• Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group

  Within 7 days post vaccination

Study Arms (3)

Vaccinated_Fluarix Tetra Group

Volunteered subjects who received GlaxoSmithKline's (GSK's) influenza vaccination (Fluarix Tetra) in 10 volunteer GP practices between 01 September and 30 November 2017.

Other: Enhanced vaccine safety surveillance

Vaccinated_Non GSK Group

Volunteered subjects who received non-GSK influenza vaccination in 10 volunteer GP practices between 01 September and 30 November 2017.

Other: Enhanced vaccine safety surveillance

Vaccinated_Unknown Group

Volunteered subjects who received influenza vaccination (GSK or non-GSK not known) in 10 volunteer GP practices between 01 September and 30 November 2017.

Other: Enhanced vaccine safety surveillance

Interventions

Enhanced vaccine safety surveillance OTHER

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.

Also known as: Data collection

Vaccinated_Fluarix Tetra Group; Vaccinated_Non GSK Group; Vaccinated_Unknown Group

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Registered patients in up to 10 general practices in UK immunized against seasonal influenza at the beginning of 2017/18 season.

You may not qualify if:

• Registered patients who have explicitly opted out of data sharing will be excluded from the analysis.

Sponsors & Collaborators

• GlaxoSmithKline: lead
• University of Surrey: collaborator

Study Sites (1)

GSK Investigational Site

Surrey, GU2 7XH, United Kingdom

Location

Related Publications (1)

• de Lusignan S, Damaso S, Ferreira F, Byford R, McGee C, Pathirannehelage S, Shende V, Yonova I, Schmidt A, Schuind A, Dos Santos G. Brand-specific enhanced safety surveillance of GSK's Fluarix Tetra seasonal influenza vaccine in England: 2017/2018 season. Hum Vaccin Immunother. 2020 Aug 2;16(8):1762-1771. doi: 10.1080/21645515.2019.1705112. Epub 2020 Mar 2.

  PMID: 32118513 DERIVED

Biospecimen

Retention: NONE RETAINED

Not applicable (no sample)

MeSH Terms

Conditions

Influenza, Human

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

emily.p.lu@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2017
• First Posted: September 11, 2017
• Study Start: September 12, 2017
• Primary Completion: November 30, 2017
• Study Completion: November 30, 2017
• Last Updated: January 13, 2020
• Results First Posted: January 13, 2020

Record last verified: 2020-01

Locations

GB (1)