Vaccine Effectiveness, Burden and Impact Studies (VEBIS), Vaccine effectiveness against COVID-19 and seasonal influenza among patients presenting to primary care physicians in EU/EEA

Study type

• Study topic:
  Human medicinal product
• Study topic, other:
  Vaccine effectiveness
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Case-control

Study drug and medical condition

• Name of medicine:
  BIMERVAX

  COMIRNATY

  JCOVDEN

  NUVAXOVID

  SPIKEVAX

  VAXZEVRIA
• Study drug International non-proprietary name (INN) or common name:
  COVID-19 MRNA VACCINE (NUCLEOSIDE-MODIFIED)

  COVID-19 VACCINE (RECOMBINANT, ADJUVANTED)

  DAVESOMERAN

  ELASOMERAN

  IMELASOMERAN

  RAXTOZINAMERAN

  TOZINAMERAN
• Anatomical Therapeutic Chemical (ATC) code:
  (J07BN) Covid-19 vaccines

  Covid-19 vaccines

  (J07BN01) covid-19, RNA-based vaccine

  covid-19, RNA-based vaccine

  (J07BN02) covid-19, viral vector, non-replicating

  covid-19, viral vector, non-replicating

  (J07BN04) covid-19, protein subunit

  covid-19, protein subunit
• Medical condition to be studied:
  COVID-19

  Influenza
• Additional medical condition(s):
  Influenza-like illness (ILI) or acute respiratory infection (ARI)

Population studied

• Short description of the study population:
  The study population comprises of community-dwelling individuals with symptoms of influenza-like illness (ILI) or acute respiratory infection (ARI) and no contraindication for influenza/COVID-19 vaccination, who consult a participating study physician.
• Age groups:
  Paediatric Population (< 18 years)

  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  Adult and elderly population (≥18 years)

  Adults (18 to < 65 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Elderly (≥ 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)

Study design details

• Study design:
  At study site/country level: test-negative, case-control study design in primary care setting.; At European level: test-negative, case-control study design in primary care setting using pooled data from several countries.
• Main study objective:
  The primary objective is to measure, for each EU/EEA primary care study site participating in IVE and CVE studies, and for pooled analyses, the direct effect of influenza and COVID-19 vaccines overall and by vaccine product against symptomatic laboratory-confirmed influenza or SARS-CoV-2
• Setting:
  The study population comprises community-dwelling individuals who present to participating physicians in the primary care setting, with symptoms meeting the case definition of their influenza or COVID-19 surveillance system, with no contraindications for influenza vaccination (for IVE) or COVID-19 vaccination (for CVE). The study period for seasonal IVE starts when the seasonal influenza vaccine of the corresponding season becomes available and the influenza season begins in the country/region, and will finish at the end of the influenza period. Cases and controls are included from the week of onset of the first influenza positive case presenting in each country-specific study.; The study period for CVE starts when the COVID-19 vaccine is available for the target group of interest in each of the participating countries and when SARS-CoV-2 is circulating. The study period is defined for each priority vaccination group, and begins for each vaccination group, when vaccination campaign in this group begins.; Physicians in participating primary care practices recruit patients and collect data throughout the year.
• Outcomes:
  IVE studies; The primary outcome of interest will be PCR laboratory-confirmed influenza in symptomatic patients of all ages consulting at primary care level. The specific outcomes of interest are:; • subtype-specific laboratory-confirmed influenza A;; • laboratory-confirmed influenza B overall and, if available, by lineage (B Victoria/B Yamagata); and; • laboratory-confirmed influenza by clade/genetic variant (where possible).; ; CVE studies; The primary outcome of interest will be PCR laboratory-confirmed SARS-CoV-2 in symptomatic patients of all ages consulting at primary care level. Confirmation with rapid-diagnostic tests can be considered if highly specific and sensitive tests are used (see section 3.6 on ‘laboratory methods’).; Secondary outcomes of interest, in the same patient group at primary care level, will be genetic variants of SARS-CoV-2.
• Data analysis plan:
  See protocol: https://www.ecdc.europa.eu/sites/default/files/documents/Core-protocol-ECDC-COVID-19-vaccine-studies-october2023.pdf

Documents

Study publications

Interim 2022/23 influenza vaccine effectiveness: six European studies, October …

Interim 2023/24 influenza A vaccine effectiveness: VEBIS European primary care …