Study type

Study topic

Human medicinal product

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

Cohort
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
Population studied

Short description of the study population

The study population was recruited from hospital- based healthcare workers (HCWs) in participating hospitals, eligible for vaccination, with no contraindication to receive COVID-19 vaccine. HCWs included all categories of staff working in the hospitals and are defined as all staff involved or providing direct care to patients, who may not have provided direct care to the patient but who have had contact with the patient’s body fluids, potentially contaminated items or environmental surfaces present as well as those who may have been in the same area as patients.
HCW who have already been vaccinated against COVID-19 as part of the routine COVID-19 vaccine rollout could be included, as long as information can be collected about the vaccine brand(s), number of doses and dates of vaccination. HCW who are not eligible for COVID-19 vaccination, or where vaccination is contra-indicated, or who have not signed an informed consent form for the winter season 2023/24 were not eligible to participate in the study and were excluded.

Age groups

Adults (18 to < 65 years)
Adults (18 to < 46 years)
Adults (46 to < 65 years)

Estimated number of subjects

3000
Study design details

Study design

Prospective longitudinal multicentre cohort study among health workers eligible for vaccination.

Main study objective

The primary objective of this study is to measure COVID-19 vaccine effectiveness (VE) amongst hospital HCWs eligible for vaccination against laboratory-confirmed SARS-CoV-2 infection.

Setting

EU/EEA hospital HCWs eligible for COVID-19 vaccination. The study should be conducted only after the study protocol is approved by the relevant ethical review committee. The study period begins any time after COVID-19 vaccines became available in each of the participating countries. The study period should ensure for all individuals enrolled a minimum follow-up of three months and longer if feasible. Follow-up time will also depend on the level of viral circulation.

Outcomes

The primary outcome was a confirmed SARS-CoV-2 infection detected by laboratory RT-PCR in any participant, regardless of symptoms.
Secondary outcomes included symptomatic COVID-19 defined as participants with confirmed SARS-CoV-2 infection detected by laboratory RT-PCR who reported 14 days before to 7 days after the first positive RT-PCR test: one or more of the symptoms or a set of clinical criteria to conform with the Influenza-like illness (ILI) and acute respiratory infection (ARI) case definition.

Data analysis plan

See protocol.
Documents
Study report
Interim analysis of COVID-19 vaccine effectiveness in healthcare workers, an EC…
Study, other information
Generic protocol for ECDC studies of influenza vaccine effectiveness against co…