Study identification

PURI

https://redirect.ema.europa.eu/resource/50294

EU PAS number

EUPAS47725

Study ID

50294

Official title and acronym

Effectiveness of heterologous and booster Covid-19 vaccination in 5 European countries, using a cohort approach in children and adults with a full primary Covid-19 vaccination regimen (Covid Vaccines Effectiveness (CoVE))

DARWIN EU® study

No

Study countries

France
Italy
Netherlands
Spain
United Kingdom

Study description

Real-world effectiveness data demonstrated that Covid-19 vaccines' protection against severe SARS-CoV-2 infection is high in the short term but wanes over time, also depending on the virus variants. This study will deepen the real-world data effectiveness evidence of heterologous, homologous, and booster vaccination different regimes on a large population scale. The goal of this study is to assess the effectiveness and waning of immunity of primary Covid-19 vaccinations and the booster in preventing different covid-19 outcomes. The Primary objective is to estimate the effectiveness and waning of effectiveness in adults and adolescents (heterologous vs homologous primary vaccinations), children (vaccinations vs non-vaccination), homologous or heterologous booster vs no booster. Secondary objective: To estimate the effectiveness of booster against all-cause mortality in adults 60+. Retrospective multi-database cohort study. Cohort entry (time0) is the date of the 2nd dose for the primary vaccination regimens, or the booster. The same date for pairs who are matched on time0, birth year, sex and region. Outcomes: severe Covid-19, Covid-19-related death, all Covid-19 infections, and all-cause mortality. The study will include 8 data sources across from Spain, Italy, Netherlands, France, and United Kingdom. The population are estimated in around 67 millions patients with complete primary vaccination. Baseline characteristics, Incident rates differences and IPW Kaplan-Meier curves for covid outcomes by matched cohorts will be estimated. Vaccine effectiveness will be estimated as 1 minus the Hazard Ratio (estimated by Cox regression) for age groups, overall matched cohorts, and brands. Meta-analyses will be performed for small subpopulations. Different access to Covid-19 testing (restricting to patients with negative tests) and healthy vaccinee effect will be investigated in sensitivity analyses.

Study status

Finalised
Research institution and networks

Institutions

RTI Health Solutions (RTI-HS)
France
Spain
Sweden
United Kingdom
United Kingdom (Northern Ireland)
United States
First published:
19/02/2024
InstitutionNot-for-profitENCePP partner
Teamit Institute
Spain
First published:
12/03/2024
InstitutionOtherENCePP partner
l’Assistance Publique-Hôpitaux de Paris (APHP) France, Teamit Institute, S.L. Spain, PHARMO Institute for Drug Outcomes Research. Netherland, Società Servizi Telematici -Pedianet. Italy, Institute of Public Health, Riga Stradins University Latvia, Democritus University of Thrace Greece, National Public Health Agency (RIVM) Netherlands

Networks

Contact details

Elisa Martín Merino

Primary lead investigator
ORCID number:
0000-0002-3576-8605
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
EMA
Study protocol
Initial protocol

D2_StudyProtocol_v0.4_ROC12_FINAL_20220615

English (1.12 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable