Real-World Effectiveness of COVID-19 Vaccines in the Netherlands: Causal Inference From A Retrospective Cohort Study Using the Target Trial Emulation framework Within the PharmLines Initiative

Study summary

No information provided.

Study identification

• EU PAS number:
  EUPAS1000000785
• Study ID:
  1000000785
• Official title and acronym:
  Real-World Effectiveness of COVID-19 Vaccines in the Netherlands: Causal Inference From A Retrospective Cohort Study Using the Target Trial Emulation framework Within the PharmLines Initiative
• DARWIN EU® study:
  No
• Study countries:
  Netherlands
• Study description:
  We will conduct a retrospective population-based new-user cohort study using linked individual-level ; data from the Lifelines cohort, Statistics Netherlands (CBS), and the IADB.nl pharmacy database. Daily target ; trials will be sequentially emulated between June 18, 2021 and October 19, 2022. Adults without prior SARS; CoV-2 infection will be assigned to partially vaccinated, fully vaccinated, booster-vaccinated, or unvaccinated ; strategies according to their eligibility at each trial start. The primary outcome is time to first laboratory-confirmed ; SARS-CoV-2 infection determined by RT-PCR testing. Generalized additive models will estimate time-varying ; hazard ratios, while pooled logistic regression will estimate odds ratios for predefined post-vaccination intervals. ; Inverse probability of treatment and censoring weights, multiple imputation, and prespecified sensitivity analyses ; will address confounding, informative censoring, and missing data.
• Study status:
  Ongoing

Research institutions and networks

Institutions

University of Groningen

Netherlands

Study timelines

Date when funding contract was signed

Planned:01/05/2025

Actual:01/05/2025

Study start date

Planned:01/11/2025

Actual:01/11/2025

Data analysis start date

Planned:01/12/2025

Actual:01/10/2026

Date of final study report

Planned:01/04/2027

Sources of funding

No external funding

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable