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A Pragmatic Randomized Trial to Evaluate the Effectiveness of High-Dose Quadrivalent Influenza Vaccine vs. Standard-Dose Quadrivalent Influenza Vaccine in Older Adults
A Pragmatic Randomized Trial to Evaluate the Effectiveness of High-Dose Quadrivalent Influenza Vaccine vs. Standard-Dose Quadrivalent Influenza Vaccine in Older Adults

NCT05517174

CompletedPhase 4

Sponsor: Tor Biering-Sørensen

Conditions: Influenza

Interventions: High-Dose Quadrivalent Influenza Vaccine, Standard-Dose Quadrivalent Influenza Vaccine

Countries: Denmark

The purpose of this pragmatic randomized trial is to evaluate the relative vaccine effectiveness of high-dose quadrivalent influenza vaccine (QIV-HD) vs. standard-dose quadrivalent influenza vaccine (QIV-SD) in older adults. Participants will be randomized 1:1 to either QIV-HD or QIV-SD.

Eligibility overview

Sex: ALL

Age: 65 Years to —

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Age 65 years and above (this inclusion criterion will be modified according to the Danish government's official recommendations for the 2022/2023 and 2023/2024 influenza seasons)
* Informed consent form has been signed and dated

Exclusion Criteria:

* There are no specific exclusion criteria for this study
Locations (2)
  • Hellerup, Capital Region, Denmark
  • Søborg, Denmark