Pooled Analysis of Methodologically Harmonized Pragmatic Randomized Trials of High-Dose vs. Standard-Dose Influenza Vaccine Against Severe Clinical Outcomes
Launched by TOR BIERING-SØRENSEN · Jul 12, 2024
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the effectiveness of two types of flu vaccines: a high-dose vaccine and a standard-dose vaccine. Researchers want to see which one is better at preventing severe health issues caused by the flu in older adults. To do this, they will combine data from two studies conducted in different countries, helping them get more accurate results and understand how well these vaccines work across different populations.
To be eligible for this trial, participants need to be involved in studies that compare the high-dose vaccine with the standard-dose vaccine and meet certain quality standards. Participants can expect to contribute to important research that could improve flu prevention strategies for older adults. It’s important to note that this trial is not yet recruiting participants, meaning they haven’t started enrolling people yet.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Pragmatic trials conducted to estimate the relative vaccine effectiveness of high-dose influenza vaccine compared with standard-dose influenza vaccine using the DANFLU-2 protocol or a protocol developed based on the DANFLU-2 protocol
- Exclusion Criteria:
- • Low data quality
- • Influenza circulation threshold was not met in any of the study seasons
- • Severe under-enrollment in all seasons
About Tor Biering Sørensen
Tor Biering-Sørensen is a distinguished clinical trial sponsor recognized for its commitment to advancing medical research and innovation. With a focus on developing effective therapeutic solutions, the organization collaborates with leading researchers and healthcare professionals to design and conduct rigorous clinical trials. Tor Biering-Sørensen prioritizes adherence to ethical standards and regulatory compliance, ensuring the safety and well-being of participants while striving to generate valuable data that contributes to the enhancement of patient care. Through its dedication to scientific excellence, the organization plays a pivotal role in translating research findings into meaningful healthcare advancements.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Trial Officials
Tor Biering-Sørensen, MD, MSc, MPH, PhD
Study Chair
Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported