A Pragmatic Randomized Trial to Evaluate the Effectiveness of High-Dose Quadrivalent Influenza Vaccine vs. Standard-Dose Quadrivalent Influenza Vaccine in Older Adults
Overview
- Phase
- Phase 4
- Intervention
- High-Dose Quadrivalent Influenza Vaccine
- Conditions
- Influenza
- Sponsor
- Tor Biering-Sørensen
- Enrollment
- 332438
- Locations
- 2
- Primary Endpoint
- Hospitalization for influenza or pneumonia
- Status
- Completed
- Last Updated
- 7 months ago
Overview
Brief Summary
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.
Detailed Description
The study is a pragmatic, registry-based, open-label, active-controlled, individually randomized trial. The Danish nationwide administrative health registries will be used for data collection including baseline information, follow-up data, and safety monitoring. The study aims to randomize 339,700 participants over 3 influenza seasons. In each season, participants will be individually randomized 1:1 to receive either QIV-HD or QIV-SD. During the 2023/2024 and 2024/2025 seasons, up to 12,000 participants will be enrolled in a sub-cohort where participants are asked to perform home self-swabs and answer symptom questionnaires in case of influenza-like illness to enable further assessment of the impact of QIV-HD vs. QIV-SD on patient-reported outcomes among individuals with influenza-like illness and laboratory-confirmed influenza.
Investigators
Tor Biering-Sørensen
Professor, MD, PhD, MPH
Herlev and Gentofte Hospital
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
Arms & Interventions
High-Dose Quadrivalent Influenza Vaccine
QIV-HD single injection at Day 0
Intervention: High-Dose Quadrivalent Influenza Vaccine
Standard-Dose Quadrivalent Influenza Vaccine
QIV-SD single injection at Day 0
Intervention: Standard-Dose Quadrivalent Influenza Vaccine
Outcomes
Primary Outcomes
Hospitalization for influenza or pneumonia
Time Frame: ≥14 days after vaccination up to 8 months
Secondary Outcomes
- Hospitalization for pneumonia(≥14 days after vaccination up to 8 months)
- Hospitalization for any cardio-respiratory disease(≥14 days after vaccination up to 8 months)
- All-cause hospitalization(≥14 days after vaccination up to 8 months)
- All-cause mortality(≥14 days after vaccination up to 8 months)
- Hospitalization for influenza(≥14 days after vaccination up to 8 months)