Status:
TERMINATED
Study to Evaluate the Effectiveness of a High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Compared to a Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) in Adults 65 Years of Age and Older
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Influenza (Healthy Volunteers)
Eligibility:
All Genders
65+ years
Phase:
PHASE3
Brief Summary
Primary Objective: To demonstrate the superior relative effectiveness of QIV-HD as compared to QIV-SD among persons 65 years of age and older for the prevention of cardiovascular and/or respiratory h...
Detailed Description
Study duration per participant was 1 day of screening and vaccination. The study was planned to be conducted over a period of 3 influenza seasons beginning in 2019-2020. The vaccination period was fro...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- \- Aged 65 years or older on the day of inclusion ("65 years" means from the day of the 65th birthday).
- Exclusion criteria:
- Participation at the time of study enrollment (or in the 4 weeks \[28 days\] preceding the study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure.
- Previous vaccination against influenza (in the preceding 6 months) with either the study vaccines or another vaccine.
- Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the study or to a vaccine containing any of the same substances.
- The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
November 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2020
Estimated Enrollment :
33096 Patients enrolled
Trial Details
Trial ID
NCT04137887
Start Date
November 4 2019
End Date
May 31 2020
Last Update
September 17 2025
Active Locations (1)
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1
Investigational Site Number 2469999
Tampere, Finland, 33520