Study to Assess the Immune Response and the Safety Profile of a High-Dose Quadrivalent Influenza … (NCT04537234) | Clinical Trial Compass
CompletedPhase 3
Study to Assess the Immune Response and the Safety Profile of a High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Compared to a Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) in Taiwanese Adults 65 Years of Age and Older
Taiwan165 participantsStarted 2020-11-10
Plain-language summary
Primary Objective:
Immunogenicity: To describe the immune response induced by high-dose quadrivalent influenza vaccine (QIV-HD) and AdimFlu-S (QIS) by hemagglutinin inhibition (HAI) measurement method in all participants.
Safety: To describe the safety profile of all participants in each study groups.
Who can participate
Age range65 Years
SexALL
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Inclusion criteria :
* 65 years and older on the day of inclusion.
* Able to attend all scheduled visits and complied with all study procedures.
Exclusion criteria:
* Participation at the time of study enrollment (or in the 4 weeks preceding the study vaccination) or planned participation during the study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure.
* Receipt of any vaccine in the 4 weeks (28 days) preceding the study vaccination or planned receipt of any vaccine prior to Visit 2.
* Previous vaccination against influenza (in the preceding 6 months) with either the study vaccine or another vaccine.
* Receipt of immune globulins, blood or blood-derived products in the past 3 months.
* Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
* Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the study or to a vaccine containing any of the same substances.
* Thrombocytopenia, bleeding disorder, or receipt of anticoagulants that based on Investigator's judgment contraindicate intramuscular vaccination.
* Deprived of freedom by an administrative or court order, or in an emergency se…
What they're measuring
1
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 0
Timeframe: Day 0 (pre-vaccination)
2
Geometric Mean Titers of Influenza Vaccine Antibodies at Day 28
Timeframe: Day 28 (post-vaccination)
3
Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine Antibodies
Timeframe: Day 0 (pre-vaccination), Day 28 (post-vaccination)
4
Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens
Timeframe: Day 28 (post-vaccination)
5
Percentage of Participants With Antibody Titers >=40 (1/Dilution) at Day 0
Timeframe: Day 0 (pre-vaccination)
6
Percentage of Participants With Antibody Titers >=40 (1/Dilution) at Day 28
Timeframe: Day 28 (post-vaccination)
7
Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs)