Safety Surveillance of VaxigripTetra® and Efluelda® Influenza Vaccines in Europe During the Influenza Season 2022/23
NCT ID: NCT05568979
Last Updated: 2024-03-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1001 participants
OBSERVATIONAL
2022-10-06
2022-11-29
Brief Summary
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The primary objective of this surveillance is to estimate the vaccinee reporting rate (RR) of suspected adverse drug reactions (ADRs) occurring within 7 days following routine vaccination with VaxigripTetra® and Efluelda®, respectively, during the Northern Hemisphere (NH) influenza season 2022/23.
The secondary objectives of the study are:
* To estimate the vaccinee reporting rate of suspected ADRs occurring within 7 days following routine vaccination with VaxigripTetra® and Efluelda®, respectively, according to the pre-defined age groups (not applicable for Efluelda®)
* To estimate the vaccinee reporting rate of serious suspected ADRs after vaccination with VaxigripTetra® and Efluelda®, respectively, at any time following vaccination, within the EPSS
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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VaxigripTetra®
Participant vaccinated with VaxigripTetra® as per routine clinical practice
Quadrivalent Influenza Vaccine
Intramuscular or subcutaneous administration
Efluelda®
Participant vaccinated with Efluelda® as per routine clinical practice
High-Dose Quadrivalent Influenza Vaccine
Intramuscular administration
Interventions
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Quadrivalent Influenza Vaccine
Intramuscular or subcutaneous administration
High-Dose Quadrivalent Influenza Vaccine
Intramuscular administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
6 Months
ALL
Yes
Sponsors
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Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Investigational Site Number : 2-2-002
Helsinki, , Finland
Investigational Site Number : 2-2-005
Jyväskylä, , Finland
Investigational Site Number : 2-2-004
Kuopio, , Finland
Investigational Site Number : 2-2-006
Rauma, , Finland
Investigational Site Number : 2-2-003
Tampere, , Finland
Investigational Site Number : 2-2-001
Turku, , Finland
Investigational Site Number : 2760011
Berlin, , Germany
Investigational Site Number : 2760005
Blankenhain, , Germany
Investigational Site Number : 2760001
Donaueschingen, , Germany
Investigational Site Number : 2760004
Düsseldorf, , Germany
Investigational Site Number : 2760007
Frankfurt am Main, , Germany
Investigational Site Number : 2760002
Fulda, , Germany
Investigational Site Number : 2760003
Grafenrheinfeld, , Germany
Investigational Site Number : 2760009
Martinsried, , Germany
Investigational Site Number : 2760008
Wendelstein, , Germany
Countries
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References
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Machado MAA, Gandhi-Banga S, Gallo S, Cousseau TG, Byrareddy RM, Nissila M, Schelling J, Monfredo C. Enhanced passive safety surveillance of high-dose and standard-dose quadrivalent inactivated split-virion influenza vaccines in Germany and Finland during the 2022/23 influenza season. Hum Vaccin Immunother. 2024 Dec 31;20(1):2322196. doi: 10.1080/21645515.2024.2322196. Epub 2024 Mar 6.
Other Identifiers
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U1111-1271-1492
Identifier Type: REGISTRY
Identifier Source: secondary_id
FLU00171
Identifier Type: OTHER
Identifier Source: secondary_id
FLU00171
Identifier Type: -
Identifier Source: org_study_id
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