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Safety Surveillance of VaxigripTetra® and Efluelda® Influenza Vaccines in Europe During the Influenza Season 2023/24

NCT ID: NCT06059456

Last Updated: 2025-03-24

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

2078 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-02

Study Completion Date

2023-12-15

Brief Summary

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This EPSS will determine the vaccinee reporting rates (RRs) of suspected ADRs following routine vaccination with VaxigripTetra® and Efluelda® respectively, during the NH influenza season 2023/24. 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 2023/24. Study duration per participant 2 months (including 6 weeks for VC distribution 2 weeks for vaccinee reporting) following the first vaccination

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Detailed Description

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Conditions

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Influenza Immunization (Healthy Volunteers)

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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VaxigripTetra®

Participant vaccinated with VaxigripTetra® as per routine clinical practice

Quadrivalent Influenza Vaccine

Intervention Type BIOLOGICAL

Intramuscular or subcutaneous administration

Efluelda®

Participant vaccinated with Efluelda® as per routine clinical practice

High-Dose Quadrivalent Influenza Vaccine

Intervention Type BIOLOGICAL

Intramuscular or subcutaneous administration

Interventions

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Quadrivalent Influenza Vaccine

Intramuscular or subcutaneous administration

Intervention Type BIOLOGICAL

High-Dose Quadrivalent Influenza Vaccine

Intramuscular or subcutaneous administration

Intervention Type BIOLOGICAL

Other Intervention Names

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VaxigripTetra® Efluelda®

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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Investigational Site Number : 2460001

Helsinki, , Finland

Site Status

Investigational Site Number : 2760001

Martinsried, , Germany

Site Status

Investigational Site Number : 2760002

Martinsried, , Germany

Site Status

Investigational Site Number : 2760003

Martinsried, , Germany

Site Status

Investigational Site Number : 2760004

Martinsried, , Germany

Site Status

Investigational Site Number : 2760005

Martinsried, , Germany

Site Status

Investigational Site Number : 2760006

Martinsried, , Germany

Site Status

Investigational Site Number : 2760007

Martinsried, , Germany

Site Status

Investigational Site Number : 2760008

Martinsried, , Germany

Site Status

Investigational Site Number : 2760009

Martinsried, , Germany

Site Status

Investigational Site Number : 2760010

Martinsried, , Germany

Site Status

Countries

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Finland Germany

References

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Amaral de Avila Machado M, Gallo S, Goldstein A, Vachhani P, Byrareddy RM, Kantele A, Valimaa H, Schelling J. Enhanced passive safety surveillance of standard-dose and high-dose influenza vaccines in Finland and Germany 2023-24 season. Hum Vaccin Immunother. 2025 Dec;21(1):2475616. doi: 10.1080/21645515.2025.2475616. Epub 2025 Mar 18.

Reference Type RESULT
PMID: 40098448 (View on PubMed)

Other Identifiers

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U1111-1280-6036

Identifier Type: REGISTRY

Identifier Source: secondary_id

FLU00172

Identifier Type: OTHER

Identifier Source: secondary_id

FLU00172

Identifier Type: -

Identifier Source: org_study_id

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