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OpenTrials
Completed

NCT Number: NCT05568979

Safety Surveillance of VaxigripTetra® and Efluelda® Influenza Vaccines in Europe During the Influenza Season 2022/23

This is an enhanced passive safety surveillance conducted in routine clinical care setting. Spontaneously reported ADRs will be collected by study staff following routine vaccination.

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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Key information

Conditions

Influenza (Healthy Volunteers) Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

6 month and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Investigational Site Number : 2-2-002, Helsinki, Finland

Loading trial locations.

About this study

Study duration per participant 2 months (including 6 weeks for VC distribution + 2 weeks for vaccinee reporting) following the first vaccination

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • There are no formal inclusion criteria. Individuals who approach the site for vaccination and agree to receive a vaccination card will be included and vaccinated with the respective vaccine brand according to the country of their location,
  • recommendations for the individual vaccines as well as national recommendations

Exclusion criteria

  • none

Treatment and study plan

Quadrivalent Influenza Vaccine

Biological

Intramuscular or subcutaneous administration

Other names: VaxigripTetra®

High-Dose Quadrivalent Influenza Vaccine

Biological

Intramuscular administration

Other names: Efluelda®

Primary outcomes

  1. Vaccinee reporting rate of suspected adverse drug reactions (ADRs) following routine vaccination with VaxigripTetra® and Efluelda®

    Time frame: Within 7 days after vaccination

    Number of vaccinees who reported at least 1 suspected ADR divided by the total number of vaccination cards (VCs) distributed

Secondary outcomes

  1. Vaccinees' reporting rate of ADRs according to age group

    Time frame: Within 7 days after vaccination

  2. Vaccinees' reporting rate of serious suspected ADRs at any time following vaccination within the EPSS period

    Time frame: From vaccination to end of data collection (maximum 2 months following first vaccination)

    Serious suspected ADRs will be collected from vaccination up to the end of data collection. Data collection ends when 1000 vaccination cards have been distributed (per vaccine brand) plus 2 weeks or 2 months following the first vaccination, whichever comes first.

  3. Vaccinees' reporting rate of suspected ADR at any time following vaccination within the EPSS period

    Time frame: From vaccination to end of data collection (maximum 2 months following first vaccination

    Suspected ADRs will be collected from vaccination up to the end of data collection. Data collection ends when 1000 vaccination cards have been distributed (per vaccine brand) plus 2 weeks or 2 months following the first vaccination, whichever comes first

Sponsors and collaborators

Lead sponsor

Sanofi Pasteur, a Sanofi Company

Industry

Registry information

Official study title

Enhanced Passive Safety Surveillance of VaxigripTetra® (Quadrivalent Inactivated Split Virion Influenza Vaccine, Intramuscular Route) and Efluelda® (High-dose Quadrivalent Inactivated Split Virion Influenza Vaccine, Intramuscular Route) Vaccines in Europe During the Influenza Season 2022/23.

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Oct 6, 2022
Registry last updated
Mar 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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