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OpenTrials
Completed

NCT Number: NCT05078060

Safety Surveillance of VaxigripTetra® and Efluelda® Influenza Vaccines in Europe During the Influenza Season 2021/22

The primary objective of the study is to estimate the reporting rate 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 2021/22.

The secondary objectives of the study are:

* To estimate the reporting rates of suspected ADRs occurring within 7 days following routine vaccination with VaxigripTetra® according to the pre-defined age groups. * To estimate the reporting rates of serious suspected ADRs after vaccination with VaxigripTetra®, and Efluelda®, respectively, at any time following vaccination, within the Enhanced Passive Safety Surveillance (EPSS) period. * To compare vaccinees' reporting rates of suspected ADRs observed during the NH influenza season 2021/22.

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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 is maximum 2 months.

Who can participate

Healthy volunteers accepted: Yes

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

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.

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. Vaccinees' reporting rate following routine vaccination with VaxigripTetra® and Efluelda®

    Time frame: Within 7 days after vaccination

    The vaccinees' reporting rate is expressed as the percentage of vaccinees who reported at least one suspected ADR among the distributed vaccination cards

  2. ADR reporting rate following routine vaccination with VaxigripTetra® and Efluelda®

    Time frame: Within 7 days after vaccination

    The ADR reporting rate is expressed as the percentage of suspected ADRs among the distributed vaccination cards

Secondary outcomes

  1. ADR reporting rate according to age group

    Time frame: Within 7 days after vaccination

  2. Vaccinees' reporting rate according to age group

    Time frame: Within 7 days after vaccination

  3. 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.

  4. Serious suspected ADR reporting rate 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.

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® (Quadrivalent Inactivated Split Virion Influenza Vaccine, Intramuscular Route) Vaccines in Europe During the Influenza Season 2021/22.

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 14, 2021
Registry last updated
Mar 24, 2023

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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