Influenza Immunization (Healthy Volunteers)NCT06059456
Safety Surveillance of VaxigripTetra® and Efluelda® Influenza Vaccines in Europe During the Influenza Season 2023/24
An observational study of Influenza Immunization (Healthy Volunteers), run by Sanofi at 11 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 months and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza Immunization (Healthy Volunteers)
- What is being tested?
- Quadrivalent Influenza Vaccine and High-Dose Quadrivalent Influenza Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 2,078 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 2 Oct 2023to 15 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: VaxigripTetra® will be given to adults (including pregnant women) and children aged 6 months and older in Finland. Efluelda® will be given to adults 60 years of age and older in Germany
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
Germany10 sites
Investigational Site Number : 2760001
Martinsried, 82152
Investigational Site Number : 2760002
Martinsried, 82152
Investigational Site Number : 2760003
Martinsried, 82152
Investigational Site Number : 2760004
Martinsried, 82152
Investigational Site Number : 2760005
Martinsried, 82152
Investigational Site Number : 2760006
Martinsried, 82152
Investigational Site Number : 2760007
Martinsried, 82152
Investigational Site Number : 2760008
Martinsried, 82152
Investigational Site Number : 2760009
Martinsried, 82152
Investigational Site Number : 2760010
Martinsried, 82152
About this study
Official 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 2023/24
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
- Being tested
- Quadrivalent Influenza Vaccine, High-Dose Quadrivalent Influenza Vaccine
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadrivalent Influenza VaccineBiological
Also called VaxigripTetra®
Intramuscular or subcutaneous administration
High-Dose Quadrivalent Influenza VaccineBiological
Also called Efluelda®
Intramuscular or subcutaneous administration
| Study group | Role | What they receive |
|---|---|---|
| VaxigripTetra® | Participant vaccinated with VaxigripTetra® as per routine clinical practice Receives: Biological: Quadrivalent Influenza Vaccine | |
| Efluelda® | Participant vaccinated with Efluelda® as per routine clinical practice Receives: Biological: High-Dose Quadrivalent Influenza Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaccinee reporting rate of suspected adverse drug reactions (ADRs) following routine vaccination with VaxigripTetra® and Efluelda®
Number of vaccinees who reported at least 1 suspected ADR divided by the total number of vaccination cards (VCs) distributed
Measured: Within 7 days after vaccination
Secondary outcomes (3)
Vaccinees' reporting rate of ADRs according to age group
Measured: Within 7 days after vaccination
Vaccinees' reporting rate of serious suspected ADRs at any time following vaccination within the EPSS period
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
Measured: From vaccination to end of data collection (maximum 2 months following first vaccination)
Vaccinees' reporting rate of suspected ADR at any time following vaccination within the EPSS period
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
Measured: From vaccination to end of data collection (maximum 2 months following first vaccination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start2 Oct 2023
- Primary completion15 Dec 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Influenza Immunization (Healthy Volunteers)Studies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 2,078 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06059456
- Sponsor's protocol ID
- FLU00172
- Other IDs
- U1111-1280-6036, FLU00172
- Status last verified
- Mar 2025
- First submitted
- 22 Sep 2023
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Publications
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.
PubMed 40098448
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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 2023/24
- ClinicalTrials.gov ID
- NCT06059456
- Acronym / sponsor ID
- FLU00172
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,078 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VaxigripTetra® | – | Biological: Quadrivalent Influenza VaccineParticipant vaccinated with VaxigripTetra® as per routine clinical practice |
| Efluelda® | – | Biological: High-Dose Quadrivalent Influenza VaccineParticipant vaccinated with Efluelda® as per routine clinical practice |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- VaxigripTetra® will be given to adults (including pregnant women) and children aged 6 months and older in Finland. Efluelda® will be given to adults 60 years of age and older in Germany
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quadrivalent Influenza VaccineAlso: VaxigripTetra®Intramuscular or subcutaneous administration | Biological | VaxigripTetra® |
| High-Dose Quadrivalent Influenza VaccineAlso: Efluelda®Intramuscular or subcutaneous administration | Biological | Efluelda® |
Primary outcome
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
3 secondary outcomes
Vaccinees' reporting rate of ADRs according to age group
Time frame: Within 7 days after vaccination
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Results publication: PubMed 40098448Amaral 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.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza Immunization (Healthy Volunteers), run by Sanofi at 11 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Germany, Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaccinee reporting rate of suspected adverse drug reactions (ADRs) following routine vaccination with VaxigripTetra® and Efluelda® (time frame: Within 7 days after vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06059456, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.