Influenza (Healthy Volunteers)NCT05078060
Safety Surveillance of VaxigripTetra® and Efluelda® Influenza Vaccines in Europe During the Influenza Season 2021/22
An observational study of Influenza (Healthy Volunteers), run by Sanofi Pasteur, a Sanofi Company at 15 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 months and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza (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
- 1,804 participants
- Where
- 15 sitesin 2 countries
- Study dates
- 12 Oct 2021to 2 Dec 2021
- 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.
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.
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
Germany10 sites
Investigational Site Number :2760005
Blankenhain, 99444
Investigational Site Number :2760008
Bochum, 44789
Investigational Site Number :2760001
Donaueschingen, 78166
Investigational Site Number :2760011
Düsseldorf, 40470
Investigational Site Number :2760007
Frankfurt am Main, 60329
Investigational Site Number :2760002
Fulda, 36037
Investigational Site Number :2760003
Grafenrheinfeld, 97506
Investigational Site Number :2760004
Haar, 85540
Investigational Site Number :2760006
Hamburg, 20099
Investigational Site Number :2760009
Wendelstein, 90530
Finland5 sites
Investigational Site Number :2-2-002
Helsinki, 00180
Investigational Site Number :2-2-005
Jyväskylä, 40100
Investigational Site Number :2-2-004
Kuopio, 70100
Investigational Site Number :2-2-003
Tampere, 33100
Investigational Site Number :2-2-011
Turku, 20100
About this study
Official 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.
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.
Read the detailed description
Study duration per participant is maximum 2 months.
- Conditions
- Influenza (Healthy Volunteers)
- 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 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.
Vaccinees' reporting rate following routine vaccination with VaxigripTetra® and Efluelda®
The vaccinees' reporting rate is expressed as the percentage of vaccinees who reported at least one suspected ADR among the distributed vaccination cards
Measured: Within 7 days after vaccination
ADR reporting rate following routine vaccination with VaxigripTetra® and Efluelda®
The ADR reporting rate is expressed as the percentage of suspected ADRs among the distributed vaccination cards
Measured: Within 7 days after vaccination
Secondary outcomes (4)
ADR reporting rate according to age group
Measured: Within 7 days after vaccination
Vaccinees' reporting rate 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)
Serious suspected ADR reporting rate 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start12 Oct 2021
- Primary completion2 Dec 2021
- Study completion2 Dec 2021
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 (Healthy Volunteers)Studies of the same condition, open and under way.
- More trials run by Sanofi Pasteur, a Sanofi CompanyThe 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
- 1,804 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05078060
- Sponsor's protocol ID
- FLU00170
- Status last verified
- 3 Mar 2023
- First submitted
- 1 Oct 2021
- Last updated
- 24 Mar 2023
- 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
Gandhi-Banga S, Wague S, Shrestha A, Syrkina O, Talanova O, Nissila M, Stuff K, Monfredo C. Enhanced passive safety surveillance of high-dose and standard-dose quadrivalent inactivated split-virion influenza vaccines in Germany and Finland during the influenza season 2021/22. Influenza Other Respir Viruses. 2023 Jan;17(1):e13071. doi: 10.1111/irv.13071. Epub 2022 Nov 29.
PubMed 36448240
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. 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® (Quadrivalent Inactivated Split Virion Influenza Vaccine, Intramuscular Route) Vaccines in Europe During the Influenza Season 2021/22.
- ClinicalTrials.gov ID
- NCT05078060
- Acronym / sponsor ID
- FLU00170
- Conditions
- Influenza (Healthy Volunteers)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,804 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- 12 Oct 2021 (actual)
- Primary completion
- 2 Dec 2021 (actual)
- Study completion
- 2 Dec 2021 (actual)
- First posted
- 14 Oct 2021 (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.
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.
Detailed description
Study duration per participant is maximum 2 months.
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.
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 administration | Biological | Efluelda® |
Primary outcome
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
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
4 secondary outcomes
ADR reporting rate according to age group
Time frame: Within 7 days after vaccination
Vaccinees' reporting rate 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)
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)
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 2023.
- Background: PubMed 36448240Gandhi-Banga S, Wague S, Shrestha A, Syrkina O, Talanova O, Nissila M, Stuff K, Monfredo C. Enhanced passive safety surveillance of high-dose and standard-dose quadrivalent inactivated split-virion influenza vaccines in Germany and Finland during the influenza season 2021/22. Influenza Other Respir Viruses. 2023 Jan;17(1):e13071. doi: 10.1111/irv.13071. Epub 2022 Nov 29.
- 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
Related trials for Influenza (Healthy Volunteers)
RecruitingObservational study
Screening for LID Clinical Studies Unit Healthy Volunteer Protocols
Zika, Influenza
RecruitingPhase 1
A Trial to Evaluate the Effect of CD388/MK1406 on the Immunogenicity of Fluzone® HD Vaccine (CD388.SQ.1.08/MK-1406-007)
Healthy Participants
Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
Not yet recruitingPhase 3
Study of a Combination SARS-CoV-2 Recombinant Spike and High-Dose Inactivated Influenza Vaccine With Matrix-M Adjuvant in Adult Participants 60 Years of Age and Older
Immunization, Healthy Volunteers
RecruitingObservational study
Post-marketing Surveillance Study for the Safety of Efluelda® Pre-filled Syringe
Influenza Immunization, Healthy Volunteers
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
15 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 (Healthy Volunteers), run by Sanofi Pasteur, a Sanofi Company at 15 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?
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 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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?
Vaccinees' reporting rate following routine vaccination with VaxigripTetra® and Efluelda® (time frame: Within 7 days after vaccination). The study lists 2 primary outcomes in all. 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 NCT05078060, 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 2023.