Influenza ImmunizationVakzimeter FLUNCT06800885
Repeated Cross Sectional Surveillance Study To Determine the Influenza Vaccination Rates in German Participants
An observational study of Influenza Immunization, run by Sanofi Pasteur, a Sanofi Company at 1 site in Germany.
Trial summary
Real-time monitoring of vaccination rates for Germany is unavailable, and up-to-date data publication is delayed, which makes it challenging to develop effective public health strategies to increase vaccination coverage. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza Immunization
- How many people
- 5,000 participants
- Where
- 1 siteGermany
- Study dates
- 22 Oct 2024to 22 Feb 2026
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The number of participants surveyed will be approximately 6,000 per season using CAWI. These are spread over a total of 6 waves per season, resulting in a sample size of 1,000 respondents per wave using CAWI. The study will target a disproportionate sample of the German population regarding age: 30% aged 18 years of age though and including 59 years of age and 70% aged 60 years of age and older. Within these age groups, the study targets a representative distribution regarding gender and region. This study is conducted as an online survey that will either be self-completed by the respondents (CAWI) or completed via an interviewer for a subgroup of respondents aged 70+ (CATI). The survey is estimated to last 10 minutes and will comprise of closed-ended questions only (i.e., respondents will not have the possibility to add any free-text). The survey will be conducted in German.
Who may be able to join
- Reside in Germany at the time of survey completion
- Be at least 18 years old at the time of survey completion.
- Agree with privacy policy and AE (Adverse Event) reporting requirements before proceeding with the survey.
- Read and agree to the ICF (Informed Consent Form) by ticking a box before proceeding with the survey or telephone interview.
Who cannot join
- Participation in the study (= completed the survey or telephone interview) in a previous wave of the current season.
- Living in nursing home Note: The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Repeated Cross Sectional Surveillance Study To Determine the Influenza Vaccination Rates in German Participants During Current Respiratory Season
Real-time monitoring of vaccination rates for Germany is unavailable, and up-to-date data publication is delayed, which makes it challenging to develop effective public health strategies to increase vaccination coverage.
This study aims to address the gap by assessing current influenza vaccination rates, particularly among those aged 60 and older, to inform public health interventions and encourage healthcare providers to recommend influenza vaccination more proactively.
Read more
The primary objective of this study is to determine the influenza vaccination rates in the German population during the current respiratory season. The study will focus on:
- Assessing the vaccination rates among the two main age groups 18 years of age through and including 59 years of age and 60 years of age (inclusive) and older
- Assessing the vaccination rate among individuals with risk-based vaccination recommendation according to Standing Committee on Vaccination (Ständige Impfkommission) (STIKO) The study will target a disproportionate sample of the German population regarding age: 30% aged 18 years of age through and including 59 year of age and 70% aged 60 years of age (inclusive) and older. Within these age groups, the study targets a representative distribution regarding gender and region.
This study is conducted as an online survey that will either be self-completed by the respondents (CAWI) or completed via an interviewer for a subgroup of respondents aged 70+ (CATI). The survey is estimated to last 10 minutes and will comprise of closed-ended questions only (i.e., respondents will not have the possibility to add any free-text). The survey will be conducted in German.
The panelists will be divided into strata based on demographic variables like gender and region. Within each stratum, participants will be randomly selected to participate in the survey.
- Conditions
- Influenza Immunization
- Keywords
- Seasonal Influenza, Influenza Vaccination Rates
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: 18 Years of Age to 59 Years of age | Healthy diverse adults aged 18 years to 59 (inclusive) years of age | |
| Group 2: 60 Years of Age and Older | Healthy diverse adults aged 60 years (inclusive) of age and older | |
| Subgroup 1: Pregnant Women 18 Years of Age to 59 Years of Age | Pregnant woman aged 18 years to 59 (inclusive) years of age | |
| Subgroup 2: Patients with Chronic Illness | Diverse patients with chronic illness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing the seasonal influenza vaccination rates among diverse healthy participants 18 years of age through and including 59 years of age
Descriptive analysis of vaccination status (yes/no) will be performed using summary statistics, i.e., proportion of vaccinated individuals among all enrolled persons per wave in the age group 18 years of age to and including 59 years of age
Measured: Throughout Study (Approximately 3 months)
Assessing the seasonal influenza vaccination rates among diverse healthy participants 18 years through and including 34 years of age
Descriptive analysis of vaccination status (yes/no) will be performed using summary statistics, i.e., proportion of vaccinated individuals among all enrolled persons per wave in the age group 18 years of age through 34 years of age
Measured: Throughout Study (Approximately 3 months)
Assessing the seasonal influenza vaccination rates among pregnant women (with or without co-morbidities)
Descriptive analysis of vaccination status (yes/no) will be performed using summary statistics, i.e., proportion of vaccinated individuals among all enrolled persons per wave in pregnant women with or without co-morbidities
Measured: Throughout Study (Approximately 3 months)
Assessing the seasonal influenza vaccination rates among diverse patients with chronic illness
Descriptive analysis of vaccination status (yes/no) will be performed using summary statistics, i.e., proportion of vaccinated individuals among all enrolled persons per wave in diverse patients with chronic illness
Measured: Throughout Study (Approximately 3 months)
Assessing the seasonal influenza vaccination rates among diverse healthy participants 35 years through and including 59 years of age
Descriptive analysis of vaccination status (yes/no) will be performed using summary statistics, i.e., proportion of vaccinated individuals among all enrolled persons per wave in the age group 35 years of age through and including 59 years of age
Measured: Throughout Study (Approximately 3 months)
Assessing the seasonal influenza vaccination rates among diverse healthy participants 18 years through and including 59 years of age
Descriptive analysis of vaccination status (yes/no) will be performed using summary statistics, i.e., proportion of vaccinated individuals among all enrolled persons per wave in the age group 18 years of age through and including 59 years of age
Measured: Throughout Study (Approximately 3 months)
Assessing the seasonal influenza vaccination rates among diverse healthy participants older than 60 years of age
Descriptive analysis of vaccination status (yes/no) will be performed using summary statistics, i.e., proportion of vaccinated individuals among all enrolled persons per wave in the older than 60 years of age group
Measured: Throughout Study (Approximately 3 months)
Assessing the seasonal influenza vaccination rates among diverse healthy participants aged 60 years of age through and including 69 years of age
Descriptive analysis of vaccination status (yes/no) will be performed using summary statistics, i.e., proportion of vaccinated individuals among all enrolled persons per wave in the age group 60 years of age through and including 69 years of age
Measured: Throughout Study (Approximately 3 months)
Assessing the seasonal influenza vaccination rates among diverse healthy participants aged 70 years of age through and including 79 years of age
Descriptive analysis of vaccination status (yes/no) will be performed using summary statistics, i.e., proportion of vaccinated individuals among all enrolled persons per wave in the age group 70 years of age through and including 79 years of age
Measured: Throughout Study (Approximately 3 months)
Assessing the seasonal influenza vaccination rates among diverse healthy participants older than 80 years of age
Descriptive analysis of vaccination status (yes/no) will be performed using summary statistics, i.e., proportion of vaccinated individuals among all enrolled persons per wave in the older than 80 years of age group
Measured: Throughout Study (Approximately 3 months)
Secondary outcomes (5)
Assessing the seasonal evolution of the influenza vaccination coverage rates (VCR) among the two main age groups 18 years of age through and including 59 years of age and 60 years of age and older (inclusive)
Descriptive analysis of VCR by time of survey during the season (as proportion of vaccinated individuals among all enrolled persons per wave in the two main age groups 18 year of age through and including 59 years of age and 60 years of age (inclusive) and older, and per subgroup/strata)
Measured: Throughout Study (approxmatley 3 months)
Assessing the seasonal evolution of the influenza vaccination coverage rates (VCR) through time trends among the two main age groups 18 years of age through and including 59 years of age and 60 years of age and older (inclusive)
Analysis of time trends over the three seasons, based on VCR data collected in January of each year (last wave) (as proportion of vaccinated individuals among all enrolled persons per wave in the two main age groups 18 year of age through and including 59 years of age and 60 years of age (inclusive) and older, and per subgroup/strata)
Measured: Throughout Study (approxmatley 3 months)
Assessing reasons for/against influenza vaccination in the target population of the STIKO recommendation for each season
Descriptive analysis of vaccination status (yes/no) and reasons for or against influenza vaccination will be performed using summary statistics, i.e., proportion of vaccinated individuals among all enrolled persons per wave in the two main age groups 18 year of age through and including 59 years of age and 60 years of age (inclusive) and older, and per subgroup/strata)
Measured: Throughout study (approximatley 3 months)
Assess the reliability of a demographic study based on randomly sampled population groups using Computer-Assisted Web Interview (CAWI) for estimating VCR
Descriptive analysis of VCR (proportions) for the two main age groups 18 years of age through 59 and 60 years (inclusive) of age and older and per subgroup/strata) in comparison with results from the Robert Koch-Institute (RKI) vaccination surveillance
Measured: Throughout the study (approximatley 3 months)
Compare the reliability of VCR estimates in the elderly population (70+ years) obtained through a mixed approach of CAWI and Computer assisted telephone interview (CATI) versus CAWI only (in the first season)
Descriptive analysis of VCR (proportions) in the regions with mixed mode data collection approach in comparison with other regions and with results from the RKI vaccination surveillance for age group 70 years of age and older
Measured: Throughout the study (approximatley 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start22 Oct 2024
- Primary completion22 Feb 2026
- Study completion22 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza ImmunizationStudies 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
- Cross-sectional
- Enrolment
- 5,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06800885
- Sponsor's protocol ID
- FLU00216
- Acronym
- Vakzimeter FLU
- Status last verified
- Mar 2026
- First submitted
- 24 Jan 2025
- Last updated
- 5 Mar 2026
- 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
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeated Cross Sectional Surveillance Study To Determine the Influenza Vaccination Rates in German Participants During Current Respiratory Season
- ClinicalTrials.gov ID
- NCT06800885
- Acronym / sponsor ID
- Vakzimeter FLU / FLU00216
- Conditions
- Influenza Immunization
- Keywords
- Seasonal Influenza, Influenza Vaccination Rates
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,000 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- 22 Oct 2024 (actual)
- Primary completion
- 22 Feb 2026 (actual)
- Study completion
- 22 Feb 2026 (actual)
- First posted
- 30 Jan 2025 (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.
Real-time monitoring of vaccination rates for Germany is unavailable, and up-to-date data publication is delayed, which makes it challenging to develop effective public health strategies to increase vaccination coverage.
This study aims to address the gap by assessing current influenza vaccination rates, particularly among those aged 60 and older, to inform public health interventions and encourage healthcare providers to recommend influenza vaccination more proactively.
The primary objective of this study is to determine the influenza vaccination rates in the German population during the current respiratory season. The study will focus on:
- Assessing the vaccination rates among the two main age groups 18 years of age through and including 59 years of age and 60 years of age (inclusive) and older
- Assessing the vaccination rate among individuals with risk-based vaccination recommendation according to Standing Committee on Vaccination (Ständige Impfkommission) (STIKO) The study will target a disproportionate sample of the German population regarding age: 30% aged 18 years of age through and including 59 year of age and 70% aged 60 years of age (inclusive) and older. Within these age groups, the study targets a representative distribution regarding gender and region.
This study is conducted as an online survey that will either be self-completed by the respondents (CAWI) or completed via an interviewer for a subgroup of respondents aged 70+ (CATI). The survey is estimated to last 10 minutes and will comprise of closed-ended questions only (i.e., respondents will not have the possibility to add any free-text). The survey will be conducted in German.
The panelists will be divided into strata based on demographic variables like gender and region. Within each stratum, participants will be randomly selected to participate in the survey.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: 18 Years of Age to 59 Years of age | – | –Healthy diverse adults aged 18 years to 59 (inclusive) years of age |
| Group 2: 60 Years of Age and Older | – | –Healthy diverse adults aged 60 years (inclusive) of age and older |
| Subgroup 1: Pregnant Women 18 Years of Age to 59 Years of Age | – | –Pregnant woman aged 18 years to 59 (inclusive) years of age |
| Subgroup 2: Patients with Chronic Illness | – | –Diverse patients with chronic illness |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The number of participants surveyed will be approximately 6,000 per season using CAWI. These are spread over a total of 6 waves per season, resulting in a sample size of 1,000 respondents per wave using CAWI. The study will target a disproportionate sample of the German population regarding age: 30% aged 18 years of age though and including 59 years of age and 70% aged 60 years of age and older. Within these age groups, the study targets a representative distribution regarding gender and region. This study is conducted as an online survey that will either be self-completed by the respondents (CAWI) or completed via an interviewer for a subgroup of respondents aged 70+ (CATI). The survey is estimated to last 10 minutes and will comprise of closed-ended questions only (i.e., respondents will not have the possibility to add any free-text). The survey will be conducted in German.
Key inclusion criteria (4 listed)
- Reside in Germany at the time of survey completion
- Be at least 18 years old at the time of survey completion.
- Agree with privacy policy and AE (Adverse Event) reporting requirements before proceeding with the survey.
- Read and agree to the ICF (Informed Consent Form) by ticking a box before proceeding with the survey or telephone interview.
Key exclusion criteria (2 listed)
- Participation in the study (= completed the survey or telephone interview) in a previous wave of the current season.
- Living in nursing home Note: The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessing the seasonal influenza vaccination rates among diverse healthy participants 18 years of age through and including 59 years of age
Time frame: Throughout Study (Approximately 3 months)
Descriptive analysis of vaccination status (yes/no) will be performed using summary statistics, i.e., proportion of vaccinated individuals among all enrolled persons per wave in the age group 18 years of age to and including 59 years of age
Assessing the seasonal influenza vaccination rates among diverse healthy participants 18 years through and including 34 years of age
Time frame: Throughout Study (Approximately 3 months)
Descriptive analysis of vaccination status (yes/no) will be performed using summary statistics, i.e., proportion of vaccinated individuals among all enrolled persons per wave in the age group 18 years of age through 34 years of age
Assessing the seasonal influenza vaccination rates among pregnant women (with or without co-morbidities)
Time frame: Throughout Study (Approximately 3 months)
Descriptive analysis of vaccination status (yes/no) will be performed using summary statistics, i.e., proportion of vaccinated individuals among all enrolled persons per wave in pregnant women with or without co-morbidities
Assessing the seasonal influenza vaccination rates among diverse patients with chronic illness
Time frame: Throughout Study (Approximately 3 months)
Descriptive analysis of vaccination status (yes/no) will be performed using summary statistics, i.e., proportion of vaccinated individuals among all enrolled persons per wave in diverse patients with chronic illness
Assessing the seasonal influenza vaccination rates among diverse healthy participants 35 years through and including 59 years of age
Time frame: Throughout Study (Approximately 3 months)
Descriptive analysis of vaccination status (yes/no) will be performed using summary statistics, i.e., proportion of vaccinated individuals among all enrolled persons per wave in the age group 35 years of age through and including 59 years of age
Assessing the seasonal influenza vaccination rates among diverse healthy participants 18 years through and including 59 years of age
Time frame: Throughout Study (Approximately 3 months)
Descriptive analysis of vaccination status (yes/no) will be performed using summary statistics, i.e., proportion of vaccinated individuals among all enrolled persons per wave in the age group 18 years of age through and including 59 years of age
Assessing the seasonal influenza vaccination rates among diverse healthy participants older than 60 years of age
Time frame: Throughout Study (Approximately 3 months)
Descriptive analysis of vaccination status (yes/no) will be performed using summary statistics, i.e., proportion of vaccinated individuals among all enrolled persons per wave in the older than 60 years of age group
Assessing the seasonal influenza vaccination rates among diverse healthy participants aged 60 years of age through and including 69 years of age
Time frame: Throughout Study (Approximately 3 months)
Descriptive analysis of vaccination status (yes/no) will be performed using summary statistics, i.e., proportion of vaccinated individuals among all enrolled persons per wave in the age group 60 years of age through and including 69 years of age
Assessing the seasonal influenza vaccination rates among diverse healthy participants aged 70 years of age through and including 79 years of age
Time frame: Throughout Study (Approximately 3 months)
Descriptive analysis of vaccination status (yes/no) will be performed using summary statistics, i.e., proportion of vaccinated individuals among all enrolled persons per wave in the age group 70 years of age through and including 79 years of age
Assessing the seasonal influenza vaccination rates among diverse healthy participants older than 80 years of age
Time frame: Throughout Study (Approximately 3 months)
Descriptive analysis of vaccination status (yes/no) will be performed using summary statistics, i.e., proportion of vaccinated individuals among all enrolled persons per wave in the older than 80 years of age group
5 secondary outcomes
Assessing the seasonal evolution of the influenza vaccination coverage rates (VCR) among the two main age groups 18 years of age through and including 59 years of age and 60 years of age and older (inclusive)
Time frame: Throughout Study (approxmatley 3 months)
Assessing the seasonal evolution of the influenza vaccination coverage rates (VCR) through time trends among the two main age groups 18 years of age through and including 59 years of age and 60 years of age and older (inclusive)
Time frame: Throughout Study (approxmatley 3 months)
Assessing reasons for/against influenza vaccination in the target population of the STIKO recommendation for each season
Time frame: Throughout study (approximatley 3 months)
Assess the reliability of a demographic study based on randomly sampled population groups using Computer-Assisted Web Interview (CAWI) for estimating VCR
Time frame: Throughout the study (approximatley 3 months)
Compare the reliability of VCR estimates in the elderly population (70+ years) obtained through a mixed approach of CAWI and Computer assisted telephone interview (CATI) versus CAWI only (in the first season)
Time frame: Throughout the study (approximatley 3 months)
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 5 Mar 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza Immunization, run by Sanofi Pasteur, a Sanofi Company at 1 site in Germany.
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 4 inclusion and 2 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 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
Assessing the seasonal influenza vaccination rates among diverse healthy participants 18 years of age through and including 59 years of age (time frame: Throughout Study (Approximately 3 months)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Mar 2026.