Respiratory Syncytial Virus ImmunizationVakzimeter RSVNCT06824207
Repeated Cross Sectional Surveillance Study To Determine the Respiratory Syncytial Virus (RSV) Immunization Rates in German Infants
An observational study of Respiratory Syncytial Virus Immunization, run by Sanofi Pasteur, a Sanofi Company at 1 site in Germany.
Trial summary
In June 2024, the German Standing Committee on Vaccination (STIKO) recommended the universal immunization of infants with nirsevimab during their first RSV season. Nirsevimab is a long-acting monoclonal antibody designed to provide passive immunity against RSV, significantly reducing the risk of severe RSV disease in… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus Immunization
- How many people
- 2,400 participants
- Where
- 1 siteGermany
- Study dates
- 13 Jan 2025to 19 May 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: This study is conducted using various recruitment approaches, including but not limited to mailings, online panels, telephone contact, in person contact. The data i.e. respondents answers will be captured via an online questionnaire. The interviews will be conducted applying various methodologies e.g. self-completion (CAWI), assisted in person completion (F2F interviews), assisted telephone completion (CATI). The study will target a sample of parents of infants either born between April and September (catch-up cohort) or between October and March (in-season cohort). The study targets a representative distribution with regards to both aforementioned subgroups and regions. To achieve the primary objective in the representative sample of the German population of eligible parents, a needed sample size of approximately 2,400 participants in total per season is assessed. These are spread over a total of three waves per season, resulting in a sample size of 800 respondents per wave.
Who may be able to join
- Be a parent of an infant born between April 2024/25/26 and March 2025/26/27, respectively
- 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.
Who cannot join
- Participation in the study (= completed the survey) in a previous wave of the current season.
- 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 Respiratory Syncytial Virus (RSV) Immunization Rates in German Infants During Three RSV Seasons
In June 2024, the German Standing Committee on Vaccination (STIKO) recommended the universal immunization of infants with nirsevimab during their first RSV season. Nirsevimab is a long-acting monoclonal antibody designed to provide passive immunity against RSV, significantly reducing the risk of severe RSV disease in infants. This recommendation marks the 2024/25 season as the first in which nirsevimab is broadly implemented for all infants in Germany.
Despite the introduction of this new prevention measure, there is currently no timely monitoring system for immunization rates. Understanding the uptake and coverage of nirsevimab is crucial for evaluating its impact on public health and guiding future vaccination strategies. Therefore, this study aims to monitor the national immunization rates of nirsevimab in children under one year of age during the initial seasons of its widespread use.
Read more
The primary objective of this study is to determine the Nirsevimab immunization rate in eligible infants in their first RSV-season in Germany. The study will focus on:
- Assessing the immunization rates among eligible infants (according to STIKO recommendation) in their first RSV-season in Germany (i.e. across all geographies)
- Assessing the immunisation rates among the "catch-up cohort", i.e. all infants born between April and September. For these infants, the STIKO recommends immunization with nirsevimab in early autumn.
- Assessing the immunization rate among the "in-season cohort", i.e. all infants born during the RSV season between October and March. For these newborns, the STIKO recommends immunization with Nirsevimab shortly after birth, preferably during the second "well-baby visit" at the age of 3-10 days of life.
- Conditions
- Respiratory Syncytial Virus Immunization
- Keywords
- RSV, RSV Immunization Rates, Nirsevimab
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 |
|---|---|---|
| Catch-Up Cohort | Parents of infants born between April and September | |
| In-Season Cohort | Parents of infants born between October and March |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing the nirsevimab immunization rates among eligible infants in both cohorts
Descriptive analysis of nirsevimab immunization status (yes/no) will be performed using summary statistics, i.e., proportion of immunized infants among all enrolled infants per wave.
Measured: Throughout Study (Approximatley 4 months)
Secondary outcomes (4)
Assessing the seasonal evolution of the nirsevimab immunization coverage rates among the two cohorts
Descriptive analysis of nirsevimab immunization status over time will be performed using summary statistics, i.e., proportion of immunized infants among all enrolled infants per wave.
Measured: Throughout Study (Approximatley 4 months)
Assessing reasons for/against nirsevimab immunization
The analysis for any potential influencing factors will be based on descriptive analytics and complemented with bi-variate analytics where applicable
Measured: Throughout Study (Approximately 4 months)
Assessing the nirsevimab immunization rates among subgroups
A descriptive analysis of immunization rates will be performed on subgroups such as: risk group (defined chronic condition or pre-term birth status), federal states and health insurance/Kassenärztliche Vereinigung, physician's association regions
Measured: Throughout Study (Approximately 4 months)
Assessing the reliability of a demographic study
Assessing reliability based on randomly sampled parent population using Computer-Assisted Web Interview (CAWI)/ Computer-Assisted Telephone Interview (CATI)/ face-to-face interviews for estimating immunization rates in Germany
Measured: Throughout the Study (Approximately 4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start13 Jan 2025
- Primary completion19 May 2026
- Study completion19 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial Virus 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
- 2,400 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
- NCT06824207
- Sponsor's protocol ID
- RSV00093
- Acronym
- Vakzimeter RSV
- Status last verified
- Jun 2026
- First submitted
- 7 Feb 2025
- Last updated
- 22 Jun 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 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeated Cross Sectional Surveillance Study To Determine the Respiratory Syncytial Virus (RSV) Immunization Rates in German Infants During Three RSV Seasons
- ClinicalTrials.gov ID
- NCT06824207
- Acronym / sponsor ID
- Vakzimeter RSV / RSV00093
- Conditions
- Respiratory Syncytial Virus Immunization
- Keywords
- RSV, RSV Immunization Rates, Nirsevimab
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,400 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- 13 Jan 2025 (actual)
- Primary completion
- 19 May 2026 (actual)
- Study completion
- 19 May 2026 (actual)
- First posted
- 13 Feb 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.
In June 2024, the German Standing Committee on Vaccination (STIKO) recommended the universal immunization of infants with nirsevimab during their first RSV season. Nirsevimab is a long-acting monoclonal antibody designed to provide passive immunity against RSV, significantly reducing the risk of severe RSV disease in infants. This recommendation marks the 2024/25 season as the first in which nirsevimab is broadly implemented for all infants in Germany.
Despite the introduction of this new prevention measure, there is currently no timely monitoring system for immunization rates. Understanding the uptake and coverage of nirsevimab is crucial for evaluating its impact on public health and guiding future vaccination strategies. Therefore, this study aims to monitor the national immunization rates of nirsevimab in children under one year of age during the initial seasons of its widespread use.
The primary objective of this study is to determine the Nirsevimab immunization rate in eligible infants in their first RSV-season in Germany. The study will focus on:
- Assessing the immunization rates among eligible infants (according to STIKO recommendation) in their first RSV-season in Germany (i.e. across all geographies)
- Assessing the immunisation rates among the "catch-up cohort", i.e. all infants born between April and September. For these infants, the STIKO recommends immunization with nirsevimab in early autumn.
- Assessing the immunization rate among the "in-season cohort", i.e. all infants born during the RSV season between October and March. For these newborns, the STIKO recommends immunization with Nirsevimab shortly after birth, preferably during the second "well-baby visit" at the age of 3-10 days of life.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Catch-Up Cohort | – | –Parents of infants born between April and September |
| In-Season Cohort | – | –Parents of infants born between October and March |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study is conducted using various recruitment approaches, including but not limited to mailings, online panels, telephone contact, in person contact. The data i.e. respondents answers will be captured via an online questionnaire. The interviews will be conducted applying various methodologies e.g. self-completion (CAWI), assisted in person completion (F2F interviews), assisted telephone completion (CATI). The study will target a sample of parents of infants either born between April and September (catch-up cohort) or between October and March (in-season cohort). The study targets a representative distribution with regards to both aforementioned subgroups and regions. To achieve the primary objective in the representative sample of the German population of eligible parents, a needed sample size of approximately 2,400 participants in total per season is assessed. These are spread over a total of three waves per season, resulting in a sample size of 800 respondents per wave.
Key inclusion criteria (5 listed)
- Be a parent of an infant born between April 2024/25/26 and March 2025/26/27, respectively
- 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.
Key exclusion criteria (2 listed)
- Participation in the study (= completed the survey) in a previous wave of the current season.
- 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 nirsevimab immunization rates among eligible infants in both cohorts
Time frame: Throughout Study (Approximatley 4 months)
Descriptive analysis of nirsevimab immunization status (yes/no) will be performed using summary statistics, i.e., proportion of immunized infants among all enrolled infants per wave.
4 secondary outcomes
Assessing the seasonal evolution of the nirsevimab immunization coverage rates among the two cohorts
Time frame: Throughout Study (Approximatley 4 months)
Assessing reasons for/against nirsevimab immunization
Time frame: Throughout Study (Approximately 4 months)
Assessing the nirsevimab immunization rates among subgroups
Time frame: Throughout Study (Approximately 4 months)
Assessing the reliability of a demographic study
Time frame: Throughout the Study (Approximately 4 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 22 Jun 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 Respiratory Syncytial Virus 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 5 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 22 Jun 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 nirsevimab immunization rates among eligible infants in both cohorts (time frame: Throughout Study (Approximatley 4 months)). 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 22 Jun 2026.