Last reviewed · How we verify
NCT06824207: Vakzimeter RSV
Repeated Cross Sectional Surveillance Study To Determine the Respiratory Syncytial Virus (RSV) Immunization Rates in German Infants
trial in Respiratory Syncytial Virus Immunization in 2,400 participants. Participants enrolled and being followed up; not accepting new ones.
30 May 2026
Quick facts
| Lead sponsor | Sanofi Pasteur, a Sanofi Company |
|---|---|
| Status | Active, enrolled |
| Study type | OBSERVATIONAL |
| Enrollment | 2,400 |
| Start date | 13 January 2025 |
| Primary completion | 30 May 2026 |
| Estimated completion | 30 May 2026 |
| Sites | 1 location across Germany |
Conditions studied
- Respiratory Syncytial Virus Immunization — all drugs for Respiratory Syncytial Virus Immunization →
Sponsor
Sanofi Pasteur, a Sanofi Company — full company profile →
Who can join
18 and older, any sex, with Respiratory Syncytial Virus Immunization. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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: 1. Assessing the immunization rates among eligible infants (according to STIKO recommendation) in their first RSV-season in Germany (i.e. across all geographies) 2. 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. 3. 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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06824207
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Respiratory Syncytial Virus Immunization
Currently open trials in the same condition.
- NCT07071558 — Study to Evaluate the Safety and Immunogenicity of Investigational Vaccines Using the RSV (Respiratory Syncytial Virus) · Phase 1 · active not recruiting
- NCT06686654 — Study of a Human Metapneumovirus/Respiratory Syncytial Virus mRNA Vaccine Candidate Encapsulated in a Lipid Nanoparticle · Phase 1, PHASE2 · active not recruiting
Other Sanofi Pasteur, a Sanofi Company trials
Trials by the same sponsor.
- NCT07536048 — A Longitudinal Study of Epstein-Barr Virus (EBV) Reactivation in Adults Aged 18 to 29 Years · not yet recruiting
- NCT07222059 — Phase 3 Single Arm, Open Study on vYF in Adults · Phase 3 · completed
- NCT07013747 — Study to Evaluate Safety, Efficacy and Immunogenicity of Acne mRNA Vaccine in Participants With Mild Acne · Phase 1, PHASE2 · recruiting
- NCT06838000 — Study of the Safety and Immunogenicity of Catch-up Vaccination With a 21-valent Pneumococcal Conjugate Vaccine (PCV21) i · Phase 3 · active not recruiting
- NCT06793826 — Post-marketing Surveillance Study for the Safety of a DTaP-IPV- HB-PRP~T Vaccine in Republic of Korea · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06824207 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sanofi Pasteur, a Sanofi Company
- Last refreshed: 5 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06824207.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing