VLA15 Lyme Disease Vaccine Safety Study Protocol Amendment
Summary
The National Library of Medicine (ClinicalTrials.gov) recorded a protocol amendment for Pfizer's VLA15 Lyme disease vaccine extension study (NCT07500506). The amendment updates the protocol summary and informed consent form to version 9 dated September 12, 2025. No changes to study procedures, inclusion/exclusion criteria, or safety monitoring requirements were made.
What changed
Pfizer submitted protocol amendment version 9 for their ongoing Phase 2 VLA15 Lyme disease vaccine extension study, updating the protocol summary and informed consent form (ICF) dated September 12, 2025. The amendment is administrative in nature with no substantive changes to study procedures or patient safety measures.
Research teams conducting this study should document the version 9 update in their trial master files and brief site staff on the updated protocol. New patient enrollments must reference the September 12, 2025 version. No immediate compliance action is required, but teams should ensure proper version control going forward.
What to do next
- Record protocol amendment version 9 in trial master file
- Brief site staff on updated protocol summary and ICF version
- Ensure all new enrollments reference version 9 dated September 12, 2025
Source document (simplified)
Show glossary
Named provisions
Related changes
Source
Classification
Who this affects
Taxonomy
Browse Categories
Get Pharma & Drug Safety alerts
Weekly digest. AI-summarized, no noise.
Free. Unsubscribe anytime.
Get alerts for this source
We'll email you when ClinicalTrials.gov publishes new changes.