Status:
ACTIVE_NOT_RECRUITING
A Study to Learn About Different Dosing Schedules of a Lyme Disease Vaccine in Healthy Adults
Lead Sponsor:
Pfizer
Conditions:
Lyme Borreliosis
Eligibility:
All Genders
18-44 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to learn about the safety and effects of the Lyme disease vaccine (called VLA15) when given at different time points. This study is seeking participants who: * are gener...
Detailed Description
This is a Phase 3, randomized, parallel-group, placebo-controlled, double-blinded (third-party unblinded) study to evaluate the safety, tolerability, and immunogenicity of different vaccination schedu...
Eligibility Criteria
Inclusion Criteria:
- Participants who are healthy as determined by medical history and clinical judgment.
- Participants willing and able to comply with all scheduled visits, IP receipt, and other procedures throughout the study.
- Able to provide Informed Consent.
Exclusion Criteria:
- Pregnant or breastfeeding participants.
- Allergies or contraindications to vaccines or their components.
- Health issues including: blood clotting deficiencies, immunodeficiencies, bone marrow disorder, or uncontrolled psychiatric conditions.
- Receipt of therapies to treat malignancies, blood/plasma products and immunoglobulins, systemic corticosteroids and immunosuppressants, or anticoagulant therapy in recent medical history.
- Any prior Lyme disease vaccination, or recent or concurrent participation in a separate interventional study.
- Staff or direct family of the study site staff and Sponsor.
Key Trial Info
Start Date :
November 19 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 27 2028
Estimated Enrollment :
207 Patients enrolled
Trial Details
Trial ID
NCT07226882
Start Date
November 19 2025
End Date
January 27 2028
Last Update
April 17 2026
Active Locations (10)
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1
University of Massachusetts Chan Medical School
Worcester, Massachusetts, United States, 01655
2
IMA Clinical Research Warren
Warren Township, New Jersey, United States, 07059
3
Smith Allergy and Asthma Specialists
Cortland, New York, United States, 13045
4
Smith Allergy & Asthma Specialists
Horseheads, New York, United States, 14845