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A Study to Learn About the Safety, Tolerability, and Immunogenicity of a Fifth Dose of 6-Valent OspA-Based Lyme Disease Vaccine
Sponsor: Pfizer
Summary
The purpose of this study is to learn about the safety effects of the Lyme disease vaccine (called VLA15), and its ability to protect people from Lyme disease after a 5th dose of the vaccine. This study is seeking participants who: * are generally healthy and 7 years of age and older, * have already been vaccinated with 4 doses of VLA15 (from the VALOR study), and have blood sample taken post dose 4. * are not currently taking, or haven't recently taken, medicines like chemotherapy, blood products, or blood thinners. * are not pregnant or breastfeeding and do not plan to become pregnant while receiving the study vaccine. All participants in this study will receive a total of 1 dose through a shot in the upper arm, either VLA15 or saline shot (saltwater). The study will compare the experiences of people receiving the study vaccine or saltwater shot. Participants will take part in this study for about 12 months. During this time, they will have 4 planned clinic visits. The clinic visits may include having a health check, giving a small amount of blood and getting the study vaccine or saltwater as a shot at the first visit.
Official title: A PHASE 3, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLINDED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A FIFTH DOSE OF 6-VALENT OSPA-BASED LYME DISEASE VACCINE, VLA15, IN HEALTHY PARTICIPANTS ≥7 YEARS OF AGE
Key Details
Gender
All
Age Range
7 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1712
Start Date
2026-04-08
Completion Date
2026-12-04
Last Updated
2026-05-06
Healthy Volunteers
Yes
Conditions
Interventions
VLA15
VLA15 injection IM
Placebo
Saline Injection
Locations (22)
Northern Light Eastern Maine Medical Center
Bangor, Maine, United States
Northern Light Family Medicine and Residency Center
Bangor, Maine, United States
University of Massachusetts Chan Medical School
Worcester, Massachusetts, United States
Hunterdon Medical Center
Flemington, New Jersey, United States
Smith Allergy and Asthma Specialists
Cortland, New York, United States
Smith Allergy & Asthma Specialists
Horseheads, New York, United States
Altoona Center For Clinical Research
Duncansville, Pennsylvania, United States
Allegheny Health and Wellness Pavilion
Erie, Pennsylvania, United States
Central Erie Primary Care
Erie, Pennsylvania, United States
Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18)
Pittsburgh, Pennsylvania, United States
Preferred Primary Care Physicians, Preferred Clinical Research - St.Clair
Pittsburgh, Pennsylvania, United States
Robert Packer Hospital
Sayre, Pennsylvania, United States
Frontier Clinical Research, LLC
Scottdale, Pennsylvania, United States
Northeast Clinical Trials Group
Scranton, Pennsylvania, United States
Frontier Clinical Research, LLC
Smithfield, Pennsylvania, United States
Preferred Primary Care Physicians
Uniontown, Pennsylvania, United States
Velocity Clinical Research, Providence
East Greenwich, Rhode Island, United States
The University of Vermont Medical Center Inc.
Burlington, Vermont, United States
Amherst Family Practice, P.C.
Winchester, Virginia, United States
Milestone Research Inc.
London, Ontario, Canada
Stouffville Medical Research Institute Inc.
Stouffville, Ontario, Canada
Diex Recherche Inc. Division Sherbrooke
Sherbrooke, Quebec, Canada