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RECRUITING
NCT07500506
PHASE3

A Study to Learn About the Safety, Tolerability, and Immunogenicity of a Fifth Dose of 6-Valent OspA-Based Lyme Disease Vaccine

Sponsor: Pfizer

View on ClinicalTrials.gov

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

BIOLOGICAL

VLA15

VLA15 injection IM

BIOLOGICAL

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