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
Status: Recruiting
Location: See all (22) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 7
Healthy Volunteers: t
View:
• 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.
• Participants must have received 4 doses of VLA15 in the C4601003 study, and have a V7 blood sample available.
Locations
United States
Massachusetts
University of Massachusetts Chan Medical School
RECRUITING
Worcester
Maine
Northern Light Eastern Maine Medical Center
NOT_YET_RECRUITING
Bangor
Northern Light Family Medicine and Residency Center
NOT_YET_RECRUITING
Bangor
New Jersey
Hunterdon Medical Center
NOT_YET_RECRUITING
Flemington
New York
Smith Allergy and Asthma Specialists
RECRUITING
Cortland
Smith Allergy & Asthma Specialists
RECRUITING
Horseheads
Pennsylvania
Altoona Center For Clinical Research
RECRUITING
Duncansville
Allegheny Health and Wellness Pavilion
RECRUITING
Erie
Central Erie Primary Care
RECRUITING
Erie
Preferred Primary Care Physicians, Preferred Clinical Research - St.Clair
NOT_YET_RECRUITING
Pittsburgh
Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18)
RECRUITING
Pittsburgh
Robert Packer Hospital
RECRUITING
Sayre
Frontier Clinical Research, LLC
RECRUITING
Scottdale
Northeast Clinical Trials Group
RECRUITING
Scranton
Frontier Clinical Research, LLC
RECRUITING
Smithfield
Preferred Primary Care Physicians
NOT_YET_RECRUITING
Uniontown
Rhode Island
Velocity Clinical Research, Providence
NOT_YET_RECRUITING
East Greenwich
Virginia
Amherst Family Practice, P.C.
NOT_YET_RECRUITING
Winchester
Vermont
The University of Vermont Medical Center Inc.
NOT_YET_RECRUITING
Burlington
Other Locations
Canada
Milestone Research Inc.
NOT_YET_RECRUITING
London
Diex Recherche Inc. Division Sherbrooke
RECRUITING
Sherbrooke
Stouffville Medical Research Institute Inc.
NOT_YET_RECRUITING
Stouffville
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date:2026-04-08
Estimated Completion Date:2026-12-04
Participants
Target number of participants:1712
Treatments
Experimental: VLA15-1A
Participants will receive a single injection in the muscle (IM) of VLA15 at Visits 1, two years after their 4th dose of VLA15
Placebo_comparator: VLA15-1B
Participants will receive a single injection in the muscle (IM) of Saline at Visits 1, two years after their 4th dose of VLA15
Experimental: VLA15-2A
Participants will receive a single injection in the muscle (IM) of VLA15 at Visits 1, one year after their 4th dose of VLA15
Placebo_comparator: VLA15-2B
Participants will receive a single injection in the muscle (IM) of saline at Visits 1, one year after their 4th dose of VLA15