Actively Recruiting
A Study to Learn About the Safety, Tolerability, and Immunogenicity of a Fifth Dose of 6-Valent OspA-Based Lyme Disease Vaccine
Led by Pfizer · Updated on 2026-05-06
1712
Participants Needed
22
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Learn About the Safety, Tolerability, and Immunogenicity of a Fifth Dose of 6-Valent OspA-Based Lyme Disease Vaccine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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.
- Recent or concurrent participation in a separate interventional study.
- Staff or direct family of the study site staff and Sponsor.
AI-Screening
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Trial Site Locations
Total: 22 locations
1
Northern Light Eastern Maine Medical Center
Bangor, Maine, United States, 04401
Not Yet Recruiting
2
Northern Light Family Medicine and Residency Center
Bangor, Maine, United States, 04401
Not Yet Recruiting
3
University of Massachusetts Chan Medical School
Worcester, Massachusetts, United States, 01655
Actively Recruiting
4
Hunterdon Medical Center
Flemington, New Jersey, United States, 08822
Not Yet Recruiting
5
Smith Allergy and Asthma Specialists
Cortland, New York, United States, 13045
Actively Recruiting
6
Smith Allergy & Asthma Specialists
Horseheads, New York, United States, 14845
Actively Recruiting
7
Altoona Center For Clinical Research
Duncansville, Pennsylvania, United States, 16635
Actively Recruiting
8
Allegheny Health and Wellness Pavilion
Erie, Pennsylvania, United States, 16506
Actively Recruiting
9
Central Erie Primary Care
Erie, Pennsylvania, United States, 16508
Actively Recruiting
10
Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18)
Pittsburgh, Pennsylvania, United States, 15236
Actively Recruiting
11
Preferred Primary Care Physicians, Preferred Clinical Research - St.Clair
Pittsburgh, Pennsylvania, United States, 15243
Not Yet Recruiting
12
Robert Packer Hospital
Sayre, Pennsylvania, United States, 18840
Actively Recruiting
13
Frontier Clinical Research, LLC
Scottdale, Pennsylvania, United States, 15683
Actively Recruiting
14
Northeast Clinical Trials Group
Scranton, Pennsylvania, United States, 18510
Actively Recruiting
15
Frontier Clinical Research, LLC
Smithfield, Pennsylvania, United States, 15478
Actively Recruiting
16
Preferred Primary Care Physicians
Uniontown, Pennsylvania, United States, 15401
Not Yet Recruiting
17
Velocity Clinical Research, Providence
East Greenwich, Rhode Island, United States, 02818
Not Yet Recruiting
18
The University of Vermont Medical Center Inc.
Burlington, Vermont, United States, 05401
Not Yet Recruiting
19
Amherst Family Practice, P.C.
Winchester, Virginia, United States, 22601
Not Yet Recruiting
20
Milestone Research Inc.
London, Ontario, Canada, N5W 6A2
Not Yet Recruiting
21
Stouffville Medical Research Institute Inc.
Stouffville, Ontario, Canada, L4A 1H2
Not Yet Recruiting
22
Diex Recherche Inc. Division Sherbrooke
Sherbrooke, Quebec, Canada, J1L 0H8
Actively Recruiting
Research Team
P
Pfizer CT.gov Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
4
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