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Clinical Trials in the USA / NCT07500506
Recruiting Phase 3

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

NCT07500506 · tracked via the Priya Life Science USA tracker
Sponsor
Pfizer
Phase
Phase 3
Started
2026-04-08
Last updated
2026-05-06

Condition(s) studied

Lyme Disease

Investigational drug(s) / intervention(s)

VLA15 →Placebo

VLA15: VLA15 injection IM

Placebo: Saline Injection

Study 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

Sex
ALL
Min age
7 Years
Max age
—
Healthy volunteers
Accepted
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. * Participants must have received 4 doses of VLA15 in the C4601003 study, and have a V7 blood sample available. 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. * Recent or concurrent participation in a separate interventional study. * Staff or direct family of the study site staff and Sponsor.

Primary outcome measure(s)

  • Percentage of participants reporting prespecified local reactions — Within 7 days following each study intervention administration
  • Percentage of participants reporting prespecified systemic events — Within 7 days following each study intervention administration
  • Percentage of participants reporting adverse events (AEs) — Through 1 month following study intervention administration
  • Percentage of participants reporting newly diagnosed chronic medical conditions (NDCMCs) — Through study completion, up to approximately 12 months.
  • Percentage of participants reporting serious adverse events (SAEs) — Through study completion, up to approximately 12 months.
  • Geometric mean ratio (GMR) of anti-OspA IgG concentrations for each serotype (ST1-ST6) — At 1 month after completion of Dose 5
    Objective to determine non-inferiority of Dose 5 compared to Dose 4 in all participants when there is a 1 year gap between Dose 4 and Dose 5.
  • Sero-response of anti-OspA IgG concentrations for each serotype (ST1-ST6). — At 1 month after completion of Dose 5
    Difference in seroresponse rate between 1 month after Dose 5 and 1 month after Dose 4 for each serotype in all participants ≥7 years of age who received a fifth dose of VLA15 1 year after their fourth dose of VLA15.

Trial sites (22)

FacilityCityRegionStatus
Northern Light Eastern Maine Medical Center Bangor Maine Not Yet Recruiting
Northern Light Family Medicine and Residency Center Bangor Maine Not Yet Recruiting
University of Massachusetts Chan Medical School Worcester Massachusetts Recruiting
Hunterdon Medical Center Flemington New Jersey Not Yet Recruiting
Smith Allergy and Asthma Specialists Cortland New York Recruiting
Smith Allergy & Asthma Specialists Horseheads New York Recruiting
Altoona Center For Clinical Research Duncansville Pennsylvania Recruiting
Allegheny Health and Wellness Pavilion Erie Pennsylvania Recruiting
Central Erie Primary Care Erie Pennsylvania Recruiting
Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18) Pittsburgh Pennsylvania Recruiting
Preferred Primary Care Physicians, Preferred Clinical Research - St.Clair Pittsburgh Pennsylvania Not Yet Recruiting
Robert Packer Hospital Sayre Pennsylvania Recruiting
Frontier Clinical Research, LLC Scottdale Pennsylvania Recruiting
Northeast Clinical Trials Group Scranton Pennsylvania Recruiting
Frontier Clinical Research, LLC Smithfield Pennsylvania Recruiting
Preferred Primary Care Physicians Uniontown Pennsylvania Not Yet Recruiting
Velocity Clinical Research, Providence East Greenwich Rhode Island Not Yet Recruiting
The University of Vermont Medical Center Inc. Burlington Vermont Not Yet Recruiting
Amherst Family Practice, P.C. Winchester Virginia Not Yet Recruiting
Milestone Research Inc. London Ontario Not Yet Recruiting
Stouffville Medical Research Institute Inc. Stouffville Ontario Not Yet Recruiting
Diex Recherche Inc. Division Sherbrooke Sherbrooke Quebec Recruiting

More Pfizer trials in the USA

A Study to Learn About the Medicine Called PF-08653944 in People With and Without Reduced Liver Function Recruiting
A Long-term Study of the Medicine Called Abrocitinib in Children Aged 2 Years and Older With Moderate to Severe Eczema Recruiting
A Study to Learn About How Food Affects the Uptake of Study Medicine Prifetrastat Into the Blood in Healthy Adults Starting soon
A Study of PF-08653945 and PF-08653944 in Adults With Overweight or Obesity Active, not recruiting
A Study to Learn How the Study Medicine Called Atirmociclib is Handled by the Body in People With Normal Liver Function and Different Levels of Liver Disease Recruiting

Other trials for the same condition

Safety and Effectiveness of the BlinkER System in Participants With Facial Nerve Palsy Starting soon
A Study to Evaluate Safety and Efficacy of TP-05 in Healthy Participants With Tick Exposure Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07500506 on ClinicalTrials.gov ↗ ← All trials in the USA