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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

NCT07500506 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1712

Last updated 2026-05-06

No results posted yet for this 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.

Conditions

Interventions

BIOLOGICAL

VLA15

VLA15 injection IM

BIOLOGICAL

Placebo

Saline Injection

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-04-08
Primary Completion
2026-12-04
Completion
2026-12-04
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07500506 on ClinicalTrials.gov