A Study to Learn About the Safety, Tolerability, and Immunogenicity of a Fifth Dose of 6-Valent OspA-Based Lyme Disease Vaccine
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Pfizer CT.gov Call Center
Principal Investigator
Pfizer
Are You a Good Fit for This Trial?
Inclusion Criteria
What Are the Treatments Tested in This Trial?
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Placebo Group
Participants will receive a single injection in the muscle (IM) of VLA15 at Visits 1, one year after their 4th dose of VLA15
Participants will receive a single injection in the muscle (IM) of VLA15 at Visits 1, two years after their 4th dose of VLA15
Participants will receive a single injection in the muscle (IM) of Saline at Visits 1, two years after their 4th dose of VLA15
Participants will receive a single injection in the muscle (IM) of saline at Visits 1, one year after their 4th dose of VLA15
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pfizer
Lead Sponsor
Albert Bourla
Pfizer
Chief Executive Officer since 2019
PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki
Patrizia Cavazzoni
Pfizer
Chief Medical Officer
MD from McGill University
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