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

Conditions

• Lyme Disease

Eligibility Criteria

Sex

ALL

Age

7 Years - N/A

Healthy Volunteers

Accepted

Interventions

• VLA15 — BIOLOGICAL
  VLA15 injection IM
• Placebo — BIOLOGICAL
  Saline Injection

Study Details

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.

Key Dates

Start date

Apr 8, 2026

Status verified

May 2026

Primary completion

Dec 4, 2026

Completion

Dec 4, 2026

Study Design

Enrollment

1,712 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• 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

Primary Outcome Measure

Percentage of participants reporting prespecified local reactions [ Time Frame: Within 7 days following each study intervention administration ]

Central Contacts

• Pfizer CT.gov Call Center
  1-800-718-1021
  [email protected]

Locations (19)

Find similar trials in Bangor, ME

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