NCT07500506 A Study to Learn About the Safety, Tolerability, and Immunogenicity of a Fifth Dose of 6-Valent OspA-Based Lyme Disease Vaccine
| NCT ID | NCT07500506 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Pfizer |
| Condition | Lyme Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,712 participants |
| Start Date | 2026-04-08 |
| Primary Completion | 2026-12-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 1,712 participants in total. It began in 2026-04-08 with a primary completion date of 2026-12-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Pfizer CT.gov Call Center
STUDY DIRECTOR
Pfizer
Frequently Asked Questions
Who can join the NCT07500506 clinical trial?
This trial is open to participants of all sexes, aged 7 Years or older, studying Lyme Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07500506 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 1,712 participants.
Is NCT07500506 currently recruiting?
Yes, NCT07500506 is actively recruiting participants. Contact the research team at ClinicalTrials.gov_Inquiries@pfizer.com for enrollment information.
Where is the NCT07500506 trial being conducted?
This trial is being conducted at Bangor, United States, Bangor, United States, Worcester, United States, Flemington, United States and 11 additional locations.
Who is sponsoring the NCT07500506 clinical trial?
NCT07500506 is sponsored by Pfizer. The principal investigator is Pfizer CT.gov Call Center at Pfizer. The trial plans to enroll 1,712 participants.