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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

RecruitingPhase 3Ages 7 Years - anyAllPfizer
NCT07500506 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 thi

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📋 Eligibility rules (as published)
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.
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What it tests

  • VLA15
  • Placebo
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Where

22 sites
Northern Light Eastern Maine Medical Center
Bangor, United States
Northern Light Family Medicine and Residency Center
Bangor, United States
University of Massachusetts Chan Medical School
Worcester, United States
Hunterdon Medical Center
Flemington, United States
Smith Allergy and Asthma Specialists
Cortland, United States
Smith Allergy & Asthma Specialists
Horseheads, United States
Altoona Center For Clinical Research
Duncansville, United States
Allegheny Health and Wellness Pavilion
Erie, United States

…and 14 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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