A Study to Learn About the Safety, Tolerability, and Immunogenicity of a Fifth Dose of 6-Valent OspA-Based Lyme Disease Vaccine
A legfontosabb adatok
- Hol
- Bangor, Burlington, Cortland, Duncansville, East Greenwich, Erie, Flemington, Horseheads, Pittsburgh, Sayre, Scottdale, Scranton, Smithfield, Uniontown, Winchester és Worcester (Egyesült Államok)Mind a 19 helyszín megnézése
- Fázis
- 3. fázis
Helyszínek itt: Egyesült Államok
- Northern Light Eastern Maine Medical CenterBangor, Egyesült ÁllamokToborzás még nem indult
- Northern Light Family Medicine and Residency CenterBangor, Egyesült ÁllamokToborzás még nem indult
- The University of Vermont Medical Center Inc.Burlington, Egyesült ÁllamokToborzás még nem indult
- Smith Allergy and Asthma SpecialistsCortland, Egyesült ÁllamokRésztvevőt keres
- Altoona Center For Clinical ResearchDuncansville, Egyesült ÁllamokRésztvevőt keres
- Velocity Clinical Research, ProvidenceEast Greenwich, Egyesült ÁllamokToborzás még nem indult
- Allegheny Health and Wellness PavilionErie, Egyesült ÁllamokRésztvevőt keres
- Central Erie Primary CareErie, Egyesült ÁllamokRésztvevőt keres
- Hunterdon Medical CenterFlemington, Egyesült ÁllamokToborzás még nem indult
- Smith Allergy & Asthma SpecialistsHorseheads, Egyesült ÁllamokRésztvevőt keres
- Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18)Pittsburgh, Egyesült ÁllamokRésztvevőt keres
- Preferred Primary Care Physicians, Preferred Clinical Research-St. ClairPittsburgh, Egyesült ÁllamokToborzás még nem indult
- Robert Packer HospitalSayre, Egyesült ÁllamokRésztvevőt keres
- Frontier Clinical Research, LLCScottdale, Egyesült ÁllamokRésztvevőt keres
- Northeast Clinical Trials GroupScranton, Egyesült ÁllamokRésztvevőt keres
- Frontier Clinical Research, LLCSmithfield, Egyesült ÁllamokRésztvevőt keres
- Preferred Primary Care PhysiciansUniontown, Egyesült ÁllamokToborzás még nem indult
- Amherst Family Practice P.C.Winchester, Egyesült ÁllamokToborzás még nem indult
- University of Massachusetts Chan Medical SchoolWorcester, Egyesült ÁllamokRésztvevőt keres
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- Pfizer
- Azonosító
- NCT07500506
- A regiszteradat frissítve
- 2026. május 6.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
A PHASE 3, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLINDED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A FIFTH DOSE OF 6-VALENT OSPA-BASED LYME DISEASE VACCINE, VLA15, IN HEALTHY PARTICIPANTS ≥7 YEARS OF AGE
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.
Bevonási feltételek: 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.
Kizáró feltételek: Recent or concurrent participation in a separate interventional study; 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; Pregnant or breastfeeding participants; Staff or direct family of the study site staff and Sponsor.