Status:
COMPLETED
Phase 2 Study Of VLA15, A Vaccine Candidate Against Lyme Borreliosis, In A Healthy Pediatric And Adult Study Population
Lead Sponsor:
Pfizer
Collaborating Sponsors:
Valneva Austria GmbH
Conditions:
Lyme Borreliosis
Eligibility:
All Genders
5-65 years
Phase:
PHASE2
Brief Summary
VLA15-221 is a Phase 2 study, which will be conducted in two parts: Main Study Phase (Part A) and Booster Phase (Part B). The study will compare the safety and immunogenicity of two different primary ...
Detailed Description
VLA15-221 is a randomized, observer-blind, placebo controlled, multicenter Phase 2 study, which is set up in two parts: Main Study Phase (Part A) and Booster Phase (Part B). In Part A 600 subjects age...
Eligibility Criteria
Inclusion
- Subject is aged 5 to 65 years at the day of screening (Visit 0)
- Subject is of good general health
- Parent(s)/legal representative(s) and subject understand the study and its procedures, agree to its provisions
- for subjects aged 18-65 years: written informed consent prior to any study related procedures
- for subjects aged 5-17 years: written informed consent by the subject's legal representative(s), according to local requirements, and written informed assent of the subject, if applicable, prior to any study related procedures.
- If subject is of childbearing potential: Subject has a negative serum pregnancy test at screening (Visit 0) and agrees to employ adequate birth control measures according to following timelines:
- Main Study Phase: duration of entire study
- Booster Phase: until 5 months after each booster vaccination (Booster 1 until Month 23, Booster 2 until Month 35 and Booster 3 until Month 47)
- Subject is willing and able to comply with scheduled visits, treatment plan, and other study procedures
- Subject is available for the duration of the study and can be contacted by telephone during study participation
Exclusion
- Subject has a chronic illness related to Lyme borreliosis (LB), an active symptomatic LB, or received treatment for LB within the last 3 months prior to Day 1;
- Subject received previous vaccination against LB;
- Subject had a tick bite within 4 weeks prior to Day 1;
- Subject has a medical history of or currently has a clinically relevant disease;
- Subject has a medical history of or currently has a neuro- inflammatory or autoimmune disease;
- Subject has a known thrombocytopenia, bleeding disorder, or received anticoagulants in the 3 weeks prior to Day 1;
- Subject has received an active or passive immunization within 4 weeks prior to Day 1;
- Subject has received any other registered or non-registered medicinal product in another clinical trial within 4 weeks prior to vaccination at Day 1;
- Subject has a known or suspected defect of the immune system or received immuno-suppressive therapy within 4 weeks prior to Day 1;
- Subject has a history of anaphylaxis of unknown cause or severe allergic reactions of unknown cause or has a known hypersensitivity or allergic reactions to one of the components of the vaccine;
- Subject had any malignancy in the past 5 years;
- Subject is pregnant, has plans to become pregnant during the course of the study or is lactating at the time of enrollment;
- Subject has donated or plans to donate blood or blood-derived products 4 weeks prior to Day 1;
- Subject has any condition that may compromise its well-being, might interfere with evaluation of study endpoints, or would limit the subject's ability to complete the study;
- Subject is in a dependent relationship with the sponsor/investigator
Key Trial Info
Start Date :
March 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 2 2025
Estimated Enrollment :
625 Patients enrolled
Trial Details
Trial ID
NCT04801420
Start Date
March 8 2021
End Date
July 2 2025
Last Update
November 12 2025
Active Locations (22)
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1
New England Research Associates
Bridgeport, Connecticut, United States, 06606
2
Stamford Therapeutics Consortium
Stamford, Connecticut, United States, 06905
3
Chase Medical Research, LLC
Waterbury, Connecticut, United States, 06708
4
Pediatric Associates of Conn. PC
Waterbury, Connecticut, United States, 06708