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Phase 2 Study Of VLA15, A Vaccine Candidate Against Lyme Borreliosis, In A Healthy Pediatric And Adult Study Population

CompletedPhase 2

Sponsor: Pfizer

Conditions: Lyme Borreliosis

Interventions: VLA15, Placebo

Countries: United States

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 immunization schedules applying three (Month 0-2-6) or two (Month 0- 6) vaccinations. Within the study, 600 healthy subjects aged 5-65 years will be included. Subjects with a history of Lyme borreliosis (previous infection with Borrelia) as well as Borrelia naïve subjects will be enrolled. Study duration per subject will be a maximum of 50 months per subject.

Eligibility overview

Sex: ALL

Age: 5 Years to 65 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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

Locations (19)

Bridgeport, Connecticut, United States
Stamford, Connecticut, United States
Waterbury, Connecticut, United States
Waterbury, Connecticut, United States
Minneapolis, Minnesota, United States
East Orange, New Jersey, United States
Irvington, New Jersey, United States
Binghamton, New York, United States
Rochester, New York, United States
Staten Island, New York, United States
The Bronx, New York, United States
Cleveland, Ohio, United States
Erie, Pennsylvania, United States
Erie, Pennsylvania, United States
Fort Washington, Pennsylvania, United States
Providence, Rhode Island, United States
Providence, Rhode Island, United States
Providence, Rhode Island, United States
Warwick, Rhode Island, United States