MedTrace Logo

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

NCT04801420 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 625

Last updated 2026-05-19

Study results available
· View outcomes & findings →

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 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.

Conditions

  • Lyme Borreliosis

Interventions

BIOLOGICAL

VLA15

a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate

BIOLOGICAL

Placebo

PBS (Phosphate Buffered Saline)

Sponsors & Collaborators

  • Valneva Austria GmbH

    collaborator INDUSTRY

  • Pfizer

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-08
Primary Completion
2022-03-25
Completion
2025-07-02
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04801420 on ClinicalTrials.gov