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Alternative Schedule Study For VLA15, a Vaccine Candidate Against Lyme Borreliosis

NCT03970733 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 246

Last updated 2023-04-21

Study results available
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Summary

In the Main Study Phase a total of 246 subjects were randomized 2:2:1 into three treatment groups to receive either VLA15 with Alum (lower or higher dose) or Placebo. Main Study Phase vaccinations were administered as intramuscular injections on Day 1, Day 57 and Day 180.

In the Booster Phase subjects from the higher dose group who completed their primary immunization schedule according to protocol will be randomized 2:1 to receive an additional higher dose VLA15 vaccination or Placebo at Month 18.

Study duration in the Main Study Phase per subject is a maximum of 20 months. Overall study Duration is estimated to be 22 months.

Study duration per subject in the Booster Phase is a maximum of approximately 13 months.

Study duration per subject in the Main Study Phase and Booster Phase together is estimated to be a maximum of approximately 33 months.

Overall study duration (i.e., First-Subject-In to Last-Subject Out/ end of Booster Phase) is estimated to be approximately 37 months.

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
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-01
Primary Completion
2020-04-07
Completion
2022-03-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03970733 on ClinicalTrials.gov