VLA1553: Trial participants previously vaccinated with VLA1553 in trial VLA1553-301 will be followed up for safety and immunogenicity.
Study summary
In this open-label Phase 3b, single arm trial, persistence of antibodies and long term safety will be evaluated in up to 375 participants rolled over from trial VLA1553-301 (NCT number: NCT04546724).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria:
* Individual participated in the VLA1553-301 clinical trial;
* Participant has an understanding of the trial and its procedures, agrees to its provisions, and voluntarily gives written informed consent prior to any trial-related procedures;
* Participant had immunogenicity blood samples taken at baseline (Visit 1) and either Day 29 (Visit 3), Day 85 (Visit 4) or Day 180 (Visit 5) in Trial VLA1553-301 and was negative for neutralizing antibodies at baseline
Exclusion Criteria:
* Participant presents with clinical conditions representing a contraindication to blood draws;
* Participant has donated blood or use of blood products prior 30 days of immunogenicity sampling;
* Participant has received an active drug with potential immunosuppressive action or investigational drug or device within a period of 30 days prior a trial visit;
* Participant has a known or suspected problem with alcohol or drug abuse as determined by the Investigator;
* Participant has any condition that, in the opinion of the Investigator, may compromise the participant's well-being, might interfere with evaluation of trial endpoints, or would limit the participant's ability to complete the trial;
* Participant is committed to an institution (by virtue of an order issued either by the judicial or the administrative authorities);
* Participant is a member of the team conducting the trial or in a dependent relationship with one of the trial team members. Dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the Investigator or site personnel conducting the trial.
Primary outcome measure(s)
Proportion of Participants With Seroresponse Levels Post-vaccination. (Defined as µPRNT50 ≥150) — Year 2 Data for Visit 1 - Day 1 are collected from Trial VLA1553-301
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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