Status:
ACTIVE_NOT_RECRUITING
Antibody Persistence And Long Term Safety Of A Chikungunya Virus Vaccine (VLA1553)
Lead Sponsor:
Valneva Austria GmbH
Conditions:
Chikungunya Virus Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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).
Detailed Description
In this open-label Phase 3b, single arm trial, persistence of antibodies and long term safety in up to 375 participants rolled over from trial VLA1553-301 (NCT number: NCT04546724) These participants...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2031
Estimated Enrollment :
363 Patients enrolled
Trial Details
Trial ID
NCT04838444
Start Date
April 2 2021
End Date
May 1 2031
Last Update
December 24 2025
Active Locations (10)
Enter a location and click search to find clinical trials sorted by distance.
1
Accelerated Enrollment Solutions (AES)
Phoenix, Arizona, United States, 85020
2
Velocity Clinical Research
Hallandale, Florida, United States, 33090
3
Accelerated Enrollment Solutions (AES)
Chicago, Illinois, United States, 60602
4
Alliance for Multispecialty Research (AMR)
Lexington, Kentucky, United States, 40509