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Long-Term Study of Antibody Persistence Over Five Years After Vaccination With MenFiveTM NmCV-5, a Pentavalent Meningococcal ACYWX Conjugate Vaccine in African Participants
Led by Serum Institute of India Pvt. Ltd. · Updated on 2026-06-03
450
Participants Needed
2
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying the persistence of immune response to the NmCV-5 vaccine, a pentavalent meningococcal ACYWX conjugate vaccine, in participants aged 2 to 29 years from Mali and The Gambia. The goal is to understand how long the antibody protection lasts more than five years after a single dose vaccination and whether a booster dose might be needed in this population. This observational long-term follow-up study involves contacting 1800 former participants from an earlier study by phone, followed by an in-person visit for a randomly selected subset of 450 participants. The study focuses on evaluating antibody levels against meningococcal serogroups A, C, Y, W, and X more than five years post-vaccination, measuring geometric mean titers and percentages of participants with specific antibody titers. Participants will be involved in a telephone interview and a clinical visit for blood sampling to assess antibody levels. Researchers will measure immune response persistence using serum bactericidal antibody titers. The study will monitor these immune markers to help determine the duration of vaccine-induced protection. Participation will last beyond five years after the initial vaccination, with safety and compliance monitored throughout.
CONDITIONS
Brief Title
Evaluation of the Antibody Persistence Beyond Five Years After Immunization With MenFiveTM (NmCV-5), a Pentavalent Meningococcal ACYWX Conjugate Vaccine
Research Team
D
Dr Prasad Kulkarni, MD, FRCP
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