See if immune protection from NmCV-5 lasts more than five years in kids and young adults
Official title: Evaluation of the Antibody Persistence in African Participants Beyond Five Years After Immunization With MenFiveTM (NmCV-5), a Pentavalent Meningococcal ACYWX Conjugate Vaccine
Run by Serum Institute of India Pvt. Ltd. · NCT07379151 · Data updated 2026-11-12
This study tests whether the meningococcal vaccine NmCV-5 keeps people aged 2–29 protected more than five years after a single dose.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 7 Years to 36 Years |
| Sex | All |
| Enrollment | 450 (estimated) |
| Sponsor | Serum Institute of India Pvt. Ltd. Industry-sponsored |
| Locations | 2 sites (Bamako and 1 other locations) |
| Status | Recruiting |
| Started | May 5, 2026 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | June 3, 2026 |
| Trial ID | NCT07379151 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals aged 2–29 years who previously received NmCV-5 in the ACYWX-03 study and consent to follow-up in Mali or The Gambia.
✕Probably not a fit
Some participants may not experience a measurable change in immune markers or may not benefit from booster recommendations.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a non-interventional, long-term follow-up study of about 1,800 participants from a prior study who received a single dose of NmCV-5. It involves one telephone contact for all participants and a follow-up visit beyond five years for a randomly selected subset of 450 to evaluate antibody persistence. The goal is to document how long the immune response lasts and whether a booster might be needed in the target population. The study is conducted in Mali and The Gambia, with participation limited to individuals meeting consent and eligibility criteria and without meningococcal disease before vaccination.
Why it matters
Potential benefit: If successful, the findings could clarify how long NmCV-5 provides immune protection and inform booster dose policies.
How similar studies have gone: Prior studies of meningococcal vaccines have shown variable persistence; this follow-up addresses long-term persistence in a real-world setting, with mixed prior results.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Written informed consent and assent (if applicable) Exclusion Criteria: * Current or previous, confirmed disease caused by Neisseria meningitidis at any given time since meningococcal vaccination * Any condition or criteria that in the opinion of the investigator might compromise the well-being of the participant or the compliance with study procedures or interfere with the outcome of the study
Where it's running
-
Centre pour le Développement des Vaccins du Mali, ex-Institut Marchoux, Ministry of Health, BP251 Bamako, Mali BP251
Bamako, Mali Recruiting -
Medical Research Council Unit The Gambia at the London School of Hygiene & Tropical Medicine, Fajara, The Gambia
Banjul, The Gambia Recruiting
Study contacts
- Study coordinator: Dr Prasad Kulkarni, MD, FRCP
- Email: drpsk@seruminstitute.com
- Phone: +91-20-71946820
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.