ClinicalTrials.gg
RecruitingNCT07379151PERS-ACYWX-03Updated Jun 3, 2026

Evaluation of the Antibody Persistence Beyond Five Years After Immunization With MenFiveTM (NmCV-5), a Pentavalent Meningococcal ACYWX Conjugate Vaccine

An observational study in Meningoccocal Disease, sponsored by Serum Institute of India Pvt. Ltd.. Recruiting at 2 sites in 2 countries. Open to participants aged 7 Years to 36 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-03.

Sponsored by Serum Institute of India Pvt. Ltd. · Observational

From the registry’s dates

  • Started May 2026; still recruiting 6 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
450
Ages
7 Years to 36 Years
Sex
All
01

Study summary

This study will measure immune persistence of the NmCV-5 more than 5 years after a single dose vaccination in participants 2-29 years of age in Mali and The Gambia.

Read the detailed description

This non-interventional long-term follow-up study will involve one telephonic contact in all 1800 former participants from study ACYWX-03 followed by one visit beyond five years after vaccination in a subset of 450 participants. This subset will be randomly selected to participate in a follow-on immune persistence evaluation. To document the duration of the immune response and any requirement of booster dose in the target population, this study is intended to explore antibody persistence.

02

Conditions studied

  • Meningoccocal Disease

Keywords

  • Seropersistence
  • Meningococcal
03

In context

Lead sponsor

Serum Institute of India Pvt. Ltd. is the lead sponsor of 26 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 36 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Participants from the previous study ACYWX-03 conducted at the Gambia and Mali

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Written and assent (if applicable)

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
450 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • NmCV-5
  • MenACWY-D
06

What researchers measure

Primary outcomes

  1. Geometric mean titers (GMTs) measured by rSBA against serogroups A, C, Y, W and X

    Time frame: five-six years after vaccination.

Secondary outcomes

  1. Percentage of participants with rSBA titers ≥ 8

    Time frame: five-six years after vaccination.

  2. Percentage of participants with rSBA titers ≥ 128

    Time frame: five-six years after vaccination

07

Study locations

2 of 2 sites recruiting
  • 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
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07379151
Responsible party
Sponsor
First posted
Jan 30, 2026
Start date
May 5, 2026
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Jun 3, 2026

Study contacts

Dr Prasad Kulkarni, MD, FRCP
Contact
drpsk@seruminstitute.com
+91-20-71946820

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Discussion

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