NCT07379151

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started Mar 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress25%
Mar 2026Dec 2026

First Submitted

Initial submission to the registry

January 23, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 30, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

February 4, 2026

Status Verified

January 1, 2026

Enrollment Period

9 months

First QC Date

January 23, 2026

Last Update Submit

January 31, 2026

Conditions

Meningoccocal Disease

Keywords

SeropersistenceMeningococcal

Outcome Measures

Primary Outcomes (1)

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

    five-six years after vaccination.

Secondary Outcomes (2)

  • Percentage of participants with rSBA titers ≥ 8

    five-six years after vaccination.

  • Percentage of participants with rSBA titers ≥ 128

    five-six years after vaccination

Study Arms (2)

NmCV-5

MenACWY-D

Eligibility Criteria

Age7 Years - 36 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Written informed consent and assent (if applicable)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2026

First Posted

January 30, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

February 4, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share