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NCT Number: NCT07379151

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

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.

Recruiting

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Key information

Conditions

Meningoccocal Disease

Age range

7 year–36 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre pour le Développement des Vaccins du Mali, ex-Institut Marchoux, Ministry of Health, BP251 Bamako, Mali BP251, Bamako, Mali

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Study contacts

Contact information is provided by the study sponsor or research team.

Dr Prasad Kulkarni, MD, FRCP

CONTACT

[email protected]

+91-20-71946820

Sponsors and collaborators

Lead sponsor

Serum Institute of India Pvt. Ltd.

Industry

Registry information

Official study title

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

Acronym: PERS-ACYWX-03

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 30, 2026
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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