Evaluation of the Antibody Persistence Beyond Five Years After Immunization With MenFiveTM (NmCV-5), a Pentavalent Meningococcal ACYWX Conjugate Vaccine (PERS-ACYWX-03)

Serum Institute of India

Status: Begins enrollment this month

Conditions: Meningoccocal Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT07379151

PERS-ACYWX-03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 450 estimated patients

Sex: All

Ages: 7 to 36 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

450 participants in 2 patient groups

NmCV-5

MenACWY-D