Health Trials

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

ConditionMeningoccocal Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age7-36
SponsorSerum Institute of India Pvt. Ltd.

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Written informed consent and assent (if applicable)

Disqualifiers

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 population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

450 Participants
are grouped into 2 trial groups
Group A: NmCV-5
Group B: MenACWY-D

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Serum Institute of India Pvt. Ltd.

Lead sponsor

Source ClinicalTrials.gov
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