Meningoccocal DiseasePERS-ACYWX-03NCT07379151
Evaluation of the Antibody Persistence Beyond Five Years After Immunization With MenFiveTM (NmCV-5), a Pentavalent Meningococcal ACYWX Conjugate Vaccine
An observational study of Meningoccocal Disease, run by Serum Institute of India Pvt. Ltd. at 2 sites in 2 countries.
Trial 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 more about this study
- Who is it for?
- Ages 7 to 36 yearsHealthy volunteers can take part
- Conditions the study is for
- Meningoccocal Disease
- How many people
- 450 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 5 May 2026to Dec 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 36 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Participants from the previous study ACYWX-03 conducted at the Gambia and Mali
Who may be able to join
- Written informed consent and assent (if applicable)
Who cannot join
- 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 locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Mali1 site, 1 recruiting
- Recruiting
Centre pour le Développement des Vaccins du Mali, ex-Institut Marchoux, Ministry of Health, BP251 Bamako, Mali BP251
Bamako
Samba Sow, MD, MSc, +223 20 23 6031, ssow@cvd-mali.org
The Gambia1 site, 1 recruiting
- Recruiting
Medical Research Council Unit The Gambia at the London School of Hygiene & Tropical Medicine, Fajara, The Gambia
Banjul
Dr. Olubukola Idoko, MB BS, MSc, PhD, +220 449 5443, Olubukola.Idoko@lshtm.ac.uk
About this study
Official title: Evaluation of the Antibody Persistence in African Participants 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.
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.
- Conditions
- Meningoccocal Disease
- Keywords
- Seropersistence, Meningococcal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| NmCV-5 | Not described | |
| MenACWY-D | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric mean titers (GMTs) measured by rSBA against serogroups A, C, Y, W and X
Measured: five-six years after vaccination.
Secondary outcomes (2)
Percentage of participants with rSBA titers ≥ 8
Measured: five-six years after vaccination.
Percentage of participants with rSBA titers ≥ 128
Measured: five-six years after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start5 May 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meningoccocal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Serum Institute of India Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07379151
- Sponsor's protocol ID
- PERS-ACYWX-03
- Acronym
- PERS-ACYWX-03
- Status last verified
- Jan 2026
- First submitted
- 23 Jan 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Antibody Persistence in African Participants Beyond Five Years After Immunization With MenFiveTM (NmCV-5), a Pentavalent Meningococcal ACYWX Conjugate Vaccine
- ClinicalTrials.gov ID
- NCT07379151
- Acronym / sponsor ID
- PERS-ACYWX-03 / PERS-ACYWX-03
- Conditions
- Meningoccocal Disease
- Keywords
- Seropersistence, Meningococcal
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Serum Institute of India Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 May 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 30 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NmCV-5 | – | – |
| MenACWY-D | – | – |
Who may qualify
- Ages
- 7 to 36 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Participants from the previous study ACYWX-03 conducted at the Gambia and Mali
Key inclusion criteria (1 listed)
- Written informed consent and assent (if applicable)
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Geometric mean titers (GMTs) measured by rSBA against serogroups A, C, Y, W and X
Time frame: five-six years after vaccination.
2 secondary outcomes
Percentage of participants with rSBA titers ≥ 8
Time frame: five-six years after vaccination.
Percentage of participants with rSBA titers ≥ 128
Time frame: five-six years after vaccination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Meningoccocal Disease, run by Serum Institute of India Pvt. Ltd. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Mali, The Gambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Prasad Kulkarni, MD, FRCP (+91-20-71946820, drpsk@seruminstitute.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geometric mean titers (GMTs) measured by rSBA against serogroups A, C, Y, W and X (time frame: five-six years after vaccination.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026; AzTrials last refreshed its copy on 26 Oct 2026.