CompletedPhase 3

Meningococcal Serogroup ACYWX Conjugate Vaccine in Comparison With MenACWY-TT Conjugate Vaccine

Mali1,325 participantsStarted 2022-03-24

Plain-language summary

Infants aged 9 months will be randomized to receive a meningococcal vaccine at 9 months or 15 months. Infants randomized to the 9-month age group will be further randomized in a 2:1 ratio to receive a single dose of the experimental meningococcal vaccine (NmCV-5) or a single dose of the comparator meningococcal vaccine (MenACWY-TT). Prospectively identified and consented infants randomized to the 15-month age group will return when aged 15 months and will be randomized in a 2:1 ratio to receive a single dose of NmCV-5 or a single dose of MenACWY-TT.

Who can participate

Age range

9 Months – 11 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male and female children between 9 months and 11 months old inclusive.
. Parent(s)/legal guardian(s) have provided written informed consent, after the nature of the study has been explained according to local regulatory requirements.
. The investigator believes that their parent(s)/guardian(s) will be available for all the subjects visits and will comply with the requirements of the protocol (e.g., timely reporting of adverse events).
. Individual is in good health as determined by medical history, physical examination, and clinical judgement of the investigator.
. Individual has completed their local infant EPI vaccines, not including 9-month EPI vaccines (at the 9-month visit) or 15- month EPI vaccines (at the 15-month visit). A birth dose of oral polio vaccine is not required.

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With Seroprotection for Meningitis Serogroups A, C, W and Y

Timeframe: Measured from time of meningococcal vaccination to blood sample collection at Day 29 visit. Follow-up time to Day 29 visit blood specimen collection was a mean (s.d.) of 30.9 (2.8) days.

Number of Participants With Seroprotection for Meningitis Serogroup X (NmCV-5) vs Lowest Comparator (MenACWY-TT)

Timeframe: Measured from time of meningococcal vaccination to blood sample collection at Day 29 visit. Follow-up time to Day 29 visit blood specimen collection was a mean (s.d.) of 30.9 (2.8) days.

Trial details

NCT IDNCT05093829

SponsorEmory University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-03-10

Results submitted2024-03-01

View on ClinicalTrials.gov More Meningitis trials

Plain-language summary

Who can participate

Age range

9 Months – 11 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male and female children between 9 months and 11 months old inclusive.
. Parent(s)/legal guardian(s) have provided written informed consent, after the nature of the study has been explained according to local regulatory requirements.
. The investigator believes that their parent(s)/guardian(s) will be available for all the subjects visits and will comply with the requirements of the protocol (e.g., timely reporting of adverse events).
. Individual is in good health as determined by medical history, physical examination, and clinical judgement of the investigator.
. Individual has completed their local infant EPI vaccines, not including 9-month EPI vaccines (at the 9-month visit) or 15- month EPI vaccines (at the 15-month visit). A birth dose of oral polio vaccine is not required.

Exclusion criteria

What they're measuring

Number of Participants With Seroprotection for Meningitis Serogroups A, C, W and Y

Timeframe: Measured from time of meningococcal vaccination to blood sample collection at Day 29 visit. Follow-up time to Day 29 visit blood specimen collection was a mean (s.d.) of 30.9 (2.8) days.

Number of Participants With Seroprotection for Meningitis Serogroup X (NmCV-5) vs Lowest Comparator (MenACWY-TT)

Timeframe: Measured from time of meningococcal vaccination to blood sample collection at Day 29 visit. Follow-up time to Day 29 visit blood specimen collection was a mean (s.d.) of 30.9 (2.8) days.