CompletedPhase 4

Adolescent MenACWY Booster Study

Canada244 participantsStarted 2018-09-20

Plain-language summary

This study is to confirm non-inferiority of the three MenACWY vaccines (Menveo, Menactra or Nimenrix) in adolescents, and to identify whether the number of previous doses of MenC influences the response to the MenACWY vaccine.

Who can participate

Age range

11 Years – 15 Years

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

. Healthy adolescent
. Previous receipt of appropriate MenC vaccine according to the relevant provincial schedule (see above)
. Parent/legal guardian has given informed consent OR participant has given consent (if participant demonstrates capacity to consent)
. Participant has given consent (as above) OR assent.

Exclusion criteria

. Has already received any doses of MenACWY vaccine at any age
. Previous confirmed or suspected meningococcal disease
. Close contact with an individual with laboratory-confirmed N. meningitidis in prior 12 months
. Previous allergic reaction to a component of any of the 3 vaccines
. Serious chronic or progressive disease
. Confirmed/suspected immunodeficiency
. Receipt of more than 1 week of immunosuppressants or immune modifying drugs (e.g. oral prednisolone \>0.5mL/kg/day or intravenous glucocorticoid steroid). Nasal, topical or inhaled steroids are allowed

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

Confirm non-inferiority of MenC protection at 1-year post-MenACWY booster between groups with differing priming schedules

Timeframe: 1 year following MenACWY adolescent booster

Confirm non-inferiority of MenC protection at 1-year post-MenACWY booster between differing vaccines

Timeframe: 1 year following MenACWY adolescent booster

Trial details

NCT IDNCT03694405

SponsorCanadian Immunization Research Network

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2021-08-01

View on ClinicalTrials.gov More Meningococcal Disease, Invasive trials

Who can participate

Age range

11 Years – 15 Years

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

. Healthy adolescent
. Previous receipt of appropriate MenC vaccine according to the relevant provincial schedule (see above)
. Parent/legal guardian has given informed consent OR participant has given consent (if participant demonstrates capacity to consent)
. Participant has given consent (as above) OR assent.

Exclusion criteria

. Has already received any doses of MenACWY vaccine at any age
. Previous confirmed or suspected meningococcal disease
. Close contact with an individual with laboratory-confirmed N. meningitidis in prior 12 months
. Previous allergic reaction to a component of any of the 3 vaccines
. Serious chronic or progressive disease
. Confirmed/suspected immunodeficiency
. Receipt of more than 1 week of immunosuppressants or immune modifying drugs (e.g. oral prednisolone \>0.5mL/kg/day or intravenous glucocorticoid steroid). Nasal, topical or inhaled steroids are allowed

What they're measuring

Confirm non-inferiority of MenC protection at 1-year post-MenACWY booster between groups with differing priming schedules

Timeframe: 1 year following MenACWY adolescent booster

Confirm non-inferiority of MenC protection at 1-year post-MenACWY booster between differing vaccines

Timeframe: 1 year following MenACWY adolescent booster