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 range11 Years – 15 Years

SexALL

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
✕. Administration of immunoglobulins within the prior 12 months and/or any blood products planned during the study period

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 range11 Years – 15 Years

SexALL

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
✕. Administration of immunoglobulins within the prior 12 months and/or any blood products planned during the study period

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