Adolescent MenACWY Booster Study

Study Overview
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Brief Summary
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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.

Detailed Description
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Participants will be randomized to receive one of the three doses of licensed MenACWY as a booster dose in adolescents. Serology will be collect at 3 time points; prior to the booster dose and 1 month and 1 year post-vaccination to measure antibody levels. The participants are healthy students in grades 7-9 who have not received their MenACWY vaccine yet and received their routine infant MenC vaccines per previous Canadian schedules.

Official Title
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A Randomized, Controlled Trial to Compare Protection in Adolescents Between Different Meningococcal Immunization Schedules Used in Canada; a Canadian Immunization Research Network (CIRN) Study.

Conditions
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Meningococcal Disease, Invasive

Intervention / Treatment
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* Biological: MenACWY-CRM
* Biological: MenACWY-DT
* Biological: MenACWY-TT


Participation Criteria
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Eligibility Criteria
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INCLUSION CRITERIA All the following need to be fulfilled: 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 The participant may not enter the trial if ANY of the following apply: 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 Pregnancy (based on history from adolescent and parent/legal guardian) Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial. TEMPORARY EXCLUSION CRITERIA If the adolescent has a temperature ≥ 38°C, then vaccination (and blood sampling if due to occur at same visit) will be postponed until resolution of fever.

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Group 1 = 3 prior doses of MenC vaccine (Alberta), Group 2 = 2 prior doses of MenC vaccine (British Columbia), Group 3 = 1 prior dose of MenC vaccine (Nova Scotia). Group A = Menveo (MenACWY-CRM), Group B = Menactra (MenACWY-DT), Group C = Nimenrix (MenACWY-TT)
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1A<br>3 doses prior MenC , randomized to receive MenACWY-CRM (Menveo) | Biological: MenACWY-CRM<br>* Booster vaccination with MenACWY-CRM<br>* Other names: Menveo;|
| Experimental: Group 1B<br>3 doses prior MenC, randomized to receive MenACWY-DT (Menactra) | Biological: MenACWY-DT<br>* Booster vaccination with MenACWY-DT<br>* Other names: Menactra;|
| Experimental: Group 1C<br>3 doses prior MenC, randomized to receive MenACWY-TT (Nimenrix) | Biological: MenACWY-TT<br>* Booster vaccination with MenACWY-TT<br>* Other names: Nimenrix;|
| Experimental: Group 2A<br>2 doses prior MenC, randomized to receive MenACWY-CRM (Menveo) | Biological: MenACWY-CRM<br>* Booster vaccination with MenACWY-CRM<br>* Other names: Menveo;|
| Experimental: Group 2B<br>2 doses prior MenC, randomized to receive MenACWY-DT (Menactra) | Biological: MenACWY-DT<br>* Booster vaccination with MenACWY-DT<br>* Other names: Menactra;|
| Experimental: Group 2C<br>2 doses prior MenC, randomized to receive MenACWY-TT (Nimenrix) | Biological: MenACWY-TT<br>* Booster vaccination with MenACWY-TT<br>* Other names: Nimenrix;|
| Experimental: Group 3A<br>1 dose prior MenC, randomized to receive MenACWY-CRM (Menveo) | Biological: MenACWY-CRM<br>* Booster vaccination with MenACWY-CRM<br>* Other names: Menveo;|
| Experimental: Group 3B<br>1 dose prior MenC, randomized to receive MenACWY-DT (Menactra) | Biological: MenACWY-DT<br>* Booster vaccination with MenACWY-DT<br>* Other names: Menactra;|
| Experimental: Group 3C<br>1 dose prior MenC, randomized to receive MenACWY-TT (Nimenrix) | Biological: MenACWY-TT<br>* Booster vaccination with MenACWY-TT<br>* Other names: Nimenrix;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Confirm non-inferiority of MenC protection at 1-year post-MenACWY booster between groups with differing priming schedules | N. meningitidis capsular group C serum bactericidal antibody titer | 1 year following MenACWY adolescent booster | 
| Confirm non-inferiority of MenC protection at 1-year post-MenACWY booster between differing vaccines | N. meningitidis capsular group C serum bactericidal antibody titer | 1 year following MenACWY adolescent booster | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Confirm non-inferiority of MenC protection at 1 month post-MenACWY booster between groups with differing MenC priming schedules. | N. meningitidis capsular group C serum bactericidal antibody titer | 1 month following MenACWY booster | 
| Confirm non-inferiority of MenC protection at 1 month post-MenACWY booster between groups with different MenACWY vaccines | N. meningitidis capsular group C serum bactericidal antibody titer | 1 month following MenACWY booster | 
| Subgroup analysis to determine effects of different MenACWY vaccines in subjects primed with different MenC schedules at 1 month and 1 year post-MenACWY booster | N. meningitidis capsular group C serum bactericidal antibody titer | 1 month and 1 year following MenACWY booster | 
| Subgroup analysis to determine effects of different MenC priming schedules in subjects receiving different MenACWY booster immunizations at 1 month and 1 year post-MenACWY booster | N. meningitidis capsular group C serum bactericidal antibody titer | 1 month and 1 year following MenACWY booster | 
| Confirm safety of MenACWY conjugate vaccines | Adverse events as reported by study participants | Up to 1 month post-vaccine | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MenACWY, Neisseria meningitidis, adolescents