Clinical trial NCT03694405: Adolescent MenACWY Booster Study
Official title: A Randomized, Controlled Trial to Compare Protection in Adolescents Between Different Meningococcal Immunization Schedules Used in Canada; a Canadian Immunization Research Network (CIRN) Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Meningococcal Disease, Invasive
Keywords: MenACWY
Neisseria meningitidis
adolescents
Lead sponsor: Canadian Immunization Research Network
Sponsor class: NETWORK
Collaborators: name: University of British Columbia
name: University of Calgary
name: Canadian Center for Vaccinology
name: Alberta Health services
name: British Columbia Centre for Disease Control
name: Canadian Institutes of Health Research (CIHR)
name: Dalhousie University
First posted: 2018-10-03
Enrollment: 244
Sex: ALL
Minimum age (years): 11
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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)
Primary purpose: PREVENTION

Brief 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.

Detailed description: 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.

Eligibility criteria: INCLUSION CRITERIA

All the following need to be fulfilled:

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

EXCLUSION CRITERIA

The participant may not enter the trial if ANY of the following apply:

1. Has already received any doses of MenACWY vaccine at any age
2. Previous confirmed or suspected meningococcal disease
3. Close contact with an individual with laboratory-confirmed N. meningitidis in prior 12 months
4. Previous allergic reaction to a component of any of the 3 vaccines
5. Serious chronic or progressive disease
6. Confirmed/suspected immunodeficiency
7. 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
8. Administration of immunoglobulins within the prior 12 months and/or any blood products planned during the study period
9. Pregnancy (based on history from adolescent and parent/legal guardian)
10. 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.

Primary outcomes:
measure: 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
measure: Confirm non-inferiority of MenC protection at 1-year post-MenACWY booster between differing vaccines
timeFrame: 1 year following MenACWY adolescent booster
Secondary outcomes:
measure: Confirm non-inferiority of MenC protection at 1 month post-MenACWY booster between groups with differing MenC priming schedules.
timeFrame: 1 month following MenACWY booster
measure: Confirm non-inferiority of MenC protection at 1 month post-MenACWY booster between groups with different MenACWY vaccines
timeFrame: 1 month following MenACWY booster
measure: 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
timeFrame: 1 month and 1 year following MenACWY booster
measure: 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
timeFrame: 1 month and 1 year following MenACWY booster
measure: Confirm safety of MenACWY conjugate vaccines
timeFrame: Up to 1 month post-vaccine
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Children's Hospital Research Institute, University of Calgary
state: Alberta
city: Vancouver
country: Canada
facility: Vaccine Evaluation Center, BC Children's Hospital Research Institute
state: British Columbia
city: Halifax
country: Canada
facility: Canadian Center for Vaccinology
state: Nova Scotia
Study officials:
affiliation: University of British Columbia
name: Manish Sadarangani, BM BCh DPhil
role: PRINCIPAL_INVESTIGATOR
References: