Adolescent MenACWY Booster Study
Sponsor:
Canadian Immunization Research Network
Collaborators:
Information provided by (Responsible Party):
，
| Tracking Information | |||
|---|---|---|---|
| First Submitted Date ICMJE | October 1, 2018 | ||
| First Posted Date ICMJE | October 3, 2018 | ||
| Last Update Posted Date | October 3, 2018 | ||
| Actual Study Start Date ICMJE | September 20, 2018 | ||
| Estimated Primary Completion Date | December 2019 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures ICMJE |
Confirm non-inferiority of MenC protection at 1-year post-MenACWY booster between groups with differing priming schedules[ Time Frame: 1 year following MenACWY adolescent booster ] N. meningitidis capsular group C serum bactericidal antibody titer Confirm non-inferiority of MenC protection at 1-year post-MenACWY booster between differing vaccines[ Time Frame: 1 year following MenACWY adolescent booster ] N. meningitidis capsular group C serum bactericidal antibody titer |
||
| Original Primary Outcome Measures ICMJE | Same as current | ||
| Current Secondary Outcome Measures ICMJE |
|
||
| Descriptive Information | |||
| Brief Title ICMJE | Adolescent MenACWY Booster Study |
||
| Official Title ICMJE | A Randomized, Controlled Trial to Compare Protection in Adolescents Between Different Meningococcal Immunization Schedules Used in Canada; a Canadian Immunization Research Network (CIRN) Study. |
||
| 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. | ||
| Study Type ICMJE | Interventional | ||
| Study Phase | Phase 4 | ||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment 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) Masking: Interventional Masking Description: Primary Purpose: Prevention |
||
| Condition ICMJE | |||
| Intervention ICMJE |
|
||
| Study Arms |
|
||
| Recruitment Information | |||
| Recruitment Status ICMJE | Recruiting | ||
| Estimated Enrollment ICMJE |
324 | ||
| Original Estimated Enrollment ICMJE | Same as current | ||
| Estimated Study Completion Date | March 2020 | ||
| Estimated Primary Completion Date | December 2019 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE | 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. | ||
| Sex/Gender |
|
||
| Ages | 11 Years and older (Adult, Older Adult) | ||
| Accepts Healthy Volunteers | No | ||
| Listed Location Countries ICMJE | Canada | ||
| Removed Location Countries | |||
| Administrative Information | Has Data Monitoring Committee | No | |
| U.S. FDA-regulated Product |
Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No |
||
| IPD Sharing Statement |
|
||
| Responsible Party | ， | ||
| Study Sponsor ICMJE | Canadian Immunization Research Network | ||
| Collaborators ICMJE | |||
| Investigators ICMJE |
|
||
| PRS Account | |||
| Verification Date | October 2018 | ||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||
请使用微信扫码报名
京公网安备 11010102003638号