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Trial record 7 of 19 for:    Vaccine | Meningococcal | Canada

Adolescent MenACWY Booster Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03694405
Recruitment Status : Active, not recruiting
First Posted : October 3, 2018
Last Update Posted : September 4, 2020
Sponsor:
Collaborators:
University of British Columbia
University of Calgary
Canadian Center for Vaccinology
Alberta Health Services
British Columbia Centre for Disease Control
Canadian Institutes of Health Research (CIHR)
Dalhousie University
Information provided by (Responsible Party):
Canadian Immunization Research Network

Tracking Information
First Submitted Date  ICMJE October 1, 2018
First Posted Date  ICMJE October 3, 2018
Last Update Posted Date September 4, 2020
Actual Study Start Date  ICMJE September 20, 2018
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 1, 2018)
  • 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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 1, 2018)
  • Confirm non-inferiority of MenC protection at 1 month post-MenACWY booster between groups with differing MenC priming schedules. [ Time Frame: 1 month following MenACWY booster ]
    N. meningitidis capsular group C serum bactericidal antibody titer
  • Confirm non-inferiority of MenC protection at 1 month post-MenACWY booster between groups with different MenACWY vaccines [ Time Frame: 1 month following MenACWY booster ]
    N. meningitidis capsular group C serum bactericidal antibody titer
  • 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 [ Time Frame: 1 month and 1 year following MenACWY booster ]
    N. meningitidis capsular group C serum bactericidal antibody titer
  • 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 [ Time Frame: 1 month and 1 year following MenACWY booster ]
    N. meningitidis capsular group C serum bactericidal antibody titer
  • Confirm safety of MenACWY conjugate vaccines [ Time Frame: Up to 1 month post-vaccine ]
    Adverse events as reported by study participants
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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  ICMJE 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: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Meningococcal Disease, Invasive
Intervention  ICMJE
  • Biological: MenACWY-CRM
    Booster vaccination with MenACWY-CRM
    Other Name: Menveo
  • Biological: MenACWY-DT
    Booster vaccination with MenACWY-DT
    Other Name: Menactra
  • Biological: MenACWY-TT
    Booster vaccination with MenACWY-TT
    Other Name: Nimenrix
Study Arms  ICMJE
  • Experimental: Group 1A
    3 doses prior MenC , randomized to receive MenACWY-CRM (Menveo)
    Intervention: Biological: MenACWY-CRM
  • Experimental: Group 1B
    3 doses prior MenC, randomized to receive MenACWY-DT (Menactra)
    Intervention: Biological: MenACWY-DT
  • Experimental: Group 1C
    3 doses prior MenC, randomized to receive MenACWY-TT (Nimenrix)
    Intervention: Biological: MenACWY-TT
  • Experimental: Group 2A
    2 doses prior MenC, randomized to receive MenACWY-CRM (Menveo)
    Intervention: Biological: MenACWY-CRM
  • Experimental: Group 2B
    2 doses prior MenC, randomized to receive MenACWY-DT (Menactra)
    Intervention: Biological: MenACWY-DT
  • Experimental: Group 2C
    2 doses prior MenC, randomized to receive MenACWY-TT (Nimenrix)
    Intervention: Biological: MenACWY-TT
  • Experimental: Group 3A
    1 dose prior MenC, randomized to receive MenACWY-CRM (Menveo)
    Intervention: Biological: MenACWY-CRM
  • Experimental: Group 3B
    1 dose prior MenC, randomized to receive MenACWY-DT (Menactra)
    Intervention: Biological: MenACWY-DT
  • Experimental: Group 3C
    1 dose prior MenC, randomized to receive MenACWY-TT (Nimenrix)
    Intervention: Biological: MenACWY-TT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 2, 2020)
244
Original Estimated Enrollment  ICMJE
 (submitted: October 1, 2018)
324
Estimated Study Completion Date  ICMJE August 2021
Estimated Primary Completion Date August 2021   (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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 11 Years to 15 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03694405
Other Study ID Numbers  ICMJE CT17_CIRN24_Achieve01
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  ICMJE Not Provided
Responsible Party Canadian Immunization Research Network
Study Sponsor  ICMJE Canadian Immunization Research Network
Collaborators  ICMJE
  • University of British Columbia
  • University of Calgary
  • Canadian Center for Vaccinology
  • Alberta Health Services
  • British Columbia Centre for Disease Control
  • Canadian Institutes of Health Research (CIHR)
  • Dalhousie University
Investigators  ICMJE
Principal Investigator: Manish Sadarangani, BM BCh DPhil University of British Columbia
PRS Account Canadian Immunization Research Network
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP