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Adolescent MenACWY Booster Study

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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

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.

Condition or disease Intervention/treatment Phase
Meningococcal Disease, Invasive Biological: MenACWY-CRM Biological: MenACWY-DT Biological: MenACWY-TT Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 244 participants
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
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.
Actual Study Start Date : September 20, 2018
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021


Arm Intervention/treatment
Experimental: Group 1A
3 doses prior MenC , randomized to receive MenACWY-CRM (Menveo)
Biological: MenACWY-CRM
Booster vaccination with MenACWY-CRM
Other Name: Menveo

Experimental: Group 1B
3 doses prior MenC, randomized to receive MenACWY-DT (Menactra)
Biological: MenACWY-DT
Booster vaccination with MenACWY-DT
Other Name: Menactra

Experimental: Group 1C
3 doses prior MenC, randomized to receive MenACWY-TT (Nimenrix)
Biological: MenACWY-TT
Booster vaccination with MenACWY-TT
Other Name: Nimenrix

Experimental: Group 2A
2 doses prior MenC, randomized to receive MenACWY-CRM (Menveo)
Biological: MenACWY-CRM
Booster vaccination with MenACWY-CRM
Other Name: Menveo

Experimental: Group 2B
2 doses prior MenC, randomized to receive MenACWY-DT (Menactra)
Biological: MenACWY-DT
Booster vaccination with MenACWY-DT
Other Name: Menactra

Experimental: Group 2C
2 doses prior MenC, randomized to receive MenACWY-TT (Nimenrix)
Biological: MenACWY-TT
Booster vaccination with MenACWY-TT
Other Name: Nimenrix

Experimental: Group 3A
1 dose prior MenC, randomized to receive MenACWY-CRM (Menveo)
Biological: MenACWY-CRM
Booster vaccination with MenACWY-CRM
Other Name: Menveo

Experimental: Group 3B
1 dose prior MenC, randomized to receive MenACWY-DT (Menactra)
Biological: MenACWY-DT
Booster vaccination with MenACWY-DT
Other Name: Menactra

Experimental: Group 3C
1 dose prior MenC, randomized to receive MenACWY-TT (Nimenrix)
Biological: MenACWY-TT
Booster vaccination with MenACWY-TT
Other Name: Nimenrix




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. Confirm safety of MenACWY conjugate vaccines [ Time Frame: Up to 1 month post-vaccine ]
    Adverse events as reported by study participants



Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03694405


Locations
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Canada, Alberta
Children's Hospital Research Institute, University of Calgary
Calgary, Alberta, Canada
Canada, British Columbia
Vaccine Evaluation Center, BC Children's Hospital Research Institute
Vancouver, British Columbia, Canada
Canada, Nova Scotia
Canadian Center for Vaccinology
Halifax, Nova Scotia, Canada
Sponsors and Collaborators
Canadian Immunization Research Network
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
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Principal Investigator: Manish Sadarangani, BM BCh DPhil University of British Columbia
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Responsible Party: Canadian Immunization Research Network
ClinicalTrials.gov Identifier: NCT03694405    
Other Study ID Numbers: CT17_CIRN24_Achieve01
First Posted: October 3, 2018    Key Record Dates
Last Update Posted: September 4, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Canadian Immunization Research Network:
MenACWY
Neisseria meningitidis
adolescents
Additional relevant MeSH terms:
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Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Infections