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Adolescent MenACWY Booster Study

Primary Purpose

Meningococcal Disease, Invasive

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
MenACWY-CRM
MenACWY-DT
MenACWY-TT
Sponsored by
Canadian Immunization Research Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Meningococcal Disease, Invasive focused on measuring MenACWY, Neisseria meningitidis, adolescents

Eligibility Criteria

11 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Children's Hospital Research Institute, University of Calgary
  • Vaccine Evaluation Center, BC Children's Hospital Research Institute
  • Canadian Center for Vaccinology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Group 1A

Group 1B

Group 1C

Group 2A

Group 2B

Group 2C

Group 3A

Group 3B

Group 3C

Arm Description

3 doses prior MenC , randomized to receive MenACWY-CRM (Menveo)

3 doses prior MenC, randomized to receive MenACWY-DT (Menactra)

3 doses prior MenC, randomized to receive MenACWY-TT (Nimenrix)

2 doses prior MenC, randomized to receive MenACWY-CRM (Menveo)

2 doses prior MenC, randomized to receive MenACWY-DT (Menactra)

2 doses prior MenC, randomized to receive MenACWY-TT (Nimenrix)

1 dose prior MenC, randomized to receive MenACWY-CRM (Menveo)

1 dose prior MenC, randomized to receive MenACWY-DT (Menactra)

1 dose prior MenC, randomized to receive MenACWY-TT (Nimenrix)

Outcomes

Primary Outcome Measures

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
Confirm non-inferiority of MenC protection at 1-year post-MenACWY booster between differing vaccines
N. meningitidis capsular group C serum bactericidal antibody titer

Secondary Outcome Measures

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
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
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
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
Confirm safety of MenACWY conjugate vaccines
Adverse events as reported by study participants

Full Information

First Posted
October 1, 2018
Last Updated
March 10, 2022
Sponsor
Canadian Immunization Research Network
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
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1. Study Identification

Unique Protocol Identification Number
NCT03694405
Brief Title
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
September 20, 2018 (Actual)
Primary Completion Date
August 1, 2021 (Actual)
Study Completion Date
August 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Canadian Immunization Research Network
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meningococcal Disease, Invasive
Keywords
MenACWY, Neisseria meningitidis, adolescents

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
244 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1A
Arm Type
Experimental
Arm Description
3 doses prior MenC , randomized to receive MenACWY-CRM (Menveo)
Arm Title
Group 1B
Arm Type
Experimental
Arm Description
3 doses prior MenC, randomized to receive MenACWY-DT (Menactra)
Arm Title
Group 1C
Arm Type
Experimental
Arm Description
3 doses prior MenC, randomized to receive MenACWY-TT (Nimenrix)
Arm Title
Group 2A
Arm Type
Experimental
Arm Description
2 doses prior MenC, randomized to receive MenACWY-CRM (Menveo)
Arm Title
Group 2B
Arm Type
Experimental
Arm Description
2 doses prior MenC, randomized to receive MenACWY-DT (Menactra)
Arm Title
Group 2C
Arm Type
Experimental
Arm Description
2 doses prior MenC, randomized to receive MenACWY-TT (Nimenrix)
Arm Title
Group 3A
Arm Type
Experimental
Arm Description
1 dose prior MenC, randomized to receive MenACWY-CRM (Menveo)
Arm Title
Group 3B
Arm Type
Experimental
Arm Description
1 dose prior MenC, randomized to receive MenACWY-DT (Menactra)
Arm Title
Group 3C
Arm Type
Experimental
Arm Description
1 dose prior MenC, randomized to receive MenACWY-TT (Nimenrix)
Intervention Type
Biological
Intervention Name(s)
MenACWY-CRM
Other Intervention Name(s)
Menveo
Intervention Description
Booster vaccination with MenACWY-CRM
Intervention Type
Biological
Intervention Name(s)
MenACWY-DT
Other Intervention Name(s)
Menactra
Intervention Description
Booster vaccination with MenACWY-DT
Intervention Type
Biological
Intervention Name(s)
MenACWY-TT
Other Intervention Name(s)
Nimenrix
Intervention Description
Booster vaccination with MenACWY-TT
Primary Outcome Measure Information:
Title
Confirm non-inferiority of MenC protection at 1-year post-MenACWY booster between groups with differing priming schedules
Description
N. meningitidis capsular group C serum bactericidal antibody titer
Time Frame
1 year following MenACWY adolescent booster
Title
Confirm non-inferiority of MenC protection at 1-year post-MenACWY booster between differing vaccines
Description
N. meningitidis capsular group C serum bactericidal antibody titer
Time Frame
1 year following MenACWY adolescent booster
Secondary Outcome Measure Information:
Title
Confirm non-inferiority of MenC protection at 1 month post-MenACWY booster between groups with differing MenC priming schedules.
Description
N. meningitidis capsular group C serum bactericidal antibody titer
Time Frame
1 month following MenACWY booster
Title
Confirm non-inferiority of MenC protection at 1 month post-MenACWY booster between groups with different MenACWY vaccines
Description
N. meningitidis capsular group C serum bactericidal antibody titer
Time Frame
1 month following MenACWY booster
Title
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
Description
N. meningitidis capsular group C serum bactericidal antibody titer
Time Frame
1 month and 1 year following MenACWY booster
Title
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
Description
N. meningitidis capsular group C serum bactericidal antibody titer
Time Frame
1 month and 1 year following MenACWY booster
Title
Confirm safety of MenACWY conjugate vaccines
Description
Adverse events as reported by study participants
Time Frame
Up to 1 month post-vaccine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manish Sadarangani, BM BCh DPhil
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital Research Institute, University of Calgary
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
Vaccine Evaluation Center, BC Children's Hospital Research Institute
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Canadian Center for Vaccinology
City
Halifax
State/Province
Nova Scotia
Country
Canada

12. IPD Sharing Statement

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Adolescent MenACWY Booster Study

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