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CompletedNCT03694405Updated Mar 11, 2022

Adolescent MenACWY Booster Study

A Phase 4 interventional study of MenACWY-CRM and MenACWY-DT in Meningococcal Disease, Invasive, sponsored by Canadian Immunization Research Network. Completed at 3 sites in Canada. Open to participants aged 11 Years to 15 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-11.

Sponsored by Canadian Immunization Research Network · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
244
Allocation
Randomized
Ages
11 Years to 15 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Meningococcal Disease, Invasive

Keywords

  • MenACWY
  • Neisseria meningitidis
  • adolescents
03

In context

Meningococcal Infections

219 studies on the registry are indexed under Meningococcal Infections; 6 are open to participants now.

This study's enrollment of 244 is below the median of 450 across 190 interventional studies indexed under Meningococcal Infections.

Browse Meningococcal Infections studies →

Lead sponsor

Canadian Immunization Research Network is the lead sponsor of 10 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
11 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.

05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
244 participants (actual)

Study arms

  • Experimental
    Group 1A

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

    Biological: MenACWY-CRM

  • Experimental
    Group 1B

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

    Biological: MenACWY-DT

  • Experimental
    Group 1C

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

    Biological: MenACWY-TT

  • Experimental
    Group 2A

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

    Biological: MenACWY-CRM

  • Experimental
    Group 2B

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

    Biological: MenACWY-DT

  • Experimental
    Group 2C

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

    Biological: MenACWY-TT

  • Experimental
    Group 3A

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

    Biological: MenACWY-CRM

  • Experimental
    Group 3B

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

    Biological: MenACWY-DT

  • Experimental
    Group 3C

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

    Biological: MenACWY-TT

Interventions

  • BiologicalMenACWY-CRM

    Booster vaccination with MenACWY-CRM

    Also known as: Menveo

  • BiologicalMenACWY-DT

    Booster vaccination with MenACWY-DT

    Also known as: Menactra

  • BiologicalMenACWY-TT

    Booster vaccination with MenACWY-TT

    Also known as: Nimenrix

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 1 year following MenACWY adolescent booster

  2. Confirm non-inferiority of MenC protection at 1-year post-MenACWY booster between differing vaccines

    N. meningitidis capsular group C serum bactericidal antibody titer

    Time frame: 1 year following MenACWY adolescent booster

Secondary outcomes

  1. 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

    Time frame: 1 month following MenACWY booster

  2. 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

    Time frame: 1 month following MenACWY booster

  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

    N. meningitidis capsular group C serum bactericidal antibody titer

    Time frame: 1 month and 1 year following MenACWY booster

  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

    N. meningitidis capsular group C serum bactericidal antibody titer

    Time frame: 1 month and 1 year following MenACWY booster

  5. Confirm safety of MenACWY conjugate vaccines

    Adverse events as reported by study participants

    Time frame: Up to 1 month post-vaccine

07

Study locations

3 sites
  • Children's Hospital Research Institute, University of Calgary
    Calgary, Alberta, Canada
  • Vaccine Evaluation Center, BC Children's Hospital Research Institute
    Vancouver, British Columbia, Canada
  • Canadian Center for Vaccinology
    Halifax, Nova Scotia, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 11, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03694405
Lead 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
Responsible party
Sponsor
First posted
Oct 3, 2018
Start date
Sep 20, 2018
Primary completion
Aug 1, 2021
Completion
Aug 1, 2021
Last update
Mar 11, 2022

Study contacts

Manish Sadarangani, BM BCh DPhil
principal investigator · University of British Columbia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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