NCT03694405

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
244

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2018

Typical duration for phase_4

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 20, 2018

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

October 1, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

March 11, 2022

Status Verified

March 1, 2022

Enrollment Period

2.9 years

First QC Date

October 1, 2018

Last Update Submit

March 10, 2022

Conditions

Meningococcal Disease, Invasive

Keywords

MenACWYNeisseria meningitidisadolescents

Outcome Measures

Primary Outcomes (2)

  • 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

    1 year following MenACWY adolescent booster

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

    N. meningitidis capsular group C serum bactericidal antibody titer

    1 year following MenACWY adolescent booster

Secondary Outcomes (5)

  • Confirm non-inferiority of MenC protection at 1 month post-MenACWY booster between groups with differing MenC priming schedules.

    1 month following MenACWY booster

  • Confirm non-inferiority of MenC protection at 1 month post-MenACWY booster between groups with different MenACWY vaccines

    1 month following MenACWY booster

  • 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

    1 month and 1 year following MenACWY booster

  • 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

    1 month and 1 year following MenACWY booster

  • Confirm safety of MenACWY conjugate vaccines

    Up to 1 month post-vaccine

Study Arms (9)

Group 1A

EXPERIMENTAL

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

Biological: MenACWY-CRM

Group 1B

EXPERIMENTAL

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

Biological: MenACWY-DT

Group 1C

EXPERIMENTAL

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

Biological: MenACWY-TT

Group 2A

EXPERIMENTAL

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

Biological: MenACWY-CRM

Group 2B

EXPERIMENTAL

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

Biological: MenACWY-DT

Group 2C

EXPERIMENTAL

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

Biological: MenACWY-TT

Group 3A

EXPERIMENTAL

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

Biological: MenACWY-CRM

Group 3B

EXPERIMENTAL

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

Biological: MenACWY-DT

Group 3C

EXPERIMENTAL

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

Biological: MenACWY-TT

Interventions

MenACWY-CRMBIOLOGICAL

Booster vaccination with MenACWY-CRM

Also known as: Menveo
Group 1AGroup 2AGroup 3A
MenACWY-DTBIOLOGICAL

Booster vaccination with MenACWY-DT

Also known as: Menactra
Group 1BGroup 2BGroup 3B
MenACWY-TTBIOLOGICAL

Booster vaccination with MenACWY-TT

Also known as: Nimenrix
Group 1CGroup 2CGroup 3C

Eligibility Criteria

Age11 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Children's Hospital Research Institute, University of Calgary

Calgary, Alberta, Canada

Location

Vaccine Evaluation Center, BC Children's Hospital Research Institute

Vancouver, British Columbia, Canada

Location

Canadian Center for Vaccinology

Halifax, Nova Scotia, Canada

Location

MeSH Terms

Conditions

Meningococcal Infections

Interventions

MenACWY-CRM vaccineMeningococcal Vaccinestetravalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine

Condition Hierarchy (Ancestors)

Neisseriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Bacterial VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Manish Sadarangani, BM BCh DPhil

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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)
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2018

First Posted

October 3, 2018

Study Start

September 20, 2018

Primary Completion

August 1, 2021

Study Completion

August 1, 2021

Last Updated

March 11, 2022

Record last verified: 2022-03

Locations

CA(3)