Adolescent MenACWY Booster Study

March 10, 2022 updated by: Canadian Immunization Research Network

A Randomized, Controlled Trial to Compare Protection in Adolescents Between Different Meningococcal Immunization Schedules Used in Canada; a Canadian Immunization Research Network (CIRN) Study.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
244

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

11 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group 1A
3 doses prior MenC , randomized to receive MenACWY-CRM (Menveo)
Biological: MenACWY-CRM
Booster vaccination with MenACWY-CRM
Other Names:
  • Menveo
Experimental: Group 1B
3 doses prior MenC, randomized to receive MenACWY-DT (Menactra)
Biological: MenACWY-DT
Booster vaccination with MenACWY-DT
Other Names:
  • Menactra
Experimental: Group 1C
3 doses prior MenC, randomized to receive MenACWY-TT (Nimenrix)
Biological: MenACWY-TT
Booster vaccination with MenACWY-TT
Other Names:
  • Nimenrix
Experimental: Group 2A
2 doses prior MenC, randomized to receive MenACWY-CRM (Menveo)
Biological: MenACWY-CRM
Booster vaccination with MenACWY-CRM
Other Names:
  • Menveo
Experimental: Group 2B
2 doses prior MenC, randomized to receive MenACWY-DT (Menactra)
Biological: MenACWY-DT
Booster vaccination with MenACWY-DT
Other Names:
  • Menactra
Experimental: Group 2C
2 doses prior MenC, randomized to receive MenACWY-TT (Nimenrix)
Biological: MenACWY-TT
Booster vaccination with MenACWY-TT
Other Names:
  • Nimenrix
Experimental: Group 3A
1 dose prior MenC, randomized to receive MenACWY-CRM (Menveo)
Biological: MenACWY-CRM
Booster vaccination with MenACWY-CRM
Other Names:
  • Menveo
Experimental: Group 3B
1 dose prior MenC, randomized to receive MenACWY-DT (Menactra)
Biological: MenACWY-DT
Booster vaccination with MenACWY-DT
Other Names:
  • Menactra
Experimental: Group 3C
1 dose prior MenC, randomized to receive MenACWY-TT (Nimenrix)
Biological: MenACWY-TT
Booster vaccination with MenACWY-TT
Other Names:
  • Nimenrix

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
1 year following MenACWY adolescent booster
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
1 year following MenACWY adolescent booster

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
1 month following MenACWY booster
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
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
Time Frame: 1 month and 1 year following MenACWY booster
N. meningitidis capsular group C serum bactericidal antibody titer
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
Time Frame: 1 month and 1 year following MenACWY booster
N. meningitidis capsular group C serum bactericidal antibody titer
1 month and 1 year following MenACWY booster
Confirm safety of MenACWY conjugate vaccines
Time Frame: Up to 1 month post-vaccine
Adverse events as reported by study participants
Up to 1 month post-vaccine

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Canadian Immunization Research Network

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of British Columbia
Canadian Institutes of Health Research (CIHR)
Alberta Health services
University of Calgary
Dalhousie University
Canadian Center for Vaccinology
British Columbia Centre for Disease Control

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Manish Sadarangani, BM BCh DPhil, University of British Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 20, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 1, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 3, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 11, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CT17_CIRN24_Achieve01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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