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Completed

NCT Number: NCT03694405

Adolescent MenACWY Booster 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.

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Key information

Age range

11 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Children's Hospital Research Institute, University of Calgary, Calgary, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MenACWY-CRM

Biological

Booster vaccination with MenACWY-CRM

Other names: Menveo

MenACWY-DT

Biological

Booster vaccination with MenACWY-DT

Other names: Menactra

MenACWY-TT

Biological

Booster vaccination with MenACWY-TT

Other names: Nimenrix

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Canadian Immunization Research Network

Network

Collaborators

  • Alberta Health services
  • British Columbia Centre for Disease Control
  • Canadian Center for Vaccinology
  • Canadian Institutes of Health Research (CIHR)
  • Dalhousie University
  • University of British Columbia
  • University of Calgary

Registry information

Official study 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.

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Oct 3, 2018
Registry last updated
Mar 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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