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Meningococcal Disease, InvasivePhase 4NCT03694405

Adolescent MenACWY Booster Study

A Phase 4 study testing MenACWY-CRM, MenACWY-DT and MenACWY-TT in people with Meningococcal Disease, Invasive, run by Canadian Immunization Research Network at 3 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 11 to 15 yearsHealthy volunteers can take part
Conditions the study is for
Meningococcal Disease, Invasive
What is being tested?
MenACWY-CRM, MenACWY-DT and MenACWY-TT
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
244 participants
Where
3 sitesCanada
Study dates
20 Sep 2018to 1 Aug 2021
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 11 to 15 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 12Show fewer
  • 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.

Trial locations and contacts

3 sites in 1 country.

Canada3 sites

  • Children's Hospital Research Institute, University of Calgary

    Calgary, Alberta

  • Canadian Center for Vaccinology

    Halifax, Nova Scotia

  • Vaccine Evaluation Center, BC Children's Hospital Research Institute

    Vancouver, British Columbia

Other trials in Canada

About this 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.

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.

Being tested
MenACWY-CRM, MenACWY-DT, MenACWY-TT
Keywords
MenACWY, Neisseria meningitidis, adolescents
Medical subject headings
Meningococcal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MenACWY-CRMBiological

    Also called Menveo

    Booster vaccination with MenACWY-CRM

  • MenACWY-DTBiological

    Also called Menactra

    Booster vaccination with MenACWY-DT

  • MenACWY-TTBiological

    Also called Nimenrix

    Booster vaccination with MenACWY-TT

Study groups in NCT03694405
Study groupRoleWhat they receive
Group 1AExperimental3 doses prior MenC , randomized to receive MenACWY-CRM (Menveo)
Receives: Biological: MenACWY-CRM
Group 1BExperimental3 doses prior MenC, randomized to receive MenACWY-DT (Menactra)
Receives: Biological: MenACWY-DT
Group 1CExperimental3 doses prior MenC, randomized to receive MenACWY-TT (Nimenrix)
Receives: Biological: MenACWY-TT
Group 2AExperimental2 doses prior MenC, randomized to receive MenACWY-CRM (Menveo)
Receives: Biological: MenACWY-CRM
Group 2BExperimental2 doses prior MenC, randomized to receive MenACWY-DT (Menactra)
Receives: Biological: MenACWY-DT
Group 2CExperimental2 doses prior MenC, randomized to receive MenACWY-TT (Nimenrix)
Receives: Biological: MenACWY-TT
Group 3AExperimental1 dose prior MenC, randomized to receive MenACWY-CRM (Menveo)
Receives: Biological: MenACWY-CRM
Group 3BExperimental1 dose prior MenC, randomized to receive MenACWY-DT (Menactra)
Receives: Biological: MenACWY-DT
Group 3CExperimental1 dose prior MenC, randomized to receive MenACWY-TT (Nimenrix)
Receives: Biological: MenACWY-TT

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    1. meningitidis capsular group C serum bactericidal antibody titer

    Measured: 1 year following MenACWY adolescent booster

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

    1. meningitidis capsular group C serum bactericidal antibody titer

    Measured: 1 year following MenACWY adolescent booster

Secondary outcomes (5)

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

    1. meningitidis capsular group C serum bactericidal antibody titer

    Measured: 1 month following MenACWY booster

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

    1. meningitidis capsular group C serum bactericidal antibody titer

    Measured: 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

    1. meningitidis capsular group C serum bactericidal antibody titer

    Measured: 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

    1. meningitidis capsular group C serum bactericidal antibody titer

    Measured: 1 month and 1 year following MenACWY booster

  5. Confirm safety of MenACWY conjugate vaccines

    Adverse events as reported by study participants

    Measured: Up to 1 month post-vaccine

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2018
  2. Study start20 Sep 2018
  3. Primary completion1 Aug 2021
  4. Study completion1 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
244 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03694405
Sponsor's protocol ID
CT17_CIRN24_Achieve01
Status last verified
Mar 2022
First submitted
1 Oct 2018
Last updated
11 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing MenACWY-CRM, MenACWY-DT and MenACWY-TT in people with Meningococcal Disease, Invasive, run by Canadian Immunization Research Network at 3 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03694405.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2022.

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