Adolescent MenACWY Booster Study

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: Completed
• Conditions: Meningococcal Disease, Invasive
• Intervention / Treatment: Biological: MenACWY-CRM; Biological: MenACWY-DT; Biological: MenACWY-TT

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: Interventional
• Enrollment (Actual): 244
• Phase: Phase 4

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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.	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	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	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	N. meningitidis capsular group C serum bactericidal antibody titer	1 month and 1 year following MenACWY booster
Confirm safety of MenACWY conjugate vaccines	Adverse events as reported by study participants	Up to 1 month post-vaccine

Collaborators and Investigators

• Sponsor: Canadian Immunization Research Network
• Collaborators: 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: Principal Investigator: Manish Sadarangani, BM BCh DPhil, University of British Columbia

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2018
• Primary Completion (Actual): August 1, 2021
• Study Completion (Actual): August 1, 2021

Study Registration Dates

• First Submitted: October 1, 2018
• First Submitted That Met QC Criteria: October 1, 2018
• First Posted (Actual): October 3, 2018

Study Record Updates

• Last Update Posted (Actual): March 11, 2022
• Last Update Submitted That Met QC Criteria: March 10, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: adolescents; Neisseria meningitidis; MenACWY
• Additional Relevant MeSH Terms: Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Neisseriaceae Infections; Meningococcal Infections
• Other Study ID 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