Adolescent MenACWY Booster Study

Canadian Immunization Research Network

Status and phase: Completed; Phase 4

Conditions: Meningococcal Disease, Invasive

Treatments: Biological: MenACWY-CRM; Biological: MenACWY-DT; Biological: MenACWY-TT

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT03694405

CT17_CIRN24_Achieve01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 244 patients

Sex: All

Ages: 11 to 15 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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244 participants in 9 patient groups

Group 1A

Experimental group

Description:

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

Treatment:

Biological: MenACWY-CRM

Group 1B

Experimental group

Description:

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

Treatment:

Biological: MenACWY-DT

Group 1C

Experimental group

Description:

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

Treatment:

Biological: MenACWY-TT

Group 2A

Experimental group

Description:

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

Treatment:

Biological: MenACWY-CRM

Group 2B

Experimental group

Description:

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

Treatment:

Biological: MenACWY-DT

Group 2C

Experimental group

Description:

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

Treatment:

Biological: MenACWY-TT

Group 3A

Experimental group

Description:

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

Treatment:

Biological: MenACWY-CRM

Group 3B

Experimental group

Description:

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

Treatment:

Biological: MenACWY-DT

Group 3C

Experimental group

Description:

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

Treatment:

Biological: MenACWY-TT