MenABCWY Noninferiority Study in Healthy Participants ≥10 to <26 Years of Age

Pfizer

Status and phase: Completed; Phase 3

Conditions: Meningococcal Vaccine

Treatments: Biological: Trumenba; Biological: MenACWY-CRM; Biological: Saline; Biological: MenABCWY

Study type: Interventional

Funder types: Industry

Identifiers

NCT04440163

2019-004313-13 (EudraCT Number)

C3511001

Details and patient eligibility

About

The aim of this study is to determine the immunologic noninferiority of MenABCWY to licensed vaccines Trumenba and MenACWY-CRM (Menveo) by assessing the safety and immunogenicity of MenABCWY and the comparators in both ACWY-naïve and ACWY-experienced healthy participants ≥10 to <26 years of age.

Enrollment: 2,431 patients

Sex: All

Ages: 10 to 25 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or female subject aged >=10 and <26 years at the time of randomization.
• Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
• Negative urine pregnancy test for all female subjects.
• ACWY-naïve participants: Participants who have never received a prior dose of a meningococcal vaccine containing ACWY serogroups.
• ACWY-experienced participants: Participants who have received not more than 1 prior dose, no sooner than 4 years prior to the date of randomization of Menactra or Menveo.

Exclusion criteria

• Previous vaccination with any meningococcal group B vaccine, any purely polysaccharide (nonconjugate) meningococcal vaccine, or monovalent/bivalent meningococcal vaccine.- Subjects receiving any allergen immunotherapy with a non-licensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
• A known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as subjects with congenital or acquired defects in B cell function, those receiving chronic systemic (oral, intravenous, or intramuscular) corticosteroid therapy, or those receiving immunosuppressive therapy. Subjects in the United States with terminal complement deficiency are excluded from participation in this study.
• Significant neurological disorder or history of seizure (excluding simple febrile seizure).
• Current chronic use of systemic antibiotics.
• Participation in other studies involving investigational drug(s) or investigational vaccine(s) within 28 days prior to study entry and/or during study participation.
• Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
• History of microbiologically proven disease caused by N meningitidis or Neisseria gonorrhoeae.
• Receipt of any blood products, including immunoglobulin, within 6 months before the first study vaccination.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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2,431 participants in 8 patient groups

1-Immuno Subset (ACWY Naive,MenABCWY/Saline)

Experimental group

Description:

ACWY Naive subjects, MenABCWY/Saline

Treatment:

Biological: Saline

Biological: MenABCWY

2-Immuno Subset (ACWY Naive, Trumenba/MenACWY-CRM)

Experimental group

Description:

ACWY Naive subjects, Trumenba/MenACWY-CRM

Treatment:

Biological: MenACWY-CRM

Biological: Trumenba

3-Immuno Subset (ACWY Experienced,MenABCWY/Saline)

Experimental group

Description:

ACWY Experienced subjects, MenABCWY/Saline

Treatment:

Biological: Saline

Biological: MenABCWY

4-Immuno Subset (ACWY Experienced,Trumenba/MenACWY-CRM)

Experimental group

Description:

ACWY Experienced subjects, Trumenba/MenACWY-CRM

Treatment:

Biological: MenACWY-CRM

Biological: Trumenba

5-Safety Subset (ACWY Naive,MenABCWY/Saline)

Experimental group

Description:

ACWY Naive subjects, MenABCWY/Saline

Treatment:

Biological: Saline

Biological: MenABCWY

6-Safety Subset (ACWY Naive,Trumenba/MenACWY-CRM)

Experimental group

Description:

ACWY Naive subjects, Trumenba/MenACWY-CRM

Treatment:

Biological: MenACWY-CRM

Biological: Trumenba

7-Safety Subset (ACWY Experienced,MenABCWY/Saline)

Experimental group

Description:

ACWY Experienced subjects, MenABCWY/Saline

Treatment:

Biological: Saline

Biological: MenABCWY

8-Safety Subset (ACWY Experienced,Trumenba/MenACWY-CRM)

Experimental group

Description:

ACWY Experienced subjects, Trumenba/MenACWY-CRM

Treatment:

Biological: MenACWY-CRM

Biological: Trumenba