A Trial to Describe the Immunogenicity and Safety of 2 Doses of Bivalent rLP2086 (Trumenba) and a Pentavalent Meningococcal Vaccine in Healthy Subjects >=10 to <26 Years of Age.

Pfizer

Status and phase: Completed; Phase 3

Conditions: Meningococcal Vaccine

Treatments: Biological: MenABCWY; Biological: rLP2086; Biological: Saline; Biological: MenACWY-CRM

Study type: Interventional

Funder types: Industry

Identifiers

NCT03135834

2016-004421-17 (EudraCT Number)

B1971057

Details and patient eligibility

About

This study is examining safety and immunogenicity of 2 doses of Trumenba administered on a 0-,6- month schedule. This trial is also studying safety and immunogenicity of a meningococcal pentavalent vaccine.

Enrollment: 1,610 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 enrollment.
• Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
• Negative urine pregnancy test for all female subjects.
• Subjects who have not received, or who have received no more than 1 prior dose within the past 4 years, of a vaccine containing 1 or more ACWY serogroup

Exclusion criteria

• Previous vaccination with any meningococcal serogroup B or purely polysaccharide (nonconjugate) meningococcal vaccine.
• Subjects receiving any allergen immunotherapy with a nonlicensed 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.
• Received any investigational vaccines, drugs, or devices within 28 days before administration of the first study vaccination.
• Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,610 participants in 4 patient groups

Group 1 (ACWY Naive subjects, MenABCWY/Saline)

Experimental group

Description:

ACWY Naive subjects, MenABCWY/Saline

Treatment:

Biological: MenABCWY

Biological: Saline

Group 2 (ACWY Naive subjects, rLP2086/MenACWY-CRM)

Experimental group

Description:

ACWY Naive subjects, rLP2086/MenACWY-CRM

Treatment:

Biological: rLP2086

Biological: MenACWY-CRM

Group 3 (ACWY Experienced subjects, MenABCWY/Saline)

Experimental group

Description:

ACWY Experienced subjects, MenABCWY/Saline

Treatment:

Biological: MenABCWY

Biological: Saline

Group 4 (ACWY Experienced subjects, rLP2086/MenACWY-CRM)

Experimental group

Description:

ACWY Experienced subjects, rLP2086/MenACWY-CRM

Treatment:

Biological: rLP2086

Biological: MenACWY-CRM