A Trial to Assess the Lot Consistency, Safety, Tolerability and Immunogenicity of Bivalent rLP2086 Vaccine When Given to Healthy Subjects Aged ≥10 to <19 Years

Pfizer

Status and phase: Completed; Phase 3

Conditions: Meningococcal Vaccine

Treatments: Biological: rLP2086; Biological: Havrix (HAV); Biological: Saline

Study type: Interventional

Funder types: Industry

Identifiers

NCT01830855

B1971009

2010-023873-20 (EudraCT Number)

6108A1-3001 (Other Identifier)

Details and patient eligibility

About

This study is looking at a new vaccine that might prevent meningococcal disease, and will study whether healthy adolescent subjects receiving different lots of vaccine respond in a similar way. The study will also look at the safety of the new vaccine as well as how it is tolerated.

Enrollment: 3,596 patients

Sex: All

Ages: 10 to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Male or female subject aged >=10 and <19 years at the time of enrollment.
2. Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
3. Negative urine pregnancy test for all female subjects.

Exclusion criteria

1. Previous vaccination with any meningococcal serogroup B vaccine.
2. Subjects who have received prior HAV vaccination.
3. Subjects who are scheduled to receive 1 or more doses of an HPV vaccine as part of a 3-dose series during the period between Visit 1 and 28 days after the second vaccination.
4. Subjects receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
5. 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.
6. Significant neurological disorder or history of seizure (excluding simple febrile seizure).
7. Current chronic use of systemic antibiotics.
8. Received any investigational vaccines, drugs, or devices within 28 days before administration of the first study vaccination.
9. 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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3,596 participants in 4 patient groups

rLP2086 lot 1

Experimental group

Treatment:

Biological: rLP2086

Biological: rLP2086

Biological: rLP2086

rLP2086 lot 2

Experimental group

Treatment:

Biological: rLP2086

Biological: rLP2086

Biological: rLP2086

rLP2086 lot 3

Experimental group

Treatment:

Biological: rLP2086

Biological: rLP2086

Biological: rLP2086

Control

Active Comparator group

Description:

Havrix (HAV) and Saline

Treatment:

Biological: Havrix (HAV)

Biological: Saline