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Study To Describe The Safety, Tolerability, And Immunogenicity Of Bivalent Rlp2086 Vaccine In Laboratory Workers ≥18 To ≤65 Years Of Age

Last updated on March 15, 2019

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Study Location
Frontage Clinical Services (Formally ABR)
Hackensack, New Jersey, 07601 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Meningococcal Meningitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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1. Laboratory personnel (inclusive of Pfizer staff) who work directly with pathogenic
Neisseria meningitidis in the context of the bivalent rLP2086 vaccine development
program.

2. Male or female subject aged ≥18 to ≤65 years at the time of enrollment.

3. Negative urine pregnancy test.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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1. Subjects receiving any allergen immunotherapy with a nonlicensed product or receiving
allergen immunotherapy with a licensed product and are not on stable maintenance
doses.

2. 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 or those receiving immunosuppressive therapy. Subjects with terminal
complement deficiency are excluded from participation in this study.

3. Significant neurological disorder or history of seizure (excluding simple febrile
seizure).

4. Current chronic use of systemic antibiotics.

5. Received any investigational drugs, vaccines, or devices within 28 days before
administration of the first study vaccination.

6. Any neuroinflammatory or autoimmune condition, including, but not limited to,
transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.

7. Prior receipt of any vaccine specifically targeting fHBP or LP2086 antigens.

8. History of microbiologically proven disease caused by Neisseria meningitidis.

NCT01768117
Pfizer
Completed
Study To Describe The Safety, Tolerability, And Immunogenicity Of Bivalent Rlp2086 Vaccine In Laboratory Workers ≥18 To ≤65 Years Of Age

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[email protected]

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