Study To Describe The Safety, Tolerability, And Immunogenicity Of Bivalent Rlp2086 Vaccine In Laboratory Workers ≥18 To ≤65 Years Of Age
Status: | Completed |
---|---|
Conditions: | Infectious Disease |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 12/22/2018 |
Start Date: | February 2013 |
End Date: | February 2014 |
A Single-arm, Open-label Study To Describe The Safety, Tolerability, And Immunogenicity Of Bivalent Rlp2086 Vaccine In Laboratory Workers >=18 To < =65 Years Of Age
This study will assess the safety, tolerability and immunogenicity of bivalent rLP2086
vaccine in laboratory workers ≥18 to ≤65 years of age administered on a Month 0, 2, and 6
schedule. The study will recruit laboratory personnel (inclusive of Pfizer staff) who work
directly with pathogenic Neisseria meningitidis in the context of the bivalent rLP2086
vaccine development program. The study will provide descriptive safety and immunogenicity
data following vaccination of these individuals with bivalent rLP2086 vaccine.
vaccine in laboratory workers ≥18 to ≤65 years of age administered on a Month 0, 2, and 6
schedule. The study will recruit laboratory personnel (inclusive of Pfizer staff) who work
directly with pathogenic Neisseria meningitidis in the context of the bivalent rLP2086
vaccine development program. The study will provide descriptive safety and immunogenicity
data following vaccination of these individuals with bivalent rLP2086 vaccine.
Inclusion Criteria:
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:
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.
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