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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

NCT ID: NCT01768117

Last Updated: 2018-12-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Meningitis, Meningococcal, Serogroup B

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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rLP2086

Group Type EXPERIMENTAL

rLP2086

Intervention Type BIOLOGICAL

0.5 ml intramuscular injection of 120 microgram bivalent rLP2085 administered at 0, 2 and 6 months

Interventions

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rLP2086

0.5 ml intramuscular injection of 120 microgram bivalent rLP2085 administered at 0, 2 and 6 months

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Frontage Clinical Services (Formally ABR)

Hackensack, New Jersey, United States

Site Status

Countries

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United States

References

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Beeslaar J, Mather S, Absalon J, Eiden JJ, York LJ, Crowther G, Maansson R, Maguire JD, Peyrani P, Perez JL. Safety data from the MenB-FHbp clinical development program in healthy individuals aged 10 years and older. Vaccine. 2022 Mar 15;40(12):1872-1878. doi: 10.1016/j.vaccine.2022.01.046. Epub 2022 Feb 11.

Reference Type DERIVED
PMID: 35164991 (View on PubMed)

Other Identifiers

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B1971042

Identifier Type: -

Identifier Source: org_study_id