Study To Describe The Safety, Tolerability, And Immunogenicity Of Bivalent Rlp2086 Vaccine In Laboratory Workers ≥18 To ≤65 Years Of Age
NCT01768117
ABOUT THIS 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.
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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Descriptive Information | ||||
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Brief Title ICMJE | Study To Describe The Safety, Tolerability, And Immunogenicity Of Bivalent Rlp2086 Vaccine In Laboratory Workers ?18 To ?65 Years Of Age | |||
Official Title ICMJE | 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 | |||
Brief Summary | 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 | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Prevention | |||
Condition ICMJE | Meningitis, Meningococcal, Serogroup B | |||
Intervention ICMJE | Biological: rLP2086
0.5 ml intramuscular injection of 120 microgram bivalent rLP2085 administered at 0, 2 and 6 months | |||
Study Arms ICMJE | Experimental: rLP2086
Intervention: Biological: rLP2086 | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 13 | |||
Original Estimated Enrollment ICMJE | 70 | |||
Actual Study Completion Date ICMJE | February 2014 | |||
Actual Primary Completion Date | February 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01768117 | |||
Other Study ID Numbers ICMJE | B1971042 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | November 2018 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |