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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 December 16, 2017

FOR MORE INFORMATION
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.
Show details

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.
Show details

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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Study To Describe The Safety, Tolerability, And Immunogenicity Of Bivalent Rlp2086 Vaccine In Laboratory Workers ?18 To ?65 Years Of Age
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.
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Meningitis, Meningococcal, Serogroup B
Biological: rLP2086
0.5 ml intramuscular injection of 120 microgram bivalent rLP2085 administered at 0, 2 and 6 months
Experimental: rLP2086
Intervention: Biological: rLP2086
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
February 2014
February 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01768117
B1971042
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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