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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 November 17, 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.
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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Descriptive Information
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 SummaryThis 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 DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
 (submitted: March 17, 2014)
13
Original Estimated Enrollment  ICMJE
 (submitted: January 11, 2013)
70
Actual Study Completion Date  ICMJE February 2014
Actual Primary Completion DateFebruary 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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 CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateNovember 2018

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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