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OpenTrials
Completed

NCT Number: NCT01768117

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Laboratory personnel (inclusive of Pfizer staff) who work directly with pathogenic Neisseria meningitidis in the context of the bivalent rLP2086 vaccine development program.
  • Male or female subject aged ≥18 to ≤65 years at the time of enrollment.
  • Negative urine pregnancy test.

Exclusion criteria

  • Subjects receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
  • 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.
  • Significant neurological disorder or history of seizure (excluding simple febrile seizure).
  • Current chronic use of systemic antibiotics.
  • Received any investigational drugs, vaccines, or devices within 28 days before administration of the first study vaccination.
  • Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
  • Prior receipt of any vaccine specifically targeting fHBP or LP2086 antigens.
  • History of microbiologically proven disease caused by Neisseria meningitidis.

Treatment and study plan

rLP2086

Biological

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

Primary outcomes

  1. Number of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)

    Time frame: 1 month after vaccination 3

  2. Percentage of Participants With at Least One Adverse Event (AE)

    Time frame: Vaccination 1 up to 1 month after Vaccination 3

Secondary outcomes

  1. Number of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level >= LLOQ

    Time frame: 1 month after vaccination (Vac) 1, 2, Immediately prior to vaccination 3

  2. Number of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level >= LLOQ For All 4 Primary Test Strains Combined

    Time frame: 1 month after vaccination 3

  3. Number of Participants With 4-fold Increase in Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level

    Time frame: 1 month after vaccination 3

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Acronym: B1971042

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 15, 2013
Registry last updated
Dec 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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