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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rLP2086 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rLP2086 | Biological | 0.5 ml intramuscular injection of 120 microgram bivalent rLP2085 administered at 0, 2 and 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) | 1 month after vaccination 3 | |
| Percentage of Participants With at Least One Adverse Event (AE) | Vaccination 1 up to 1 month after Vaccination 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level >= LLOQ | 1 month after vaccination (Vac) 1, 2, Immediately prior to vaccination 3 | |
| Number of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level >= LLOQ For All 4 Primary Test Strains Combined |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Frontage Clinical Services (Formally ABR) | Hackensack | New Jersey | 07601 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35164991 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | rLP2086 | Enrolled to receive on a 0, 2-, 6- month schedule |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | rLP2086 | Enrolled to receive on a 0, 2-, 6- month schedule |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) | Posted | Number | participants | 1 month after vaccination 3 |
|
|
AE reported from Vaccination 1 to 1 month after last administration of investigational product (bivalent rLP2086). SAE reported from Vaccination 1 to 6 months after last administration of investigational product (bivalent rLP2086)
Events collected on case report form were reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | rLP2086 | Enrolled to receive on a 0, 2-, 6- month schedule |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye Pain | Eye disorders | MedDRA 16.1 | Non-systematic Assessment |
Results of immunogenicity endpoints were reported in ''number'' and not in ''proportion'' as per team's input.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D008585 | Meningitis, Meningococcal |
| ID | Term |
|---|---|
| D016920 | Meningitis, Bacterial |
| D020806 | Central Nervous System Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| C484699 | factor H-binding protein, Neisseria meningitidis |
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| 1 month after vaccination 3 |
| Number of Participants With 4-fold Increase in Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level | 1 month after vaccination 3 |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Primary | Percentage of Participants With at Least One Adverse Event (AE) | Posted | Number | percentage of participants | Vaccination 1 up to 1 month after Vaccination 3 |
|
|
|
| Secondary | Number of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level >= LLOQ | Posted | Number | participants | 1 month after vaccination (Vac) 1, 2, Immediately prior to vaccination 3 |
|
|
|
| Secondary | Number of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level >= LLOQ For All 4 Primary Test Strains Combined | Posted | Number | participants | 1 month after vaccination 3 |
|
|
|
| Secondary | Number of Participants With 4-fold Increase in Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level | Posted | Number | participants | 1 month after vaccination 3 |
|
|
|
| 0 |
| 13 |
| 6 |
| 13 |
| Respiratory tract infection viral | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Gouty arthritis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA 16.1 | Systematic Assessment | An occurrence of chills reported as a systemic event, was also reported as an AE. |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D007239 | Infections |
| D008589 | Meningococcal Infections |
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D002494 | Central Nervous System Infections |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008581 | Meningitis |
| D000090862 | Neuroinflammatory Diseases |