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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
13
0.5 ml intramuscular injection of 120 microgram bivalent rLP2085 administered at 0, 2 and 6 months
Frontage Clinical Services (Formally ABR)
Hackensack, New Jersey, United States
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
Percentage of Participants With at Least One Adverse Event (AE)
Time frame: Vaccination 1 up to 1 month after Vaccination 3
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
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
Number of Participants With 4-fold Increase in Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level
Time frame: 1 month after vaccination 3
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.