The primary purpose of this study is to evaluate the safety and immunogenicity of an investigational meningococcal B vaccine in healthy infants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
46
vaccination
vaccination
vaccination
Clínica Mediterráneo
Almería, Almeria, Spain
Hospital Clinico Universitario de Santiago
Santiado de Compostela, La Coruña, Spain
Hospital Gral. Gregorio Maranon
Madrid, Madrid, Spain
Hospital 12 de Octubre Materno-Infantil Unidad de Lactantes
Madrid, Madrid, Spain
Percentage of Participants Achieving at Least 1:4 rLP2086-specific Serum Bactericidal Assay (SBA) Titer to 1 Subfamily A Strain and 1 Subfamily B Strain
Time frame: 1 month after Dose 3
Percentage of Participants With at Least One Adverse Event (AE)
Time frame: From signing of informed consent form to completion of study (up to 2 years)
Serum Bactericidal Assay (SBA) Geometric Mean Titers (GMTs) for 1 Subfamily A Strain and 1 Subfamily B Strain
Time frame: 1 month after Dose 2, Dose 3; before Dose 4
Percentage of Participants Achieving at Least 1:4, 1:8, 1:16, 1:32, 1:64, 1:128 rLP2086-specific SBA Titer to 1 Subfamily A Strain and 1 Subfamily B Strain
Time frame: 1 month after Dose 2, Dose 3; before Dose 4
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vaccination
vaccination
Hospital Universitario de Mostóles
Mostóles, Madrid, Spain
Hospital Virgen del Camino
Pamplona, Navarre, Spain
Hospital Xeral de Vigo
Vigo, Spain