This study is aimed to evaluate safety, tolerability and immunogenicity of three doses of Novartis 4CMenB and of one dose of Novartis Meningococcal ACWY vaccine when administered to healthy at-risk adults.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
54
A single dose of a 0.5 mL injectable solution
All subjects received the study vaccine following a 0,2,6 vaccination schedule. Pre-filled syringe, administered by intramuscular injection into the deltoid area of the non dominant arm.
Azienda USL 7 of Siena
Siena, Italy
Geometric Mean Titer of the Meningococcal B Vaccine Against the Different Strains at One Month After First, Second and Third Vaccination.
Geometric mean titers(GMT) and the respective confidence intervals measured after each vaccination against the three different meningococcal strains.
Time frame: One month after vaccinations
Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination.
Percentage of participants with serum bactericidal activity (SBA) of the Meningococcal ACWY vaccine at one month after vaccination against A, C, W-135 and Y strains. Bactericidal activity (% ≥ 1:4, i.e., percentage of subjects with BCA titer ≥ 1:4; % ≥ 1:8, i.e. percentage of subjects with BCA titer ≥ 1:8) against a panel of genetically distinct meningococcal B strains: * prior to the first vaccination * 30 days following the first, second, prior to the third and 30 days after the third vaccination
Time frame: One month after vaccinations
Geometric Mean Titer (GMT) of the Meningococcal ACWY Vaccine at One Month After Vaccination.
Geometric mean titer (GMT) of the Meningococcal ACWY Vaccine at One Month After the Immunization against the A, C, W-135 and Y strains.
Time frame: One month after vaccinations
Percentage of Participants With Serum Bactericidal Activity of the Meningococcal ACWY Vaccine at One Month After Vaccination
Percentage of participants with serum bactericidal activity (SBA) of the Meningococcal ACWY vaccine at one month after vaccination against A, C, W-135 and Y strains. Bactericidal activity (% ≥ 1:4, i.e., percentage of subjects with BCA titer ≥ 1:4; % ≥ 1:8, i.e. percentage of subjects with BCA titer ≥ 1:8) against a panel of genetically distinct meningococcal B strains: * prior to the first vaccination * 30 days following the first, second, prior to the third and 30 days after the third vaccination
Time frame: One month after vaccinations
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Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination.
The number of subjects who reported solicited reactions after the administration of the Meningococcal B vaccine at a 0, 2, 6-month schedule and the administration of the Meningococcal A, C, W, and Y vaccine at month 7.
Time frame: One month after vaccinations