Immunogenicity and safety of quadrivalent meningococcal polysaccharide-protein conjugate vaccine among Japanese people aged >=56 years
Not Applicable
- Conditions
- meningococcal disease
- Registration Number
- JPRN-UMIN000022803
- Lead Sponsor
- Tokyo Medical University Hospital Travellers' Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 23
Inclusion Criteria
Not provided
Exclusion Criteria
acute febrile illness immunodeficiency allergy against vaccine contents
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Functional meningococcal antibody activity against serogroups A,C,Y,and W-135 antigens seroprotection to meningococcal antigens (serogroups A,C,Y,and W-135)28 days after vaccination with Meningococcal vaccine Seroprotection was defined as a post-vaccination titer (>= 1:128) dilution against meningococcal serogroups A,C,Y,and W-135 based on the serum bactericidal assay using baby rabbit complement (SBA-BR)
- Secondary Outcome Measures
Name Time Method Immunogenicity Meningococcal serogroups A,C,Y,and W-135 antibody titers using the SBA-BR on day 0 before vaccination and on day 28 post-vaccination with the parameters including >=4 fold-rise, geometric mean titers (GMTs) Safety any unsolicited systemic adverse events (AEs) reported within 30 minutes after vaccination solicited injection site reactions systemic reactions occurring from day 0 through day 7 unsolicited AEs within 28 days after vaccination