Immunogenicity and safety of quadrivalent meningococcal polysaccharide-protein conjugate vaccine among Japanese people aged >=56 years

Immunogenicity and safety of quadrivalent meningococcal polysaccharide-protein conjugate vaccine among Japanese people aged >=56 years - Immunogenicity and safety of quadrivalent meningococcal polysaccharide-protein conjugate vaccine among Japanese people aged >=56 years

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000022803

Enrollment

Registered

2016-09-01

Start date

2016-10-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

meningococcal disease

Interventions

Single dose of quadrivalent meningococcal polysaccharide-protein conjugate vaccine

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: healthy volunteer

Exclusion criteria

Exclusion criteria: acute febrile illness immunodeficiency allergy against vaccine contents

Design outcomes

Primary

Measure	Time frame
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)	—

Measure

Time frame

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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Japan

Contacts

Public ContactSHINJI FUKUSHIMA

Tokyo Medical University Hospital Travellers' Medical Center

fuku789@tokyo-med.ac.jp03-3342-6111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026

Immunogenicity and safety of quadrivalent meningococcal polysaccharide-protein conjugate vaccine among Japanese people aged &gt;=56 years