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Studies on evaluation of immunogenicity of meningococcal vaccine in Korea

Studies on evaluation ofimmunogenicity of meningococcal vaccine in Korea

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0002460
Enrollment
90
Registered
2017-09-08
Start date
2016-05-09
Completion date
Unknown
Last updated
2019-03-11

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

Conditions

None listed

Interventions

Biological/Vaccine, Non-Stem Cell : The subjects will be randomly divided into two groups (1:1) to receive either of the two vaccines intramuscularly on their deltoid muscle: group A, MenACWY-diphth
group B, MenACWY-CRM197. The sera will be obtained before vaccination and one month after vaccination and tested for serogroup-specific serum bactericidal activity using baby rabbit complement.

Sponsors

Ewha Womans University Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Eligible individuals were healthy adults aged 19-50 years old who gave informed consents.

Exclusion criteria

Exclusion criteria: Subjects were excluded if they had a history of a previous meningococcal disease or Guillan-Barre Syndrome, immunization with meningococcal vaccines, a disease requiring treatment using immunosuppressive drugs, a history of hypersensitivity to vaccines or any vaccine components, or receipt of antibiotics within seven days. Subjects were also excluded if they received a blood products (including immunoglobulin) within 6 months.

Design outcomes

Primary

MeasureTime frame
Serum bactericidal index

Secondary

MeasureTime frame
the proportion of subjects with a serum bactericidal index equal or greater than 8 or 128

Countries

Korea, Republic of

Contacts

Public ContactHan Wool Kim

Ewha Womans University Medical Center

jshw84@naver.com+82-2-2650-2547

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 22, 2026