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Non-randomized clinical trial to compare the immunogenicity of revaccination with 23-valent pneumococcal polysaccharide vaccine between healthy elderly and those with diabetes in Korea

Non-randomized clinical trial to compare the immunogenicity of revaccination with 23-valent pneumococcal polysaccharide vaccine between healthy elderly and those with diabetes in Korea

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0005125
Enrollment
254
Registered
2020-06-15
Start date
2020-06-15
Completion date
Unknown
Last updated
2020-07-13

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

Conditions

None listed

Interventions

None listed

Sponsors

MSD Korea
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: ? Inclusion criteria: subjects aged 70-75 years who received PPSV23 in previous 5-7 years, Subjects who after hearing and fully understanding the details of this clinical trial, voluntarily decides to participate and agrees in writing to comply, who is determined to be appropriate to participate in this clinical trial through self-disease, physical examination, and researcher's clinical judgment that can be visited and traced to all predetermined schedules of this clinical trial.

Exclusion criteria

Exclusion criteria: Those who have been identified for pneumococcal infection in the past 5 years, those who have been treated with anti-cancer therapy for malignant tumors within the past 30 days, those who have received high doses of systemic steroids within the past 30 days (Prednisolone>0.5 mg/kg/day ), those who have received a blood product within the past 6 months, patients with significant acute or chronic infections within the past 7 days, or those who have had a fever in the previous day, who have a serious chronic or progressive disease, for medical reasons or other reasons, therefore, the investigator is determined to be unsuitable for participation in the clinical trial.

Design outcomes

Primary

MeasureTime frame
GMT and seroconversion rates of IgG antibody titers against 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F and 23F);GMT and seroconversion rates of opsonophagocytic killing assay (OPA) for 4 pneumococcal serotypes (serotypes 5, 6B, 18C, 19A)

Secondary

MeasureTime frame
Evaluation of adverse reactions in the inoculation site such as pain, tenderness, induration, and redness;systemic adverse reactions such as fever, fatigue, muscle pain, and headache;All unexpected adverse events that occur within 1 month after inoculation in addition to the expected adverse events.

Countries

Korea, Republic of

Contacts

Public ContactHye Seong

Koera University Guro Hospital

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026