A Prospective Cohort Study of the 20-Valent Pneumococcal Conjugate Vaccine

Immunogenicity and Safety of the 20-Valent Pneumococcal Conjugate Vaccine in Patients with Chronic Respiratory Diseases: A Prospective Cohort Study

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1031240601

Enrollment

110

Registered

2025-01-14

Start date

2025-01-07

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

Asthma, COPD, Interstitial pneumonia Asthma, Pulmonary Disease, Chronic Obstructive, Lung Diseases, Interstitial

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Subjects who meet all of the following criteria (1-4): 1 Meet both conditions (a and b): a. Aged 65 years or older b. Diagnosed with a respiratory disease (COPD, asthma, or interstitial pneumonia) 2 Outpatients of Kameda General Hospital 3 Individuals who voluntarily receive the PCV20 (Prevnar 20) vaccine as their initial dose 4 Individuals who provide written informed consent to participate in the study of their own free will

Exclusion criteria

Exclusion criteria: Subjects who meet any of the following criteria: 1) Known history of anaphylaxis to any component of the PCV20 (Prevnar 20) vaccine or diphtheria toxoid 2) Presence of fever at the time of vaccination 3) Presence of an acute severe illness at the time of vaccination 4) History of prior vaccination with the 13-valent pneumococcal conjugate vaccine (PCV13) or the 15-valent pneumococcal conjugate vaccine (PCV15) 5) History of receiving PPSV23 (23-valent pneumococcal polysaccharide vaccine) two or more times 6) History of receiving PPSV23 within the past year 7) Patients with malignant tumors 8) Patients with other severe comorbidities (including cirrhosis, those undergoing dialysis, or severe heart failure) as determined by the principal investigator or sub-investigators to be serious 9) Patients with COPD or asthma who have active autoimmune diseases under treatment (patients with interstitial pneumonia may have autoimmune diseases) 10) History of microbiologically confirmed invasive pneumococcal disease 11) History of splenectomy 12) History of experiencing an acute illness requiring antibiotics or steroids within the past month 13) Any other condition deemed inappropriate for participation in the study by the principal investigator or sub-investigators

Design outcomes

Primary

Measure	Time frame
Geometric Mean Antibody Titer 1 Month	—

Secondary

Measure	Time frame
1. Antibody seroconversion at 1 month 2. Geometric mean antibody titer at 6 months 3. Antibody seroconversion at 6 months 4. Adverse reactions	—

Contacts

Public ContactKei Nakashima

Kameda Medical Center

kei.7.nakashima@gmail.com+81-4-7092-2211

Outcome results