CPI study

Efficacy of sequential administration of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine in the adults with immunocompromising conditions -A double blind randomized controlled trial- - CPI study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs031180147

Enrollment

2000

Registered

2019-02-22

Start date

2019-02-22

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

pneumonia pneumonia

Interventions

Study Intervention: sequential administration of PCV13 and PPSV23 Control Intervention: single administration of PPSV23

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Immunocompromised patients >=19 years based on the recommendation of ACIP in 2012 [3] 1. Patients with human immunodeficiency virus infection 2. Patients with hematologic malignancy (leukemia, lymphoma or multiple myeloma) 3. Patients with generalized malignancy 4. Patients with congenital or acquired immunodeficiency 5. Patients with chronic renal failure needed hemodialysis 6. Patients with solid organ transplant 7. Patients with diseases requiring treatment with systemic corticosteroids >= 14days 8. Patients with diseases requiring treatment with immunosuppressive drugs

Exclusion criteria

Exclusion criteria: 1) Patients given pneumococcal vaccine within 5 years 2) Patients hypersensitive to vaccine components. 3) Patients who had Guillain-Barre syndrome or acute disseminated encephalomyelitis previously 4) Women with pregnancy or lactation 5) Patients judged by the investigator to be inappropriate for inclusion for any other reason including severe disease

Design outcomes

Primary

Measure	Time frame
1.Incidence of pneumococcal pneumonia	—

Secondary

Measure	Time frame
1.Incidence of all cause pneumonia 2.Incidence of invasive pneumococcal disease (IPD) 3.Incidence of all pneumococcal disease 4.Incidence of vaccine type pneumococcal disease 5.Severity of pneumococcal pneumonia 6.Severity of all cause pneumonia 7.Severity of IPD 8.Severity of all pneumococcal disease 9.Severity of vaccine type pneumococcal disease 10.Incidence of death from pneumococcal pneumonia 11.Incidence of death from all cause pneumonia 12.Incidence of death from IPD 13.Incidence of death from all pneumococcal disease 14.Incidence of death from vaccine type pneumococcal disease 15. Incidence of death from all causes 16.Safety of the vaccination 17.Immunogenicity of the vaccination	—

Measure

Time frame

1.Incidence of all cause pneumonia 2.Incidence of invasive pneumococcal disease (IPD) 3.Incidence of all pneumococcal disease 4.Incidence of vaccine type pneumococcal disease 5.Severity of pneumococcal pneumonia 6.Severity of all cause pneumonia 7.Severity of IPD 8.Severity of all pneumococcal disease 9.Severity of vaccine type pneumococcal disease 10.Incidence of death from pneumococcal pneumonia 11.Incidence of death from all cause pneumonia 12.Incidence of death from IPD 13.Incidence of death from all pneumococcal disease 14.Incidence of death from vaccine type pneumococcal disease 15. Incidence of death from all causes 16.Safety of the vaccination 17.Immunogenicity of the vaccination

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Contacts

Public ContactTakaya Maruyama

National Hospital Organization National Mie Hospital

maruyamatyhy@gmail.com+81-59-232-2531

Outcome results

None listed

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