Efficacy of 23-valent pneumococcal polysaccharide vaccine in nursinghome residents - A double blind, randomized and placebo controlled trial -

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1090220024

Enrollment

1000

Registered

2008-11-28

Start date

2006-03-08

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

Pneumococcal pneumonia in nursinghome residents

Interventions

Intervention type:VACCINE Name of intervention:23-valent pneumococcal polysaccharide vaccine Dose form / Japanese Medical Device Nomenclature:INJECTION Route of administration / Site of application:IN

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Japanese nursinghome residents 2.Signed informed consent from the patient or atorney. 3. The patient or atorney is able to comply with the study protocol for the duration of the study; available to undergo physical examinations as required by the protocol; and able to report on their health conditions such as symptoms.

Exclusion criteria

Exclusion criteria: 1. Patients previously given pneumococcal vaccine. 2. Patients hypersensitive to vaccine components. 3. Immunocompromised people with presumed poor response to the vaccine (such as patients with myeloma or active malignant disease, neutrophils <1.0x109/L, hypogammmaglobulinaemia, human immunodeficiency virus (HIV) infection, solid-organ or bone-marrow transplantation or those under dialysis) 4. Patients judged by the investigator to be inappropriate for inclusion for any other reason.

Design outcomes

Primary

Measure	Time frame
1. Clinical endpoints: 1) Incidence of pneumonia 2) Incidence of pneumococcal pneumonia 2. Safety endpoints The type, severity, duration and frequency of adverse events and adverse drug reactions reported during the period from the first administration of study vaccine (Day 0) to the end of follow up period. 3.Immunological end points Antibody titers against 23 valent pneumococcal vaccine at 2 months and the end of follow up period after each vaccination.	—

Measure

Time frame

1. Clinical endpoints: 1) Incidence of pneumonia 2) Incidence of pneumococcal pneumonia 2. Safety endpoints The type, severity, duration and frequency of adverse events and adverse drug reactions reported during the period from the first administration of study vaccine (Day 0) to the end of follow up period. 3.Immunological end points Antibody titers against 23 valent pneumococcal vaccine at 2 months and the end of follow up period after each vaccination.

—

Secondary

Measure	Time frame
1) Incidence of influenzavirus 2) Incidence of pneumonia recurrence 3) Incidence of hospital admission from pneumonia overall 4) Incidence of hospital admission from all causes 5) Incidence of death from pneumonia overall 6) Incidence of death from all causes	—

Countries

Japan

Outcome results

None listed

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