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A phase IV clinical trial to evaluate the immunogenicity and safety of 23-valent pneumococcal polysaccharide vaccine revaccinations in the elderly

A phase IV clinical trial to evaluate the immunogenicity and safety of 23-valent pneumococcal polysaccharide vaccine revaccinations in the elderly

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100042000
Enrollment
Unknown
Registered
2021-01-12
Start date
2021-01-04
Completion date
Unknown
Last updated
2021-04-12

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

Conditions

Bacterial pneumonia

Interventions

Experimental group:PPV23 revaccination

Sponsors

Sichuan Center for Disease Control and Prevention
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 60 to 65 years old on the day of enrollment; 2. The subjects have signed the informed consent and signed the date; 3. The subjects are able to participate in all planned follow-up visits and were able to follow all trial procedures (e.g. complete diary card / contact card, return to visit); 4. The subjects in the study group had been vaccinated with 23 valent pneumococcal polysaccharide vaccine made in China for more than 5 years; 5. The control group had never been vaccinated with any pneumococcal vaccine; 6. Axillary temperature <= 37.0 degrees C.

Exclusion criteria

Exclusion criteria: 1. With a medical history with hypersensitiveness, eclampsia, epilepsy, cerebropathia and neurological illness; 2. Allergic to any ingredient of vaccine or with allergy history to any vaccine; 3. Subjects with immunodeficency or suspected impairment of immunologic function (e.g. caused by HIV), or subjects are in the process of immunosuppressor therapy(Taking orally injecting of steroid hormone); 4. Administration of immunoglobulins within 30 days prior to this study; 5. Acute febrile disease(temperature >= 37.degrees C) or infectious disease; 6. With a clearly diagnosed history of thrombocytopenia or other coagulopathy, may cause contraindications for subcutaneous injection; 7. With any serious chronic illness, acute infectious diseases, or respiratory diseases; 8. Suffering from serious cardiovascular diseases (pulmonary heart disease, pulmonary edema, hypertension can not be controlled to normal by drugs), liver and kidney diseases, diabetes with complications; 9. With any kind of infectious, purulent, or allergic skin diseases; 10. With any other factor that makes the investigator determines the subject is unsuitable for this study.

Design outcomes

Secondary

MeasureTime frame
Antibody GMC level;Incidence of adverse reactions;

Primary

MeasureTime frame
Antibody double growth rate;

Countries

China

Contacts

Public ContactQianli Ma

Sichuan Center for Disease Control and Prevention

342492293@qq.com+86 28-85587021

Outcome results

None listed

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