A phase IV clinical trial to evaluate the safety and immunogenicity of 23 valent pneumococcal polysaccharide vaccine revaccinated in 60-70 years old in Shanghai

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100041932

Enrollment

Unknown

Registered

2021-01-10

Start date

2021-01-04

Completion date

Unknown

Last updated

2021-03-30

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

Conditions

Bacterial pneumonia

Interventions

Study Group:PPV23 Revccination

Control Group:PPV23 Vaccination

Eligibility

Sex/Gender

All

Age

60 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.The age was 60-70 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.

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 >= 37.0 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

Primary

Measure	Time frame
Antibody doubling rate;	—

Secondary

Measure	Time frame
Antibody GMC level;	—

Countries

China

Contacts

Public ContactXiang Guo

Shanghai municipal center for disease control and prevention

guoxiang@scdc.sh.cn+86 13818010874

Outcome results

None listed

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