A Clinical Trial to Evaluate the Safety and Immunogenicity of PPV23 Vaccine Revaccinated in 60-70 Years Old

Phase 4

Completed

• Conditions: Vaccination
• Interventions: Biological: 23-valent pneumococcal polysaccharide vaccine

• Registration Number: NCT04700618
• Lead Sponsor: China National Biotec Group Company Limited

Brief Summary

Objective: To evaluate the safety and immunogenicity of PPV23 vaccine revaccinated in 60-70 years old in Shanghai.

Detailed Description

1. Antibody double growth rate in 28-40 days after immunization;

2. Antibody GMC level in 28-40days after immunization;

3. Incidence of adverse reactions in 0-30days.

Study Timeline

• Study First Submitted: 2021-01-06
• Study First Submitted QC: 2021-01-06
• Study First Posted: 2021-01-08
• Study Start: 2021-03-21
• Primary Completion: 2021-08-22
• Status Verified: 2022-02
• Study Completion: 2022-02-13
• Last Update Submitted: 2022-02-15
• Last Update Posted: 2022-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 330

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℃.

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°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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	23-valent pneumococcal polysaccharide vaccine	The control group had never been vaccinated with any pneumococcal vaccine.
Study group	23-valent pneumococcal polysaccharide vaccine	The subjects in the study group had been vaccinated with 23 valent pneumococcal polysaccharide vaccine made in China for more than 5 years.

Primary Outcome Measures

Name	Time	Method
Antibody doubling rate	The blood collection time was 28-40 days after vaccination.	The difference of serum antibody double growth level between the two groups was compared.

Secondary Outcome Measures

Name	Time	Method
Antibody GMC level	The blood collection time was 28-40 days after vaccination.	The difference of serum antibody GMC level between the two groups was compared.
Incidence of adverse reactions	Within 30 days after vaccination.	Adverse reactions were collected during the observation period.

Trial Locations

Locations (1)

Shanghai municipal center for disease control and prevention; 🇨🇳 Shanghai, Shanghai, China