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

NCT ID: NCT04700618

Last Updated: 2022-02-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 330 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-21
• Study Completion Date: 2022-02-13

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.

Conditions

Vaccination

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Study group

The subjects in the study group had been vaccinated with 23 valent pneumococcal polysaccharide vaccine made in China for more than 5 years.

Group Type: EXPERIMENTAL

23-valent pneumococcal polysaccharide vaccine

Intervention Type: BIOLOGICAL

The study group and the control group were vaccinated with one dose of vaccine and blood was collected after 28-40 days.

Control group

The control group had never been vaccinated with any pneumococcal vaccine.

Group Type: PLACEBO_COMPARATOR

23-valent pneumococcal polysaccharide vaccine

Intervention Type: BIOLOGICAL

The study group and the control group were vaccinated with one dose of vaccine and blood was collected after 28-40 days.

Interventions

23-valent pneumococcal polysaccharide vaccine

The study group and the control group were vaccinated with one dose of vaccine and blood was collected after 28-40 days.

Intervention Type: BIOLOGICAL

Eligibility 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℃.

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai Municipal Center for Disease Control and Prevention

OTHER

Sponsor Role: collaborator

China National Biotec Group Company Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiang Guo

Role: STUDY_CHAIR

Shanghai Municipal Center for Disease Control and Prevention

Locations

Shanghai municipal center for disease control and prevention

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

PPV23-2021-2

Identifier Type: -

Identifier Source: org_study_id