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

NCT04700618 | Completed Phase 4

• 1 other identifier: PPV23-2021-2
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Vaccination

Keywords

safety; immunogenicity

Outcome Measures

Primary Outcomes (1)

• Antibody doubling rate

  The difference of serum antibody double growth level between the two groups was compared.

  The blood collection time was 28-40 days after vaccination.

Secondary Outcomes (2)

• Antibody GMC level

  The blood collection time was 28-40 days after vaccination.

• Incidence of adverse reactions

  Within 30 days after vaccination.

Study Arms (2)

Study group

EXPERIMENTAL

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

Biological: 23-valent pneumococcal polysaccharide vaccine

Control group

PLACEBO COMPARATOR

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

Biological: 23-valent pneumococcal polysaccharide vaccine

Interventions

23-valent pneumococcal polysaccharide vaccine 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; Study group

Eligibility Criteria

• Age: 60 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The age was 60-70 years old on the day of enrollment;
• The subjects have signed the informed consent and signed the date;
• 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);
• The subjects in the study group had been vaccinated with 23 valent pneumococcal polysaccharide vaccine made in China for more than 5 years;
• The control group had never been vaccinated with any pneumococcal vaccine; 6.Axillary temperature ≤37.0℃.

You may not qualify if:

• With a medical history with hypersensitiveness, eclampsia, epilepsy, cerebropathia and neurological illness;
• 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);
• 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.

Sponsors & Collaborators

• China National Biotec Group Company Limited: lead
• Shanghai Municipal Center for Disease Control and Prevention: collaborator

Study Sites (1)

Shanghai municipal center for disease control and prevention

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Interventions

23-valent pneumococcal capsular polysaccharide vaccine

Study Officials

• Xiang Guo

  Shanghai Municipal Center for Disease Control and Prevention

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Study group is PPV23 revaccination and control group PPV23-vaccination.

Study Record Dates

• First Submitted: January 6, 2021
• First Posted: January 8, 2021
• Study Start: March 21, 2021
• Primary Completion: August 22, 2021
• Study Completion: February 13, 2022
• Last Updated: February 16, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)