A Clinical Trial to Evaluate the Immunogenicity and Safety of PPV23 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

To evaluate the the immunogenicity and safety of 23-valent pneumococcal polysaccharide vaccine revaccinations in the elderly

Study Overview

• Status: Completed
• Conditions: Vaccination
• Intervention / Treatment: Biological: 23-valent pneumococcal polysaccharide vaccine

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 Type: Interventional
• Enrollment (Actual): 331
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Sichuan Center for Disease Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1.The age was 60-65 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℃.

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Biological: 23-valent pneumococcal polysaccharide vaccine; The study group and the control group were injected with a dose of 23-valent pneumococcal polysaccharide vaccine. One month later, blood was collected and serum was separated.
Placebo Comparator: Control group; The control group had never been vaccinated with any pneumococcal vaccine.	Biological: 23-valent pneumococcal polysaccharide vaccine; The study group and the control group were injected with a dose of 23-valent pneumococcal polysaccharide vaccine. One month later, blood was collected and serum was separated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
2-fold growth rate of antibody	The serum antibody level of pneumococci was determined by modified enzyme-linked immunosorbent assay. The double growth rate of serum antibody level was calculated.	The blood collection time was 28-40 days after vaccination.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antibody GMC level	The serum antibody level of pneumococci was determined by modified enzyme-linked immunosorbent assay.	The blood collection time was 28-40 days after vaccination.
Incidence of adverse reactions	Adverse reactions were collected during the observation period.	Within 30 days after vaccination.

Collaborators and Investigators

• Sponsor: China National Biotec Group Company Limited
• Collaborators: Sichuan Center for Disease Control and Prevention
• Investigators: Study Director: Qianli Ma, Sichuan Center for Disease Control and Prevention

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2021
• Primary Completion (Actual): December 20, 2021
• Study Completion (Actual): February 15, 2022

Study Registration Dates

• First Submitted: January 6, 2021
• First Submitted That Met QC Criteria: January 6, 2021
• First Posted (Actual): January 8, 2021

Study Record Updates

• Last Update Posted (Actual): February 16, 2022
• Last Update Submitted That Met QC Criteria: February 15, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Heptavalent Pneumococcal Conjugate Vaccine
• Other Study ID Numbers: PPV23-2021-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No