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

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

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

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): 330
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Shanghai Municipal Center for Disease Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 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 vaccinated with one dose of vaccine and blood was collected after 28-40 days.
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 vaccinated with one dose of vaccine and blood was collected after 28-40 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: China National Biotec Group Company Limited
• Collaborators: Shanghai Municipal Center for Disease Control and Prevention
• Investigators: Study Chair: Xiang Guo, Shanghai Municipal Center for Disease Control and Prevention

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2021
• Primary Completion (Actual): August 22, 2021
• Study Completion (Actual): February 13, 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

• Keywords: safety; immunogenicity
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Heptavalent Pneumococcal Conjugate Vaccine
• Other Study ID Numbers: PPV23-2021-2

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