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

Vaccination Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04700618
• Other study ID #: PPV23-2021-2
• Status: Completed
• Phase: Phase 4
• Start date: March 21, 2021
• Est. completion date: February 13, 2022

Study information

• Verified date: February 2022
• Source: China National Biotec Group Company Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: February 13, 2022
• Est. primary completion date: August 22, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Vaccination

Intervention

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.

Locations

Country	Name	City	State
China	Shanghai municipal center for disease control and prevention	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
China National Biotec Group Company Limited	Shanghai Municipal Center for Disease Control and Prevention

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	Incidence of adverse reactions	Adverse reactions were collected during the observation period.	Within 30 days after vaccination.