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

• Sponsor: China National Biotec Group Company Limited (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04700618
• Collaborator: Shanghai Municipal Center for Disease Control and Prevention (Other)
• Enrollment: 330
• Location: 1
• Arms: 2
• Actual Duration (Months): 10.8
• Patients Per Site Per Month: 30.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Vaccination	Biological: 23-valent pneumococcal polysaccharide vaccine	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 330 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Study group is PPV23 revaccination and control group PPV23-vaccination.Study group is PPV23 revaccination and control group PPV23-vaccination.
• Masking: None (Open Label)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: Mar 21, 2021
• Actual Primary Completion Date: Aug 22, 2021
• Actual Study Completion Date: Feb 13, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Antibody doubling rate [The blood collection time was 28-40 days after vaccination.]

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

Secondary Outcome Measures

1. Antibody GMC level [The blood collection time was 28-40 days after vaccination.]

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

2. Incidence of adverse reactions [Within 30 days after vaccination.]

   Adverse reactions were collected during the observation period.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanghai municipal center for disease control and prevention	Shanghai	Shanghai	China

Sponsors and Collaborators

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

Investigators

• Study Chair: Xiang Guo, Shanghai Municipal Center for Disease Control and Prevention

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: China National Biotec Group Company Limited
• ClinicalTrials.gov Identifier: NCT04700618
• Other Study ID Numbers: PPV23-2021-2
• First Posted: Jan 8, 2021
• Last Update Posted: Feb 16, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by China National Biotec Group Company Limited: safety; immunogenicity
• Additional relevant MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine

Study Results

No Results Posted as of Feb 16, 2022