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Clinical Trial of 23-valent Pneumococcal Polysaccharide Vaccine in Healthy Chinese Population Aged 2 Years and Above

Primary Purpose

Pneumonia

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
23-valent pneumococcal polysaccharide vaccine
pneumococcal vaccine polyvalent
Sponsored by
Ab&b Biotechnology Co., Ltd.JS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pneumonia

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: ≥2 years old healthy population; Subjects and/or guardians or trustees voluntarily signed informed consent forms and could comply with the requirements of the clinical trial protocol; Had not received any pneumonia vaccine in the last 5 years; Note: Healthy people do not include the following conditions: ① congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.; ② History of epilepsy and mental illness; ③ Patients with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), juvenile rheumatoid arthritis (JRA), or other autoimmune diseases; Have been diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, or other autoimmune diseases; ⑤ serious liver and kidney diseases, malignant tumors, all kinds of acute diseases or in the acute phase of chronic disease; Adults have diabetes, severe cardiovascular disease, and high blood pressure (systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg) that cannot be controlled by medication. Exclusion Criteria: Armpit temperature >37.0℃ before inoculation; Family history of seizures or convulsions, epilepsy, and mental illness; People with a progressive neurological disorder or a history of Guillain-Barre syndrome; The patients with clinically significant abnormalities in blood biochemistry and routine blood tests were tested before vaccination; People who received immunoenhancement or suppressant therapy within 3 months (continuous oral or intravenous infusion for more than 14 days); History of abnormal coagulation function (such as deficiency of coagulation factor, coagulation disease); Primary and secondary immunocompromised individuals (thyroid, pancreas, liver, spleen excision history, or need treatment for thyroid disease within the last 12 months); History of severe allergic reactions to vaccinations; Allergy to any component of the investigational vaccine; Have received live attenuated vaccine within 14 days; Other vaccines received within 7 days; Participating in or planning to participate in other clinical trials; Women of childbearing age are lactating, pregnant or planning to become pregnant in the near future; The investigator determined that other conditions were not suitable for participation in the clinical trial.

Sites / Locations

  • Ab&b Biotechnology Co., Ltd.JS

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Experimental group aged 18-59 years

Control group aged 18-59 years

Experimental group aged ≥60 years

Control group aged ≥60 years

Experimental group aged 2-17 years

Control group aged 2-17 years

Arm Description

Subjects in the age group 18-59 years received 1 dose of 0.5 mL 23-valent pneumococcal polysaccharide vaccine

Subjects in the age group 18-59 years received 1 dose of 0.5 mL pneumococcal vaccine polyvalent

Subjects in the age group ≥60 years received 1 dose of 0.5 mL 23-valent pneumococcal polysaccharide vaccine

Subjects in the age group ≥60 years received 1 dose of 0.5 mL pneumococcal vaccine polyvalent

Subjects in the age group 2-17 years received 1 dose of 0.5 mL 23-valent pneumococcal polysaccharide vaccine

Subjects in the age group 2-17 years received 1 dose of 0.5 mL pneumococcal vaccine polyvalent

Outcomes

Primary Outcome Measures

Incidence of any adverse event within 30 minutes after vaccination.
Incidence of any adverse event within 30 minutes after vaccination.
The incidence of abnormal indicators of blood biochemistry and blood routine on the 4th day after vaccination
The incidence of abnormal indicators of blood biochemistry and blood routine on the 4th day after vaccination
Incidence of any adverse event within 0-7 days after vaccination.
Incidence of any adverse event within 0-7 days after vaccination.
Incidence of any adverse event within 8-28 days after vaccination.
Incidence of any adverse event within 8-28 days after vaccination.
Incidence of any serious adverse event within 6 months after vaccination.
Incidence of any serious adverse event within 6 months after vaccination.

Secondary Outcome Measures

Serum IgG antibody seroconversion rate of subjects 28 days after vaccination.
Serum IgG antibody seroconversion rate of subjects 28 days after vaccination.
Serum IgG antibody GMC of subjects 28 days after vaccination.
Serum IgG antibody GMC of subjects 28 days after vaccination.

Full Information

First Posted
April 3, 2023
Last Updated
August 14, 2023
Sponsor
Ab&b Biotechnology Co., Ltd.JS
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1. Study Identification

Unique Protocol Identification Number
NCT05815264
Brief Title
Clinical Trial of 23-valent Pneumococcal Polysaccharide Vaccine in Healthy Chinese Population Aged 2 Years and Above
Official Title
A Randomized, Blind, Parallel Controlled Phase I Clinical Trial to Evaluate the Safety and Preliminary Immunogenicity of 23-valent Pneumococcal Polysaccharide Vaccine in Healthy Population Aged 2 Years and Older
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
September 7, 2020 (Actual)
Primary Completion Date
April 6, 2021 (Actual)
Study Completion Date
April 6, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ab&b Biotechnology Co., Ltd.JS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The group aged 18-59 years old, the group ≥60 years old, and the group aged 2-17 years old were successively assigned to the group. Subjects in each age group were randomly vaccinated with 1 dose of experimental vaccine or control vaccine in a ratio of 1:1, with 48 people in each group receiving each dose. After the safety assessment was conducted on the 8th day after the first dose, the next age group could be enrolled only if the preliminary safety assessment results met the protocol requirements. When each age group is enrolled, laboratory index screening can be conducted 3 days in advance (the validity period of laboratory index detection results is 3 days). The progression of age groups is as follows: Group 18-59 years old (48 people: 1 dose) → Group ≥60 years old (48 people: 1 dose) → Group 2-17 years old (48 people: 1 dose) Safety observation: All subjects were observed on site for 30 minutes after vaccination, abnormal laboratory indicators (blood biochemistry, blood routine) of all subjects were observed on day 4 after vaccination, and adverse events of all subjects within 0-7 days were actively followed up by the researchers, and subjects were instructed to record the body temperature measured every day and adverse events (if they occurred) in the diary card. All subjects continued to observe adverse events within 8-28 days and made relevant records. All subjects were required to continue follow-up for SAE status up to 6 months after basic immunization. Immunogenicity observation: Blood samples were collected before and 28 days after vaccination, and serum antibodies were detected by ELISA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
144 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group aged 18-59 years
Arm Type
Experimental
Arm Description
Subjects in the age group 18-59 years received 1 dose of 0.5 mL 23-valent pneumococcal polysaccharide vaccine
Arm Title
Control group aged 18-59 years
Arm Type
Active Comparator
Arm Description
Subjects in the age group 18-59 years received 1 dose of 0.5 mL pneumococcal vaccine polyvalent
Arm Title
Experimental group aged ≥60 years
Arm Type
Experimental
Arm Description
Subjects in the age group ≥60 years received 1 dose of 0.5 mL 23-valent pneumococcal polysaccharide vaccine
Arm Title
Control group aged ≥60 years
Arm Type
Active Comparator
Arm Description
Subjects in the age group ≥60 years received 1 dose of 0.5 mL pneumococcal vaccine polyvalent
Arm Title
Experimental group aged 2-17 years
Arm Type
Experimental
Arm Description
Subjects in the age group 2-17 years received 1 dose of 0.5 mL 23-valent pneumococcal polysaccharide vaccine
Arm Title
Control group aged 2-17 years
Arm Type
Active Comparator
Arm Description
Subjects in the age group 2-17 years received 1 dose of 0.5 mL pneumococcal vaccine polyvalent
Intervention Type
Biological
Intervention Name(s)
23-valent pneumococcal polysaccharide vaccine
Intervention Description
This vaccine(0.5ml) is produced by Ab&b Biotechnology Co., Ltd.JS. Subjects will receive one dose of 23-valent pneumococcal polysaccharide vaccine administered by intramuscular injection.
Intervention Type
Biological
Intervention Name(s)
pneumococcal vaccine polyvalent
Intervention Description
This vaccine(0.5ml) is produced by Merck Sharp & Dohme Corp. Subjects will receive one dose of pneumococcal vaccine polyvalent administered by intramuscular injection.
Primary Outcome Measure Information:
Title
Incidence of any adverse event within 30 minutes after vaccination.
Description
Incidence of any adverse event within 30 minutes after vaccination.
Time Frame
Within 30 minutes of vaccination
Title
The incidence of abnormal indicators of blood biochemistry and blood routine on the 4th day after vaccination
Description
The incidence of abnormal indicators of blood biochemistry and blood routine on the 4th day after vaccination
Time Frame
Within 4 days of vaccination
Title
Incidence of any adverse event within 0-7 days after vaccination.
Description
Incidence of any adverse event within 0-7 days after vaccination.
Time Frame
Within 0-7 days of vaccination
Title
Incidence of any adverse event within 8-28 days after vaccination.
Description
Incidence of any adverse event within 8-28 days after vaccination.
Time Frame
Within 8-28 days of vaccination
Title
Incidence of any serious adverse event within 6 months after vaccination.
Description
Incidence of any serious adverse event within 6 months after vaccination.
Time Frame
Within 6 months of vaccination
Secondary Outcome Measure Information:
Title
Serum IgG antibody seroconversion rate of subjects 28 days after vaccination.
Description
Serum IgG antibody seroconversion rate of subjects 28 days after vaccination.
Time Frame
At 28 days after vaccination
Title
Serum IgG antibody GMC of subjects 28 days after vaccination.
Description
Serum IgG antibody GMC of subjects 28 days after vaccination.
Time Frame
At 28 days after vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: ≥2 years old healthy population; Subjects and/or guardians or trustees voluntarily signed informed consent forms and could comply with the requirements of the clinical trial protocol; Had not received any pneumonia vaccine in the last 5 years; Note: Healthy people do not include the following conditions: ① congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.; ② History of epilepsy and mental illness; ③ Patients with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), juvenile rheumatoid arthritis (JRA), or other autoimmune diseases; Have been diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, or other autoimmune diseases; ⑤ serious liver and kidney diseases, malignant tumors, all kinds of acute diseases or in the acute phase of chronic disease; Adults have diabetes, severe cardiovascular disease, and high blood pressure (systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg) that cannot be controlled by medication. Exclusion Criteria: Armpit temperature >37.0℃ before inoculation; Family history of seizures or convulsions, epilepsy, and mental illness; People with a progressive neurological disorder or a history of Guillain-Barre syndrome; The patients with clinically significant abnormalities in blood biochemistry and routine blood tests were tested before vaccination; People who received immunoenhancement or suppressant therapy within 3 months (continuous oral or intravenous infusion for more than 14 days); History of abnormal coagulation function (such as deficiency of coagulation factor, coagulation disease); Primary and secondary immunocompromised individuals (thyroid, pancreas, liver, spleen excision history, or need treatment for thyroid disease within the last 12 months); History of severe allergic reactions to vaccinations; Allergy to any component of the investigational vaccine; Have received live attenuated vaccine within 14 days; Other vaccines received within 7 days; Participating in or planning to participate in other clinical trials; Women of childbearing age are lactating, pregnant or planning to become pregnant in the near future; The investigator determined that other conditions were not suitable for participation in the clinical trial.
Facility Information:
Facility Name
Ab&b Biotechnology Co., Ltd.JS
City
Taizhou
State/Province
Jiangsu
ZIP/Postal Code
Jiangsu
Country
China

12. IPD Sharing Statement

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Clinical Trial of 23-valent Pneumococcal Polysaccharide Vaccine in Healthy Chinese Population Aged 2 Years and Above

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