A Phase 1 interventional study of 23-valent pneumococcal polysaccharide vaccine and pneumococcal vaccine polyvalent in Pneumonia, sponsored by Ab&B Bio-tech Co., Ltd.JS. Completed at 1 site in China. Open to participants aged 2 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-02.
Sponsored by Ab&B Bio-tech Co., Ltd.JS · Phase 1, Interventional, and Prevention
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.
2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.
This study's enrollment of 144 is above the median of 106 across 1,247 interventional studies indexed under Pneumonia.
Browse Pneumonia studies →Ab&B Bio-tech Co., Ltd.JS is the lead sponsor of 11 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects in the age group 18-59 years received 1 dose of 0.5 mL 23-valent pneumococcal polysaccharide vaccine
Biological: 23-valent pneumococcal polysaccharide vaccine
Subjects in the age group 18-59 years received 1 dose of 0.5 mL pneumococcal vaccine polyvalent
Biological: pneumococcal vaccine polyvalent
Subjects in the age group ≥60 years received 1 dose of 0.5 mL 23-valent pneumococcal polysaccharide vaccine
Biological: 23-valent pneumococcal polysaccharide vaccine
Subjects in the age group ≥60 years received 1 dose of 0.5 mL pneumococcal vaccine polyvalent
Biological: pneumococcal vaccine polyvalent
Subjects in the age group 2-17 years received 1 dose of 0.5 mL 23-valent pneumococcal polysaccharide vaccine
Biological: 23-valent pneumococcal polysaccharide vaccine
Subjects in the age group 2-17 years received 1 dose of 0.5 mL pneumococcal vaccine polyvalent
Biological: pneumococcal vaccine polyvalent
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.
This vaccine（0.5ml） is produced by Merck Sharp \& Dohme Corp. Subjects will receive one dose of pneumococcal vaccine polyvalent administered by intramuscular injection.
Incidence of any adverse event within 30 minutes after vaccination.
Incidence of any adverse event within 30 minutes after vaccination.
Time frame: Within 30 minutes of 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
Time frame: Within 4 days of vaccination
Incidence of any adverse event within 0-7 days after vaccination.
Incidence of any adverse event within 0-7 days after vaccination.
Time frame: Within 0-7 days of vaccination
Incidence of any adverse event within 8-28 days after vaccination.
Incidence of any adverse event within 8-28 days after vaccination.
Time frame: Within 8-28 days of vaccination
Incidence of any serious adverse event within 6 months after vaccination.
Incidence of any serious adverse event within 6 months after vaccination.
Time frame: Within 6 months of vaccination
Serum IgG antibody seroconversion rate of subjects 28 days after vaccination.
Serum IgG antibody seroconversion rate of subjects 28 days after vaccination.
Time frame: At 28 days after vaccination
Serum IgG antibody GMC of subjects 28 days after vaccination.
Serum IgG antibody GMC of subjects 28 days after vaccination.
Time frame: At 28 days after vaccination
Plan to share: No
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This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Ab&B Bio-tech Co., Ltd.JS