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| Name | Class |
|---|---|
| Henan Center for Disease Control and Prevention | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group aged 18-59 years | Experimental | Subjects in the age group 18-59 years received 1 dose of 0.5 mL 23-valent pneumococcal polysaccharide vaccine |
|
| Control group aged 18-59 years | Active Comparator | Subjects in the age group 18-59 years received 1 dose of 0.5 mL pneumococcal vaccine polyvalent |
|
| Experimental group aged ≥60 years | Experimental | Subjects in the age group ≥60 years received 1 dose of 0.5 mL 23-valent pneumococcal polysaccharide vaccine |
|
| Control group aged ≥60 years | Active Comparator | Subjects in the age group ≥60 years received 1 dose of 0.5 mL pneumococcal vaccine polyvalent |
|
| Experimental group aged 2-17 years | Experimental | Subjects in the age group 2-17 years received 1 dose of 0.5 mL 23-valent pneumococcal polysaccharide vaccine |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 23-valent pneumococcal polysaccharide vaccine | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of any adverse event within 30 minutes after vaccination. | Incidence of any adverse event within 30 minutes after vaccination. | 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 | 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. | 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. | 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. | Within 6 months of vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Serum IgG antibody seroconversion rate of subjects 28 days after vaccination. | Serum IgG antibody seroconversion rate of subjects 28 days after vaccination. | At 28 days after vaccination |
| Serum IgG antibody GMC of subjects 28 days after vaccination. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yanxia Wang | Henan Center for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qi County Center for Disease Control and Prevention | Hebi | Henan | China |
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| ID | Term |
|---|---|
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C414006 | 23-valent pneumococcal capsular polysaccharide vaccine |
| D022242 | Pneumococcal Vaccines |
| ID | Term |
|---|---|
| D022541 | Streptococcal Vaccines |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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| Control group aged 2-17 years | Active Comparator | Subjects in the age group 2-17 years received 1 dose of 0.5 mL pneumococcal vaccine polyvalent |
|
| pneumococcal vaccine polyvalent | Biological | This vaccine(0.5ml) is produced by Merck Sharp & Dohme Corp. Subjects will receive one dose of pneumococcal vaccine polyvalent administered by intramuscular injection. |
|
Serum IgG antibody GMC of subjects 28 days after vaccination.
| At 28 days after vaccination |
| D045424 |
| Complex Mixtures |