Related diseases caused by 23 serotype pneum
Conditions
Interventions
Pre-experimental group:Receive 1 dose of expermental vaccine
experimental group:Receive 1 dose of expermental vaccine
Positive control group:Receive 1 dose of positive control vaccine
Sponsors
Guangxi Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
2 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged 2 years old and above healthy people; 2. Subject or legal representative who consent and has signed written informed consent; 3. Subject or legal representative who is able to comply with all study procedures; 4. Subject who didn't vaccinate pneumococcal vaccines and did't immune with any live vaccine within 14 days and inactivated vaccine within 7 days before vaccination; 5. Axillary temperature <=37.0 degree C.
Exclusion criteria
Exclusion criteria: 1. History of allergyeclampsia, epilepsy, encephalopathy and mental disease or family disease; 2. Allergic history after vaccination; 3. Known allergy to any component of the test vaccine (the test vaccine mainly contains 23 types of pneumococcal polysaccharide and PBS buffer); 4. Subjects who diagnosis of thrombocytopenia or other history of coagulopathy; 5. Known immunological impairment or dysfunction; 6. Subjects who have received whole blood, plasma, and immunoglobulin therapy within one month; 7. Known severe congenital malformations, developmental disorders; clinically diagnosed serious chronic diseases: down's syndrome, diabetes, sickle cell anemia or neurological disorders, Guillain Barre syndrome; 8. Known or suspected to suffer from: respiratory system diseaseacute infection or chronic disease active periodsevere cardiovascular disease, liver and kidney disease, malignant tumor, skin disease,children's mother has HIV infection and other serious and infectious diseases; 9. In pregnancy or lactation or pregnant women; 10. Subjects aged 18 years and above whose systolic blood pressure>=160mmHg and diastolic blood pressure>=100mmHg. 11. Any contraindications that investigators consider related to vaccination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immunogenicity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety; | — |
Countries
China
Contacts
Public ContactMo Yi
Guangxi Center for Disease Control and Prevention
Outcome results
None listed