Pneumonia
Conditions
Interventions
3A:0.5ml, once by Intramuscular
4A:0.5ml, once by Intramuscular
5A:0.5ml, one dose each in 0, 2month by Intramuscular
6A:0.5ml, one dose each in 0, 1, 2month by Intramuscular
7A:0.5ml, one dose each in 0, 2, 4month by Intramuscular
7B:0.5ml, one dose each in 0, 2, 4month by Intramuscular
Sponsors
He'nan Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy volunteers of 2 months (minimum 6 weeks), 3 months, 7 months and above; 2. Willing to provide legal personal identification; 3. Without vaccination history of pneumococcal vaccine; 4. None-pregnancy or do not plan to pregnancy recently; 5. Volunteers of 18 years old and above who have the ability to understand clinical studie progress and sign informed consent; 6. Volunteers of 8-17 years old and their guardians who willing sign informed consent; 7. Able to understand and sign the informed consent by their guardians or trustees for the volunteers of 8 years old and below; 8. Able and willing comply with the requirements of the protocol.
Exclusion criteria
Exclusion criteria: 1. Volunteer whose axillary body temperature was > 37.0 degrees C before vaccination; 2. Volunteer who suffered from Congenital malformation or developmental disorder, genetic defect, severe malnutrition, etc.; 3. Volunteer who has a history of epilepsy, convulsions or psychosis; 4. Volunteer who has received immunoenhancement or inhibitor therapy within 3 months (continuous oral or instillation for more than 14 days); 5. Volunteer who has been diagnosed with a congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia or other autoimmune disease; 6. Spleen-free and defective spleen function due to any reason; 7. With severe liver and kidney disease, malignant tumors, various acute diseases or acute exacerbations of chronic diseases; 8. With history of coagulopathy (such as coagulation factor deficiency, coagulopathy); History of severe allergic reactions to vaccination; 9. Who are allergic to any component of the test vaccine; 10. With any prior administration of blood products in last 3 month; 11. With any prior administration of other research medicines in last 1 month; 12. With any prior administration of attenuated live vaccine in last 14 days or inactivated vaccines in last 7 days; 13. Who plans to participate in or is participating in any other drug clinical study; 14. According to the investigator's judgement, the subjects have any other factors that make them unfit to enroll the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of adverse reactions;Occurrence of SAE;abnormal changes of Hematological examination, Blood biochemistry test, Urine test;abnormal changes of blood pressure, heart rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Serotype-specific seropositivity rates of Immunoglobulin G concentrations above 0.35ug/ml;Serotype specific IgG GMC of each the pneumococcal serotypes;Serological response in terms of GMT for each of the pneumococcal serotypes tested by OPA; | — |
Countries
China
Contacts
Public ContactXia Shengli
He'nan Center for Disease Control and Prevention
Outcome results
None listed