Pneumonia
Conditions
Interventions
Low-dose group:received three doses at 0, 2, 4 month
Middle-dose group:received three doses at 0, 2, 4 month
High-dose group:received three doses at 0, 2, 4 month
Sponsors
Henan Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
18 Years to 49 Years
Inclusion criteria
Inclusion criteria: 1. Healthy volunteers aged 18 to 49 years old; 2. Willing to provide proof of identity; 3. Able to understand and sign the informed consent; 4. Able and willing comply with the requirements of the protocol.
Exclusion criteria
Exclusion criteria: 1. Hypertensive volunteers with uncontrollable medications (on-site measurement: systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); 2. Abnormal changes of laboratory measures (with clinical significance); 3. Woman is pregnant and lactating (by urine pregnancy test) 4. Suffered from pneumonia in the past three years; 5. Invasive diseases caused by Streptococcus pneumoniae (such as meningitis, bacteremia, pericarditis, peritonitis, etc.) in the past three years; 6. Allergic person; 7. Any prior administration of blood products in last 3 month; 8. Any prior administration of other research medicines in last 1 month; 9. Plans to participate in or is participating in any other drug clinical study; 10. Any prior administration of attenuated live vaccine in last 14 days; 11. Any prior administration of subunit or inactivated vaccines in last 7 days; 12. Had fever before vaccination, volunteers with temperature > 37.0 degree C on axillary setting; 13. According to the investigator's judgment, the volunteers have any otherfactors that make them unfit to participate in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of solicited adverse reactions;Occurrence of unsolicited adverse reactions; | — |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of SAE;Geometric mean concentration(GMC) and Geometric mean increase(GMI)of antibodies in serum;the seropositivity rates of antibodies in serum; | — |
Countries
China
Contacts
Public ContactXia Shengli
CanSino Biologics Inc.
Outcome results
None listed