Status:
COMPLETED
Phase Ⅰa Clinical Trial of a Pneumococcal Vaccine
Lead Sponsor:
CanSino Biologics Inc.
Collaborating Sponsors:
Henan Center for Disease Control and Prevention
Conditions:
Pneumonia
Respiratory Tract Diseases
Eligibility:
All Genders
18-49 years
Phase:
EARLY_PHASE1
Brief Summary
Infections with Streptococcus pneumoniae often cause serious health problems, especially for infants and the elderly.Failure to cover all polysaccharide types is an even greater problem with adults th...
Detailed Description
The polysaccharide vaccine protected 60% of elderly adults who were at risk for pneumococcal infection.However, pneumococci are highly diverse with respect to their capsular types , and the polysaccha...
Eligibility Criteria
Inclusion
- Healthy volunteers aged 18 to 49 years old;
- Willing to provide proof of identity;
- Able to understand and sign the informed consent;
- Able and willing comply with the requirements of the protocol
Exclusion
- Hypertensive volunteers with uncontrollable medications (on-site measurement: systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg);
- Abnormal changes of laboratory measures (with clinical significance);
- Woman is pregnant and lactating (by urine pregnancy test)
- Suffered from pneumonia in the past three years;
- Invasive diseases caused by Streptococcus pneumoniae (such as meningitis, bacteremia, pericarditis, peritonitis, etc.) in the past three years;
- Allergic person;
- Any prior administration of blood products in last 3 month;
- Any prior administration of other research medicines in last 1 month;
- Plans to participate in or is participating in any other drug clinical study;
- Any prior administration of attenuated live vaccine in last 14 days;
- Any prior administration of subunit or inactivated vaccines in last 7 days;
- Had fever before vaccination, volunteers with temperature \>37.0℃ on axillary setting;
- According to the investigator's judgment, the volunteers have any otherfactors that make them unfit to participate in the clinical trial
Key Trial Info
Start Date :
April 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2022
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04087460
Start Date
April 10 2020
End Date
June 30 2022
Last Update
November 4 2022
Active Locations (1)
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1
Suixian Center for Disease Control and Prevention
Shangqiu, Henan, China, 450016