Status:
COMPLETED
Immunogenicity and Safety of 23-Valent Pneumococcal Polysaccharide Vaccine in Healthy Volunteers Aged 2 Years and Above
Lead Sponsor:
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Conditions:
Pneumonia, Pneumococcal
Eligibility:
All Genders
2+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate Immunogenicity and safety of 23-Valent Pneumococcal Polysaccharide Vaccine in healthy volunteers aged 2 Years and above.
Eligibility Criteria
Inclusion
- 2 years old and above healthy people.
- Subject or legal representative who consent and has signed written informed consent.
- Subject or legal representative who is able to comply with all study procedures.
- 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.
- Axillary temperature ≤37.0 ℃.
Exclusion
- History of allergy，eclampsia, epilepsy, encephalopathy and mental disease or family disease.
- Allergic history after vaccination.
- Known allergy to any component of the test vaccine（the test vaccine mainly contains 23 types of pneumococcal polysaccharide and PBS buffer）
- Subjects who diagnosis of thrombocytopenia or other history of coagulopathy.
- Known immunological impairment or dysfunction.
- Subjects who have received whole blood, plasma, and immunoglobulin therapy within one month.
- Known severe congenital malformations, developmental disorders; clinically diagnosed serious chronic diseases: down's syndrome, diabetes, sickle cell anemia or neurological disorders, Guillain Barre syndrome.
- Known or suspected to suffer from: respiratory system disease，acute infection or chronic disease active period，severe cardiovascular disease, liver and kidney disease, malignant tumor, skin disease,children's mother has HIV infection and other serious and infectious diseases.
- In pregnancy or lactation or pregnant women.
- Subjects aged 18 years and above whose systolic blood pressure≥160mmHg and diastolic blood pressure≥100mmHg.
- Any contraindications that investigators consider related to vaccination.
Key Trial Info
Start Date :
January 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 7 2018
Estimated Enrollment :
1940 Patients enrolled
Trial Details
Trial ID
NCT04278248
Start Date
January 12 2018
End Date
June 7 2018
Last Update
February 20 2020
Active Locations (1)
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1
Yizhou Center for Disease Control and Prevention
Yizhou, Guangxi, China, 530028