Status:
UNKNOWN
Safety Study of 15-Valent Pneumococcal Conjugate Vaccine in Healthy Volunteers Aged Above 2 Months
Lead Sponsor:
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Collaborating Sponsors:
Hebei Center for Disease Control and Prevention
Laishui Center for Disease Control and Prevention
Conditions:
Pneumonia, Pneumococcal
Eligibility:
All Genders
6+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate safety of 15-Valent Pneumococcal Conjugate Vaccine in healthy volunteers aged above 3 Months.
Eligibility Criteria
Inclusion
- 2 months old (at a minimum of 6 weeks old) and above healthy people.
- Subject or legal representative who consent and has signed written informed consent.
- Subject and parent/guardian who is able to comply with all study procedures and to use thermometer, scale and fill in diary card and contact card as required.
- Subject who didn't vaccinate 13-valent or 7-valent pneumococcal conjugate vaccine.
- Subject who did't immune with any live vaccine within 14 days and inactivated vaccine within 7 days before vaccination.
- Axillary temperature ≤37.0 ℃.
Exclusion
- Subject with a history of a prior bacterial culture of an aggressive disease caused by S. pneumoniae.
- Subject with any previous history of severe vaccination or drug allergy, occurrence of fever ≥ 39.0° related to vaccination of biological products for previous vaccination.
- Subject who are allergic to diphtheria toxins.
- Children below 1 year old with abnormal labor（dystocia, instrument midwifery), birth weight \<2500g, asphyxia rescue history, nerve organ damage history, and pathological history of yellow plague determined by diagnosis.
- History of allergy，eclampsia, epilepsy,brain trauma,encephalopathy and mental disease or family disease.
- Subject who diagnosis of thrombocytopenia or other history of coagulopathy.
- 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: severe cardiovascular disease, liver and kidney disease, malignant tumor, skin disease, serious respiratory system disease, acute infection or chronic disease active period.
- Known or suspected to suffer from immunological abnormalities, including immunosuppressive therapy (radiotherapy, chemotherapy, corticosteroids, antimetabolic drugs, cytotoxicity drugs), HIV infection, etc.
- Received blood products or immunoglobulin within 3 months before enrolling (hepatitis B immunoglobulin was acceptable), or planned to use it during the clinical trial period (before blood samples were collected after immunization).
- Subject who plan to participate in or is in any other clinical trial (vaccines, drugs, medical devices, etc.).
- In pregnancy or lactation or pregnant women.
- ≥18-year-old subject with blood routine, blood chemistry or urinalysis laboratory collection abnormalities.
- Any condition that, in the judgment of investigator, may affect trial assessment.
Key Trial Info
Start Date :
June 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2020
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04108845
Start Date
June 5 2019
End Date
August 1 2020
Last Update
September 30 2019
Active Locations (1)
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1
Laishui Center for Disease Control and Prevention
Laishui, Hebei, China, 074199