Safety Study of 15-Valent Pneumococcal Conjugate Vaccine in Healthy Volunteers Aged Above 2 Months
NCT ID: NCT04108845
Last Updated: 2019-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
80 participants
INTERVENTIONAL
2019-06-05
2020-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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experimental group
Received Vaccine: 15-valent pneumococcal Conjugate Vaccine, 0.5 ml/dose
15-Valent Pneumococcal Conjugate Vaccine
3/1 dose(s) according to age of subjects. Single intramuscular dose contains 0.5ml 15-Valent Pneumococcal Conjugate Vaccine.
Interventions
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15-Valent Pneumococcal Conjugate Vaccine
3/1 dose(s) according to age of subjects. Single intramuscular dose contains 0.5ml 15-Valent Pneumococcal Conjugate Vaccine.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
6 Weeks
ALL
Yes
Sponsors
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Hebei Center for Disease Control and Prevention
UNKNOWN
Laishui Center for Disease Control and Prevention
UNKNOWN
National Institutes for Food and Drug Control, China
OTHER
Simoon Record Pharma Information Consulting Co., Ltd.
INDUSTRY
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Du Lin, Master
Role: STUDY_CHAIR
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Locations
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Laishui Center for Disease Control and Prevention
Laishui, Hebei, China
Countries
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Facility Contacts
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Zhang Po
Role: primary
Other Identifiers
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201807001
Identifier Type: -
Identifier Source: org_study_id