Immunogenicity and Safety Study of 15-Valent Pneumococcal Conjugate Vaccine in 2-month-old and 3-month-old Healthy Volunteers
NCT ID: NCT04357522
Last Updated: 2020-04-22
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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NOT_YET_RECRUITING
PHASE3
1950 participants
INTERVENTIONAL
2020-07-31
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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experimental group
Received Vaccine: 15-valent pneumococcal Conjugate Vaccine(experimental vaccine), 0.5 ml/dose
15-Valent Pneumococcal Conjugate Vaccine
4/1 dose(s) according to age of subjects. Single intramuscular dose contains 0.5ml 15-Valent Pneumococcal Conjugate Vaccine.
Positive control group
Received Vaccine: 13-valent pneumococcal Conjugate Vaccine(positive control vaccine), 0.5 ml/dose
13-Valent Pneumococcal Conjugate Vaccine
4/1 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
4/1 dose(s) according to age of subjects. Single intramuscular dose contains 0.5ml 15-Valent Pneumococcal Conjugate Vaccine.
13-Valent Pneumococcal Conjugate Vaccine
4/1 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
* The guardian understands the vaccination and research procedures, volunteers to participate in the research and sign the informed consent.
* The guardian can follow the clinical research program, will be able to follow up until 3 years after booster immunization and have the ability to use thermometers, scale and fill in diary and contact cards as required.
* There was no history of other live vaccines in the past 14 days and no history of other inactivated vaccines in the seventh day.
* Subaxillary body temperature \<=37.0 C.
* Determine health based on medical history, physical examination, and researcher's judgment.
Exclusion Criteria
* History of invasive diseases caused by Streptococcus pneumoniae confirmed by bacterial culture in the past.
* In the past, there was any history of vaccination or serious allergy to drugs. In the past, fever of over 39.5 C related to vaccination occurred in biological products for vaccination and prophylaxis.
* History of convulsion, epilepsy, encephalopathy and psychiatry or family history.
* Had abnormal labor (dystocia, device midwifery), history of asphyxia rescue and nerve organ damage.
* History of pathological jaundice confirmed by diagnosis.
* A history of thrombocytopenia or other coagulation disorders with definite diagnosis.
* Human serum gamma globulin injection after birth.
* There are known or suspected immunological abnormalities, including immunosuppressive therapy (radiotherapy, chemotherapy, corticosteroids, antimetabolites, cytotoxic drugs), HIV infection, etc.
* Congenital malformations, severe malnutrition, developmental disorders, genetic defects (e.g. broad bean disease).
* Severe chronic disease, infectious disease, active infection, liver disease, kidney disease, cardiovascular disease, malignant tumor.
* Severe asthma.
* Systemic rash, dermatophytes, skin pus or blister.
* Participation in other drug clinical trials.
* Anything that the researcher considers likely to affect the evaluation of the study.
6 Weeks
3 Months
ALL
Yes
Sponsors
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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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Daming Center for Disease Control and Prevention
Daming, Hebei, China
Laishui Center for Disease Control and Prevention
Laishui, Hebei, China
Zhengding Center for Disease Control and Prevention
Zhengding, Hebei, China
Countries
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Facility Contacts
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Other Identifiers
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201904002
Identifier Type: -
Identifier Source: org_study_id
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