Status:
NOT_YET_RECRUITING
Immunogenicity and Safety Study of 15-Valent Pneumococcal Conjugate Vaccine in 2-month-old and 3-month-old Healthy Volunteers
Lead Sponsor:
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Conditions:
Pneumonia, Pneumococcal
Eligibility:
All Genders
6-3 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate Immunogenicity and safety of 15-Valent Pneumococcal Conjugate Vaccine in healthy volunteers aged 2 and 3 months.
Eligibility Criteria
Inclusion
- Aged above 2 months (minimum to 6 weeks), term (37-42 weeks gestation) and birth weight ≥2.5 kg.
- 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
- Have been vaccinated a listed or experimental pneumococcal vaccine.
- 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.
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
1950 Patients enrolled
Trial Details
Trial ID
NCT04357522
Start Date
July 1 2020
End Date
March 1 2026
Last Update
April 22 2020
Active Locations (3)
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1
Daming Center for Disease Control and Prevention
Daming, Hebei, China, 056900
2
Laishui Center for Disease Control and Prevention
Laishui, Hebei, China, 074199
3
Zhengding Center for Disease Control and Prevention
Zhengding, Hebei, China, 050800